Page last updated: 2024-12-05

methylphenidate

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

N-phenyl-4-(quinolin-2-ylmethyl)piperazine-1-carboxamide: a fatty acid amide hydrolase inhibitor; structure in first source [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Methylphenidate: A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

methylphenidate : A racemate comprising equimolar amounts of the two threo isomers of methyl phenyl(piperidin-2-yl)acetate. A central stimulant and indirect-acting sympathomimetic, is used (generally as the hydrochloride salt) in the treatment of hyperactivity disorders in children and for the treatment of narcolepsy. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

methyl phenyl(piperidin-2-yl)acetate : A amino acid ester that is methyl phenylacetate in which one of the hydrogens alpha to the carbonyl group is replaced by a piperidin-2-yl group. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID11515763
CHEMBL ID513789
SCHEMBL ID3600412
MeSH IDM0013660
PubMed CID4158
CHEMBL ID796
CHEBI ID84276
CHEBI ID6887
SCHEMBL ID37178
MeSH IDM0013660

Synonyms (94)

Synonym
bdbm26741
pf-622
n-phenyl-4-(quinolin-2-ylmethyl)piperazine-1-carboxamide
CHEMBL513789
898235-65-9
SCHEMBL3600412
DTXSID00467917
faah inhibitor, pf-622
NCGC00388308-02
methyl phenyl(piperidin-2-yl)acetate
methylin
.alpha.-phenyl-2-piperidineacetic acid methyl ester
2-piperidineacetic acid, .alpha.-phenyl-, methyl ester
daytrana (tn)
methylphenidate (usan/inn)
D04999
dea no. 1724
einecs 204-028-6
alpha-phenyl-alpha-(2-piperidyl)acetic acid methyl ester
methylfenidan
methyl (2-phenyl-2-(2-piperidyl)acetate)
4311/b ciba
nci-c56280
methyl phenidate
metilfenidato [inn-spanish]
methylphenidatum [inn-latin]
metilfenidato [italian]
c 4311
plimasine
2-piperidineacetic acid, alpha-phenyl-, methyl ester
calocain
hsdb 3126
methylphenidate
C07196
113-45-1
methyl alpha-phenyl-alpha-(2-piperidyl)acetate
methylphenidan
DB00422
alpha-phenyl-2-piperidineacetic acid methyl ester
methyl phenidylacetate
methyl alpha-phenyl-alpha-2-piperidinylacetate
phenidylate
prc-063
chebi:84276 ,
methylphenidate extended release
CHEMBL796 ,
L001307
bdbm50062912
methyl 2-phenyl-2-piperidin-2-ylacetate
NCGC00248587-01
methylphenidatum
metilfenidato
methylphenidate [usan:inn:ban]
cotempla xr-odt
methyl phenidyl acetate
centedein
d-methylphenidate hcl
gtpl7236
methyl 2-phenyl-2-(piperidin-2-yl)acetate
jornay pm (a.k.a. hld200)
SCHEMBL37178
CS-4657
methyl alpha-piperid-2-ylphenylacetate
ritaline (salt/mix)
methyl .alpha.-phenyl-2-piperidineacetate
methyl .alpha.-phenyl-.alpha.-2-piperidinylacetate
methylin (salt/mix)
centedein (salt/mix)
methyl .alpha.-phenyl-.alpha.-(2-piperidyl)acetate
methyl .alpha.-phenyl-2-piperidine-acetate
centedrin (salt/mix)
rubifen
methyl phenyl(2-piperidinyl)acetate #
centedrine (salt/mix)
ritalin (salt/mix)
HY-B1091
AB01563134_01
DTXSID5023299 ,
SBI-0206868.P001
phenyl-piperidin-2-yl-acetic acid methyl ester
BCP18286
Q422112
BRD-A19585813-003-01-7
NCGC00248587-03
2-piperidineacetic acid, ?-phenyl-, methyl ester
methylphenidate (ii)
dtxcid003299
chebi:6887
metilfenidato (inn-spanish)
methylphenidate (mart.)
n06ba04
methylphenidate transdermal system
methylphenidatum (inn-latin)
rac-methyl (2r)-phenyl((2r)-piperidin-2-yl)acetate

Research Excerpts

Overview

Methylphenidate (MPH) is a central nervous system stimulant known for its effectiveness in the treatment of Attention Deficit Hyperactivity Disorder (ADHD), a neuropsychiatric condition that has a high incidence in childhood and affects behavior and cognition. It is a first-line treatment for ADHD; its contribution to sleep problems in adult ADHD is currently unclear.

ExcerptReferenceRelevance
"Methylphenidate is a powerful central nervous system stimulant with a high potential for abuse in horse racing. "( Detection of Methylphenidate in Equine Hair Using Liquid Chromatography-High-Resolution Mass Spectrometry.
Alarcio, G; Arthur, RM; Clifford, A; Flores, L; Moeller, BC; Mosburg, M, 2021
)
2.43
"Methylphenidate (MPH) is an important emerging pollutant found in effluents and wastewater. "( Development and validation of a LC-PDA method for methylphenidate analysis in sewage.
Bertol, CD; Freddo, N; Friedrich, MT; Nardi, J; Paixão, MCS; Rosano, VA; Rossato-Grando, LG; Vieira, BF, 2022
)
2.42
"Methylphenidate is a first-line treatment for ADHD, and it is known to affect the subcortical and dopaminergic systems."( Subcortical volumetric alterations as potential predictors of methylphenidate treatment response in youth with attention-deficit/hyperactivity disorder.
Hwang, CS; Kim, JS; Kim, JW; Lee, KH,
)
1.09
"Methylphenidate (MPH) is a psychostimulant, beneficial in attention deficit hyperactivity disorder (ADHD). "( Effect of Methylphenidate and buspirone-methylphenidate co-administration on biochemical and hematological parameters in rats: Implications for safe and confrontational use.
Alam, N; Ikram, R; Kashif, SS; Khan, SS; Khatoon, H; Naeem, S; Siddiqui, T, 2021
)
2.47
"Methylphenidate (MPH) is a central nervous system (CNS) stimulant known for its effectiveness in the treatment of Attention Deficit Hyperactivity Disorder (ADHD), a neuropsychiatric condition that has a high incidence in childhood and affects behavior and cognition. "( Evidence of methylphenidate effect on mitochondria, redox homeostasis, and inflammatory aspects: Insights from animal studies.
Foschiera, LN; Schmitz, F; Wyse, ATS, 2022
)
2.54
"Methylphenidate is a first-line treatment for ADHD; its contribution to sleep problems in adult ADHD is currently unclear. "( Effects of methylphenidate on subjective sleep parameters in adults with ADHD: a prospective, non-randomized, non-blinded 6-week trial.
Fagerlund, B; Glenthøj, B; Habekost, T; Jepsen, JRM; le Sommer, J; Low, AM; Vangkilde, S, 2023
)
2.74
"Methylphenidate is a widely used first-line treatment for attention deficit/hyperactivity disorder (ADHD), but the underlying circuit mechanisms are poorly understood. "( Methylphenidate remediates aberrant brain network dynamics in children with attention-deficit/hyperactivity disorder: A randomized controlled trial.
Cai, W; Makita, K; Menon, V; Mizuno, Y; Supekar, K; Takiguchi, S; Tomoda, A, 2022
)
3.61
"Methylphenidate (MP) is a psychostimulant chronically prescribed for the treatment of attention deficit hyperactivity disorder (ADHD). "( Abstinence following intermittent methylphenidate exposure dose-dependently modifies brain glucose metabolism in the rat brain.
Arnavut, E; Hadjiargyrou, M; Hamilton, J; Komatsu, D; Sajjad, M; Thanos, PK; Yao, R, 2022
)
2.44
"Methylphenidate (MPD) is a psychostimulant that is widely prescribed to treat attention deficit-hyperactivity disorder, but it is abused recreationally as well. "( Age differences to methylphenidate-NAc neuronal and behavioral recordings from freely behaving animals.
Dafny, N; Kabani, A; Medina, AC; Reyes-Vasquez, C, 2022
)
2.49
"Methylphenidate is a 'prescription only' drug against attention disorders which is increasingly used by adults. "( General practice database on mortality in adults on methylphenidate: cohort study.
Cheung, K; Stricker, B; Verhamme, K, 2022
)
2.41
"Methylphenidate is a stimulant used to treat attention deficit and hyperactivity disorder (ADHD). "( Pre-clinical evidence that methylphenidate increases motivation and/or reward preference to search for high value rewards.
Baltazar, G; Da Cunha, C; Esaki, JY; Fuentes, R; Levcik, D; Pochapski, JA; Pulido, LN; Sanchez, WN; Stresser, JL; Sugi, A, 2023
)
2.65
"Methylphenidate (MPH) is a chiral compound with two chiral centers."( Chiral separation and quantitation of methylphenidate, ethylphenidate, and ritalinic acid in blood using supercritical fluid chromatography.
Kronstrand, R; Smith, C; Swortwood, MJ; Vikingsson, S, 2023
)
1.9
"Methylphenidate (MPH) is a central nervous stimulant, which is mainly used in attention deficit hyperactivity disorder (ADHD) and narcolepsy. "( Characteristics and outcomes of cases with methylphenidate abuse, dependence or withdrawal: an analysis of spontaneous reports in EudraVigilance.
Bachmann, CJ; Hartmayer, LT; Hoffmann, F; Jobski, K, 2023
)
2.62
"Methylphenidate (MPH) is a psychostimulant which inhibits the uptake of dopamine and norepinephrine transporters, DAT and NET, and is mostly used to treat Attention Deficit/Hyperactivity Disorder. "( An exploratory analysis of the performance of methylphenidate regimens based on a PKPD model of dopamine and norepinephrine transporter occupancy.
Nekka, F; Robaey, P; Soufsaf, S, 2023
)
2.61
"Methylphenidate (MPD) is a psychostimulant used to treat attention deficit hyperactivity disorder. "( Methylphenidate induces a different response in the dorsal raphe as compared to ventral tegmental area and locus coeruleus: behavioral and concomitant neuronal recordings in adult rats.
Claussen, C; Dafny, N; Jones, Z; Tang, B; Yuan, A, 2023
)
3.8
"Methylphenidate is a widely used and effective treatment for attention-deficit/hyperactivity disorder (ADHD), yet the underlying neural mechanisms and their relationship to changes in behavior are not fully understood. "( Bayesian dynamical system analysis of the effects of methylphenidate in children with attention-deficit/hyperactivity disorder: a randomized trial.
Cai, W; Menon, V; Mizuno, Y; Tomoda, A, 2023
)
2.6
"Methylphenidate is an effective first-line treatment for attention-deficit/hyperactivity disorder (ADHD). "( The Adverse Effects and Nonmedical Use of Methylphenidate Before and After the Outbreak of COVID-19: Machine Learning Analysis.
Kim, E; Lee, H; Oh, S; Park, S; Purja, S; Shin, H; Yuniar, CT, 2023
)
2.62
"Methylphenidate (MPH) is a central nervous system stimulant that is mainly used for Attention-Deficit/Hyperactivity Disorder (ADHD). "( Methylphenidate exposure in juvenile period elicits locomotion changes and anxiolytic-like behavior in adulthood: Evidence using zebrafish as a translational model.
Barcellos, LJG; Berton, N; Biazus, IC; do Prado, L; Fortuna, M; Freddo, N; Nardi, J; Oliveira, AP; Pompermaier, A; Rossato-Grando, LG; Siqueira, L; Soares, SM; Tamagno, WA; Varela, ACC, 2024
)
4.33
"Methylphenidate is an established treatment for attention-deficit hyperactivity disorder that also has abuse potential. "( Role of homeostatic feedback mechanisms in modulating methylphenidate actions on phasic dopamine signaling in the striatum of awake behaving rats.
Burrell, MH; Fuller, JA; Hyland, BI; Lipski, J; Liyanagama, K; Wickens, JR; Yee, AG, 2019
)
2.21
"Methylphenidate (MPH) is a piperidine similar to amphetamines, and is indicated for attention deficit hyperactivity disorder. "( Methylphenidate and stuttering.
Azzouz, B; Claustre, G; Djerada, Z; Herlem, E; Morel, A; Trenque, A; Trenque, T, 2019
)
3.4
"Methylphenidate (MP) is a commonly prescribed psychostimulant to individuals with Attention Deficit Hyperactivity Disorder, and is often used illicitly among healthy individuals with intermittent breaks to coincide with breaks from school. "( Brief and extended abstinence from chronic oral methylphenidate treatment produces reversible behavioral and physiological effects.
Carias, E; Connor, C; Hadjiargyrou, M; Kalinowski, L; Komatsu, DE; Mackintosh, M; Martin, C; Popoola, D; Richer, K; Smith, L; Somanesan, R; Thanos, PK, 2020
)
2.26
"Methylphenidate (MPH), which is a psychostimulant drug, has been often prescribed for the treatment of ADHD in patients."( Effects of medications on ventricular repolarization in children with attention deficit hyperactivity disorder.
Akpinar, M; Esedova, C; İrdem, A; Türkmenoğlu, YE; Uysal, T, 2020
)
1.28
"Methylphenidate is a first-line treatment for ADHD, however no previous meta-analysis has evaluated its overall efficacy for ADHD in children with comorbid intellectual disability (ID) or borderline intellectual functioning."( Therapeutic effects of methylphenidate for attention-deficit/hyperactivity disorder in children with borderline intellectual functioning or intellectual disability: A systematic review and meta-analysis.
Carvalho, AF; Chen, TY; Chen, YW; Cheng, YS; Li, DJ; Lin, PY; Stubbs, B; Sun, CK; Tseng, PT; Wu, CK; Wu, MK, 2019
)
1.55
"Methylphenidate (Ritalin®) is a psychostimulant used chronically to treat attention deficit hyperactivity disorder. "( Chronic methylphenidate induces increased quinone production and subsequent depletion of the antioxidant glutathione in the striatum.
Archibald, KM; Ensley, T; Hall, AN; Ketchem, S; Oakes, HV; Pond, BB, 2019
)
2.39
"Methylphenidate (MPH) is a dopamine transporter (DAT) inhibitor used to treat attention-deficit/hyperactivity-disorder (ADHD). "( Ventral striatum supports Methylphenidate therapeutic effects on impulsive choices expressed in temporal discounting task.
Drui, G; Martinez, E; Météreau, É; Pasquereau, B; Saga, Y; Tremblay, L, 2020
)
2.3
"Methylphenidate (MPH) is an important drug that modulates the catecholaminergic system."( Task experience eliminates catecholaminergic effects on inhibitory control - A randomized, double-blind cross-over neurophysiological study.
Beste, C; Mückschel, M; Roessner, V, 2020
)
1.28
"Methylphenidate (MPH) is a psychostimulant widely misused to increase wakefulness by drivers and students. "( Stimulants cocktail: Methylphenidate plus caffeine impairs memory and cognition and alters mitochondrial and oxidative status.
Barcellos, LJG; de Alcantara Barcellos, HH; Fortuna, M; Freddo, N; Koakoski, G; Maffi, VC; Mozzato, MT; Pompermaier, A; Rossato-Grando, LG; Soares, SM; Varela, ACC, 2021
)
2.38
"Methylphenidate (MPH) is a first-line treatment option for attention-deficit hyperactive disorder and narcolepsy. "( Co-abuse of alprazolam augments the hepato-renal toxic effects of methylphenidate.
Chopra, K; Dharavath, RN; Dutt, M; Kaur, N; Kaur, T; Sharma, S,
)
1.81
"Methylphenidate (MPH) is a psychostimulant drug used as first-line treatment for ADHD and it inhibits dopamine and norepinephrine reuptake transporters."( Is contrast sensitivity a physiological marker in attention-deficit hyperactivity disorder?
Atas, PBU; Berker, M; Çankaya, C; Ceylan, OM; Dönmez, YE; Güntürkün, PN; Özcan, ÖÖ, 2020
)
1.28
"Methylphenidate (MPH) is an efficacious treatment for ADHD but concerns have been raised about potential adverse effects of extended treatment on growth."( Long term methylphenidate exposure and growth in children and adolescents with ADHD. A systematic review and meta-analysis.
Balia, C; Banaschewski, T; Buitelaar, JK; Carucci, S; Coghill, D; Danckaerts, M; Dittmann, RW; Gagliano, A; Garas, P; Hollis, C; Inglis, S; Konrad, K; Kovshoff, H; Lampis, A; Liddle, EB; McCarthy, S; Nagy, P; Panei, P; Romaniello, R; Sonuga-Barke, E; Usala, T; Wong, ICK; Zuddas, A, 2021
)
2.47
"Methylphenidate is a psychostimulant drug used to treat fatigue in patients with advanced cancer, for which there is no gold standard of treatment."( Improved cancer-related fatigue in a randomised clinical trial: methylphenidate no better than placebo.
Centeno, C; Cuervo, MA; De Santiago, A; Gagnon, B; Gandara, A; Portela, MA; Ramos, D; Rojí, R; Salgado, E; Sanz, A, 2022
)
2.4
"Methylphenidate (MPH) is a mild CNS stimulant that has been used in hyperactive children, and patients with neurodegenerative and major depressive disorders. "( Cannabidiol attenuated the maintenance and reinstatement of extinguished methylphenidate-induced conditioned place preference in rats.
Haghparast, A; Jamali, S; Kashefi, A; Rashidy-Pour, A; Tomaz, C; Vafaei, AA, 2021
)
2.3
"Methylphenidate (MPH) is a stimulant, FDA-approved for the treatment of ADHD, and often used for ADHD in the setting of pediatric epilepsy."( Methylphenidate for attention problems in epilepsy patients: Safety and efficacy.
Adams, J; Devinsky, O; Leeman-Markowski, BA; Martin, SP; Meador, KJ, 2021
)
2.79
"Methylphenidate (MP) is a widely used psychostimulant prescribed for Attention Deficit Hyperactivity Disorder and is also used illicitly by healthy individuals. "( Abstinence from Chronic Methylphenidate Exposure Modifies Cannabinoid Receptor 1 Levels in the Brain in a Dose-dependent Manner.
Connor, C; Hadjiargyrou, M; Hamilton, J; Komatsu, D; Robison, L; Thanos, P, 2022
)
2.47
"Methylphenidate (MPH) is an indirect-acting sympathomimetic drug and structurally related to amphetamine. "( Acute myocardial infarction due to spontaneous coronary artery dissection in a 6-year-old boy with ADHD on the third day of treatment with methylphenidate.
Becker, M; Kerst, G; Ostermayer, S; Pitzer, M; Pohlmann, U; Rascher, W; Stammschulte, T, 2022
)
2.37
"Methylphenidate (MPH) is a compound commonly used to modulate the catecholaminergic system. "( Perception-Action Integration Is Modulated by the Catecholaminergic System Depending on Learning Experience.
Beste, C; Bluschke, A; Eggert, E; Kleimaker, M; Mückschel, M; Münchau, A; Roessner, V; Takacs, A, 2021
)
2.06
"Methylphenidate (MPH) is a medication used to combat attention-deficit/hyperactivity disorder by speeding up brain activity. "( Short- and Long-Term Stability of Methylphenidate and Its Metabolites in Blood.
Smith, CR; Swortwood, MJ, 2021
)
2.34
"Methylphenidate is a drug widely prescribed to treat ADHD."( "Real-world" effectiveness of methylphenidate in improving the academic achievement of Attention-Deficit Hyperactivity Disorder diagnosed students-A systematic review.
da Silveira, VT; de Faria, JCM; Duarte, LJR; Ferreira, LA; Menezes de Pádua, C; Perini, E, 2022
)
1.73
"Methylphenidate is a stimulant drug commonly prescribed to individuals with attention-deficit/hyperactivity disorder. "( Effect of Biperiden Treatment in Acute Orofacial and Extremity Dyskinesia With Methylphenidate Therapy.
Arslan, E; Arslan, EA; Göksu, Ö; Kilinç, A, 2018
)
2.15
"Methylphenidate is a first-line therapeutic option for treating attention-deficit/hyperactivity disorder (ADHD); however, elicited changes on resting-state functional networks (RSFNs) are not well understood. "( Treatment effect of methylphenidate on intrinsic functional brain network in medication-naïve ADHD children: A multivariate analysis.
Choi, J; Jeong, B; Kim, D; Yoo, JH, 2018
)
2.25
"Methylphenidate (MPH) is a prescription stimulant used to treat attention-deficit hyperactivity disorder. "( Methylphenidate disintegration from oral formulations for intravenous use by experienced substance users.
Asgrimsson, V; Bjarnadottir, GD; Bragadottir, H; Haraldsson, HM; Johannsson, M; Magnusson, A; Rafnar, BO; Sigurdsson, E; Snorradottir, I; Steingrimsson, S, 2017
)
3.34
"Methylphenidate (MPH) is a prescription-stimulant medication which is authorized in France for two indications: attention-deficit hyperactivity disorder in children (aged≥6years) and narcolepsy in cases where modafinil is ineffective (for children and adults). "( Methylphenidate: Gender trends in adult and pediatric populations over a 7year period.
Boucherie, Q; Braunstein, D; Ehrhardt, C; Frauger, E; Micallef, J; Pauly, V; Ronflé, E; Thirion, X, 2017
)
3.34
"Methylphenidate (MPH) is a dopamine-reuptake inhibitor approved for the treatment of attention-deficit/hyperactivity disorder (ADHD). "( Methylphenidate ameliorates hypoxia-induced mitochondrial damage in human neuroblastoma SH-SY5Y cells through inhibition of oxidative stress.
Hu, J; Jiao, Y; Ma, X; Shang, B; Tian, Y; Wang, Y; Zhang, H; Zhang, J; Zhang, Y; Zhu, M, 2018
)
3.37
"Methylphenidate (MPH) is a widely prescribed drug for the treatment of attention-deficit hyperactivity disorder. "( Methylphenidate induces state-dependency of social recognition learning: Central components.
Bühler, L; Cavalcante, LE; de Carvalho Myskiw, J; Fagundes Ferreira, F; Garrido Zinn, C; Guerino Furini, CR; Izquierdo, I; Schmidt, SD; Zanini, ML, 2018
)
3.37
"Methylphenidate (MPH) is a first-line stimulant drug to treat attention deficit hyperactivity disorder (ADHD). "( Methylphenidate clinically oral doses improved brain and heart glutathione redox status and evoked renal and cardiac tissue injury in rats.
Capela, JP; Carvalho, F; Costa, VM; Duarte, JA; Duarte-Araújo, M; Gonçalves-Monteiro, S; Loureiro-Vieira, S; Maria de Lourdes, B, 2018
)
3.37
"Methylphenidate is a central nervous system stimulant that is structurally close to amphetamine and acts as a norepinephrine and dopamine reuptake inhibitor."( [Supervised off-label prescribing of methylphenidate in adult ADHD].
Amad, A; Bordet, R; Brigadeau, F; Carton, L; Cottencin, O; Danel, T; Deheul, S; Devos, D; Dondaine, T; Gautier, S; Marquié, C; Ménard, O, 2019
)
1.51
"Methylphenidate (MP) is a commonly prescribed psychostimulant for Attention Deficit Hyperactivity Disorder (ADHD). "( Weekday-only chronic oral methylphenidate self-administration in male rats: Reversibility of the behavioral and physiological effects.
Carias, E; Fricke, D; Hadjiargyrou, M; Kalinowski, L; Komatsu, DE; Martin, C; Popoola, D; Smith, L; Somanesan, R; Thanos, PK; Vijayashanthar, A, 2019
)
2.26
"Methylphenidate (MP) is a widely prescribed psychostimulant used to treat attention deficit hyperactivity disorder. "( Chronic oral methylphenidate treatment increases microglial activation in rats.
Carias, E; Delis, F; Eiden, R; Hadjiargyrou, M; Hamilton, J; Komatsu, D; Quattrin, T; Robison, LS; Thanos, PK, 2018
)
2.29
"Methylphenidate is a psychostimulant used to treat attention deficit hyperactivity disorder. "( Neurogenesis within the hippocampus after chronic methylphenidate exposure.
Allen, SA; DeVee, CE; Ensley, T; Farmer, B; Hall, AN; Hanley, A; Medlock, K; Oakes, HV; Pond, BB, 2019
)
2.21
"Methylphenidate (MPD) is a psychostimulant used to treat attention deficit hyperactivity disorder (ADHD). "( Methylphenidate and alcohol effects on flash-evoked potentials, body temperature, and behavior in Long-Evans rats.
Hetzler, BE; McLester-Davis, LWY; Tenpas, SE, 2019
)
3.4
"Methylphenidate (MPD) is a psychostimulant used for the treatment of ADHD and works by increasing the bioavailability of dopamine (DA) in the brain. "( Acute and chronic methylphenidate administration in intact and VTA-specific and nonspecific lesioned rats.
Dafny, N; Ihezie, SA; Thomas, MM, 2019
)
2.29
"Methylphenidate (MPH) is a common and effective treatment for attention deficit hyperactivity disorder (ADHD), but little is known about the relationship between early childhood intake of MPH and onset of antidepressant treatment during adolescence. "( Childhood methylphenidate adherence as a predictor of antidepressants use during adolescence.
Akriv, A; Ghilai, A; Hoshen, M; Krivoy, A; Leventer-Roberts, M; Madjar, N; Shlosberg, D; Shoval, G; Zalsman, G, 2019
)
2.36
"Methylphenidate is a widely-used drug for the treatment of attention deficit/hyperactivity disorder (ADHD) and other neuropsychiatric disorders. "( How does methylphenidate affect default mode network? A systematic review.
Goncalves, R; Pedroso, S; Santos, PH, 2019
)
2.37
"Methylphenidate is a psychostimulant used for the treatment of (ADHD) attention deficit hyperactivity syndrome in children and adults. "( Methylphenidate increases the urinary excretion of vanillylmandelic acid in rats that is attenuated by buspirone co-administration.
Alam, N; Bashir, L; Ikram, R; Kashif, SS; Naeem, S; Naz, S; Siddiqui, T; Wasi, N, 2019
)
3.4
"Methylphenidate (MPH) is a first line drug for attention-deficit/hyperactivity disorder (ADHD), yet the neuronal mechanisms underlying the condition and the treatment are still not fully understood. "( Effects of methylphenidate on the ERP amplitude in youth with ADHD: A double-blind placebo-controlled cross-over EEG study.
Gothelf, D; Horowitz, I; Levit-Binnun, N; Moses, E; Naim-Feil, J; Rubinson, M, 2019
)
2.35
"Methylphenidate (MPD) is a widely prescribed psychostimulant for the treatment of attention deficit hyperactivity disorder, and is growing in use as a recreational drug and academic enhancer. "( Glutaminergic signaling in the caudate nucleus is required for behavioral sensitization to methylphenidate.
Dafny, N; Floren, S; Kharas, N; King, N; Thomas, M, 2019
)
2.18
"Methylphenidate (MPH) is a phenethylamine derivative used in the treatment of attention-deficit hyperactivity disorder (ADHD). "( Determination of methylphenidate in plasma and saliva by liquid chromatography/tandem mass spectrometry.
Bijleveld, YA; Burggraaf, J; Jorjani, S; Mathôt, RA; Schrier, L; Seçilir, A; Toersche, JH; van Gerven, J, 2013
)
2.17
"Methylphenidate (MPH) is an effective treatment to improve attentional difficulties in children with attention deficit/hyperactivity disorder (ADHD)."( Methylphenidate improves some but not all measures of attention, as measured by the TEA-Ch in medication-naïve children with ADHD.
Barry, E; Bellgrove, MA; Fitzgerald, M; Gill, M; Hammond, P; Johnson, KA; Kirley, A; McNicholas, F; Paton, K; Robertson, IH, 2014
)
2.57
"Methylphenidate (MPH) is a common medication for ADHD."( Areas of the brain modulated by single-dose methylphenidate treatment in youth with ADHD during task-based fMRI: a systematic review.
Czerniak, SM; Frazier, J; Kennedy, DN; King, JA; Mick, E; Moore, CM; Sikoglu, EM,
)
1.11
"Methylphenidate is a psychostimulant medication that produces improvements in functions associated with multiple neurocognitive systems. "( Distributed effects of methylphenidate on the network structure of the resting brain: a connectomic pattern classification analysis.
Angstadt, M; Kessler, D; Liberzon, I; Phan, KL; Scott, C; Sripada, CS; Welsh, R, 2013
)
2.14
"Methylphenidate is a widely prescribed psychostimulant for treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents, which raises questions regarding its potential interference with the developing brain. "( Long-term oral methylphenidate treatment in adolescent and adult rats: differential effects on brain morphology and function.
Dijkhuizen, RM; Homberg, JR; Klomp, A; Lucassen, PJ; Meerhoff, GF; Reneman, L; Schipper, P; van der Marel, K, 2014
)
2.2
"Methylphenidate (MPH) is an effective treatment for ADHD symptoms, but its impact on cognition is less clearly understood."( Effects of methylphenidate on cognitive functions in children and adolescents with attention-deficit/hyperactivity disorder: evidence from a systematic review and a meta-analysis.
Coghill, DR; Currie, J; Gagliano, A; Pedroso, S; Seth, S; Usala, T, 2014
)
1.51
"Methylphenidate is an important element of therapeutic strategies for ADHD."( [Cardiovascular risks and management during Attention Deficit Hyperactivity Disorder treatment with methylphenidate].
Acquaviva, E; Bange, F; Delorme, R; Le Heuzey, MF; Mouren, MC, 2014
)
1.34
"Methylphenidate (MPD) is a widely prescribed stimulant used primarily for the treatment for attention-deficit/hyperactivity disorder (ADHD). "( Fatal oral methylphenidate intoxication with postmortem concentrations.
Cantrell, FL; Mallett, P; McIntyre, IM; Ogera, P, 2014
)
2.23
"Methylphenidate (MPH) is a dopamine and norepinephrine reuptake inhibitor that is widely used for the treatment of attention-deficit/hyperactivity disorder in children and adults. "( Object memory impairment at post-drug Day 15 but not at Day 1 after a regimen of repeated treatment with oral methylphenidate.
Bigney, EE; Fry, MD; Hooper, C; Taukulis, HK, 2014
)
2.06
"Methylphenidate is a psychostimulant that has been used to relieve depressive symptoms in advanced cancer patients. "( Multicentre, double-blind, randomised placebo-controlled clinical trial on the efficacy of methylphenidate on depressive symptoms in advanced cancer patients.
Almaraz, MJ; Centeno, C; Cuervo, MA; Gonzalez, J; Hernansanz, S; Lama, M; Nabal, M; Pascual, A; Ramos, D; Sanz, A; Vara, F, 2012
)
2.04
"Methylphenidate (MPH) is an indirect dopaminergic and noradrenergic agonist that is used to treat attention deficit hyperactivity disorder and that has shown therapeutic potential in neuropsychiatric diseases such as depression, dementia, and Parkinson's disease. "( The effects of methylphenidate on whole brain intrinsic functional connectivity.
Berman, A; Coates, U; Costa, A; Ettinger, U; Keeser, D; Meindl, T; Möller, HJ; Mueller, S; Pogarell, O; Reiser, MF; Riedel, M, 2014
)
2.2
"Methylphenidate (MPH) is a psychostimulant drug which acts by blocking the dopamine and norepinephrine transporters and is the main drug used to treat attention deficit hyperactivity disorder in children and adolescents. "( Effects of repeated administration of methylphenidate on reproductive parameters in male rats.
Anselmo-Franci, JA; dos Santos, AH; Fernandes, GS; Gerardin, DC; Mesquita, Sde F; Montagnini, BG; Silva, LS, 2014
)
2.12
"Methylphenidate is a central nervous system simulant that is used for management of opioid-induced sedation. "( Evaluation of concomitant methylphenidate and opioid use in patients with pain.
Atayee, RS; Best, BM; Jiang, JY; Ma, JD; Morello, CM, 2014
)
2.15
"Methylphenidate (MPH) is a stimulant prescribed to treat attention-deficit/ hyperactivity disorder. "( Chronic methylphenidate treatment during early life is associated with greater ethanol intake in socially isolated rats.
Beveridge, TJ; Chappell, AM; Gill, KE; Porrino, LJ; Weiner, JL, 2014
)
2.28
"Methylphenidate (MPH) is a commonly used stimulant medication for treating attention-deficit/hyperactivity disorder (ADHD). "( A preliminary study on methylphenidate-regulated gene expression in lymphoblastoid cells of ADHD patients.
Heupel, J; Hilscher, M; Jacob, C; Kittel-Schneider, S; Kopf, J; Lesch, KP; Reichert, S; Reif, A; Schmidt, B; Scholz, CJ; Schwarz, R; Volkert, J; Weber, H; Weissflog, L, 2015
)
2.17
"Methylphenidate (MPH) is a common treatment for adult Attention Deficit Hyperactivity Disorder (ADHD). "( Effects of perinatal methylphenidate (MPH) treatment on postweaning behaviors of male and female Sprague-Dawley rats.
Delbert Law, C; Ferguson, SA; Montenegro, SV; Sahin, L,
)
1.89
"Methylphenidate (MPH) is a commonly-used medication for the treatment of children with Attention-Deficit/Hyperactivity Disorders (ADHD). "( Prenatal exposure to methylphenidate affects the dopamine system and the reactivity to natural reward in adulthood in rats.
Belzung, C; Castelnau, P; Chalon, S; Cortese, S; Emond, P; Faraone, SV; Galineau, L; Lepelletier, FX; Nicolas, C; Solinas, M; Tauber, C, 2014
)
2.16
"Methylphenidate is a non-addictive psychostimulant, although its mode of action resembles that of cocaine, a well-known addictive and abused drug."( Alterations in brain neurotrophic and glial factors following early age chronic methylphenidate and cocaine administration.
Rehavi, M; Simchon-Tenenbaum, Y; Weizman, A, 2015
)
1.37
"Methylphenidate (MPH) is a stimulant that is commonly used in the treatment of attention-deficit/hyperactivity disorder in children and adults. "( Methylphenidate-induced awake bruxism: a case report.
Bilgiç, A; Sivri, RÇ,
)
3.02
"Methylphenidate (MPH) is a central nervous system stimulant that is widely used to treat attention deficit hyperactivity disorder (ADHD) and has been shown to improve attention, cognitive function and behaviors in both patients and animal models of ADHD. "( Distinct lncRNA expression profiles in the prefrontal cortex of SD rats after exposure to methylphenidate.
Chen, C; Chen, R; Chi, X; Cui, X; Fu, Z; Guo, X; Hong, Q; Ji, C; Jia, J; Tong, M; Wang, J; Wu, T; Yang, L; Zhang, M; Zhang, X, 2015
)
2.08
"Methylphenidate (MPH) is a widely prescribed stimulant drug for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents. "( Effects of long-term methylphenidate treatment in adolescent and adult rats on hippocampal shape, functional connectivity and adult neurogenesis.
Bouet, V; Boulouard, M; Dauphin, F; Dijkhuizen, RM; Freret, T; Homberg, JR; Klomp, A; Lucassen, PJ; Meerhoff, GF; Reneman, L; van der Marel, K, 2015
)
2.18
"Methylphenidate (MPD) is a dopamine uptake inhibitor and the most commonly prescribed drug for the treatment of attention-deficit/hyperactivity disorder in children. "( Repeated methylphenidate administration during lactation reduces maternal behavior, induces maternal tolerance, and increases anxiety-like behavior in pups in adulthood.
Bernardi, MM; Coelho, CP; Florio, JC; Kirsten, TB; Oshiro, A; Ponchio, RA; Teodorov, E,
)
1.99
"Methylphenidate (MPH) is a central stimulant, prescribed for the treatment of attention deficit/hyperactivity disorder. "( Effects of chronic treatment with methylphenidate on oxidative stress and inflammation in hippocampus of adult rats.
Motaghinejad, M; Motevalian, M; Shabab, B, 2016
)
2.16
"Methylphenidate (MPH) is a central nervous system stimulant drug that increases concentration and energy level. "( Investigation of possible teratogenic effects in the offspring of mice exposed to methylphenidate during pregnancy.
Bacchi, AD; Costa, Gde A; Galvão, TC; Moreira, EG; Salles, MJ, 2016
)
2.1
"Methylphenidate (MPD) is a central nervous system (CNS) stimulant, which belongs to the phenethylamine group and is mainly used in the treatment of attention deficit hyperactive disorder (ADHD). "( From Clinical Application to Cognitive Enhancement: The Example of Methylphenidate.
Busardò, FP; Cipolloni, L; Frati, P; Kyriakou, C; Zaami, S, 2016
)
2.11
"Methylphenidate (MPH) is a widely prescribed stimulant compound that may be effective against ADHD symptoms in children and adults."( A candidate gene investigation of methylphenidate response in adult attention-deficit/hyperactivity disorder patients: results from a naturalistic study.
Fredriksen, M; Haavik, J; Hegvik, TA; Jacobsen, KK; Zayats, T, 2016
)
1.43
"Methylphenidate is a central nervous system stimulant medicinally used in the treatment of attention-deficit disorder with or without hyperactivity (ADD/ADHD). "( Methylphenidate in Pregnancy: A Multicenter, Prospective, Comparative, Observational Study.
Arnon, J; Beck, E; Borisch, C; Bozzo, P; Diav-Citrin, O; Nulman, I; Ornoy, A; Richardson, JL; Shechtman, S; Wajnberg, R, 2016
)
3.32
"Methylphenidate (MPH) is a psychostimulant commonly used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). "( MicroPET/CT assessment of FDG uptake in brain after long-term methylphenidate treatment in nonhuman primates.
Apana, SM; Berridge, MS; Callicott, R; Liu, S; Newport, GD; Paule, MG; Slikker, W; Thompson, J; Wang, C; Zhang, X,
)
1.81
"Methylphenidate (MPH) is a neural stimulant with unclear neurochemical and behavioral effects. "( The neuroprotective effect of lithium against high dose methylphenidate: Possible role of BDNF.
Asadi, M; Motaghinejad, M; Motevalian, M; Seyedjavadein, Z, 2016
)
2.12
"Methylphenidate (MPH) is a stimulatory agent in brain with unknown long-term consequences. "( Effects of acute doses of methylphenidate on inflammation and oxidative stress in isolated hippocampus and cerebral cortex of adult rats.
Fatima, S; Motaghinejad, M; Motevalian, M; Shabab, B, 2017
)
2.2
"Methylphenidate (MPD) is a widely prescribed psychostimulants used for the treatment of attention deficit hyperactive disorder (ADHD). "( Methylphenidate modulates dorsal raphe neuronal activity: Behavioral and neuronal recordings from adolescent rats.
Dafny, N; Kharas, N; Reyes-Vasquez, C; Whitt, H, 2017
)
3.34
"Methylphenidate (MPH) is a stimulant drug and an effective treatment for attention-deficit/hyperactivity disorder (ADHD) in both children and adults. "( The age-dependent effects of a single-dose methylphenidate challenge on cerebral perfusion in patients with attention-deficit/hyperactivity disorder.
Bottelier, MA; Bouziane, C; Mutsaerts, H; Reneman, L; Schrantee, A; Tamminga, H, 2017
)
2.16
"Methylphenidate is a noradrenaline and dopamine reuptake inhibitor and commonly used in the pharmacological treatment of individuals with attention deficit/hyperactivity disorder (ADHD)."( Effects of methylphenidate on attention in Wistar rats treated with the neurotoxin N-(2-chloroethyl)-N-ethyl-2-bromobenzylamine (DSP4).
Hauser, J; Lange, KW; Reissmann, A; Sontag, TA; Tucha, O, 2017
)
1.57
"Methylphenidate (MPH) is a central nervous system stimulant derived from an amphetamine and acts as a potent inhibitor of catecholamine reuptake and increases dopamine levels in the brain. "( Methylphenidate for the treatment of Parkinson disease and other neurological disorders.
Auriel, E; Giladi, N; Hausdorff, JM,
)
3.02
"Methylphenidate is a psychostimulant that acts blocking the dopamine transporter has been used as an effective treatment for Attention Deficit Hyperactivity Disorder."( Cerebral DARPP-32 expression after methylphenidate administration in young and adult rats.
Gomes, KM; Gomez, MV; Inácio, CG; Martins, MR; Quevedo, J; Réus, GZ; Romano-Silva, MA; Rosa, DV; Soares, EC; Souza, BR; Souza, RP; Valvassori, SS, 2009
)
1.35
"Methylphenidate (MPH) is an effective medication to improve these cognitive difficulties."( Effects of methylphenidate on working memory functioning in children with attention deficit/hyperactivity disorder.
Bechtel, N; Klarhöfer, M; Kobel, M; Opwis, K; Penner, IK; Scheffler, K; Specht, K; Weber, P, 2009
)
1.46
"Methylphenidate is a potent central nervous system stimulant that exerts its effects by increasing synaptic levels of dopamine and norepinephrine. "( A case of acute cardiomyopathy and pericarditis associated with methylphenidate.
Dadfarmay, S; Dixon, J, 2009
)
2.03
"Methylphenidate is a piperidine derivative structurally related to amphetamines and acts as a central nervous system stimulant."( Methylphenidate has positive hypocholesterolemic and hypotriglyceridemic effects: new data.
Charach, G; Grosskopf, I; Kaysar, N; Rabinovich, A; Weintraub, M, 2009
)
2.52
"Methylphenidate is a frequently prescribed stimulant for the treatment of attention deficit hyperactivity disorder (ADHD). "( Plasma and brain concentrations of oral therapeutic doses of methylphenidate and their impact on brain monoamine content in mice.
Balcioglu, A; Bhide, PG; Biederman, J; McCarthy, D; Ren, JQ; Spencer, TJ, 2009
)
2.04
"Methylphenidate is a central nervous system (CNS)-stimulating agent. "( [Paradoxical effect of methylphenidate in the treatment of a patient with severe traumatic brain injury].
Grønborg, P; Jansen, J; Liljegren, J, 2009
)
2.11
"Methylphenidate is a piperidine derivative and is the drug most often used to treat attention deficit/hyperactivity disorder of children and young adults. "( Dose-related immunohistochemical and ultrastructural changes after oral methylphenidate administration in cerebrum and cerebellum of the rat.
Bahcelioglu, M; Bardakci, Y; Calguner, E; Elmas, C; Erdogan, D; Gozil, R; Kadioglu, D; Oktem, H; Sargon, MF; Senol, S; Take, G; Tas, M; Yazici, AC, 2009
)
2.03
"Methylphenidate (Ritalin) is a selective dopamine reuptake inhibitor and an effective treatment for attention deficit hyperactivity disorder (ADHD) however the anatomical foci and neuronal circuits involved in these therapeutic benefits are unclear. "( Mapping the central effects of methylphenidate in the rat using pharmacological MRI BOLD contrast.
Easton, N; Fone, KC; Marsden, CA; Marshall, FH, 2009
)
2.08
"Methylphenidate (MPH) is an amphetamine derivative widely prescribed for the treatment of attention deficit-hyperactivity disorder. "( The effects of chronic methylphenidate administration on operant test battery performance in juvenile rhesus monkeys.
Allen, RR; Doerge, DR; Hotchkiss, CE; Mattison, DR; Morris, SM; Paule, MG; Rodriguez, JS,
)
1.88
"Methylphenidate is a central nervous system stimulant used for the treatment of attention-deficit hyperactivity disorder. "( Methylphenidate treatment increases Na(+), K (+)-ATPase activity in the cerebrum of young and adult rats.
Comim, CM; Ferreira, AG; Gomes, KM; Matté, C; Mattos, C; Quevedo, J; Scherer, EB; Streck, EL; Wyse, AT, 2009
)
3.24
"Dexmethylphenidate is a single-isomer stimulant medication approved for the treatment of attention deficit hyperactivity disorder (ADHD). "( Dexmethylphenidate for attention deficit hyperactivity disorder.
Coury, D, 2009
)
1.6
"Dexmethylphenidate is a safe and effective treatment for ADHD. "( Dexmethylphenidate for attention deficit hyperactivity disorder.
Coury, D, 2009
)
1.6
"Methylphenidate (MPH) is an effective medication for the treatment of attention deficit hyperactivity disorder (ADHD). "( Variability of response time as a predictor of methylphenidate treatment response in korean children with attention deficit hyperactivity disorder.
Cheon, KA; Ha, EH; Joung, YS; Kim, BN; Lee, SH; Shin, DW; Shin, YJ; Song, DH; Yoo, HJ, 2009
)
2.05
"Dexmethylphenidate XR is a stimulant treatment in a single isomer form, and has an efficacy and tolerability similar to two doses of immediate-release (IR) dexmethylphenidate when taken 4 hours apart, but is dosed at half of the usual d,l-methylphenidate dose."( Attention-deficit hyperactivity disorder: recent advances in paediatric pharmacotherapy.
Kratochvil, CJ; May, DE, 2010
)
0.87
"Methylphenidate (MPH) is an efficacious and normally well-tolerated treatment for attention-deficit/hyperactivity disorder (ADHD). "( Measuring methylphenidate response in attention-deficit/hyperactvity disorder: how are laboratory classroom-based measures related to parent ratings?
Coghill, D; DeBacker, M; Sonuga-Barke, EJ; Swanson, J, 2009
)
2.2
"Methylphenidate (MPH) is a stimulant medication widely used for treating attention-deficit hyperactivity disorder (ADHD) in children and adolescents. "( Pharmacokinetics of methylphenidate in oral fluid and sweat of a pediatric subject.
Farrè, M; García-Algar, O; Marchei, E; Pacifici, R; Pellegrini, M; Pichini, S; Vall, O, 2010
)
2.13
"Methylphenidate (MPH) is a very effective treatment option for children and adolescents with attention-deficit/hyperactivity disorder. "( Diurnal differences in memory and learning in young and adult rats treated with methylphenidate.
Comim, CM; Gomes, KM; Inácio, CG; Martins, MR; Quevedo, J; Réus, GZ; Souza, RP; Valvassori, SS, 2010
)
2.03
"Methylphenidate is a psychostimulant widely used in the treatment of attention deficit hyperactivity disorder (ADHD). "( Methylphenidate attenuates rats' preference for a novel spatial stimulus introduced into a familiar environment: assessment using a force-plate actometer.
Fowler, SC; Levant, B; Zarcone, TJ, 2010
)
3.25
"Methylphenidate (MPH) is a psychostimulant commonly used to manage ADHD symptoms."( Manganese in children with attention-deficit/hyperactivity disorder: relationship with methylphenidate exposure.
Benko, CR; Cordeiro, ML; Costa, MT; Cunha, A; Farias, AC; Farias, LG; McCracken, JT, 2010
)
1.3
"Methylphenidate (MPH) is an immediate-release (IR) or sustained-release (SR) drug used to treat attention-deficit hyperactivity disorder. "( Pharmacokinetics of methylphenidate following two oral formulations (immediate and sustained release) in the dog.
Giorgi, M; Lavy, E; Neri, D; Prise, U; Soldani, G, 2010
)
2.13
"Methylphenidate (MPH) is a drug administered either as an immediate- or sustained-release preparation for the treatment of attention deficit hyperactivity disorder in humans. "( Pharmacokinetics of methylphenidate after oral administration of immediate and sustained-release preparations in Beagle dogs.
Bar Chaim, A; Brandriss, N; Giorgi, M; Lavy, E; Neri, D; Prise, U; Soldani, G, 2011
)
2.14
"Methylphenidate is a dopamine/norepinephrine reuptake inhibitor that produces altered gene expression in the forebrain; these effects partly mimic gene regulation by cocaine (dopamine/norepinephrine/serotonin reuptake inhibitor)."( Selective serotonin reuptake inhibitor antidepressants potentiate methylphenidate (Ritalin)-induced gene regulation in the adolescent striatum.
Beverley, J; Marinelli, M; Steiner, H; Van Waes, V, 2010
)
1.32
"Methylphenidate (MPH) is a stimulant drug that amplifies dopamineric and noradrenergic signaling in the brain, which is believed to underlie its cognition enhancing effects. "( Methylphenidate enhances brain activation and deactivation responses to visual attention and working memory tasks in healthy controls.
Caparelli, EC; Fowler, JS; Jayne, M; Telang, F; Tomasi, D; Volkow, ND; Wang, GJ; Wang, R; Wong, C, 2011
)
3.25
"Methylphenidate is a psychostimulant widely used in the treatment of attention deficit hyperactivity disorder. "( Differences in methylphenidate dose response between periadolescent and adult rats in the familiar arena-novel alcove task.
Davis, PF; Fowler, SC; Levant, B; Ozias, MK; Zarcone, TJ, 2011
)
2.16
"Methylphenidate (MPD) is a psychostimulant widely used to treat behavioral problems such as attention deficit hyperactivity disorder. "( Methylphenidate alters basal ganglia neurotensin systems through dopaminergic mechanisms: a comparison with cocaine treatment.
Alburges, ME; Fleckenstein, AE; Hanson, GR; Hoonakker, AJ; Horner, KA, 2011
)
3.25
"Methylphenidate is a psychostimulant drug indicated for the treatment of attention-deficit hyperactivity disorder (ADHD). "( Patterns of methylphenidate use and assessment of its abuse and diversion in two French administrative areas using a proxy of deviant behaviour determined from a reimbursement database: main trends from 2005 to 2008.
Coudert, H; Frauger, E; Micallef, J; Natali, F; Pauly, V; Pradel, V; Reggio, P; Thirion, X, 2011
)
2.19
"Methylphenidate (MPH) is an efficient treatment to reduce behavioral symptoms of attention-deficit/hyperactivity disorder (ADHD); however, its impact on cognitive functioning has not been sufficiently demonstrated so far. "( Effects of methylphenidate on intelligence and attention components in boys with attention-deficit/hyperactivity disorder.
Daseking, M; Goldbeck, L; Hellwig-Brida, S; Keller, F; Petermann, F, 2011
)
2.2
"Methylphenidate is an amphetamine psychostimulant used as a symptomatic treatment for attention-deficit hyperactivity disorder. "( Methylphenidate: growth retardation.
, 2011
)
3.25
"Methylphenidate is a psychostimulant given for extended periods of time as a treatment of attention-deficit/hyperactivity disorder (ADHD). "( Methylphenidate treatment in the spontaneously hypertensive rat: influence on methylphenidate self-administration and reinstatement in comparison with Wistar rats.
Cheong, JH; dela Peña, I; dela Peña, JB; Lee, JC; Ryu, JH; Shin, CY; Sohn, AR; Yoon, SY, 2012
)
3.26
"Methylphenidate is a psychostimulant originally used for the treatment of attention-deficit disorder. "( Methylphenidate: established and expanding roles in symptom management.
Prommer, E, 2012
)
3.26
"Methylphenidate (MPH) is a drug that is licensed for treatment of ADHD and also narcolepsy. "( Determination of methylphenidate and its metabolite ritalinic acid in urine by liquid chromatography/tandem mass spectrometry.
Florkowski, CM; George, PM; Moore, GA; Paterson, SM, 2012
)
2.16
"Methylphenidate (MPD) is a psychostimulant that enhances dopaminergic neurotransmission in the central nervous system by using mechanisms similar to cocaine and amphetamine. "( Nucleus accumbens neuronal activity in freely behaving rats is modulated following acute and chronic methylphenidate administration.
Chong, SL; Claussen, CM; Dafny, N, 2012
)
2.04
"Methylphenidate (MPH) is an indirect dopamine and noradrenalin agonist, commonly used for the treatment of attention-deficit hyperactivity disorder for which it reduces undesirable behavior as evaluated by peers and authority figures, indicative of increased conformity."( Modulation of social influence by methylphenidate.
Campbell-Meiklejohn, DK; Frith, CD; Gjerløff, T; Jensen, M; Møller, A; Roepstorff, A; Scheel-Kruger, J; Simonsen, A; Wohlert, V, 2012
)
1.38
"Methylphenidate (MPH) is a commonly abused psychostimulant prescribed for the treatment of attention deficit hyperactivity disorder. "( Methylphenidate and cocaine self-administration produce distinct dopamine terminal alterations.
Bermejo, K; Calipari, ES; Ferris, MJ; Jones, SR; Melchior, JR; Roberts, DC; Salahpour, A, 2014
)
3.29
"Methylphenidate (MPD) is a psychostimulant that is prescribed to treat attention-deficit/hyperactivity disorder (ADHD) and has been used as a recreational drug. "( GABA system changes in methylphenidate sensitized female rats.
Barros, HM; Couto-Pereira, NS; Ferigolo, M; Freese, L; Muller, EJ; Souza, MF; Tosca, CF, 2012
)
2.13
"Methylphenidate (MP) is a psychostimulant widely prescribed to treat Attention Deficit Hyperactivity Disorder (ADHD). "( Chronic exposure to methylphenidate impairs appendicular bone quality in young rats.
Ananth, M; Hadjiargyrou, M; Janda, HA; John, CM; Komatsu, DE; Mary, MN; Robison, L; Swanson, JM; Thanos, PK; Volkow, ND, 2012
)
2.15
"Methylphenidate (MPH) is a psychostimulant that exerts its pharmacological effects via preferential blockade of the dopamine transporter (DAT) and the norepinephrine transporter (NET), resulting in increased monoamine levels in the synapse. "( Methylphenidate exposure induces dopamine neuron loss and activation of microglia in the basal ganglia of mice.
Jiao, Y; Pani, AK; Pond, BB; Qu, C; Sadasivan, S; Smeyne, RJ, 2012
)
3.26
"Methylphenidate is a medication used routinely in the management of attention deficit hyperactivity disorder. "( Methylphenidate-induced erections in a prepubertal child.
Brady, CM; Kelly, BD; Lundon, DJ; McGuinness, D, 2013
)
3.28
"Methylphenidate (MPH) is a catecholamine transporter blocker, with dopamine agonistic effects in the basal ganglia. "( Methylphenidate effects on neural activity during response inhibition in healthy humans.
Costa, A; Ettinger, U; Meindl, T; Menzel-Zelnitschek, F; Möller, HJ; Pogarell, O; Reiser, M; Riedel, M; Rubia, K; Schwarz, M, 2013
)
3.28
"Methylphenidate (MPH) is a psychostimulant used in the treatment of attention-deficit/hyperactivity disorder in children and adults. "( Chronic methylphenidate administration in mice produces depressive-like behaviors and altered responses to fluoxetine.
Brookshire, BR; Jones, SR, 2012
)
2.26
"Methylphenidate (MPH) is a first line option in the psychopharmacologic treatment of adults with Attention-Deficit/Hyperactivity Disorder (ADHD). "( Pharmacogenetics of response to methylphenidate in adult patients with Attention-Deficit/Hyperactivity Disorder (ADHD): a systematic review.
Bau, CH; Contini, V; Grevet, EH; Rohde, LA; Rovaris, DL; Victor, MM, 2013
)
2.12
"Methylphenidate is a short-acting stimulant. "( Methylphenidate-induced acute orofacial and extremity dyskinesia.
Donmez, A; Isik, B; Orun, E; Sonmez, FM; Tas, T; Yilmaz, AE, 2013
)
3.28
"Methylphenidate (MPH) is a stimulant that increases extracellular levels of dopamine and noradrenaline. "( In for a penny, in for a pound: methylphenidate reduces the inhibitory effect of high stakes on persistent risky choice.
Campbell-Meiklejohn, D; Frith, CD; Gjerløff, T; Møller, A; Roepstorff, A; Rogers, RD; Scheel-Krüger, J; Simonsen, A; Wohlert, V, 2012
)
2.11
"Methylphenidate is a centrally acting sympathomimetic used for the treatment of attention deficit/hyperactivity disorder in children and adolescents and for narcolepsy in adults. "( First trimester in utero exposure to methylphenidate.
Aagaard, L; Damkier, P; Dideriksen, D; Hallas, J; Pottegård, A, 2013
)
2.11
"Methylphenidate is a CNS stimulant that blocks the DaT and the noradrenaline (norepinephrine) transporter in the striatum and the prefrontal cortex in particular."( Methylphenidate : a treatment for Parkinson's disease?
Bordet, R; Defebvre, L; Delval, A; Devos, D; Dujardin, K; Moreau, C, 2013
)
2.55
"Methylphenidate is a standard pharmaceutical intervention for ADHD."( An experimental comparison of Pycnogenol and methylphenidate in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).
Dodd, DK; Green, L; Paull, JC; Sparrow, EP; Tenenbaum, S, 2002
)
1.3
"D-methylphenidate is an enantiomer of D,L-methylphenidate and was developed as an improved treatment for attention deficit hyperactivity disorder (ADHD) in children. "( The perinatal and postnatal toxicity of D-methylphenidate and D,L-methylphenidate in rats.
Christian, MS; Hoberman, AM; Khetani, VD; Stirling, DI; Teo, SK; Thomas, SD,
)
1.12
"D-methylphenidate is an enantiomer of D,L-methylphenidate and was developed as an improved treatment for attention deficit hyperactivity disorder in children. "( A 90-day oral gavage toxicity study of D-methylphenidate and D,L-methylphenidate in Sprague-Dawley rats.
Hoberman, A; Khetani, V; Kiorpes, A; Stirling, D; Teo, S; Thomas, S, 2002
)
1.3
"Dexmethylphenidate is a schedule II drug."( Dexmethylphenidate--Novartis/Celgene. Focalin, D-MPH, D-methylphenidate hydrochloride, D-methylphenidate, dexmethylphenidate, dexmethylphenidate hydrochloride.
, 2002
)
1.45
"Methylphenidate (MPH) is an effective symptomatic treatment of attention deficit hyperactivity disorder (ADHD), but the mechanisms of its therapeutic action have not been fully elucidated. "( Effects of methylphenidate discontinuation on cerebral blood flow in prepubescent boys with attention deficit hyperactivity disorder.
Acton, PD; Austin, G; Elman, I; Krikorian, G; Langleben, DD; Monterosso, JR; Portnoy, O; Ridlehuber, HW; Strauss, HW, 2002
)
2.15
"Methylphenidate (Ritalin) is a commonly used central nervous stimulant. "( Ritalin revisited: does it really help in neurological injury?
Kajs-Wyllie, M, 2002
)
1.76
"Methylphenidate (Ritalin) is a psychostimulant drug used to treat children with attention deficit hyperactivity disorder. "( Daily methylphenidate administration attenuates c-fos expression in the striatum of prepubertal rats.
Brown, RE; Carrey, N; Chase, TD; Wilkinson, M, 2003
)
2.24
"Methylphenidate is a psychostimulant which inhibits the dopamine transporter and produces dopamine overflow in the striatum, similar to the effects of cocaine. "( Repeated methylphenidate treatment in adolescent rats alters gene regulation in the striatum.
Brandon, CL; Steiner, H, 2003
)
2.18
"OROS methylphenidate HCL (MPH) is a recently developed long-acting stimulant medication used to treat attention-deficit/hyperactivity disorder (ADHD). "( A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder.
Black, DO; Conlon, C; Newcorn, JH; Pearl, PL; Robb, AS; Sarampote, CS; Seymour, KE; Stein, MA; Waldman, ID, 2003
)
1.12
"Methylphenidate (MPH) is a psychomotor stimulant medication widely used for the treatment of attention-deficit/hyperactivity disorder (ADHD). "( Methylphenidate treatment during pre- and periadolescence alters behavioral responses to emotional stimuli at adulthood.
Barrot, M; Berton, O; Bolaños, CA; Nestler, EJ; Wallace-Black, D, 2003
)
3.2
"Methylphenidate (MPH) is a stimulant prescribed for the treatment of attention-deficit/hyperactivity disorder (ADHD). "( Enduring behavioral effects of early exposure to methylphenidate in rats.
Andersen, SL; Carlezon, WA; Mague, SD, 2003
)
2.02
"Methylphenidate is a rapidly absorbed medication that, in its d-isomer form, readily penetrates the CNS, particularly the striatum."( Pharmacokinetic considerations in the treatment of attention-deficit hyperactivity disorder with methylphenidate.
Doffing, MA; Wolraich, ML, 2004
)
1.26
"Methylphenidate is a central nervous system stimulant used for the treatment of attention deficit hyperactivity disorder and narcolepsy and like other psychostimulants has a potential for abuse."( Lacunar stroke associated with methylphenidate abuse.
Sadeghian, H, 2004
)
2.05
"Methylphenidate is an important stimulant prescribed to treat attention-deficit hyperactivity disorder. "( Methylphenidate is stereoselectively hydrolyzed by human carboxylesterase CES1A1.
Bosron, WF; Davis, WI; Hurley, TD; Kedishvili, NY; Murry, DJ; Sanghani, SP; Sun, Z; Zou, Q, 2004
)
3.21
"Methylphenidate seems to be an effective treatment for ODD, as well as for ADHD itself. "( The effect of methylphenidate on oppositional defiant disorder comorbid with attention deficit/hyperactivity disorder.
Gomes, F; Mattos, P; Pastura, G; Serra-Pinheiro, MA; Souza, I, 2004
)
2.13
"Methylphenidate proves to be an effective and well tolerated treatment for symptoms of ADHD in adults in the short term. "( Efficacy and safety of methylphenidate in 45 adults with attention-deficit/hyperactivity disorder. A randomized placebo-controlled double-blind cross-over trial.
Boonstra, AM; Buitelaar, JK; Burger, H; Kalma, LE; Kooij, JJ; Van der Linden, PD, 2004
)
2.08
"Methylphenidate (MPH) is a dopamine and noradrenaline enhancing drug used to treat attentional deficits. "( Plasma level-dependent effects of methylphenidate on task-related functional magnetic resonance imaging signal changes.
Brown, J; Bullmore, ET; Faessel, H; Honey, G; Müller, U; Robbins, TW; Routledge, C; Suckling, J; Williams, SC; Zelaya, F, 2005
)
2.05
"Methylphenidate is a first-line therapy for attention deficit hyperactivity disorder, the most prevalent neuropsychiatric disorder of childhood. "( Methylphenidate HCl: therapy for attention deficit hyperactivity disorder.
Capp, PK; Conlon, C; Pearl, PL, 2005
)
3.21
"Methylphenidate (MPH) is a prescription stimulant drug with known abuse potential; however, little is known about its patterns of misuse or the characteristics of its abusers."( Characteristics of methylphenidate misuse in a university student sample.
Barrett, SP; Bordy, LE; Darredeau, C; Pihl, RO, 2005
)
2.1
"Methylphenidate is a cornerstone of attention-deficit/hyperactivity disorder (ADHD) treatment. "( Successful desensitization of methylphenidate-induced rash.
Confino-Cohen, R; Goldberg, A, 2005
)
2.06
"Methylphenidate (MPH) is a psychostimulant effective in treating attention-deficit/hyperactivity disorder (ADHD). "( Different adaptations in ventral tegmental area dopamine neurons in control and ethanol exposed rats after methylphenidate treatment.
Choong, KC; Shen, RY, 2006
)
1.99
"OROS-methylphenidate (OROS-MPH) is a once-daily controlled-release formulation of methylphenidate (MPH) developed to overcome some of the limitations associated with IR-MPH and first-generation sustained-release formulations."( A randomized, controlled effectiveness trial of OROS-methylphenidate compared to usual care with immediate-release methylphenidate in attention deficit-hyperactivity disorder.
Binder, CE; Prinzo, RS; Steele, M; Swanson, J; Wang, J; Weiss, M, 2006
)
1.04
"Methylphenidate (MPH) is a potential therapeutic tool for Attention Deficit with Hyperactivity Disorders (ADHD). "( [Benefit of the extended-release methylphenidate formulations: a comparative study in childhood].
Barthez, MA; Brault, F; Castelnau, P; Deseille-Turlotte, G; Favreau, A; Giraudeau, B; Krier, C, 2006
)
2.06
"Methylphenidate is a stimulant used in the treatment of attention deficit hyperactivity disorder in children and is subject to abuse. "( Methylphenidate abuse in Texas, 1998-2004.
Forrester, MB, 2006
)
3.22
"Methylphenidate (MPH) is a CNS agent thought to act on dopamine and noradrenaline (norepinephrine) pathways and thereby blocks the reuptake of these neurotransmitters into the presynaptic neuron."( Methylphenidate transdermal system: In attention-deficit hyperactivity disorder in children.
Anderson, VR; Scott, LJ, 2006
)
2.5
"Methylphenidate (MPH) is a highly effective and commonly used treatment for ADHD but, like cocaine, is a cardiovascular and central nervous system stimulant with the potential to cause toxicity at high doses."( Methylphenidate and cocaine: a placebo-controlled drug interaction study.
Apparaju, S; Chiang, CN; Desai, P; Elkashef, A; Harrer, J; Horn, P; Mezinskis, J; Singal, BM; Somoza, E; Winhusen, T, 2006
)
2.5
"Methylphenidate (MPH) is a drug of choice for treating attention-deficit/hyperactivity disorder (ADHD), although its use has been complicated by its short duration of action. "( Methylphenidate blood levels and therapeutic response in children with attention-deficit hyperactivity disorder: I. Effects of different dosing regimens.
Chang, WW; Foley, M; McGreenery, CE; McKay, G; Midha, KK; Polcari, A; Teicher, MH; Valente, E, 2006
)
3.22
"Methylphenidate is a stimulant medication that is sometimes used as an antidepressant in bipolar adults and is frequently used in children with comorbid bipolar and attention-deficit disorder."( Naturalistic long-term use of methylphenidate in bipolar disorder.
El-Mallakh, RS; Lydon, E, 2006
)
1.34
"Dexmethylphenidate is a chirally pure d-isomer of the racemic mixture of methylphenidate. "( Dexmethylphenidate extended-release capsules for the treatment of attention deficit hyperactivity disorder.
Kowalik, S; Minami, H; Silva, R, 2006
)
1.58
"Methylphenidate (MPH) is a psychostimulant drug used to treat attention deficit hyperactivity disorder in children. "( Methylphenidate regulates activity regulated cytoskeletal associated but not brain-derived neurotrophic factor gene expression in the developing rat striatum.
Carrey, N; Chase, T; Soo, E; Wilkinson, M, 2007
)
3.23
"Methylphenidate is a central nervous system stimulant approved by the U.S."( NTP-CERHR monograph on the potential human reproductive and developmental effects of methylphenidate.
, 2005
)
1.27
"Methylphenidate is an effective treatment for reducing intravenous drug use in patients with severe amphetamine dependence."( A comparison of aripiprazole, methylphenidate, and placebo for amphetamine dependence.
Föhr, J; Haukka, J; Kuikanmäki, O; Kuoppasalmi, K; Meririnne, E; Sokero, P; Tiihonen, J; Tuomola, P; Vorma, H, 2007
)
2.07
"g. methylphenidate) proved to be an effective in patients with ADHD."( [Methylphenidate double-blind trial: indication and performing].
Becker, K; Bliznakova, L; Gerstner, S; Schmidt, MH,
)
1.56
"Methylphenidate (MPH) is a DA agonist that blocks the dopamine transporter (DAT)."( Gender associations with chronic methylphenidate treatment and behavioral performance following experimental traumatic brain injury.
Dixon, CE; Kline, AE; Ren, D; Wagner, AK; Wenger, MK; Willard, LA; Zafonte, RD, 2007
)
1.34
"Methylphenidate (MPH) is a drug that is widely used in the treatment of children in whom ADHD has been diagnosed."( Acute effect of methylphenidate on QT interval duration and dispersion in children with attention deficit hyperactivity disorder.
Akpinar, O; Congologlu, A; Ilgenli, TF; Kilicaslan, F; Ozturk, C; Turkbay, T,
)
1.2
"Methylphenidate (MPH) is a widely prescribed psychostimulant for the treatment of attention-deficit hyperactivity disorder (ADHD). "( DNA damage in rats after treatment with methylphenidate.
Andreazza, AC; Berk, M; Cassini, C; Comim, CM; Frey, BN; Gomes, KM; Gonçalves, CA; Kapczinski, F; Quevedo, J; Ribeiro, LC; Stertz, L; Valvassori, SS; Zanotto, C, 2007
)
2.05
"Methylphenidate (MPH) is a phenethylamine derivative used in the treatment of childhood attention-deficit hyperactivity disorder. "( Development and validation of a liquid chromatography-mass spectrometry assay for hair analysis of methylphenidate.
García-Algar, O; Marchei, E; Muñoz, JA; Pellegrini, M; Pichini, S; Vall, O; Zuccaro, P, 2008
)
2.01
"Methylphenidate (MPH) is a centrally acting (psycho)stimulant which reversibly blocks the dopamine re-uptake transporter. "( Association of Parkinson's disease with symptoms of attention deficit hyperactivity disorder in childhood.
Gerlach, M; Herhaus, G; Lange, KW; Melfsen, S; Müller, T; Scheuerpflug, P; Walitza, S; Warnke, A, 2007
)
1.78
"Methylphenidate-OROS is a cost-effective treatment for youths with ADHD for whom treatment with IR methylphenidate is suboptimal. "( Long-acting methylphenidate-OROS in youths with attention-deficit hyperactivity disorder suboptimally controlled with immediate-release methylphenidate: a study of cost effectiveness in The Netherlands.
Annemans, L; de Jong-van den Berg, LT; Faber, A; Kalverdijk, LJ; Postma, MJ; Tobi, H; van Agthoven, M, 2008
)
2.17
"Methylphenidate is a leading first-line treatment for ADHD (AD/HD). "( Effects of once-daily oral and transdermal methylphenidate on sleep behavior of children with ADHD.
Arnold, LE; Bukstein, OG; Faraone, SV; Findling, RL; Glatt, SJ; Lopez, FA, 2009
)
2.06
"Methylphenidate is an effective short-term treatment for oppositional behavior in children with comorbid ADHD and chronic multiple tic disorder."( Methylphenidate in children with oppositional defiant disorder and both comorbid chronic multiple tic disorder and ADHD.
Gadow, KD; Nolan, EE; Schneider, J; Sprafkin, J; Sverd, J, 2008
)
2.51
"Methylphenidate is a central nervous system stimulant with a spectrum of action similar to the effects of d-amphetamine. "( A comparison of the hypothermic effects of methylphenidate and d-amphetamine.
Ben-Uriah, Y; Carasso, RL; Yehuda, S, 1981
)
1.97
"Methylphenidate appears to be a safe and effective treatment for attention-deficit hyperactivity disorder in the majority of children with comorbid tic disorder."( Efficacy of methylphenidate for attention-deficit hyperactivity disorder in children with tic disorder.
Ezor, SN; Gadow, KD; Nolan, EE; Sprafkin, J; Sverd, J, 1995
)
2.11
"Methylphenidate is a low-cost, potentially efficacious intervention for reducing the duration of comas, for preventing life-threatening and costly complications of prolonged unconsciousness, and for promoting early ambulation and recovery."( Methylphenidate in the treatment of coma.
Comfort, M; Fetters, MD; Worzniak, M, 1997
)
2.46
"Methylphenidate is a useful adjunct in the treatment of some children with Williams syndrome."( Treatment of children with Williams syndrome with methylphenidate.
Bawden, HN; MacDonald, GW; Shea, S, 1997
)
1.27
"Methylphenidate appears to be an effective, rapidly acting agent in this setting at dosages of 10-20 mg/day, with minimal side effects."( Methylphenidate in post liver transplant patients.
Chodoff, L; Drooker, M; Plutchik, L; Sheiner, P; Snyder, S,
)
2.3
"Methylphenidate appears to be a safe and effective intervention in early poststroke rehabilitation that may expedite recovery."( Methylphenidate in early poststroke recovery: a double-blind, placebo-controlled study.
Blackwell, B; Chrostowski, J; Grade, C; Redford, B; Toussaint, L, 1998
)
3.19
"Methylphenidate is a short-acting stimulant with a duration of action of 1 to 4 hours and a pharmacokinetic half-life of 2 to 3 hours."( Pharmacokinetics and clinical effectiveness of methylphenidate.
Abernethy, DR; Cross, JT; Kimko, HC, 1999
)
1.28
"Methylphenidate (MP, Ritalin) is a psychotropic drug widely prescribed to children for treating the symptoms of attention deficit disorder with and without hyperactivity. "( Analysis of methylphenidate and its metabolite ritalinic acid in monkey plasma by liquid chromatography/electrospray ionization mass spectrometry.
Bajic, S; Doerge, DR; Fogle, CM; McCullagh, M; Paule, MG, 2000
)
2.13
"Methylphenidate is a commonly used medication in the United States. "( Methylphenidate: its pharmacology and uses.
Challman, TD; Lipsky, JJ, 2000
)
3.19
"Methylphenidate (MPD) is a drug widely used for treating attention-deficit/hyperactivity disorder in children. "( NMDA receptor antagonist disrupts acute and chronic effects of methylphenidate.
Dafny, N; Swann, A; Yang, P,
)
1.81
"Methylphenidate is a CNS stimulant that is thought to block the reuptake of dopamine and noradrenaline (norepinephrine) into the presynaptic neuron. "( Methylphenidate (OROS formulation).
Jarvis, B; Keating, GM; McClellan, K, 2001
)
3.2
"Methylphenidate is a psychostimulant most commonly used in the treatment of attention deficit hyperactivity disorder."( Palliative uses of methylphenidate in patients with cancer: a review.
Dreisbach, A; Kahn, MJ; Lertora, JJ; Rozans, M, 2002
)
1.36
"Methylphenidate (Ritalin) is an effective drug in the treatment of attention deficit hyperactivity disorder. "( Relationship between blockade of dopamine transporters by oral methylphenidate and the increases in extracellular dopamine: therapeutic implications.
Ding, YS; Fowler, JS; Franceschi, D; Gatley, SJ; Gifford, A; Logan, J; Maynard, L; Swanson, JM; Volkow, ND; Wang, GJ; Zhu, W, 2002
)
2
"Methylphenidate is a useful, proven method for the effective treatment of minimal brain dysfunction (MBD). "( Methylphenidate: a review.
Majovski, LV; Oettinger, L, 1976
)
3.14

Effects

Methylphenidate (MPH) has a long history of being an effective medication for attention deficit/hyperactivity disorder (ADHD) There are increasing reports of recreational use of methylphenidate.

Methylphenidate (MPH) has been used for decades to treat attention-deficit/hyperactivity disorder (ADHD) and narcolepsy. It has been shown to facilitate cognitive processing and reduce connectivity between the thalamus and lateral prefrontal cortex. M methylphenidate has many general side effects including ocular findings.

ExcerptReferenceRelevance
"Methylphenidate (MET) has a putative cognitive enhancer effect that has led adolescents and young adults to increase and indiscriminate its use aiming to ameliorate their productivity. "( The influence of early exposure to methylphenidate on addiction-related behaviors in mice.
Cata-Preta, EG; de Brito, ACL; de Oliveira Lima, AJ; Dos Anjos-Santos, A; Dos Santos, TB; Libarino-Santos, M; Marinho, EAV; Oliveira, TS; Oliveira-Campos, D; Patti, CL; Reis, HS, 2021
)
2.34
"Methylphenidate has a wide margin of safety and relatively mild adverse effects, most commonly appetite suppression and insomnia."( Pharmacokinetic considerations in the treatment of attention-deficit hyperactivity disorder with methylphenidate.
Doffing, MA; Wolraich, ML, 2004
)
1.26
"Methylphenidate (MPH) has a long history of being an effective medication for attention deficit/hyperactivity disorder (ADHD). "( Characteristics and motives of college students who engage in nonmedical use of methylphenidate.
Bucher, RH; Coleman, JJ; Dupont, RL; Wilford, BB,
)
1.8
"Methylphenidate has an abuse potential, and there are increasing reports of recreational use of methylphenidate."( Characterization of methylphenidate self-administration and reinstatement in the rat.
Botly, LC; Burton, CL; Fletcher, PJ; Rizos, Z, 2008
)
1.39
"Methylphenidate has a short plasma half-life (1-2 h) and thus needs to be frequently administered for effective therapy."( Transdermal iontophoretic delivery of methylphenidate HCl in vitro.
Boniello, S; Dinh, S; Liu, P; Singh, P, 1999
)
1.3
"Methylphenidate also has an adverse event profile that requires consideration."( How efficacious and safe is short-acting methylphenidate for the treatment of attention-deficit disorder in children and adolescents? A meta-analysis.
King, J; Langford, S; Moher, D; Pham, B; Schachter, HM, 2001
)
1.3
"Methylphenidate (MPH) has been widely misused by children and adolescents who do not meet all diagnostic criteria for attention-deficit/hyperactivity disorder without a consensus about the consequences. "( Evidence That Methylphenidate Treatment Evokes Anxiety-Like Behavior Through Glucose Hypometabolism and Disruption of the Orbitofrontal Cortex Metabolic Networks.
Da Costa, JC; Greggio, S; Schmitz, F; Schu, G; Silveira, JS; Venturin, GT; Wyse, ATS; Zimmer, ER, 2021
)
2.42
"Methylphenidate has many general side effects including ocular findings."( Does methylphenidate treatment affect functional and structural ocular parameters in patients with attention deficit hyperactivity disorder? - A prospective, one year follow-up study.
Atilla, H; Bingöl-Kızıltunç, P; Yürümez, E, 2022
)
1.96
"Methylphenidate (MPH) has been widely misused by children and adolescents who do not meet all diagnostic criteria for attention-deficit/hyperactivity disorder. "( Effects of methylphenidate after a long period of discontinuation include changes in exploratory behavior and increases brain activities of Na
Ferreira, FS; Schmitz, F; Silveira, JS; T S Wyse, A; V R Júnior, O, 2022
)
2.55
"Methylphenidate has also been found to reduce temper problems, affective instability, and emotional over-reactivity in adults with ADHD, although with variable effect sizes."( Revisiting stimulant use for emotional dysregulation in attention-deficit/hyperactivity disorder (ADHD).
Acierno, D; Barbuti, M; Brancati, GE; Elefante, C; Gemignani, S; Perugi, G; Raia, A,
)
0.85
"Methylphenidate (MPH) has been used for decades to treat attention-deficit/hyperactivity disorder (ADHD) and narcolepsy. "( Dichotomous effect of methylphenidate on microglia and astrocytes: Insights from in vitro and animal studies.
Leitão, RA; Lourenço, T; Muga, M; Novo, JP; Sanches, ES; Silva, AP, 2023
)
2.67
"Methylphenidate has been a first line treatment for ADHD, with relatively large numbers of usage."( Fetal safety of methylphenidate-A scoping review and meta analysis.
Barer, Y; Koren, G; Ornoy, A, 2020
)
1.63
"Methylphenidate has been shown to facilitate cognitive processing and reduce connectivity between the thalamus and lateral prefrontal cortex."( Intrinsic connections between thalamic sub-regions and the lateral prefrontal cortex are differentially impacted by acute methylphenidate.
Balderston, N; Ernst, M; Fuchs, B; Gorka, AX; Grillon, C; Lago, TR; Torrisi, S, 2020
)
1.49
"Methylphenidate has been an established treatment for ADHD, but due to its relatively short half-life, numerous intermediate- and long-acting products have been developed. "( Update on methylphenidate and dexmethylphenidate formulations for children with attention-deficit/hyperactivity disorder.
Ehret, MJ; Pheils, J, 2021
)
2.47
"Methylphenidate (MET) has a putative cognitive enhancer effect that has led adolescents and young adults to increase and indiscriminate its use aiming to ameliorate their productivity. "( The influence of early exposure to methylphenidate on addiction-related behaviors in mice.
Cata-Preta, EG; de Brito, ACL; de Oliveira Lima, AJ; Dos Anjos-Santos, A; Dos Santos, TB; Libarino-Santos, M; Marinho, EAV; Oliveira, TS; Oliveira-Campos, D; Patti, CL; Reis, HS, 2021
)
2.34
"Methylphenidate has prominent effects in the dopamine-rich striatum that are absent for the selective norepinephrine transporter inhibitor atomoxetine. "( Striatal Activation Predicts Differential Therapeutic Responses to Methylphenidate and Atomoxetine.
Bédard, AV; Fan, J; Halperin, JM; Hildebrandt, TB; Ivanov, I; Newcorn, JH; Schulz, KP; Stein, MA, 2017
)
2.13
"Methylphenidate (MPH) has been shown to modulate the amplitude of the no-go P3 component of the event-related potential (ERP; Øgrim, Aasen, & Brunner, 2016). "( Methylphenidate selectively modulates one sub-component of the no-go P3 in pediatric ADHD medication responders.
Aasen, IE; Brunner, JF; Kropotov, J; Øgrim, G, 2018
)
3.37
"Methylphenidate/Ritalin has been used for decades to treat attention deficit disorders and narcolepsy. "( Use of cognitive enhancers: methylphenidate and analogs.
Busardò, FP; Carlier, J; Giorgetti, R; Pirani, F; Ricci, G; Varì, MR, 2019
)
2.25
"Methylphenidate (MPH) has been shown to be effective in the treatment of attention deficit hyperactivity disorder (ADHD) in children. "( An observational study of response heterogeneity in children with attention deficit hyperactivity disorder following treatment switch to modified-release methylphenidate.
Döpfner, M; Hautmann, C; Rothenberger, A, 2013
)
2.03
"Methylphenidate (MPH) has been the most commonly used intravenous (i.v.) substance in Iceland in recent years. "( Intravenous Use of Prescription Psychostimulants; A Comparison of the Pattern and Subjective Experience between Different Methylphenidate Preparations, Amphetamine and Cocaine.
Bjarnadottir, GD; Bragadottir, H; Haraldsson, HM; Johannsson, M; Magnusson, A; Rafnar, BO; Sigurdsson, E; Steingrimsson, S, 2016
)
2.08
"Methylphenidate has been shown to decrease impulsive choice (increase choices of a larger more delayed reinforcer). "( Effects of methylphenidate on sensitivity to reinforcement delay and to reinforcement amount in pigeons: Implications for impulsive choice.
Cummings, C; Cummings, CW; Hughes, CE; Pitts, RC; Woodcock, RL, 2016
)
2.27
"Methylphenidate has been used as an effective treatment for attention deficit hyperactivity disorder (ADHD). "( Methylphenidate alters NCS-1 expression in rat brain.
Barichello, T; Gomes, KM; Gomez, MV; Quevedo, J; Réus, GZ; Romano-Silva, MA; Rosa, DV; Soares, EC; Souza, BR; Souza, RP, 2008
)
3.23
"Methylphenidate has been studied most and is effective and well tolerated despite common side effects."( Pharmacologic treatment options for cancer-related fatigue: current state of clinical research.
Alici, Y; Breitbart, W, 2008
)
1.07
"Methylphenidate has been used to treat these symptoms because of its rapid effect."( Methylphenidate for the treatment of depressive symptoms, including fatigue and apathy, in medically ill older adults and terminally ill adults.
Hardy, SE, 2009
)
2.52
"Methylphenidate has short-term symptomatic efficacy but also many adverse effects, including a risk of sudden death."( Atomoxetine. Attention-deficit/hyperactivity disorder: no better than methylphenidate.
, 2010
)
1.32
"Methylphenidate has been shown to be an effective therapy in patients with refractory neurocardiogenic syncope. "( Use of methylphenidate in the treatment of patients suffering from refractory postural tachycardia syndrome.
Grubb, BP; Kanjwal, K; Kanjwal, Y; Karabin, B; Saeed, B, 2012
)
2.28
"Methylphenidate (MPH) has been shown to block the norepinephrine transporter (NET), and genetic investigations have demonstrated that the norepinephrine transporter gene (SLC6A2) is associated with ADHD."( Possible association of norepinephrine transporter -3081(A/T) polymorphism with methylphenidate response in attention deficit hyperactivity disorder.
Cho, SC; Hong, SB; Kim, BN; Kim, JW; Shin, MS; Yoo, HJ, 2010
)
1.31
"methylphenidate has rewarding effects, although i.p."( Oral methylphenidate establishes a conditioned place preference in rats.
Bardo, MT; Walton, MT; Wooters, TE, 2011
)
1.6
"Methylphenidate (MPH) has long been used to treat attention-deficit/hyperactivity disorder (ADHD); however, its cellular mechanisms of action and potential effects on prefrontal cortical circuitry are not well understood, particularly in the developing brain system. "( Distinct age-dependent effects of methylphenidate on developing and adult prefrontal neurons.
Gao, WJ; Urban, KR; Waterhouse, BD, 2012
)
2.1
"Dexmethylphenidate has been found to be effective and well tolerated in clinical trials, involving a total of 684 children with ADHD and in 15 healthy adult volunteers."( Dexmethylphenidate--Novartis/Celgene. Focalin, D-MPH, D-methylphenidate hydrochloride, D-methylphenidate, dexmethylphenidate, dexmethylphenidate hydrochloride.
, 2002
)
1.45
"Methylphenidate has been advocated in patients with traumatic brain injury and stroke for a variety of cognitive, attention, and behavioral problems."( Ritalin revisited: does it really help in neurological injury?
Kajs-Wyllie, M, 2002
)
1.04
"D-Methylphenidate has been shown to be efficacious in patients at half the dose of D,L-MPH with a potentially improved therapeutic profile."( D-methylphenidate and D,L-methylphenidate are not developmental toxicants in rats and rabbits.
Christian, MS; Hoberman, AM; Khetani, VD; Stirling, DI; Teo, SK; Thomas, SD, 2003
)
1.6
"Methylphenidate has a wide margin of safety and relatively mild adverse effects, most commonly appetite suppression and insomnia."( Pharmacokinetic considerations in the treatment of attention-deficit hyperactivity disorder with methylphenidate.
Doffing, MA; Wolraich, ML, 2004
)
1.26
"Methylphenidate has four optical isomers due to two asymmetries (erythro-threo and dextro-levo). "( Comparative pharmacodynamics and plasma concentrations of d-threo-methylphenidate hydrochloride after single doses of d-threo-methylphenidate hydrochloride and d,l-threo-methylphenidate hydrochloride in a double-blind, placebo-controlled, crossover labora
Cooper, T; Dariani, M; Hirsch, S; Ottolini, Y; Quinn, D; Roffman, M; Swanson, J; Wigal, S; Zeldis, J, 2004
)
2
"Methylphenidate has potential for abuse because it produces behavioural effects similar to those observed with other abused stimulants, such as d-amphetamine and cocaine. "( Reinforcing, subject-rated, performance and physiological effects of methylphenidate and d-amphetamine in stimulant abusing humans.
Fillmore, MT; Glaser, PE; Rush, CR; Stoops, WW, 2004
)
2
"Methylphenidate has been suggested to exert its therapeutic effect mainly by blocking the dopamine transporter. "( Actions of methylphenidate on dopaminergic neurons of the ventral midbrain.
Bernardi, G; Federici, M; Geracitano, R; Mercuri, NB, 2005
)
2.16
"Methylphenidate has been rigorously studied and found to be a safe and effective drug."( [Attention deficit hyperactivity disorder: pharmacological options that are not "Ritalin"].
Gross-Tsur, V; Shmueli, D, 2005
)
1.05
"Methylphenidate (MPH) has been shown to be effective in the treatment of attention deficits in children with attention deficit hyperactivity disorder (ADHD). "( Effects of methylphenidate on multiple components of attention in children with attention deficit hyperactivity disorder.
Bormann-Kischkel, C; Kübber, S; Lange, KW; Linder, M; Mecklinger, L; Prell, S; Tucha, O; Walitza, S, 2006
)
2.17
"dl-Methylphenidate (MPH) has been widely used to treat attention-deficit/hyperactivity disorder (ADHD) for the last half century. "( A comprehensive in vitro screening of d-, l-, and dl-threo-methylphenidate: an exploratory study.
DeVane, CL; Markowitz, JS; Muniz, R; Patrick, KS; Pestreich, LK, 2006
)
1.2
"Methylphenidate has been shown elsewhere to improve hyperactivity in about half of treated children who have pervasive developmental disorders (PDD) and significant hyperactive-inattentive symptoms. "( Positive effects of methylphenidate on inattention and hyperactivity in pervasive developmental disorders: an analysis of secondary measures.
Aman, MG; Arnold, LE; Carroll, DH; Chuang, SZ; Cronin, P; Davies, M; McCracken, JT; McDougle, CJ; Posey, DJ; Ramadan, Y; Scahill, L; Shah, B; Swiezy, NB; Tierney, E; Vitiello, B; Wheeler, C; Witwer, AN; Young, C, 2007
)
2.11
"Methylphenidate has been shown to have psychostimulus effects similar to methamphetamine."( Lack of development of behavioral sensitization to methylphenidate in mice: correlation with reversible astrocytic activation.
Higashiyama, K; Kurokawa, K; Miyatake, M; Narita, M; Shindo, K; Suzuki, M; Suzuki, T, 2007
)
1.31
"Methylphenidate has been studied most and seems to be effective and well tolerated despite common side effects."( Update on psychotropic medications for cancer-related fatigue.
Alici-Evcimen, Y; Breitbart, W, 2007
)
1.06
"Methylphenidate (MPH) has shown high response rates and no increase in seizures in small trials."( Attention-deficit/hyperactivity disorder in pediatric patients with epilepsy: review of pharmacological treatment.
Gonzalez-Heydrich, J; Torres, AR; Whitney, J, 2008
)
1.07
"Methylphenidate (MPH) has a long history of being an effective medication for attention deficit/hyperactivity disorder (ADHD). "( Characteristics and motives of college students who engage in nonmedical use of methylphenidate.
Bucher, RH; Coleman, JJ; Dupont, RL; Wilford, BB,
)
1.8
"Methylphenidate has an abuse potential, and there are increasing reports of recreational use of methylphenidate."( Characterization of methylphenidate self-administration and reinstatement in the rat.
Botly, LC; Burton, CL; Fletcher, PJ; Rizos, Z, 2008
)
1.39
"Methylphenidate has been found to be a safe and effective treatment of depression in the medically ill elderly."( Depression in the medically ill elderly: a focus on methylphenidate.
Emptage, RE; Semla, TP, 1996
)
1.27
"Methylphenidate has short-term positive effects on children and adolescents with CD. "( Clinical efficacy of methylphenidate in conduct disorder with and without attention deficit hyperactivity disorder.
Abikoff, H; Ganeles, D; Klass, E; Klein, RG; Pollack, S; Seese, LM, 1997
)
2.06
"Methylphenidate (MPH) has been used safely and effectively for many years in children for the treatment of attention deficit disorder with hyperactivity (ADHD). "( The use of methylphenidate in paediatric traumatic brain injury.
Hornyak, JE; Hurvitz, EA; Nelson, VS,
)
1.96
"Methylphenidate has a short plasma half-life (1-2 h) and thus needs to be frequently administered for effective therapy."( Transdermal iontophoretic delivery of methylphenidate HCl in vitro.
Boniello, S; Dinh, S; Liu, P; Singh, P, 1999
)
1.3
"Methylphenidate has 2 chiral centres, but the drug used in therapy comprises only the threo pair of enantiomers."( Pharmacokinetics and clinical effectiveness of methylphenidate.
Abernethy, DR; Cross, JT; Kimko, HC, 1999
)
1.28
"Methylphenidate has been advocated as an effective antidepressant agent in unipolar depression, and depression secondary to medical illness."( An open study of methylphenidate in bipolar depression.
El-Mallakh, RS, 2000
)
1.37
"Methylphenidate also has an adverse event profile that requires consideration."( How efficacious and safe is short-acting methylphenidate for the treatment of attention-deficit disorder in children and adolescents? A meta-analysis.
King, J; Langford, S; Moher, D; Pham, B; Schachter, HM, 2001
)
1.3
"Methylphenidate (Ritalin) has been shown to have differential effects on hyperactive children's behavior as a function of dose level. "( Methylphenidate in hyperactive children: differential effects of dose on academic, learning, and social behavior.
Birmingham, BK; DuPaul, GJ; Rapport, MD; Stoner, G; Tucker, S, 1985
)
3.15

Actions

Methylphenidate treatment may lower the risk of all-cause fractures from both study designs. Evidence for benefit in Parkinson's disease and schizophrenia is inconclusive. Methylphenidated did not increase 24-h heart rates.

ExcerptReferenceRelevance
"Methylphenidate treatment may lower the risk of all-cause fractures from both study designs; however, further evidence is needed about the treatment duration and sex effect. "( Treatment with methylphenidate and the risk of fractures among children and young people: A systematic review and self-controlled case series study.
Cheung, CL; Coghill, D; Fan, M; Gao, L; Ge, GMQ; Ip, P; Lau, WCY; Man, KKC; Wong, ICK; Wong, KHTW, 2023
)
2.71
"methylphenidate may cause more adverse events considered non-serious versus placebo or no intervention (RR 1.23, 95% CI 1.11 to 1.37; I² = 72%; 35 trials 5342 participants; very low-certainty evidence). "( Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD).
Callesen, HE; Darling Rasmussen, P; Gluud, C; Groth, C; Huus, CL; Kirubakaran, R; Pereira Ribeiro, J; Schaug, JP; Simonsen, E; Skoog, M; Storebø, OJ; Storm, MRO; Zwi, M, 2023
)
3.8
"Methylphenidate appears to produce dose-dependent benefits to individuals with attention-deficit/hyperactivity disorder, but the evidence for benefit in Parkinson's disease and schizophrenia is inconclusive."( Is Methylphenidate Beneficial and Safe in Pharmacological Cognitive Enhancement?
Kapur, A, 2020
)
1.9
"Methylphenidate did not increase 24-h heart rates, whereas omega-3 fatty acid supplementation significantly decreased elevated heart rates and increased HRV in adolescents with IST."( Diagnosis and management of an inappropriate sinus tachycardia in adolescence based upon a Holter ECG: A retrospective analysis of 479 patients.
Baumann, C; Buchhorn, R; Gündogdu, S; Rakowski, U; Willaschek, C, 2020
)
1.28
"Does methylphenidate cause liver damage? An analysis of ad hoc reports to the "Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)" Abstract. "( [Does methylphenidate cause liver damage? An analysis of ad hoc reports to the "Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)"].
Fekete, S; Gerlach, M; Romanos, M, 2018
)
1.48
"Methylphenidate is known to produce some addiction-related gene regulation."( Selective serotonin re-uptake inhibitors potentiate gene blunting induced by repeated methylphenidate treatment: Zif268 versus Homer1a.
Beverley, J; Steiner, H; Van Waes, V; Vandrevala, M, 2014
)
1.35
"Methylphenidate did not enhance the psychotropic effects of MDMA, although it produced psychostimulant effects on its own."( Pharmacokinetic and pharmacodynamic effects of methylphenidate and MDMA administered alone or in combination.
Donzelli, M; Grouzmann, E; Hysek, CM; Liechti, ME; Meyer, N; Schillinger, N; Schmid, Y; Simmler, LD, 2014
)
1.38
"Methylphenidate (MPH) plays a principal role in the multimodal treatment of attention-deficit/hyperactivity disorder (ADHD). "( An evaluation of the pharmacokinetics of methylphenidate for the treatment of attention-deficit/ hyperactivity disorder.
Banaschewski, T; Döpfner, M; Frölich, J; Görtz-Dorten, A, 2014
)
2.11
"Methylphenidate alone can produce gene regulation effects that mimic addiction-related gene regulation by cocaine, consistent with its moderate addiction liability."( Fluoxetine potentiation of methylphenidate-induced gene regulation in striatal output pathways: potential role for 5-HT1B receptor.
Beverley, JA; Ehrlich, S; Steiner, H; Van Waes, V, 2015
)
1.44
"Methylphenidate dose and SHSS increase were negatively correlated with baseline SHSS scores."( Methylphenidate facilitates hypnotizability in adults with ADHD: a naturalistic cohort study.
Abramowitz, EG; Bonne, O; Lotan, A, 2015
)
2.58
"Methylphenidate caused an increase in the alveolar diameter of rats, which was compatible with human pulmonary emphysema."( Pulmonary emphysema induced by methylphenidate: experimental study.
Antoniolli, A; Facco, G; Pazetti, R; Pêgo-Fernandes, PM; Pereira, DM; Rapello, GV,
)
1.86
"Methylphenidate, which inhibit dopamine transporter is effective in the treatment of ADHD (attention deficit hyperactivity disorder), but long term use of this drug is often associated with addiction and dependence. "( Attenuation of methylphenidate-induced sensitization by co-administration of buspirone.
Alam, N; Naeem, S; Najam, R, 2016
)
2.23
"Methylphenidate causes an increase in HR as well as increases in both systolic and diastolic BP, but no change in cardiac depolarisation and repolarisation duration or homogeneity."( The effect of sympathomimetic medication on cardiovascular functioning of children with attention-deficit/hyperactivity disorder.
Crafford, D; Negrao, BL; Viljoen, M,
)
1.57
"Methylphenidate appears to cause minor increases in BP and HR."( Cardiovascular effects of methylphenidate, amphetamines and atomoxetine in the treatment of attention-deficit hyperactivity disorder.
Besag, FM; Stiefel, G, 2010
)
1.38
"Methylphenidate can enhance cognitive performance in ADHD patients thus evaluating their IQ scores, although the effect size seems to be relatively small. "( Effect of methylphenidate on intelligence quotient scores in Chinese children with attention-deficit/hyperactivity disorder.
Jin, X; Zhang, L; Zhang, Y, 2011
)
2.21
"Methylphenidate displays a high degree of effectiveness and safety in the treatment of adults at doses of around 1 mg/kg/day."( [Diagnosis and treatment of attention deficit hyperactivity disorder in adults].
Bosch, R; Casas, M; Chalita, PJ; Palomar, G; Prats, L; Ramos-Quiroga, JA; Vidal, R, 2012
)
1.1
"Methylphenidate led to an increase in activation in this region but had no effect on task performance."( The effects of methylphenidate on neural systems of attention in attention deficit hyperactivity disorder.
Gore, JC; Marchione, KE; Shafritz, KM; Shaywitz, BA; Shaywitz, SE, 2004
)
1.4
"Methylphenidate did not produce any changes in coherence values."( Effects of methylphenidate on EEG coherence in attention-deficit/hyperactivity disorder.
Abbott, I; Barry, RJ; Clarke, AR; Croft, RJ; Hsu, CI; Johnstone, SJ; Lawrence, CA; Magee, CA; McCarthy, R; Selikowitz, M, 2005
)
1.44
"dl-Methylphenidate did not inhibit dextrorphan formation in either microsome preparation, and dl-methylphenidate metabolism was unaffected by dextromethorphan or dextrorphan."( Potential interactions of methylphenidate and atomoxetine with dextromethorphan.
Ciccone, PE; Jessen, LM; Ramabadran, K,
)
0.95
"Methylphenidate tended to increase the time "on" as measured by tapping (P = .09) but not by walking time or dyskinesia scores (P = .40 and .42, respectively). "( Effects of methylphenidate on response to oral levodopa: a double-blind clinical trial.
Carlson, NE; Carter, JH; Nutt, JG, 2007
)
2.17
"Methylphenidate promotes a dose-dependent behavioral profile that is very comparable to that of amphetamine. "( Effects of methylphenidate on extracellular dopamine, serotonin, and norepinephrine: comparison with amphetamine.
Kuczenski, R; Segal, DS, 1997
)
2.13
"Methylphenidate did not increase cocaine craving nor ratings suggesting abuse potential (i.e., Morphine-Benzedrine Group or drug-liking scores, etc.)."( Laboratory measures of methylphenidate effects in cocaine-dependent patients receiving treatment.
Creson, DL; Grabowski, J; Rhoades, HM; Roache, JD; Schmitz, JM, 2000
)
1.34
"Methylphenidate can enhance cognitive performance in adults and children diagnosed with AD/HD (Kempton et al., 1999; Riordan et al., 1999) and also in normal human volunteers on tasks sensitive to frontal lobe damage, including aspects of spatial working memory (SWM) performance (Elliott et al., 1997)."( Methylphenidate enhances working memory by modulating discrete frontal and parietal lobe regions in the human brain.
Mavaddat, N; Mehta, MA; Owen, AM; Pickard, JD; Robbins, TW; Sahakian, BJ, 2000
)
2.47
"Methylphenidate produced an increase in psychopathology reflected by a worsening of both positive and negative symptoms."( Behavioral response to methylphenidate and treatment outcome in first episode schizophrenia.
Alvir, JM; Geisler, S; Jody, D; Lieberman, JA; Szymanski, S, 1990
)
1.31

Treatment

Methylphenidate (MPH) is the treatment of first choice for developmental ADHD. Treatment with methylphenidate at dosages ranging from 2.5 mg/day to 20mg/day produced mild to marked improvement in 54% of the patients.

ExcerptReferenceRelevance
"Methylphenidate (MPH) is the treatment of first choice for developmental ADHD. "( Moderators and Other Predictors of Methylphenidate Response in Children and Adolescents with ADHD.
D'Aiello, B; De Rossi, P; Di Vara, S; Menghini, D; Pretelli, I; Vicari, S, 2022
)
2.44
"Methylphenidate treatment was effective in improving daytime sleepiness in NT1 patients with ADHD (PSQ, 16.7 ± 2.1 vs 13.5 ± 1.9, p<0.05) but was ineffective on ADHD symptoms (ADHD-RS, 25.3 ± 9.1 vs 26.4 ± 8.9, p>0.05)."( A comparison of mood, quality of life and executive function among narcolepsy type 1 patients with or without ADHD symptoms in China.
Dong, X; Han, F; Li, C; Qu, S; Wang, M; Wang, P; Xu, L, 2022
)
1.44
"Methylphenidate, a first-line treatment for attention-deficit/hyperactivity disorder (ADHD), is thought to influence dopaminergic neurotransmission in the nucleus accumbens (NAc) and its associated brain circuitry, but this hypothesis has yet to be systematically tested."( Methylphenidate Enhances Spontaneous Fluctuations in Reward and Cognitive Control Networks in Children With Attention-Deficit/Hyperactivity Disorder.
Cai, W; Makita, K; Menon, V; Mizuno, Y; Silk, TJ; Supekar, K; Takiguchi, S; Tomoda, A, 2023
)
3.8
"Methylphenidate treatment may lower the risk of all-cause fractures from both study designs; however, further evidence is needed about the treatment duration and sex effect. "( Treatment with methylphenidate and the risk of fractures among children and young people: A systematic review and self-controlled case series study.
Cheung, CL; Coghill, D; Fan, M; Gao, L; Ge, GMQ; Ip, P; Lau, WCY; Man, KKC; Wong, ICK; Wong, KHTW, 2023
)
2.71
"Methylphenidate treatment duration ranged from 1 to 425 days, with a mean duration of 28.8 days."( Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD).
Callesen, HE; Darling Rasmussen, P; Gluud, C; Groth, C; Huus, CL; Kirubakaran, R; Pereira Ribeiro, J; Schaug, JP; Simonsen, E; Skoog, M; Storebø, OJ; Storm, MRO; Zwi, M, 2023
)
3.07
"Methylphenidate treatment was linked to lower risk for TBI in patients with ADHD and the inverse association was persistent among those with other comorbid mental disorders and epilepsy."( Methylphenidate and TBI in ADHD and co-occurring epilepsy and mental disorders: a self-controlled case series study.
Chen, VC; Chen, YL; Dewey, ME; Gossop, M; Lee, CT; Yang, YH, 2022
)
2.89
"Methylphenidate treatment improves the working memory, inhibitory control and mental flexibility of ADHD boys."( Attention-deficit/hyperactivity disorder: the impact of methylphenidate on working memory, inhibition capacity and mental flexibility.
Bolfer, C; Carreira, WS; Casella, BB; Casella, EB; Pacheco, SP; Tsunemi, MH, 2017
)
2.14
"Methylphenidate treatment does not have an effect on performance-based measures of delay aversion and executive functioning, but may have significant effects on self-reported delay aversion and executive functioning. "( Delay Aversion and Executive Functioning in Adults With Attention-Deficit/Hyperactivity Disorder: Before and After Stimulant Treatment.
Fagerlund, B; Glenthøj, B; Habekost, T; Jepsen, JRM; le Sommer, J; Low, AM; Sonuga-Barke, E; Vangkilde, S, 2018
)
1.92
"15 Methylphenidate (Mph)-treated and 15 Mph-free children of the ADHD-combined type and 17 control children performed a selective attention task with three feedback conditions: no-feedback, gain and loss. "( Processing of continuously provided punishment and reward in children with ADHD and the modulating effects of stimulant medication: an ERP study.
Althaus, M; Groen, Y; Tucha, O; Wijers, AA, 2013
)
1.01
"Methylphenidate treatment of apathy in Alzheimer's disease was associated with significant improvement in 2 of 3 efficacy outcomes and a trend toward improved global cognition with minimal adverse events, supporting the safety and efficacy of methylphenidate treatment for apathy in Alzheimer's disease."( Safety and efficacy of methylphenidate for apathy in Alzheimer's disease: a randomized, placebo-controlled trial.
Bachman, DL; Drye, LT; Herrmann, N; Lanctôt, KL; Mintzer, JE; Rosenberg, PB; Scherer, RW, 2013
)
2.14
"Methylphenidate treatment is effective for both ADHD and SSD symptoms. "( Attention-deficit/hyperactivity disorder and comorbid subsyndromal depression: what is the impact of methylphenidate on mood?
Golubchik, P; Kodesh, A; Weizman, A,
)
1.79
"Methylphenidate treatment reduces attention deficit hyperactivity disorder symptoms and the risk for relapse to substance use in criminal offenders with attention deficit hyperactivity disorder and substance dependence."( Methylphenidate for attention deficit hyperactivity disorder and drug relapse in criminal offenders with substance dependence: a 24-week randomized placebo-controlled trial.
Beck, O; Franck, J; Guterstam, J; Jayaram-Lindström, N; Konstenius, M; Philips, B, 2014
)
3.29
"Methylphenidate treatment for ADHD was associated with both symptom alleviation in children with ADHD and improvement in parental depressive mood and quality of life, suggesting that the effects of treatment could go beyond symptom improvement in ADHD."( Parental quality of life and depressive mood following methylphenidate treatment of children with attention-deficit hyperactivity disorder.
Chang, JS; Cho, SC; Hwang, JW; Kim, B; Kim, BN; Kim, Y, 2014
)
2.09
"Methylphenidate treatment did not affect patients' worst level of fatigue or other symptoms."( A randomized, double-blind, 2-period, placebo-controlled crossover trial of a sustained-release methylphenidate in the treatment of fatigue in cancer patients.
Alvarez, RH; Cleeland, C; Escalante, CP; Gonzalez-Angulo, AM; Holmes, H; Hwang, J; Liu, W; Manzullo, E; Mendoza, T; Meyers, C; Morrow, PK; Overman, M; Pisters, K; Qiao, W; Reuben, JM; Wang, X; Wang, XS,
)
1.07
"Methylphenidate treatment and higher cognitive level were associated with improved treatment outcome, while seizure freedom had no clear effect."( Comparing stimulant effects in youth with ADHD symptoms and epilepsy.
Azeem, MW; Biederman, J; Bourgeois, B; Gonzalez-Heydrich, J; Gumlak, S; Hickory, M; Hsin, O; Kimball, K; Mezzacappa, E; Mrakotsky, C; Rober, A; Torres, A, 2014
)
1.12
"Methylphenidate-based treatments must therefore be implemented after a specialist has evaluated the patient and be prescribed following the recommendations."( [Prescription of methylphenidate for children: importance of recommendations to limit misuse].
Amar, M; Bétaud, C; Chéron-Blümel, A; Grall-Bronnec, M; Jolliet, P; Péron, E; Victorri-Vigneau, C, 2014
)
1.46
"Methylphenidate treatment did not significantly change any parameter of sleep architecture."( Sleep in children with attention-deficit/hyperactivity disorder (ADHD) before and after 6-month treatment with methylphenidate: a pilot study.
Bagnasco, I; Cortese, S; Delia, G; Galloni, GB; Mana, M; Moletto, A; Vigliano, P, 2016
)
1.37
"OROS methylphenidate-treated subjects exhibited a significantly greater mean (SD) AISRS score improvement than placebo subjects (-17.1 [12.44] vs -11.7 [13.30]; P < .001)."( Randomized, 6-Week, Placebo-Controlled Study of Treatment for Adult Attention-Deficit/Hyperactivity Disorder: Individualized Dosing of Osmotic-Release Oral System (OROS) Methylphenidate With a Goal of Symptom Remission.
Armstrong, RB; Ascher, S; Goodman, DW; Ma, YW; Rostain, AL; Starr, HL, 2017
)
1.1
"OROS methylphenidate treatment with individualized doses titrated to achieve symptom remission demonstrated greater ADHD symptom reduction than placebo treatment. "( Randomized, 6-Week, Placebo-Controlled Study of Treatment for Adult Attention-Deficit/Hyperactivity Disorder: Individualized Dosing of Osmotic-Release Oral System (OROS) Methylphenidate With a Goal of Symptom Remission.
Armstrong, RB; Ascher, S; Goodman, DW; Ma, YW; Rostain, AL; Starr, HL, 2017
)
1.16
"Methylphenidate treatment for ADHD and CD has acute effects on these processes."( Acute effects of methylphenidate on impulsivity and attentional behavior among adolescents comorbid for ADHD and conduct disorder.
Acheson, A; Dougherty, DM; Hill-Kapturczak, N; Mathias, CW; Olvera, RL; Ryan, SR, 2016
)
1.5
"Methylphenidate (MPH) treatment in patients with attention-deficit/hyperactivity disorder (ADHD) is reported to reduce the risk for injuries. "( No Superiority of Treatment With Osmotic Controlled-Release Oral Delivery System-Methylphenidate Over Short/Medium-Acting Methylphenidate Preparations in the Rate and Timing of Injuries in Children With Attention-Deficit/Hyperactivity Disorder.
Golubchik, P; Kodesh, A; Weizman, A,
)
1.8
"Methylphenidate treatment is used for Attention Deficit Hyperactivity Disorder and can improve learning and memory. "( Methylphenidate amplifies long-term plasticity in the hippocampus via noradrenergic mechanisms.
Dommett, EJ; Greenfield, SA; Henderson, EL; Westwell, MS, 2008
)
3.23
"Methylphenidate is the treatment of choice in attention-deficit/hyperactivity disorder (ADHD). "( Desensitization to methylphenidate--the relevance of continued drug intake for a successful outcome.
Botelho, C; Cadinha, S; Castel-Branco, MG; Rodrigues, J,
)
1.9
"Methylphenidate treatment is equally efficient in children with isolated attention-deficit hyperactivity disorder and in children with attention-deficit hyperactivity disorder and epilepsy (70%-77%)."( Attention-deficit disorders and epilepsy in childhood: incidence, causative relations and treatment possibilities.
Goldberg-Stern, H; Kaufmann, R; Shuper, A, 2009
)
1.07
"Methylphenidate treatment however did not cause any differences in the number of labelled cells in any group."( Effect of postnatal methamphetamine trauma and adolescent methylphenidate treatment on adult hippocampal neurogenesis in gerbils.
Bagorda, F; Brummelte, S; Schaefers, AT; Teuchert-Noodt, G, 2009
)
1.32
"Methylphenidate (MPH) treatment in boys diagnosed with ADHD is reported to decrease the risk of drug abuse in adulthood. "( Cocaine responsiveness or anhedonia in rats treated with methylphenidate during adolescence.
Boctor, SY; Ferguson, SA,
)
1.82
"Methylphenidate treatment did not significantly affect height, weight, or overweight status."( Body mass index of children with attention-deficit/hyperactivity disorder.
Berger, I; Dubnov-Raz, G; Perry, A, 2011
)
1.09
"Methylphenidate-treated children with ADHD had more dyskinesia than children in the control group. "( Methylphenidate treatment and dyskinesia in children with attention-deficit/hyperactivity disorder.
Balázs, J; Czobor, P; Dallos, G; Gádoros, J; Keresztény, A, 2011
)
3.25
"Methylphenidate pretreatment reduced responding for methylphenidate in SHR but did not affect self-administration behaviors of Wistar rats (PR)."( Methylphenidate treatment in the spontaneously hypertensive rat: influence on methylphenidate self-administration and reinstatement in comparison with Wistar rats.
Cheong, JH; dela Peña, I; dela Peña, JB; Lee, JC; Ryu, JH; Shin, CY; Sohn, AR; Yoon, SY, 2012
)
2.54
"Methylphenidate treatment is recommended in cases when ADHD diagnosis was confirmed."( [Efficacy and safety of stimulants and non-stimulants in adults with attention deficit hyperactivity disorder (ADHD)].
Golubchik, P; Sever, J; Weizman, A, 2011
)
1.09
"Methylphenidate treatment, as assessed by teachers' ratings, resulted in a significant improvement in ADHD symptomatology (t = 2.29, df = 27, P < .05); however, a trend for improvement was noted only on the parents' ratings."( Efficacy of methylphenidate in patients with cerebral palsy and attention-deficit hyperactivity disorder (ADHD).
Badihi, N; Gross-Tsur, V; Manor, O; Shalev, RS, 2002
)
1.41
"Methylphenidate treatment also resulted in rCBF increase in superior prefrontal and reduction in ventral higher visual areas bilaterally."( Regional cerebral blood flow in children with attention deficit hyperactivity disorder: comparison before and after methylphenidate treatment.
Cho, SC; Chung, JK; Kang, E; Kim, BN; Kim, YK; Lee, DS; Lee, JS; Lee, MC, 2005
)
1.26
"Methylphenidate-treated animals and vehicle-treated animals yielded striatal equilibrium ratios (V''3) of 0.24+/-0.26 (mean +/- SD) and 1.09+/-0.42, respectively (t test, two-tailed, p<0.0001). "( Quantitation of dopamine transporter blockade by methylphenidate: first in vivo investigation using [123I]FP-CIT and a dedicated small animal SPECT.
Antke, C; Arkian, S; Larisch, R; Müller, HW; Nikolaus, S; Schramm, N; Wirrwar, A, 2005
)
2.03
"Methylphenidate treatment did not significantly affect SDS of height, weight, BMI, IGF-I and IGFBP-3 in the long run."( Height, weight, IGF-I, IGFBP-3 and thyroid functions in prepubertal children with attention deficit hyperactivity disorder: effect of methylphenidate treatment.
Bereket, A; Haklar, G; Karaman, MG; Ozbay, F; Turan, S; Yazgan, MY, 2005
)
1.25
"Methylphenidate treatment had no sustained effects on growth parameters, IGF-I and IGFBP-3 during the follow-up period of this study."( Height, weight, IGF-I, IGFBP-3 and thyroid functions in prepubertal children with attention deficit hyperactivity disorder: effect of methylphenidate treatment.
Bereket, A; Haklar, G; Karaman, MG; Ozbay, F; Turan, S; Yazgan, MY, 2005
)
1.25
"Methylphenidate is still the treatment of choice for the condition and, although it has been shown that neither methylphenidate nor other psychostimulants provoke seizures, there is still a possibility that seizure frequency may increase in children with active epilepsy."( Optimizing therapy of seizures in children and adolescents with ADHD.
Aldenkamp, AP; Arzimanoglou, A; Reijs, R; Van Mil, S, 2006
)
1.06
"Methylphenidate treatment resulted in improved information processing, e.g., better visu-motor coordination under high-stress conditions, improved visual orientation and sustained visual attention compared to baseline and our untreated control group."( Driving-related risks and impact of methylphenidate treatment on driving in adults with attention-deficit/hyperactivity disorder (ADHD).
Alm, B; Kettler, N; Mattern, R; Sabljic, D; Skopp, G; Sobanski, E; Strohbeck-Kühner, P, 2008
)
1.34
"In methylphenidate-treated patients, 4.3% discontinued due to adverse event; one serious adverse event was possibly related to study drug."( A randomized, placebo-controlled trial of three fixed dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder.
Buitelaar, JK; Casas, M; Kooij, JJ; Lee, E; Medori, R; Niemelä, A; Ramos-Quiroga, JA; Trott, GE, 2008
)
1.08
"Methylphenidate treatment produces an increase in dopamine (DA) signaling through multiple actions, including blockade of the DA reuptake transporter and amplification of DA response duration, disinhibition of DA D2 autoreceptors and amplification of DA tone, and activation of D1 receptors on the postsynaptic neuron."( Effects of methylphenidate on the catecholaminergic system in attention-deficit/hyperactivity disorder.
Wilens, TE, 2008
)
1.46
"The methylphenidate treated rats showed no change in sensitivity to atropine in the conditioned gustatory avoidance paradigm as compared to control rats which indicated that prior exposure to the nonspecific effects of a stimulant without monoaminergic alterations does not alter the sensitivity of atropine's avoidance-inducing properties."( Effects of methamphetamine on atropine-induced conditioned gustatory avoidance.
Preston, KL; Schuster, CR; Seiden, LS; Wagner, GC, 1984
)
0.75
"The methylphenidate-treated group consisted of 11 age-matched subjects with narcolepsy."( REM changes in narcolepsy with selegiline.
MacFarlane, JG; Reinish, LW; Sandor, P; Shapiro, CM, 1995
)
0.77
"Methylphenidate pretreatment decreased basal ganglia uptake but not cortical or cerebellar binding and reduced DVBG/DVCB by 62% and Bmax/Kd by 91%."( A new PET ligand for the dopamine transporter: studies in the human brain.
Ding, YS; Fowler, JS; Gatley, SJ; Logan, J; Pappas, N; Schlyer, DJ; Volkow, ND; Wang, GJ, 1995
)
1.01
"Methylphenidate treatment (3 mg/kg daily for 14 days) did not normalize the decreased electrically-stimulated release of [(3)H]dopamine from SHR caudate-putamen slices nor did it affect postsynaptic D(2) receptor function."( Methylphenidate affects striatal dopamine differently in an animal model for attention-deficit/hyperactivity disorder--the spontaneously hypertensive rat.
de Villiers, AS; Lamm, MC; Russell, VA; Sagvolden, T; Taljaard, JJ, 2000
)
2.47
"Methylphenidate-treated children showed significant weight loss but no significant changes in blood pressure or pulse."( Blood pressure and pulse changes in hyperactive children treated with imipramine and methylphenidate.
Greenberg, LM; Yellin, AM, 1975
)
1.2
"Methylphenidate treatment did not significantly alter serotonin or 5-hydroxyindoleacetic acid excretion."( Stimulants, urinary catecholamines, and indoleamines in hyperactivity. A comparison of methylphenidate and dextroamphetamine.
Brown, GL; Chuang, LW; Karoum, F; Linnoila, M; Rapoport, JL; Wyatt, RJ; Zametkin, AJ, 1985
)
1.21
"With methylphenidate treatment, the mean scores on the ADD-H Comprehensive Teacher Rating Scale displayed an increase in attention span and a decrease in hyperactivity, the Connors' Parent Rating Scale-Revised showed a significant decrease in ADD/H behavior, and the Gordon Diagnostic System mean scores indicated no significant change."( Parent, teacher, child. A trilateral approach to attention deficit disorder.
Atkinson, AW; Cohen, ML; Kelly, PC, 1989
)
0.73
"Methylphenidate treatment of illness-related, nonpsychotic depression in the elderly appears to be an effective, quick-acting, and relatively safe therapeutic option."( Elderly depressed females as a possible subgroup of patients responsive to methylphenidate.
Askinazi, C; Karamouz, N; Weintraub, RJ, 1986
)
1.22
"Treatment with methylphenidate is associated with clinically significant improvement of ADHD symptoms in 60-75% of patients."( Attention deficit/hyperactivity disorder and epilepsy.
Auvin, S; Rheims, S, 2021
)
0.96
"Treatment with methylphenidate and/or atomoxetine increased choice of the large, delayed reward in SHR/NCrl and Wistar rats and changed, in varying degrees, mRNA levels of Nr4a2, Btg2, and Homer2, genes with previously described roles in neuropsychiatric disorders characterized by impulsivity."( Methylphenidate and Atomoxetine-Responsive Prefrontal Cortical Genetic Overlaps in "Impulsive" SHR/NCrl and Wistar Rats.
Cheong, JH; de la Peña, JB; Dela Peña, I; Dela Peña, IJ; Han, DH; Kim, BN; Kim, HJ; Ryu, JH; Shin, CY, 2017
)
2.24
"Treatment with methylphenidate medication (mean dose 65.54 mg/d, SD=10.39) was not associated with improvements in performance-based measures of delay aversion and executive functioning compared to controls, although improvements in self-report executive functioning and delay aversion were found."( Delay Aversion and Executive Functioning in Adults With Attention-Deficit/Hyperactivity Disorder: Before and After Stimulant Treatment.
Fagerlund, B; Glenthøj, B; Habekost, T; Jepsen, JRM; le Sommer, J; Low, AM; Sonuga-Barke, E; Vangkilde, S, 2018
)
0.82
"Treatment with methylphenidate (5 mg/kg), the most commonly used medication for ADHD, improved attention and normalized expression levels of dopamine-related genes in THRSP OE mice."( Overexpression of the Thyroid Hormone-Responsive (THRSP) Gene in the Striatum Leads to the Development of Inattentive-like Phenotype in Mice.
Abiero, A; Botanas, CJ; Cheong, JH; Custodio, RJP; de la Peña, JB; Dela Peña, IJ; Kim, BN; Kim, HJ; Kim, M; Ryoo, ZY; Sayson, LV, 2018
)
0.82
"Treatment with methylphenidate, which blocks dopamine and noradrenaline transporters, is clinically efficacious in reducing the symptoms of ADHD."( Meta-analysis of the association between dopamine transporter genotype and response to methylphenidate treatment in ADHD.
Ettinger, U; Kambeitz, J; Romanos, M, 2014
)
0.96
"Pretreatment with methylphenidate significantly impaired novel object recognition in wild-type mice."( Methylphenidate restores novel object recognition in DARPP-32 knockout mice.
Fienberg, AA; Heyser, CJ; McNaughton, CH; Vishnevetsky, D, 2013
)
2.16
"Treatment with methylphenidate (MPD) has improved learning disabilities in ADHD by acting on neurotransmitters."( The effect of methylphenidate on neurofibromatosis type 1: a randomised, double-blind, placebo-controlled, crossover trial.
Bréant, V; Combemale, P; Coutinho, V; des Portes, V; Gérard, D; Ginhoux, T; Gueyffier, F; Herbillon, V; Kassaï, B; Kemlin, I; Lion-François, L; Mercier, C; Peyric, E; Pinson, S; Rodriguez, D, 2014
)
1.1
"Treatment with methylphenidate resulted in normalisation of the resting state to task activation pattern."( Normalisation of frontal theta activity following methylphenidate treatment in adult attention-deficit/hyperactivity disorder.
Asherson, P; Banaschewski, T; Brandeis, D; Kuntsi, J; McLoughlin, G; Skirrow, C, 2015
)
1.01
"Treatment with methylphenidate or atomoxetine based on prescription data."( Injury prevention by medication among children with attention-deficit/hyperactivity disorder: a case-only study.
Garbe, E; Horn, J; Langner, I; Lindemann, C; Mikolajczyk, R; Schmedt, N, 2015
)
0.77
"Is treatment with methylphenidate associated with benefits or harms for children and adolescents with attention-deficit/hyperactivity disorder (ADHD)?"( Methylphenidate for Attention-Deficit/Hyperactivity Disorder in Children and Adolescents.
Gluud, C; Simonsen, E; Storebø, OJ, 2016
)
2.21
"The treatment with methylphenidate (10mg/kg, ip) increased locomotion in the open field test."( Lithium and valproate prevent methylphenidate-induced mania-like behaviors in the hole board test.
Asth, L; Gavioli, EC; Lobão-Soares, B; Medeiros, IU; Santos, WB; Silva, EF; Soares-Rachetti, VP; Souza, LS, 2016
)
1.04
"The treatment with methylphenidate had no beneficial effect on the rats' performance regardless of the DSP4 treatment."( Effects of methylphenidate on attention in Wistar rats treated with the neurotoxin N-(2-chloroethyl)-N-ethyl-2-bromobenzylamine (DSP4).
Hauser, J; Lange, KW; Reissmann, A; Sontag, TA; Tucha, O, 2017
)
1.16
"Treatment with methylphenidate at an early age (P21 to P35) did not alter ethanol consumption in adult SHR or WKY, suggesting that it does not increase susceptibility to ethanol addiction in these rats."( Methylphenidate does not increase ethanol consumption in a rat model for attention-deficit hyperactivity disorder-the spontaneously hypertensive rat.
Howells, FM; Russell, VA; Soeters, HS, 2008
)
2.13
"Treatment with methylphenidate, which disrupts social play behavior in adolescent rats, but not social exploratory behavior, prevented the development of socially-induced CPP."( Conditioned place preference induced by social play behavior: parametrics, extinction, reinstatement and disruption by methylphenidate.
Damsteegt, R; Trezza, V; Vanderschuren, LJ, 2009
)
0.9
"Treatment with methylphenidate has been shown to induce improvements of various attentional functions."( [Graphomotor functions in children with attention deficit hyperactivity disorder (ADHD)].
Lange, KW; Stasik, D; Tucha, L; Tucha, O; Walitza, S,
)
0.47
"Treatment with methylphenidate has long been considered as a first choice for disabling forms of ADHD, but recent data do not show evidence for superiority of methylphenidate compared to non pharmacological approach at long-term."( [Attention deficit disorder in childhood].
Van Bogaert, P, 2009
)
0.69
"Treatment with methylphenidate normalises this threshold, rendering their pattern of task-related DMN deactivation indistinguishable from that of typically developing children."( Task-related default mode network modulation and inhibitory control in ADHD: effects of motivation and methylphenidate.
Batty, MJ; Groom, MJ; Hollis, C; Liddle, EB; Liddle, PF; Liotti, M; Scerif, G; Totman, JJ, 2011
)
0.92
"Pretreatment with methylphenidate (0.56 mg/kg) did not significantly alter methamphetamine self-administration."( Comparison of the effects of methamphetamine, bupropion, and methylphenidate on the self-administration of methamphetamine by rhesus monkeys.
Gilman, JP; Goldberg, SR; McCann, DJ; Panlilio, LV; Schindler, CW, 2011
)
0.93
"Treatment with methylphenidate showed a significant change in median scores on the Daytime Sleepiness Scale (-3.0 vs -0.5; P = 0.003) and the Epworth Sleepiness Scale (-3.0 vs -1.5; P = 0.039)."( Efficacy and tolerability of a 20-mg dose of methylphenidate for the treatment of daytime sleepiness in adult patients with myotonic dystrophy type 1: a 2-center, randomized, double-blind, placebo-controlled, 3-week crossover trial.
Bouchard, JP; Mathieu, J; Puymirat, J, 2012
)
0.98
"Treatment with methylphenidate or nisoxetine ameliorated CAR impairments in DAT-KO mice."( Impaired cliff avoidance reaction in dopamine transporter knockout mice.
Hall, FS; Kasahara, Y; Kobayashi, H; Numachi, Y; Sakakibara, Y; Sora, I; Uchiumi, O; Uhl, GR; Yamashita, M; Yoshida, S, 2013
)
0.73
"Treatment with methylphenidate (MPH) entails a dependency risk as MPH is a psychotropic drug."( [Methylphenidate prescriptions in the city of Cologne: overrepresentation of privately insured patients. Results of an analysis based on prescription data].
Bessou, H; Puteanus, U; Zeeb, H, 2007
)
1.59
"Treatment with methylphenidate (MPH) in the United States has increased to a current prescription rate of > 5 million per year."( Does methylphenidate cause a cytogenetic effect in children with attention deficit hyperactivity disorder?
Gerlach, M; Romanos, M; Stopper, H; Walitza, S; Warnke, A; Werner, B, 2007
)
1.19
"Treatment with methylphenidate resulted in increased sleep efficiency as well as a subjective feeling of improved restorative value of sleep."( Sleep in adults with attention deficit hyperactivity disorder (ADHD) before and during treatment with methylphenidate: a controlled polysomnographic study.
Alm, B; Kettler, N; Schredl, M; Sobanski, E, 2008
)
0.9
"Treatment with methylphenidate resulted in marked reductions of hyperactive, disruptive, and aggressive behavior, which was evident even for the 0.1 mg/kg dose."( School observations of children with attention-deficit hyperactivity disorder and comorbid tic disorder: effects of methylphenidate treatment.
Gadow, KD; Nolan, E; Sprafkin, J; Sverd, J, 1995
)
0.84
"Pretreatment with methylphenidate decreased binding only in striatum (40%)."( Is methylphenidate like cocaine? Studies on their pharmacokinetics and distribution in the human brain.
Ashby, C; Dewey, S; Ding, YS; Fowler, JS; Gatley, JS; Hitzemann, R; Liebermann, J; Logan, J; Volkow, ND; Wang, GJ, 1995
)
1.24
"Treatment with methylphenidate resulted in complete resolution of symptoms in two patients and significant improvement in the other two."( Consideration of narcolepsy in the differential diagnosis of chronic fatigue syndrome.
Ambrogetti, A; Olson, LG, 1994
)
0.64
"Treatment with methylphenidate may provide neurostimulations by augmenting the activity of injured neuronal tissue within the reticular activating system, and by amplifying the net effect of the reduced number of viable neurons."( Methylphenidate in the treatment of coma.
Comfort, M; Fetters, MD; Worzniak, M, 1997
)
2.08
"Pretreatment with methylphenidate reduced the specific binding of [99mTc]TRODAT-1 to DAT sites [(STR-CB)/CB] from 2.45+/-0.13 to 0.32+/-0.04 without any effect on its binding to SERT sites [(MB-CB)/CB], which was confirmed by the co-registration of the [11C](+)McN5652/PET scans."( In vivo imaging of serotonin transporters with [99mTc]TRODAT-1 in nonhuman primates.
Dresel, SH; Hou, C; Huang, X; Karp, J; Kung, HF; Kung, MP; Plössl, K; Shiue, CY, 1999
)
0.63
"Treatment with methylphenidate has been advocated in patients with traumatic brain injury and stroke, cancer patients, and those with human immunodeficiency virus infection."( Methylphenidate: its pharmacology and uses.
Challman, TD; Lipsky, JJ, 2000
)
2.09
"Treatment with methylphenidate was more effective and better tolerated than treatment with clonidine."( [Functioning, comorbidity and treatment of 141 adults with attention deficit hyperactivity disorder (ADHD) at a psychiatric outpatient department].
Aeckerlin, LP; Buitelaar, JK; Kooij, JJ, 2001
)
0.65
"Treatment with methylphenidate and clomipramine was effective; methylphenidate (30 mg/day) improved his wakefulness and alertness throughout the day, and clomipramine (20 mg/day) reduced the number of cataplexic episodes."( [Narcolepsy in a prepubertal boy].
Chang, S; Ishikawa, T; Mizuno, K; Tsukamoto, H, 2001
)
0.65
"Treatment with methylphenidate at dosages ranging from 2.5 mg/day to 20 mg/day produced mild to marked improvement in 54% of the patients; the fact that 6 of the 7 responders were female may be indicative of a more responsive subgroup."( Elderly depressed females as a possible subgroup of patients responsive to methylphenidate.
Askinazi, C; Karamouz, N; Weintraub, RJ, 1986
)
0.84

Toxicity

Sleep problems is the most common side effect of methylphenidate (MPH) treatment in ADHD youth and carry potential to negatively impact long-term self-regulatory functioning. Among the machine learning models using SNS data to analyze the adverse effects and nonmedical use, the random forest model had the highest performance.

ExcerptReferenceRelevance
"2 years) meeting DSM-III-R criteria for major depression were followed-up during a 3-week efficacy and side effect trial involving methylphenidate."( Efficacy and side effects of methylphenidate for poststroke depression.
Abassian, M; Fawcett, J; Groves, L; Hartman, C; Kartan, U; Lazarus, LW; Lingam, VR; Neyman, I; Winemiller, DR, 1992
)
0.78
"Results of this methylphenidate trial for poststroke depression in elderly patients suggest that it is a safe and effective treatment for poststroke depression."( Efficacy and side effects of methylphenidate for poststroke depression.
Abassian, M; Fawcett, J; Groves, L; Hartman, C; Kartan, U; Lazarus, LW; Lingam, VR; Neyman, I; Winemiller, DR, 1992
)
0.92
"The adverse side effects of methylphenidate were evaluated in 27 children with attention deficit hyperactivity disorder and IQs of 48 to 74 who participated in a double-blind study of two doses of methylphenidate and placebo."( Adverse side effects of methylphenidate among mentally retarded children with ADHD.
Breaux, AM; Feldman, H; Gosling, A; Handen, BL; McAuliffe, S, 1991
)
0.88
" Side effect ratings and EKGs were done weekly."( Side effects of methylphenidate and desipramine alone and in combination in children.
Biancaniello, TM; Carlson, GA; Kelly, KL; Pataki, CS; Rapport, MD, 1993
)
0.63
"Methylphenidate is effective in treating children with epilepsy and ADHD and safe in children who are seizure free."( Epilepsy and attention deficit hyperactivity disorder: is methylphenidate safe and effective?
Gross-Tsur, V; Joseph, A; Manor, O; Shalev, RS; van der Meere, J, 1997
)
1.98
" It is both well tolerated and efficacious in the treatment of attention deficit hyperactivity disorder, and is associated with few serious adverse effects."( Safety issues in the use of methylphenidate. An American perspective.
Rappley, MD, 1997
)
0.59
"To compare the side effect profiles of methylphenidate (MPH) and dexamphetamine (DEX) in children with attention deficit hyperactivity disorder (ADHD), as well as to determine which symptoms are genuine adverse effects of stimulant medication, as opposed to aspects of the child's underlying behavioral phenotype."( Side effects of methylphenidate and dexamphetamine in children with attention deficit hyperactivity disorder: a double-blind, crossover trial.
Barker, M; Efron, D; Jarman, F, 1997
)
0.91
" Overall, both MPH and DEX were well tolerated by most subjects, with only four subjects discontinuing the trial period because of severe adverse effects (2 -1."( Side effects of methylphenidate and dexamphetamine in children with attention deficit hyperactivity disorder: a double-blind, crossover trial.
Barker, M; Efron, D; Jarman, F, 1997
)
0.64
"Methylphenidate is effective in treating children with epilepsy and ADHD and safe in children who are seizure free."( Epilepsy and attention deficit hyperactivity disorder: is methylphenidate safe and effective?
Gross-Tsur, V; Joseph, A; Manor, O; Shalev, RS; van der Meere, J, 1997
)
1.98
" In general, methylphenidate was tolerated relatively well, with no children withdrawing because of adverse effects."( Short-term side effects of stimulant medication are increased in preschool children with attention-deficit/hyperactivity disorder: a double-blind placebo-controlled study.
Bennett, S; Firestone, P; Mercer, J; Musten, LM; Pisterman, S, 1998
)
0.67
" Methylphenidate also has an adverse event profile that requires consideration."( How efficacious and safe is short-acting methylphenidate for the treatment of attention-deficit disorder in children and adolescents? A meta-analysis.
King, J; Langford, S; Moher, D; Pham, B; Schachter, HM, 2001
)
1.49
" Neither compound produced any other significant adverse findings in F0 and F1 generation rats at doses that were at least 25 times the maximum daily human therapeutic dose."( The perinatal and postnatal toxicity of D-methylphenidate and D,L-methylphenidate in rats.
Christian, MS; Hoberman, AM; Khetani, VD; Stirling, DI; Teo, SK; Thomas, SD,
)
0.4
" Based on body weight changes, the no observed adverse effect level for D-MPH in rats was 20 mg/kg."( A 90-day oral gavage toxicity study of D-methylphenidate and D,L-methylphenidate in Sprague-Dawley rats.
Hoberman, A; Khetani, V; Kiorpes, A; Stirling, D; Teo, S; Thomas, S, 2002
)
0.58
" These initial efficacy and side effect studies in the LSP provided missing information about the basic pharmacokinetic (PK) and pharmacodynamic (PD) properties of MPH and AMP and produced some new discoveries (i."( The use of a laboratory school protocol to evaluate concepts about efficacy and side effects of new formulations of stimulant medications.
Freid, J; Greenhill, L; Lerner, M; Posner, K; Steinhoff, K; Swanson, JM; Wigal, S; Wigal, T, 2002
)
0.31
" Adverse events were recorded throughout the study, and Epworth Sleepiness Scale scores were determined at the end of the study."( Initiating treatment with modafinil for control of excessive daytime sleepiness in patients switching from methylphenidate: an open-label safety study assessing three strategies.
Hayduk, R; Kovacevic-Ristanovic, R; Schwartz, JR; Thorpy, MJ, 2003
)
0.53
" All three switching strategies were well tolerated, with adverse events mild or moderate in nature."( Initiating treatment with modafinil for control of excessive daytime sleepiness in patients switching from methylphenidate: an open-label safety study assessing three strategies.
Hayduk, R; Kovacevic-Ristanovic, R; Schwartz, JR; Thorpy, MJ, 2003
)
0.53
" Adverse events were monitored throughout the study."( Efficacy and safety of modafinil for improving daytime wakefulness in patients treated previously with psychostimulants.
Feldman, NT; Fry, JM; Harsh, J; Schwartz, JR, 2003
)
0.32
" The most frequent adverse events were headache, nausea, and insomnia; the majority of adverse events were mild or moderate in nature."( Efficacy and safety of modafinil for improving daytime wakefulness in patients treated previously with psychostimulants.
Feldman, NT; Fry, JM; Harsh, J; Schwartz, JR, 2003
)
0.32
" Children with ADHD treated with stimulants for as long as 2 years continue to benefit from the treatment, with improvements observed in ADHD symptoms, comorbid oppositional defiant disorder, and academic and social functioning, with no significant problems of tolerance or adverse effects."( Long-term use of stimulants in children with attention deficit hyperactivity disorder: safety, efficacy, and long-term outcome.
Greenfield, B; Hechtman, L, 2003
)
0.32
" The adverse events reported were generally mild or moderate, and were similar in both groups."( Efficacy and safety of Ritalin LA, a new, once daily, extended-release dosage form of methylphenidate, in children with attention deficit hyperactivity disorder.
Biederman, J; Edson, K; Karlsson, G; Markabi, S; Pohlmann, H; Quinn, D; Weidenman, M; Weiss, M; Wigal, S, 2003
)
0.54
"To study methylphenidate's adverse effects and impact on vital signs within the adult traumatic brain injury population."( Effect of methylphenidate on vital signs and adverse effects in adults with traumatic brain injury.
Alban, JP; Hopson, MM; Ly, V; Whyte, J, 2004
)
1.14
" Participants filled out weekly questionnaires pertaining to the adverse effects."( Effect of methylphenidate on vital signs and adverse effects in adults with traumatic brain injury.
Alban, JP; Hopson, MM; Ly, V; Whyte, J, 2004
)
0.73
"Poor appetite was the only adverse effect related to methylphenidate."( Effect of methylphenidate on vital signs and adverse effects in adults with traumatic brain injury.
Alban, JP; Hopson, MM; Ly, V; Whyte, J, 2004
)
0.98
"Methylphenidate appears to be safe for the adult population with traumatic brain injury."( Effect of methylphenidate on vital signs and adverse effects in adults with traumatic brain injury.
Alban, JP; Hopson, MM; Ly, V; Whyte, J, 2004
)
2.17
"To evaluate the impact of adherence and medication status on effectiveness and adverse effects of stimulant use in children with attention-deficit/hyperactivity disorder (ADHD) over 5 years."( Stimulant treatment over five years: adherence, effectiveness, and adverse effects.
Charach, A; Ickowicz, A; Schachar, R, 2004
)
0.32
" Adherence to stimulants, treatment response, and adverse effects were evaluated annually for 5 years."( Stimulant treatment over five years: adherence, effectiveness, and adverse effects.
Charach, A; Ickowicz, A; Schachar, R, 2004
)
0.32
" Clinically significant adverse effects were present for 5 years, most commonly loss of appetite."( Stimulant treatment over five years: adherence, effectiveness, and adverse effects.
Charach, A; Ickowicz, A; Schachar, R, 2004
)
0.32
"Psychostimulants improve ADHD symptoms for up to 5 years, but adverse effects persist."( Stimulant treatment over five years: adherence, effectiveness, and adverse effects.
Charach, A; Ickowicz, A; Schachar, R, 2004
)
0.32
"The aim of this study was to investigate the effects of ongoing methylphenidate (MPH) on ADHD-related and autistic symptoms in Pervasive Developmental Disorders (PDD) in children who did not present any adverse effects to an initial acute dose administered at the clinic."( Methylphenidate for pervasive developmental disorders: safety and efficacy of acute single dose test and ongoing therapy: an open-pilot study.
Cianchetti, C; Di Martino, A; Melis, G; Zuddas, A, 2004
)
2
" No significant adverse effects were observed in any of the 8 subjects."( Methylphenidate for pervasive developmental disorders: safety and efficacy of acute single dose test and ongoing therapy: an open-pilot study.
Cianchetti, C; Di Martino, A; Melis, G; Zuddas, A, 2004
)
1.77
" Although the overall percentage of subjects having any side effect on both methylphenidate and placebo was rather high, side effects on methylphenidate over and above those on placebo were few and mild."( Efficacy and safety of methylphenidate in 45 adults with attention-deficit/hyperactivity disorder. A randomized placebo-controlled double-blind cross-over trial.
Boonstra, AM; Buitelaar, JK; Burger, H; Kalma, LE; Kooij, JJ; Van der Linden, PD, 2004
)
0.86
" None of the patients with comorbid epilepsy experienced adverse effects on seizure control or antiepileptic drug use."( Effectiveness and safety of methylphenidate in adult attention deficit hyperactivity disorder in patients with epilepsy: an open treatment trial.
Aldenkamp, AP; van der Feltz-Cornelis, CM, 2006
)
0.63
" It was effective against adult ADHD, and there were no adverse effects on seizure severity and frequency."( Effectiveness and safety of methylphenidate in adult attention deficit hyperactivity disorder in patients with epilepsy: an open treatment trial.
Aldenkamp, AP; van der Feltz-Cornelis, CM, 2006
)
0.63
" Headache, anorexia, and insomnia were the most frequently reported treatment-related adverse events."( Once-daily OROS methylphenidate is safe and well tolerated in adolescents with attention-deficit/hyperactivity disorder.
Bukstein, O; Greenhill, L; Lerner, M; McBurnett, K; McGough, JJ; Stein, M; Wilens, TE, 2006
)
0.68
"5%) spontaneously reported adverse events suspected as drug related."( Efficacy and safety of dexmethylphenidate extended-release capsules in children with attention-deficit/hyperactivity disorder.
Ball, RR; Greenhill, LL; Jiang, H; Levine, A; Muniz, R; Pestreich, L, 2006
)
0.63
" Pulse, blood pressure, and the presence of treatment emergent adverse events (AEs), parent and teacher AE ratings, and vital signs were recorded in each phase."( Safety and tolerability of methylphenidate in preschool children with ADHD.
Abikoff, H; Chuang, S; Davies, M; Ghuman, J; Greenhill, L; Kollins, S; McCRACKEN, J; McGOUGH, J; Posner, K; Riddle, M; Skrobala, A; Stehli, A; Swanson, J; Thorp, B; Vitiello, B; Wigal, S; Wigal, T, 2006
)
0.63
"Once-daily d-MPH-ER at 20 mg, 30 mg, or 40 mg is a safe and effective treatment for adults with ADHD."( Efficacy and safety of dexmethylphenidate extended-release capsules in adults with attention-deficit/hyperactivity disorder.
Adler, LA; Jiang, H; McGough, JJ; Muniz, R; Pestreich, L; Spencer, TJ, 2007
)
0.64
" Groups were compared regarding adverse events and changes from baseline to week 16 in electrocardiograms and vital signs."( Clonidine for attention-deficit/hyperactivity disorder: II. ECG changes and adverse events analysis.
Bukstein, OG; Daviss, WB; Harris, P; McDERMOTT, MP; Palumbo, D; Patel, NC; Pelham, WE; Robb, AS; Sallee, FR, 2008
)
0.35
" Moderate or severe adverse events were more common in subjects on clonidine (79."( Clonidine for attention-deficit/hyperactivity disorder: II. ECG changes and adverse events analysis.
Bukstein, OG; Daviss, WB; Harris, P; McDERMOTT, MP; Palumbo, D; Patel, NC; Pelham, WE; Robb, AS; Sallee, FR, 2008
)
0.35
"Clonidine, used alone or with methylphenidate, appears safe and well tolerated in childhood ADHD."( Clonidine for attention-deficit/hyperactivity disorder: II. ECG changes and adverse events analysis.
Bukstein, OG; Daviss, WB; Harris, P; McDERMOTT, MP; Palumbo, D; Patel, NC; Pelham, WE; Robb, AS; Sallee, FR, 2008
)
0.63
" Similar side effect profile, superior adherence, and improved efficacy were demonstrated in intra-individual comparison of the OROS and IR methylphenidate forms."( National survey of adherence, efficacy, and side effects of methylphenidate in children with attention-deficit/hyperactivity disorder in Taiwan.
Chang, HL; Chen, SJ; Cheng, H; Chou, MC; Chou, WJ; Gau, SS; Hsu, YC; Huang, YF; Huang, YS; Liang, HY; Lu, HH; Tang, CS; Tzang, RF; Wu, YY, 2008
)
0.79
" Adverse events and vital signs were assessed."( Long-term, open-label safety and efficacy of atomoxetine in adults with ADHD: final report of a 4-year study.
Adler, LA; Michelson, D; Moore, RJ; Spencer, TJ; Williams, DW, 2008
)
0.35
" Adverse events consisted primarily of pharmacologically (noradrenergic) expected effects."( Long-term, open-label safety and efficacy of atomoxetine in adults with ADHD: final report of a 4-year study.
Adler, LA; Michelson, D; Moore, RJ; Spencer, TJ; Williams, DW, 2008
)
0.35
" There is little information on the long-term safety of methylphenidate in adults, although the number of serious adverse effects reported to regulatory authorities has, so far, been low."( Safety of therapeutic methylphenidate in adults: a systematic review of the evidence.
Godfrey, J, 2009
)
0.91
" Adverse events were monitored throughout the study period."( Efficacy and safety of extended-release dexmethylphenidate compared with d,l-methylphenidate and placebo in the treatment of children with attention-deficit/hyperactivity disorder: a 12-hour laboratory classroom study.
Brams, M; Mao, A; McCague, K; Muniz, R; Pestreich, L; Silva, R, 2008
)
0.61
" d-MPH-ER was well tolerated; the most common adverse events (>15%) were headache, insomnia, and decreased appetite."( Long-term effectiveness and safety of dexmethylphenidate extended-release capsules in adult ADHD.
Adler, LA; Jiang, H; McGough, JJ; Muniz, R; Spencer, T, 2009
)
0.62
"Once-daily d-MPH-ER 20 to 40 mg is safe and effective for long-term treatment of adult ADHD."( Long-term effectiveness and safety of dexmethylphenidate extended-release capsules in adult ADHD.
Adler, LA; Jiang, H; McGough, JJ; Muniz, R; Spencer, T, 2009
)
0.62
" Other assessments included the Clinical Global Impressions-Improvement scale, a post hoc responder analysis, adverse events, and vital signs."( Efficacy and safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, double-blind, parallel group, dose-escalation study.
Adler, LA; Orman, C; Palumbo, J; Silber, S; Spencer, T; Starr, HL; Zimmerman, B, 2009
)
0.65
" Adverse events were reported by 93 (84."( Efficacy and safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, double-blind, parallel group, dose-escalation study.
Adler, LA; Orman, C; Palumbo, J; Silber, S; Spencer, T; Starr, HL; Zimmerman, B, 2009
)
0.65
" These changes did not, however, appear to be symptomatic, as no participants were withdrawn due to adverse events, and there was no significant self-report of increased heart rate with methylphenidate."( Safety of methylphenidate following traumatic brain injury: impact on vital signs and side-effects during inpatient rehabilitation.
Olver, J; Ponsford, J; Ponsford, M; Willmott, C, 2009
)
0.95
"3 mg/kg body weight appears to be safe in the inpatient rehabilitation phase."( Safety of methylphenidate following traumatic brain injury: impact on vital signs and side-effects during inpatient rehabilitation.
Olver, J; Ponsford, J; Ponsford, M; Willmott, C, 2009
)
0.76
"Safety concerns about central nervous system stimulants for the treatment of attention-deficit/hyperactivity disorder (ADHD) include adverse cardiac effects."( Cardiac safety of methylphenidate versus amphetamine salts in the treatment of ADHD.
Gerhard, T; Saidi, A; Shuster, J; Winterstein, AG, 2009
)
0.69
"To investigate the frequency and severity of side effects of methylphenidate among childhood survivors of acute lymphoblastic leukemia and brain tumors and identify predictors of higher adverse effect levels."( Side effects of methylphenidate in childhood cancer survivors: a randomized placebo-controlled trial.
Conklin, HM; Howard, SC; Jasper, BW; Khan, RB; Lawford, J; Morris, EB; Ogg, SW; Wu, S; Xiong, X, 2009
)
0.94
" Female gender and lower IQ were associated with higher adverse effect levels."( Side effects of methylphenidate in childhood cancer survivors: a randomized placebo-controlled trial.
Conklin, HM; Howard, SC; Jasper, BW; Khan, RB; Lawford, J; Morris, EB; Ogg, SW; Wu, S; Xiong, X, 2009
)
0.7
" Adverse events were mild to moderate in severity and similar to previous observations for this class of neurostimulants."( Efficacy and safety of dexmethylphenidate extended-release capsules administered once daily to children with attention-deficit/hyperactivity disorder.
Childress, AC; Gerstner, O; Lopez, F; Muniz, R; Post, A; Spencer, T; Thulasiraman, A, 2009
)
0.65
" Methylphenidate (MP) appears safe when used in the treatment of depression and fatigue in advanced cancer."( Methylphenidate side effects in advanced cancer: a retrospective analysis.
Davis, MP; Khoshknabi, DS; Lasheen, W; Mahmoud, F; Rivera, N; Walsh, D, 2010
)
2.71
" They are generally safe in special populations."( Safety of stimulant treatment in attention deficit hyperactivity disorder: Part I.
Kuchibhatla, A; Merkel, RL, 2009
)
0.35
"Safety assessments included adverse events (AEs), vital signs, physical examination, clinical laboratory tests, the Pediatric Daytime Sleepiness Scale, and the Pittsburgh Side Effects Rating Scale."( Safety and effectiveness of coadministration of guanfacine extended release and psychostimulants in children and adolescents with attention-deficit/hyperactivity disorder.
Ginsberg, LD; Greenbaum, M; Murphy, WR; Spencer, TJ, 2009
)
0.35
"Coadministration of GXR and MPH or AMP was generally safe and associated with statistically significant and clinically meaningful ADHD symptom improvement in children and adolescents."( Safety and effectiveness of coadministration of guanfacine extended release and psychostimulants in children and adolescents with attention-deficit/hyperactivity disorder.
Ginsberg, LD; Greenbaum, M; Murphy, WR; Spencer, TJ, 2009
)
0.35
" An understanding of structure-activity relationships (SARs) of chemicals can make a significant contribution to the identification of potential toxic effects early in the drug development process and aid in avoiding such problems."( Developing structure-activity relationships for the prediction of hepatotoxicity.
Fisk, L; Greene, N; Naven, RT; Note, RR; Patel, ML; Pelletier, DJ, 2010
)
0.36
" Despite their efficacy and long history of use, there is concern about their potential for adverse cardiovascular effects in children and adolescents."( Cardiovascular safety of stimulant medications for pediatric attention-deficit hyperactivity disorder.
Muniz, R; Silva, RR; Skimming, JW, 2010
)
0.36
" Intensity and frequency of adverse events were comparable between the two formulations."( A double-blind, randomized, placebo/active controlled crossover evaluation of the efficacy and safety of Ritalin ® LA in children with attention-deficit/hyperactivity disorder in a laboratory classroom setting.
Fleischhaker, C; Haessler, F; Heiser, P; Hennighausen, K; Huss, M; Klatt, J; Linder, M; Oehler, KU; Schmidt, M; Schulte-Markworth, M; Schulz, E; Sieder, C; Tracik, F; Warnke, A, 2010
)
0.36
" Physicians were presented with a hypothetical pharmaceutical cognitive enhancer that had been approved by the regulatory authorities for use in healthy adults, and was characterized as being safe, effective, and without significant adverse side effects."( Physician attitudes towards pharmacological cognitive enhancement: safety concerns are paramount.
Banjo, OC; Nadler, R; Reiner, PB, 2010
)
0.36
" Dosing began at 36 mg/d, with titration in 18-mg increments every 7 days until a predefined outcome (efficacy threshold, maximum dosage of 108 mg/d, or limiting adverse event)."( Long-term safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: an open-label, dose-titration, 1-year study.
Adler, LA; Berwaerts, J; Cooper, K; Harrison, DD; Orman, C; Palumbo, J; Silber, S; Starr, HL, 2011
)
0.67
" Most common adverse events included decreased appetite (26."( Long-term safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: an open-label, dose-titration, 1-year study.
Adler, LA; Berwaerts, J; Cooper, K; Harrison, DD; Orman, C; Palumbo, J; Silber, S; Starr, HL, 2011
)
0.67
" The adverse events related to the therapy with IR-MPH, OROS-MPH or AHC were mild and the incidence rates of adverse events were not significantly different among the three groups."( [Effectiveness and safety of methylphenidate and atomoxetine for attention deficit hyperactivity disorder: a systematic review].
Lv, XZ; Shu, Z; Wu, SS; Zhan, SY; Zhang, YW, 2011
)
0.66
"16% of patients permanently discontinued treatment due to adverse events."( An observational study of once-daily modified-release methylphenidate in ADHD: effectiveness on symptoms and impairment, and safety.
Breuer, D; Döpfner, M; Görtz-Dorten, A; Rothenberger, A, 2011
)
0.62
"Psychostimulants are effective treatments for attention-deficit/hyperactivity disorder (ADHD) but may be associated with euphoric effects, misuse/diversion, and adverse effects."( Subjective effects, misuse, and adverse effects of osmotic-release methylphenidate treatment in adolescent substance abusers with attention-deficit/hyperactivity disorder.
Adler, LA; Davies, RD; Lewis, DF; Riggs, PD; Somoza, EC; Sonne, S; Winhusen, TM, 2011
)
0.61
" Outcome measures included the Massachusetts General Hospital Liking Scale, self-reported medication compliance, pill counts, and adverse events (AEs)."( Subjective effects, misuse, and adverse effects of osmotic-release methylphenidate treatment in adolescent substance abusers with attention-deficit/hyperactivity disorder.
Adler, LA; Davies, RD; Lewis, DF; Riggs, PD; Somoza, EC; Sonne, S; Winhusen, TM, 2011
)
0.61
" Methylphenidate was found to be tolerable and safe in short term treatment when given in its immediate release and long-acting preparations to adults with ADHD."( [Efficacy and safety of stimulants and non-stimulants in adults with attention deficit hyperactivity disorder (ADHD)].
Golubchik, P; Sever, J; Weizman, A, 2011
)
1.28
" Adverse effects were also evaluated."( Efficacy and adverse effects of venlafaxine in children and adolescents with ADHD: a systematic review of non-controlled and controlled trials.
Berk, M; Freeman, RD; Ghanizadeh, A, 2013
)
0.39
"Our intensive pharmacosurveillance monitoring program was performed to increase the number of adverse drug reactions (ADRs) recorded in the Italian spontaneous reporting database, and to systematically collect more thorough data about atomoxetine (ATX) and methylphenidate (MPH) safety in the pediatric setting."( Safety of attention-deficit/hyperactivity disorder medications in children: an intensive pharmacosurveillance monitoring study.
Bravaccio, C; Capuano, A; Granato, R; Grimaldi, G; Panei, P; Parretta, E; Pascotto, A; Rafaniello, C; Rinaldi, B; Rossi, F; Ruggiero, S; Sportiello, L, 2012
)
0.56
"From September 2007 to October 2010, 1841 youth were enrolled in the Italian Attention- Deficit/Hyperactivity Disorder Register, but we report here on the 76 children from the five Reference Prescription Centers in Campania, an Italian region where we administered our systematic adverse event checklist."( Safety of attention-deficit/hyperactivity disorder medications in children: an intensive pharmacosurveillance monitoring study.
Bravaccio, C; Capuano, A; Granato, R; Grimaldi, G; Panei, P; Parretta, E; Pascotto, A; Rafaniello, C; Rinaldi, B; Rossi, F; Ruggiero, S; Sportiello, L, 2012
)
0.38
" While medications for ADHD are generally well-tolerated, there are common, although less severe, as well as rare but severe adverse events AEs during treatment with ADHD drugs."( Practitioner review: current best practice in the management of adverse events during treatment with ADHD medications in children and adolescents.
Banaschewski, T; Buitelaar, J; Coghill, D; Cortese, S; Danckaerts, M; Dittmann, RW; Graham, J; Holtmann, M; Sergeant, J; Taylor, E, 2013
)
0.39
"We explored two different methods of determining adverse events (AEs) among methylphenidate (MPH)-treated adolescents with attention-deficit/hyperactivity disorder (ADHD)."( Two different solicitation methods for obtaining information on adverse events associated with methylphenidate in adolescents: a 12-week multicenter, open-label study.
Choi, J; Hong, SD; Joung, YS; Kim, JH; Lee, MS; Lee, SI, 2013
)
0.84
" We hypothesized that the risk of an emotional side effect to methylphenidate (MPH) treatment may be associated with NTF3 genotypes."( Neurotrophin 3 genotype and emotional adverse effects of osmotic-release oral system methylphenidate (OROS-MPH) in children with attention-deficit/hyperactivity disorder.
Cho, SC; Chung, US; Han, DH; Kim, BN; Kim, JH; Kim, JW; Park, S; Shin, MS; Shin, YM; Son, JW, 2014
)
0.87
" ADHD and associated psychiatric symptoms, medication status and dosage frequency, treatment adherence and adverse events were assessed at baseline and after a median treatment length with Medikinet(®) retard of 70 days."( A non-interventional study of extended-release methylphenidate in the routine treatment of adolescents with ADHD: effectiveness, safety and adherence to treatment.
Döpfner, M; Fischer, R; Ose, C; Sobanski, E, 2013
)
0.65
"Methylphenidate treatment of apathy in Alzheimer's disease was associated with significant improvement in 2 of 3 efficacy outcomes and a trend toward improved global cognition with minimal adverse events, supporting the safety and efficacy of methylphenidate treatment for apathy in Alzheimer's disease."( Safety and efficacy of methylphenidate for apathy in Alzheimer's disease: a randomized, placebo-controlled trial.
Bachman, DL; Drye, LT; Herrmann, N; Lanctôt, KL; Mintzer, JE; Rosenberg, PB; Scherer, RW, 2013
)
2.14
" An association between two CES1 SNP markers and the occurrence of sadness as a side effect of short-acting methylphenidate was found."( Methylphenidate side effect profile is influenced by genetic variation in the attention-deficit/hyperactivity disorder-associated CES1 gene.
Barry, E; Bellgrove, MA; Fitzgerald, M; Gill, M; Hawi, Z; Johnson, KA; Kirley, A; Lambert, D; McNicholas, F, 2013
)
2.05
"This study found an association between two CES1 SNP markers and the occurrence of sadness as a side effect of short-acting methylphenidate."( Methylphenidate side effect profile is influenced by genetic variation in the attention-deficit/hyperactivity disorder-associated CES1 gene.
Barry, E; Bellgrove, MA; Fitzgerald, M; Gill, M; Hawi, Z; Johnson, KA; Kirley, A; Lambert, D; McNicholas, F, 2013
)
2.04
" Five participants discontinued, four females due to adverse reactions and one male due to attenuated motivation."( Evaluation of dosage, safety and effects of methylphenidate on post-traumatic brain injury symptoms with a focus on mental fatigue and pain.
Andréll, P; Johansson, B; Mannheimer, C; Odenstedt, J; Rönnbäck, L; Wentzel, AP, 2014
)
0.66
"Methylphenidate decreased mental fatigue for subjects suffering a traumatic brain injury, the treatment is considered to be safe and is recommended, starting with a low dose."( Evaluation of dosage, safety and effects of methylphenidate on post-traumatic brain injury symptoms with a focus on mental fatigue and pain.
Andréll, P; Johansson, B; Mannheimer, C; Odenstedt, J; Rönnbäck, L; Wentzel, AP, 2014
)
2.11
" Although treatment-emergent adverse events were reported more frequently in the OROS MPH group (81."( A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of osmotic-controlled release oral delivery system methylphenidate HCl in adults with attention-deficit/hyperactivity disorder in Japan.
Kashimoto, Y; Koh, T; Matsumura, T; Saito, Y; Takahashi, N; Tominaga, Y, 2014
)
0.6
" Adverse events were numerically less frequent with Omega-3/6 or MPH + Omega-3/6 than MPH alone."( Efficacy and Safety of Omega-3/6 Fatty Acids, Methylphenidate, and a Combined Treatment in Children With ADHD.
Barragán, E; Breuer, D; Döpfner, M, 2017
)
0.71
"The purpose of this study was to investigate whether the availability of both dextroamphetamine and methylphenidate provides an opportunity to minimize adverse events in a pediatric attention-deficit/hyperactivity disorder (ADHD) stimulant trial."( Minimizing adverse events while maintaining clinical improvement in a pediatric attention-deficit/hyperactivity disorder crossover trial with dextroamphetamine and methylphenidate.
Aabech, HS; Ramtvedt, BE; Sundet, K, 2014
)
0.81
" Barkley's Side-Effect Rating Scale (SERS), rated by parents, was used to assess adverse events."( Minimizing adverse events while maintaining clinical improvement in a pediatric attention-deficit/hyperactivity disorder crossover trial with dextroamphetamine and methylphenidate.
Aabech, HS; Ramtvedt, BE; Sundet, K, 2014
)
0.6
"The side-effect profiles of dextroamphetamine and methylphenidate appeared similar at the group level."( Minimizing adverse events while maintaining clinical improvement in a pediatric attention-deficit/hyperactivity disorder crossover trial with dextroamphetamine and methylphenidate.
Aabech, HS; Ramtvedt, BE; Sundet, K, 2014
)
0.85
"The availability of both dextroamphetamine and methylphenidate may contribute to minimize adverse events in a subsample of children in pediatric ADHD stimulant trials."( Minimizing adverse events while maintaining clinical improvement in a pediatric attention-deficit/hyperactivity disorder crossover trial with dextroamphetamine and methylphenidate.
Aabech, HS; Ramtvedt, BE; Sundet, K, 2014
)
0.85
"A bibliographic search was performed in the MEDLINE, EMBASE and PsycINFO databases for prospective studies evaluating the incidence of adverse events (AEs) in children and adolescents treated for ADHD."( Safety of medicines used for ADHD in children: a review of published prospective clinical trials.
Bonati, M; Clavenna, A, 2014
)
0.4
" No occurrences of suicidal ideation or behavior were recorded; the most common open-label treatment-emergent adverse events were typical of stimulant use: decreased appetite, insomnia, and abdominal pain."( Efficacy, Safety, and Tolerability of a Novel Methylphenidate Extended-Release Oral Suspension (MEROS) in ADHD.
Belden, HW; Berry, SA; Childress, AC; Findling, RL; Robb, AS; Wigal, SB, 2017
)
0.71
" Adverse events (AEs) and serious adverse events (SAEs) were reported at the end of extension study for events monitored from (1) maintenance of effect phase baseline (core study; 12 months) and (2) extension study baseline (6 months)."( Long-term (1 year) safety and efficacy of methylphenidate modified-release long-acting formulation (MPH-LA) in adults with attention-deficit hyperactivity disorder: a 26-week, flexible-dose, open-label extension to a 40-week, double-blind, randomised, pla
Arngrim, T; Chen, CW; Gandhi, P; Ginsberg, Y; Huss, M; Kumar, V; Philipsen, A, 2014
)
0.67
"7 %) had treatment-related adverse events with one case being serious; 23 patients (8."( Effectiveness and safety of a long-acting, once-daily, two-phase release formulation of methylphenidate (Ritalin ® LA) in school children under daily practice conditions.
Bilke-Hentsch, O; Haertling, F; Mueller, B, 2015
)
0.64
"Despite the occurrence of IED, the use of MPH was safe during 2 years follow-up."( Attention deficit/hyperactivity disorder and interictal epileptiform discharges: it is safe to use methylphenidate?
Aurlien, D; Herigstad, A; Larsen, TK; Socanski, D; Thomsen, PH, 2015
)
0.63
"We found significant intraclass correlations in family member response to methylphenidate-immediate release and side effect profile, including emotional symptoms and loss of appetite and weight."( High Familial Correlation in Methylphenidate Response and Side Effect Profile.
Brand-Gothelf, A; Dubnov-Raz, G; Gazer-Snitovsky, M; Gothelf, D; Weizman, A, 2019
)
1.04
"We present a case of adverse neurological effects of methylphenidate therapy for attention deficit and hyperactivity disorder (ADHD)."( Neurological adverse effects of methylphenidate may be misdiagnosed as meningoencephalitis.
Bakshi, D; Snell, LB, 2015
)
0.95
"The aim of this study was to assess the type and frequency of adverse events (AEs) in children with attention-deficit/hyperactivity disorder (ADHD) treated with methylphenidate or atomoxetine over a 5-year period in a large naturalistic study."( Safety of Methylphenidate and Atomoxetine in Children with Attention-Deficit/Hyperactivity Disorder (ADHD): Data from the Italian National ADHD Registry.
Arcieri, R; Capuano, A; Chiarotti, F; Cortese, S; Curatolo, P; Germinario, EA; Margari, L; Panei, P, 2015
)
1.02
" Methylphenidate is safe in healthy children and has shown to have no cardiac side effects in these patients."( Psychopharmacology of Attention-Deficit Hyperactivity Disorder: Effects and Side Effects.
Golmirzaei, J; Hamzei, E; Kamal, MA; Mahboobi, H; Mushtaq, G; Yazdanparast, M, 2016
)
1.34
"Methylphenidate is excreted in breast milk only in small amounts, and to date there have been no reports of breastfed infants demonstrating any adverse effects."( Is it safe to breastfeed while taking methylphenidate?
Bozzo, P; Koren, G; Marchese, M, 2015
)
2.13
"The FDA addressed interchangeability problems with generic modified-release alternatives of bupropion and methylphenidate including lack of bioequivalence, reduced efficacy, and increased incidence of adverse events."( Interchangeability, Safety and Efficacy of Modified-Release Drug Formulations in the USA: The Case of Opioid and Other Nervous System Drugs.
Hansen, R; Rodriguez-Monguio, R; Seoane-Vazquez, E, 2016
)
0.65
"There is no questionnaire to specifically monitor perceived adverse events of methylphenidate (MPH) on cognition, motivation, and mood."( Reports of Perceived Adverse Events of Stimulant Medication on Cognition, Motivation, and Mood: Qualitative Investigation and the Generation of Items for the Medication and Cognition Rating Scale.
Banaschewski, T; Buitelaar, JK; Carucci, S; Coghill, D; Danckaerts, M; Dittmann, RW; Falissard, B; Grimshaw, DG; Hollis, C; Inglis, S; Konrad, K; Kovshoff, H; Liddle, E; McCarthy, S; Nagy, P; Sonuga-Barke, EJ; Thompson, M; Wong, IC; Zuddas, A, 2016
)
0.66
" Purposeful sampling was used to selectively recruit ADHD participants whose histories suggested a degree of vulnerability to MPH adverse events."( Reports of Perceived Adverse Events of Stimulant Medication on Cognition, Motivation, and Mood: Qualitative Investigation and the Generation of Items for the Medication and Cognition Rating Scale.
Banaschewski, T; Buitelaar, JK; Carucci, S; Coghill, D; Danckaerts, M; Dittmann, RW; Falissard, B; Grimshaw, DG; Hollis, C; Inglis, S; Konrad, K; Kovshoff, H; Liddle, E; McCarthy, S; Nagy, P; Sonuga-Barke, EJ; Thompson, M; Wong, IC; Zuddas, A, 2016
)
0.43
"While we probed purposefully for cognitive and motivational adverse events, a third domain, related to mood, emerged from the reports."( Reports of Perceived Adverse Events of Stimulant Medication on Cognition, Motivation, and Mood: Qualitative Investigation and the Generation of Items for the Medication and Cognition Rating Scale.
Banaschewski, T; Buitelaar, JK; Carucci, S; Coghill, D; Danckaerts, M; Dittmann, RW; Falissard, B; Grimshaw, DG; Hollis, C; Inglis, S; Konrad, K; Kovshoff, H; Liddle, E; McCarthy, S; Nagy, P; Sonuga-Barke, EJ; Thompson, M; Wong, IC; Zuddas, A, 2016
)
0.43
"Items were identified that capture potential/perceived cognitive, motivational, and mood-related adverse events of MPH."( Reports of Perceived Adverse Events of Stimulant Medication on Cognition, Motivation, and Mood: Qualitative Investigation and the Generation of Items for the Medication and Cognition Rating Scale.
Banaschewski, T; Buitelaar, JK; Carucci, S; Coghill, D; Danckaerts, M; Dittmann, RW; Falissard, B; Grimshaw, DG; Hollis, C; Inglis, S; Konrad, K; Kovshoff, H; Liddle, E; McCarthy, S; Nagy, P; Sonuga-Barke, EJ; Thompson, M; Wong, IC; Zuddas, A, 2016
)
0.43
" Safety assessments included adverse events (AEs), physical examinations, electrocardiograms (ECGs), and the Columbia Suicide Severity Rating Scale (C-SSRS)."( Efficacy, Safety, and Tolerability of an Extended-Release Orally Disintegrating Methylphenidate Tablet in Children 6-12 Years of Age with Attention-Deficit/Hyperactivity Disorder in the Laboratory Classroom Setting.
Childress, AC; Cutler, AJ; Kollins, SH; Marraffino, A; Sikes, CR, 2017
)
0.68
" A recorded diagnosis (either a primary or secondary cause) of any of the following cardiovascular adverse events: arrhythmias (ICD-10 (international classification of diseases, 10th revision) codes I44, I45, I47, I48, I49), hypertension (codes I10-I15), myocardial infarction (code I21), ischemic stroke (code I63), or heart failure (code I50)."( Cardiovascular safety of methylphenidate among children and young people with attention-deficit/hyperactivity disorder (ADHD): nationwide self controlled case series study.
Park, BJ; Pratt, NL; Roughead, EE; Shin, JY, 2016
)
0.74
" Withdrawals due to all-cause, adverse effects and lack of efficacy were defined as primary outcomes evaluating the safety of such medications."( An Evaluation on the Efficacy and Safety of Treatments for Attention Deficit Hyperactivity Disorder in Children and Adolescents: a Comparison of Multiple Treatments.
Gao, J; He, S; Li, Y; Wang, Q; Zhang, Y, 2017
)
0.46
"To identify and characterize cases of chemical leukoderma, an underrecognized adverse event, associated with the methylphenidate transdermal system (MTS) reported to the US Food and Drug Administration Adverse Event Reporting System (FAERS)."( Chemical Leukoderma Associated with Methylphenidate Transdermal System: Data From the US Food and Drug Administration Adverse Event Reporting System.
Brinker, A; Cheng, C; Diak, IL; La Grenade, L; Levin, RL, 2017
)
0.94
"We searched the Food and Drug Administration Adverse Event Reporting System for reports of chemical leukoderma associated with MTS, received by the Food and Drug Administration from April 6, 2006 to December 23, 2014."( Chemical Leukoderma Associated with Methylphenidate Transdermal System: Data From the US Food and Drug Administration Adverse Event Reporting System.
Brinker, A; Cheng, C; Diak, IL; La Grenade, L; Levin, RL, 2017
)
0.73
" Outcomes like response rate, ADHD Rating Scale (ADHD-RS) score, and adverse events were compared between ATX and MPH treatments."( Comparative efficacy and safety of methylphenidate and atomoxetine for attention-deficit hyperactivity disorder in children and adolescents: Meta-analysis based on head-to-head trials.
Fang, Q; Liu, Q; Qin, L; Zhang, H, 2017
)
0.73
"01]) and lower risk of adverse events (drowsiness: RR = 0."( Comparative efficacy and safety of methylphenidate and atomoxetine for attention-deficit hyperactivity disorder in children and adolescents: Meta-analysis based on head-to-head trials.
Fang, Q; Liu, Q; Qin, L; Zhang, H, 2017
)
0.73
" Areas covered: Physical adverse effects, psychiatric adverse events and brain development Expert opinion: Some physical adverse events have been described (e."( An update on the safety of psychostimulants for the treatment of attention-deficit/hyperactivity disorder.
Dietrich, A; Groenman, AP; Hoekstra, PJ; Schweren, LJ, 2017
)
0.46
" Safety assessments included adverse event (AE) monitoring and the Columbia-Suicide Severity Rating Scale (C-SSRS)."( Efficacy and Safety of a Chewable Methylphenidate Extended-Release Tablet in Children with Attention-Deficit/Hyperactivity Disorder.
Belden, H; Berry, SA; Chappell, P; Childress, A; Orazem, J; Palumbo, D; Sherman, N; Walters, F; Wigal, SB, 2017
)
0.73
" MPH ERCT was generally safe and well tolerated, with a safety profile consistent with other MPH ER formulations."( Efficacy and Safety of a Chewable Methylphenidate Extended-Release Tablet in Children with Attention-Deficit/Hyperactivity Disorder.
Belden, H; Berry, SA; Chappell, P; Childress, A; Orazem, J; Palumbo, D; Sherman, N; Walters, F; Wigal, SB, 2017
)
0.73
"To study in more depth the relationship between type, dose, or duration of methylphenidate offered to children and adolescents with attention deficit hyperactivity disorder and their risks of gastrointestinal adverse events based on our Cochrane systematic review."( Gastrointestinal adverse events during methylphenidate treatment of children and adolescents with attention deficit hyperactivity disorder: A systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials.
Gillies, D; Gluud, C; Groth, C; Holmskov, M; Krogh, HB; Magnusson, FL; Moreira-Maia, CR; Ramstad, E; Simonsen, E; Skoog, M; Storebø, OJ; Zwi, M, 2017
)
0.95
" Randomised parallel-group trials and cross-over trials reporting gastrointestinal adverse events associated with methylphenidate were included."( Gastrointestinal adverse events during methylphenidate treatment of children and adolescents with attention deficit hyperactivity disorder: A systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials.
Gillies, D; Gluud, C; Groth, C; Holmskov, M; Krogh, HB; Magnusson, FL; Moreira-Maia, CR; Ramstad, E; Simonsen, E; Skoog, M; Storebø, OJ; Zwi, M, 2017
)
0.93
" No differences in the risks of gastrointestinal adverse events according to type, dose, or duration of administration were found."( Gastrointestinal adverse events during methylphenidate treatment of children and adolescents with attention deficit hyperactivity disorder: A systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials.
Gillies, D; Gluud, C; Groth, C; Holmskov, M; Krogh, HB; Magnusson, FL; Moreira-Maia, CR; Ramstad, E; Simonsen, E; Skoog, M; Storebø, OJ; Zwi, M, 2017
)
0.72
"Our study evaluated adverse events of therapeutic failure (and specifically reduced duration of action) with the use of a branded product, Osmotic Release Oral System (OROS) methylphenidate, which is approved for the treatment of attention deficit/hyperactivity disorder, and a generic product (methylphenidate, methylphenidate ER-C), which was approved for marketing in Canada based on bioequivalence to OROS methylphenidate."( Differences in Adverse Event Reporting Rates of Therapeutic Failure Between Two Once-daily Extended-release Methylphenidate Medications in Canada: Analysis of Spontaneous Adverse Event Reporting Databases.
Almagor, D; Castillon, G; Park-Wyllie, L; Sherman, SE; van Stralen, J, 2017
)
0.86
"Through methodology similar to that used by the US Food and Drug Administration to investigate the issue with the US-marketed generic, reporting rates were calculated from cases of therapeutic failure identified in the Canadian Vigilance Adverse Reaction Online database for a 1-year period beginning 8 months after each product launch."( Differences in Adverse Event Reporting Rates of Therapeutic Failure Between Two Once-daily Extended-release Methylphenidate Medications in Canada: Analysis of Spontaneous Adverse Event Reporting Databases.
Almagor, D; Castillon, G; Park-Wyllie, L; Sherman, SE; van Stralen, J, 2017
)
0.67
" Impacts on social functioning, such as disruption in work or school performance or adverse social behaviors, were found in 51 cases (22."( Differences in Adverse Event Reporting Rates of Therapeutic Failure Between Two Once-daily Extended-release Methylphenidate Medications in Canada: Analysis of Spontaneous Adverse Event Reporting Databases.
Almagor, D; Castillon, G; Park-Wyllie, L; Sherman, SE; van Stralen, J, 2017
)
0.67
" While these results should be interpreted with caution due to the limitations of spontaneous adverse event reporting, which may confound comparisons across products, similar findings nonetheless led the US Food and Drug Administration to declare in 2014 that 2 methylphenidate ER generic products in the United States were neither bioequivalent nor interchangeable with OROS methylphenidate-their reference product."( Differences in Adverse Event Reporting Rates of Therapeutic Failure Between Two Once-daily Extended-release Methylphenidate Medications in Canada: Analysis of Spontaneous Adverse Event Reporting Databases.
Almagor, D; Castillon, G; Park-Wyllie, L; Sherman, SE; van Stralen, J, 2017
)
0.85
" Safety measures included spontaneously reported treatment-emergent adverse events (TEAEs) and two TEAEs of special interest, appetite suppression and insomnia (with direct questioning on sleep disturbance)."( Efficacy and Safety of HLD200, Delayed-Release and Extended-Release Methylphenidate, in Children with Attention-Deficit/Hyperactivity Disorder.
Arnold, VK; Bostrom, S; Cutler, AJ; DeSousa, NJ; Incledon, B; López, FA; Marraffino, A; Newcorn, JH; Pliszka, SR; Sallee, FR; Wilens, TE, 2017
)
0.69
" Concerning adverse events associated with the treatment, our systematic review of randomised clinical trials (RCTs) demonstrated no increase in serious adverse events, but a high proportion of participants suffered a range of non-serious adverse events."( Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of adverse events in non-randomised studies.
Aagaard, L; Buch Rasmussen, K; Gauci, D; Gerner, T; Gillies, D; Gluud, C; Groth, C; Håkonsen, SJ; Holmskov, M; Kielsholm, ML; Kirubakaran, R; Krogh, HB; Magnusson, FL; Moreira-Maia, CR; Nielsen, SS; Pedersen, N; Ramstad, E; Rosendal, S; Simonsen, E; Skoog, M; Storebø, OJ; Zwi, M, 2018
)
1.92
"To assess the adverse events associated with methylphenidate treatment for children and adolescents with ADHD in non-randomised studies."( Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of adverse events in non-randomised studies.
Aagaard, L; Buch Rasmussen, K; Gauci, D; Gerner, T; Gillies, D; Gluud, C; Groth, C; Håkonsen, SJ; Holmskov, M; Kielsholm, ML; Kirubakaran, R; Krogh, HB; Magnusson, FL; Moreira-Maia, CR; Nielsen, SS; Pedersen, N; Ramstad, E; Rosendal, S; Simonsen, E; Skoog, M; Storebø, OJ; Zwi, M, 2018
)
2.18
" We defined serious adverse events according to the International Committee of Harmonization as any lethal, life-threatening or life-changing event."( Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of adverse events in non-randomised studies.
Aagaard, L; Buch Rasmussen, K; Gauci, D; Gerner, T; Gillies, D; Gluud, C; Groth, C; Håkonsen, SJ; Holmskov, M; Kielsholm, ML; Kirubakaran, R; Krogh, HB; Magnusson, FL; Moreira-Maia, CR; Nielsen, SS; Pedersen, N; Ramstad, E; Rosendal, S; Simonsen, E; Skoog, M; Storebø, OJ; Zwi, M, 2018
)
1.92
"Our findings suggest that methylphenidate may be associated with a number of serious adverse events as well as a large number of non-serious adverse events in children and adolescents, which often lead to withdrawal of methylphenidate."( Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of adverse events in non-randomised studies.
Aagaard, L; Buch Rasmussen, K; Gauci, D; Gerner, T; Gillies, D; Gluud, C; Groth, C; Håkonsen, SJ; Holmskov, M; Kielsholm, ML; Kirubakaran, R; Krogh, HB; Magnusson, FL; Moreira-Maia, CR; Nielsen, SS; Pedersen, N; Ramstad, E; Rosendal, S; Simonsen, E; Skoog, M; Storebø, OJ; Zwi, M, 2018
)
2.22
" The most common adverse effects in subjects still on treatment with MPH were decreased appetite (28%), dry mouth (24%), anxiousness/restlessness and increased pulse frequency (19% each), decreased sexual desire (17%), and perspiration (15%)."( Long-Term Tolerability and Safety of Pharmacological Treatment of Adult Attention-Deficit/Hyperactivity Disorder: A 6-Year Prospective Naturalistic Study.
Edvinsson, D; Ekselius, L, 2018
)
0.48
" Those diagnosed with ADHD and on long-term treatment with stimulants experience mild and tolerable adverse effects."( Long-Term Tolerability and Safety of Pharmacological Treatment of Adult Attention-Deficit/Hyperactivity Disorder: A 6-Year Prospective Naturalistic Study.
Edvinsson, D; Ekselius, L, 2018
)
0.48
"Sleep disturbances are a feature of attention-deficit/hyperactivity disorder (ADHD) and an adverse event (AE) of methylphenidate treatment."( Sleep-Associated Adverse Events During Methylphenidate Treatment of Attention-Deficit/Hyperactivity Disorder: A Meta-Analysis.
Cortese, S; Faraone, SV; Komolova, M; Po, MD, 2019
)
0.99
"To determine the evidence on dose titration and adverse events associated with dose titration of stimulants for ADHD."( Evaluation of Methylphenidate Safety and Maximum-Dose Titration Rationale in Attention-Deficit/Hyperactivity Disorder: A Meta-analysis.
Ching, C; Eslick, GD; Poulton, AS, 2019
)
0.87
"The outcomes of interest were (1) the doses used in published clinical trials, (2) the clinical justification given by researchers for their selected dose range, and (3) the adverse effects associated with methylphenidate when the dose is established by titration."( Evaluation of Methylphenidate Safety and Maximum-Dose Titration Rationale in Attention-Deficit/Hyperactivity Disorder: A Meta-analysis.
Ching, C; Eslick, GD; Poulton, AS, 2019
)
1.06
" Reports of life-threatening adverse events were absent; further studies of the efficacy, tolerability, and safety of methylphenidate titrated purely on clinical grounds, without reference to any set maximum dose, are needed."( Evaluation of Methylphenidate Safety and Maximum-Dose Titration Rationale in Attention-Deficit/Hyperactivity Disorder: A Meta-analysis.
Ching, C; Eslick, GD; Poulton, AS, 2019
)
1.08
" These may also be triggered by drugs and appear as adverse drug reactions (ADRs)."( Adverse Drug Reactions Related to Mood and Emotion in Pediatric Patients Treated for Attention Deficit/Hyperactivity Disorder: A Comparative Analysis of the US Food and Drug Administration Adverse Event Reporting System Database.
Carnovale, C; Clementi, E; Gentili, M; Mazhar, F; Nobile, M; Peeters, GGAM; Pozzi, M; Radice, S,
)
0.13
"We mined data from the US Food and Drug Administration Adverse Event Reporting System pharmacovigilance database, focused on methylphenidate, atomoxetine, amphetamine, lisdexamfetamine, and their derivatives."( Adverse Drug Reactions Related to Mood and Emotion in Pediatric Patients Treated for Attention Deficit/Hyperactivity Disorder: A Comparative Analysis of the US Food and Drug Administration Adverse Event Reporting System Database.
Carnovale, C; Clementi, E; Gentili, M; Mazhar, F; Nobile, M; Peeters, GGAM; Pozzi, M; Radice, S,
)
0.34
"We conclude that real-world data from the US Food and Drug Administration Adverse Event Reporting System are consistent with previous evidence from meta-analyses."( Adverse Drug Reactions Related to Mood and Emotion in Pediatric Patients Treated for Attention Deficit/Hyperactivity Disorder: A Comparative Analysis of the US Food and Drug Administration Adverse Event Reporting System Database.
Carnovale, C; Clementi, E; Gentili, M; Mazhar, F; Nobile, M; Peeters, GGAM; Pozzi, M; Radice, S,
)
0.13
" The frequencies of adverse events were similar between the two groups."( Efficacy and safety of tipepidine as adjunctive therapy in children with attention-deficit/hyperactivity disorder: Randomized, double-blind, placebo-controlled clinical trial.
Akhondzadeh, S; Bagheri, S; Dehbozorghi, S; Mohammadi, MR; Moradi, K; Shokraee, K, 2019
)
0.51
" Any long-term psychotropic treatment in childhood raises concerns about possible adverse neurological and psychiatric outcomes."( Neurological and psychiatric adverse effects of long-term methylphenidate treatment in ADHD: A map of the current evidence.
Ansari, MT; Banaschewski, T; Buitelaar, JK; Carucci, S; Coghill, D; Danckaerts, M; Dittmann, RW; Falissard, B; Garas, P; Groom, MJ; Hall, CL; Hollis, C; Inglis, SK; Kochhar, P; Konrad, K; Kovshoff, H; Krinzinger, H; Liddle, EB; McCarthy, S; Nagy, P; Neubert, A; Roberts, S; Sayal, K; Sonuga-Barke, E; Wong, ICK; Xia, J; Zuddas, A, 2019
)
0.76
"Sleep problems is the most common side effect of methylphenidate (MPH) treatment in ADHD youth and carry potential to negatively impact long-term self-regulatory functioning."( Prediction of sleep side effects following methylphenidate treatment in ADHD youth.
Hong, SB; Kim, BN; Kim, JW; McMakin, DL; Ryan, ND; Sharma, V; Yoo, JH; Zalesky, A, 2020
)
1.08
" Outcomes were the improvement of apathy scales score (primary), mini-mental state examination (MMSE) score, activities of daily living scale score, Zarit burden interview score, all-cause discontinuation, discontinuation due to adverse events, and incidence of at least 1 adverse event."( Efficacy and Safety of Psychostimulants for Alzheimer's Disease: A Systematic Review and Meta-Analysis.
Iwata, N; Kishi, T; Sakuma, K, 2020
)
0.56
" Features such as personal noun, nonmedical use terms, medical use terms, side effect terms, sentiment scores, and the presence of a URL were generated for supervised learning."( Twitter Analysis of the Nonmedical Use and Side Effects of Methylphenidate: Machine Learning Study.
Jeong, J; Kim, J; Kim, MG; Kim, SC, 2020
)
0.8
"The co-abuse of ALZ has amplified the hepato-renal toxic effects of MPH."( Co-abuse of alprazolam augments the hepato-renal toxic effects of methylphenidate.
Chopra, K; Dharavath, RN; Dutt, M; Kaur, N; Kaur, T; Sharma, S,
)
0.37
" Among 433 randomized patients, adverse events (AEs) were documented and analyzed on an "as received" basis during week 0-52."( Safety Profile of Methylphenidate Under Long-Term Treatment in Adult ADHD Patients - Results of the COMPAS Study.
Abdel-Hamid, M; Alm, B; Berger, M; Borel, P; Colla, M; Graf, E; Heßmann, P; Huss, M; Jacob, C; Jans, T; Kis, B; Lücke, C; Matthies, S; Müller, HHO; Philipsen, A; Retz, W; Rösler, M; Sobanski, E; van Elst, LT, 2020
)
0.89
"In this so far longest-running clinical trial, methylphenidate treatment was safe and well-tolerated."( Safety Profile of Methylphenidate Under Long-Term Treatment in Adult ADHD Patients - Results of the COMPAS Study.
Abdel-Hamid, M; Alm, B; Berger, M; Borel, P; Colla, M; Graf, E; Heßmann, P; Huss, M; Jacob, C; Jans, T; Kis, B; Lücke, C; Matthies, S; Müller, HHO; Philipsen, A; Retz, W; Rösler, M; Sobanski, E; van Elst, LT, 2020
)
1.15
" As compared with placebo (38 [31%] of 124 patients), higher proportions of participants reported adverse events while taking amantadine (49 [39%] of 127 patients), modafinil (50 [40%] of 125 patients), and methylphenidate (51 [40%] of 129 patients)."( Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial.
Aljarallah, S; Auvray, C; Cordano, C; Creasman, J; Jin, C; Krysko, K; Manguinao, M; McCulloch, C; Morris, B; Mowry, E; Nourbakhsh, B; Revirajan, N; Rutatangwa, A; Waubant, E, 2021
)
1.06
"Amantadine, modafinil, and methylphenidate were not superior to placebo in improving multiple sclerosis fatigue and caused more frequent adverse events."( Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial.
Aljarallah, S; Auvray, C; Cordano, C; Creasman, J; Jin, C; Krysko, K; Manguinao, M; McCulloch, C; Morris, B; Mowry, E; Nourbakhsh, B; Revirajan, N; Rutatangwa, A; Waubant, E, 2021
)
1.17
"Although attention-deficit/hyperactivity disorder (ADHD) is widely studied, problems regarding the adverse effect risks and non-responder problems still need to be addressed."( Synergistic efficacy and diminished adverse effect profile of composite treatment of several ADHD medications.
Adil, KJ; Cheong, JH; Han, SH; Jeon, SJ; Kim, HJ; Kim, HY; Kim, R; Kwon, KJ; Mabunga, DFN; Park, D; Ryu, O; Shin, CY; Valencia, S, 2021
)
0.62
"To evaluate the validity of online information regarding the adverse effects of methylphenidate."( Can parents believe websites' information about methylphenidate's side effects?
Arsac England, T; Tuthill, D, 2021
)
1.1
" Three quarters (19 websites; 76%) had at least one side-effect that did not appear in the BNFC; with six websites documenting more than five side-effects not found in the BNFC."( Can parents believe websites' information about methylphenidate's side effects?
Arsac England, T; Tuthill, D, 2021
)
0.88
"013), and similar side effect rates."( Stimulant treatment effectiveness, safety and risk for psychosis in individuals with 22q11.2 deletion syndrome.
Basel, D; Eliez, S; Gothelf, D; Maeder, J; Mosheva, M; Schneider, M; Shani, S; Weinberger, R, 2022
)
0.72
"Methylphenidate was effective and safe in treating ADHD in 76% of cases in children with DS, with few serious side effects to report."( Efficacy and safety of methylphenidate on attention deficit hyperactivity disorder in children with Down syndrome.
Cieuta-Walti, C; Conte, M; Durand, S; Falquero, S; Labidi, A; Mégarbané, A; Mircher, C; Prioux, E; Ravel, A; Roche, M; Stora, S; Toulas, J, 2021
)
2.37
", response, adverse events) and standardized mean differences (SMDs) for continuous outcomes (e."( Comparative efficacy and safety of stimulant-type medications for depression: A systematic review and network meta-analysis.
Bahji, A; Mesbah-Oskui, L, 2021
)
0.62
" The most frequent adverse events during dose optimization were headache, decreased appetite, and insomnia."( Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Adult Laboratory Classroom Study of the Efficacy and Safety of PRC-063 (Extended-Release Methylphenidate) for the Treatment of ADHD.
Bhaskar, S; Childress, A; Cutler, AJ; Donnelly, G; Marraffino, AH, 2022
)
0.92
" Trials of amphetamines, atomoxetine, bupropion, clonidine, guanfacine, methylphenidate, and modafinil with a placebo arm and reporting data on headache as an adverse event, were included."( Headache in ADHD as comorbidity and a side effect of medications: a systematic review and meta-analysis.
Banaschewski, T; Bölte, S; Buitelaar, JK; Coghill, D; Cortese, S; Häge, A; Hohmann, S; Jonsson, U; Nobel Norrman, H; Pan, PY; Şahpazoğlu Çakmak, SS, 2022
)
0.95
" Thus, results suggested that prolong co-administration of MPH-buspirone is safe and effective for ADHD patients by preventing adverse effects not only on behavioral but also on biochemical and hematological parameter."( Effect of Methylphenidate and buspirone-methylphenidate co-administration on biochemical and hematological parameters in rats: Implications for safe and confrontational use.
Alam, N; Ikram, R; Kashif, SS; Khan, SS; Khatoon, H; Naeem, S; Siddiqui, T, 2021
)
1.02
" Children in the methylphenidate plus educational intervention group had more mild adverse events than the other two groups, and there were no between-group differences for moderate or severe adverse events."( Efficacy and safety of methylphenidate and behavioural parent training for children aged 3-5 years with attention-deficit hyperactivity disorder: a randomised, double-blind, placebo-controlled, and sham behavioural parent training-controlled trial.
Dalmaso, BB; de Morais, EM; de Sousa Gurgel, W; Del Prette, G; Leibenluft, E; Pilatti, CD; Polanczyk, GV; Rohde, LA; Salum, GA; Sugaya, LS, 2022
)
1.37
"PRC-063 is an efficacious and safe treatment for ADHD, especially in children and adolescents."( Efficacy and Safety of PRC-063 for Attention-Deficit/Hyperactivity Disorder: A Systematic Review and Meta-analysis From Randomized Controlled Trials.
Chen, G; Gao, H; Wang, J; Wang, T; Yang, S; Yu, Z; Zhu, S, 2023
)
0.91
"The concomitant use of MPHs and SSRIs showed generally safe profiles in adolescent ADHD patients with depression."( Safety outcomes of selective serotonin reuptake inhibitors in adolescent attention-deficit/hyperactivity disorder with comorbid depression:
Alhambra, DP; Kim, C; Kim, SJ; Lee, DY; Lee, J; Lee, S; Lee, YH; Park, J; Park, RW; Shin, Y; Tan, EH; Yang, SJ, 2023
)
0.91
" After controlling for the effects of these variables using propensity scores, there was little evidence of an effect on growth (24 months height velocity SD score difference -0·07 (95% CI -0·18 to 0·04; p=0·20) or increased risk of psychiatric or neurological adverse events in the methylphenidate group compared with the no-methylphenidate group."( Long-term safety of methylphenidate in children and adolescents with ADHD: 2-year outcomes of the Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects (ADDUCE) study.
Banaschewski, T; Buitelaar, J; Carucci, S; Coghill, D; Danckaerts, M; Dittmann, RW; Falissard, B; Garas, P; Häge, A; Hollis, C; Inglis, SK; Konrad, K; Kovshoff, H; Liddle, E; Man, KKC; McCarthy, S; Nagy, P; Neubert, A; Rosenthal, E; Sonuga-Barke, EJS; Wong, ICK; Zuddas, A, 2023
)
1.41
" RRs of adverse events and all-cause discontinuation were secondary and acceptability outcomes, respectively."( Efficacy and safety of selegiline across different psychiatric disorders: A systematic review and meta-analysis of oral and transdermal formulations.
Birkenhager, TK; Caiazza, C; Cattaneo, CI; de Bartolomeis, A; Fornaro, M; Gillman, K; Iasevoli, F; Rossano, F; Ruhé, HG; Sobrino, A; Solini, N; Stahl, S; Van den Eynde, V; Vellucci, A; Zotti, N, 2023
)
0.91
" However, many adverse effects of methylphenidate have been recorded from randomized clinical trials and patient-reported outcomes, but it is difficult to determine abuse from them."( The Adverse Effects and Nonmedical Use of Methylphenidate Before and After the Outbreak of COVID-19: Machine Learning Analysis.
Kim, E; Lee, H; Oh, S; Park, S; Purja, S; Shin, H; Yuniar, CT, 2023
)
1.45
"To analyze the effect of the COVID-19 pandemic on the use of methylphenidate, this study analyzed the adverse effects and nonmedical use of methylphenidate and evaluated the change in frequency of nonmedical use based on SNS data before and after the outbreak of COVID-19."( The Adverse Effects and Nonmedical Use of Methylphenidate Before and After the Outbreak of COVID-19: Machine Learning Analysis.
Kim, E; Lee, H; Oh, S; Park, S; Purja, S; Shin, H; Yuniar, CT, 2023
)
1.42
" The frequency of adverse effects, nonmedical use, and drug use before and after the COVID-19 pandemic were compared and analyzed."( The Adverse Effects and Nonmedical Use of Methylphenidate Before and After the Outbreak of COVID-19: Machine Learning Analysis.
Kim, E; Lee, H; Oh, S; Park, S; Purja, S; Shin, H; Yuniar, CT, 2023
)
1.17
" Psychiatric problems (521/1683, 31%) had the highest frequency among the adverse effects."( The Adverse Effects and Nonmedical Use of Methylphenidate Before and After the Outbreak of COVID-19: Machine Learning Analysis.
Kim, E; Lee, H; Oh, S; Park, S; Purja, S; Shin, H; Yuniar, CT, 2023
)
1.17
" Among the machine learning models using SNS data to analyze the adverse effects and nonmedical use of methylphenidate, the random forest model had the highest performance."( The Adverse Effects and Nonmedical Use of Methylphenidate Before and After the Outbreak of COVID-19: Machine Learning Analysis.
Kim, E; Lee, H; Oh, S; Park, S; Purja, S; Shin, H; Yuniar, CT, 2023
)
1.39
" The review included patients diagnosed with chorea and NKX2-1-RD genetic diagnosis, drug therapy as intervention, no comparator, and outcomes of chorea improvement and adverse events."( Systematic review of drug therapy for chorea in NXK2-1-related disorders: Efficacy and safety evidence from case studies and series.
Bachoud-Lévi, AC; Blasco-Amaro, JA; Capuano, A; Isabel-Gómez, R; Martín-Gómez, C; Nou-Fontanet, L; Ortigoza-Escobar, JD; Zorzi, G, 2023
)
0.91
" No clinical improvements were observed with carbidopa/levodopa, tetrabenazine, or clonazepam, and various adverse effects were reported."( Systematic review of drug therapy for chorea in NXK2-1-related disorders: Efficacy and safety evidence from case studies and series.
Bachoud-Lévi, AC; Blasco-Amaro, JA; Capuano, A; Isabel-Gómez, R; Martín-Gómez, C; Nou-Fontanet, L; Ortigoza-Escobar, JD; Zorzi, G, 2023
)
0.91

Pharmacokinetics

Methylphenidate hydrochloride (MPH) extended release, alone and in combination. To evaluate the pharmacokinetic properties of the methylphenidate transdermal system (MTS) in pediatric patients diagnosed with ADHD.

ExcerptReferenceRelevance
"1 Pharmacokinetic study has been carried out following oral administration of 10-20 mg of methylphenidate hydrochloride to four behaviorally disorders children."( Pharmacokinetics of methylphenidate in hyperkinetic children.
Hungund, BL; Hurwic, MJ; Perel, JM; Sverd, J; Winsberg, BG, 1979
)
0.8
" The two-compartment open pharmacokinetic model fit the data."( Pharmacokinetics of methylphenidate in the rat using single-ion monitoring GLC-mass spectrometry.
Cho, AK; Flamm, BL; Gal, J; Hodshon, BJ; Pintauro, C, 1977
)
0.58
" Nine males with ADDH participated in a 1-day pharmacokinetic study following a single morning dose of 20 mg."( Sustained release methylphenidate: pharmacokinetic studies in ADDH males.
Birmaher, B; Cooper, TB; Fried, J; Greenhill, LL; Maminski, B, 1989
)
0.61
"The pharmacokinetic behaviour of haloperidol (0."( Pharmacokinetics and effects of haloperidol in the isolated mouse.
Baumann, GH; Zetler, G, 1985
)
0.27
" Newborns and premature infants can metabolize and eliminate diazepam, although the parent drug has a longer half-life and decreased rate of biotransformation to its primary metabolites than in older children and adults."( Pharmacokinetics of benzodiazepines and psychostimulants in children.
Coffey, B; Greenblatt, DJ; Shader, RI, 1983
)
0.27
"A definitive enantioselective pharmacokinetic evaluation of dl-threo-methylphenidate (MPH) was carried out in 11 healthy volunteers, all of whom received, in a randomized crossover design, three oral administrations of MPH: immediate release (IR), slow release (SR), and SR chewed before swallowing (CH)."( Enantioselective pharmacokinetics of dl-threo-methylphenidate in humans.
Hubbard, JW; Korchinski, ED; Midha, KK; Srinivas, NR, 1993
)
0.78
" The clockwise hysteresis between the MPD concentration and the DA level in the dialysate could be explained by the pharmacodynamic model considering Michaelis-Menten type reuptake process of the extracellular DA into the terminal of the dopaminergic nerve and its competitive inhibition by the extracellular MPD."( Pharmacodynamic modeling for change of locomotor activity by methylphenidate in rats.
Aoyama, T; Iga, T; Kotaki, H; Sawada, Y; Yamamoto, K, 1997
)
0.54
" Pharmacokinetic parameters were determined by noncompartmental methods, but could not be evaluated for modafinil sulfone due to plasma levels that were close to the assay quantitation limit."( Single-dose pharmacokinetics of modafinil and methylphenidate given alone or in combination in healthy male volunteers.
Grebow, PE; King, SP; Laughton, WB; McCormick, GC; Wong, YN, 1998
)
0.56
" Calculated mean residence time and elimination half-life values for d-p-Br MPH were significantly longer than those for d-MPH and d-p-OCH3 MPH, and clearance of the bromo derivative was substantially lower than the latter two compounds."( Comparative pharmacokinetics and tissue distribution of the d-enantiomers of para-substituted methylphenidate analogs.
Perel, JM; Rudolph, GR; Thai, DL; Yurasits, LN, 1999
)
0.52
" A nonlinear regression model was applied to estimate overall population values of MP clearance and elimination half-life (t1/2), assuming a one-component model with first-order absorption and elimination, and further assuming that clearance is linearly related to body weight."( Population pharmacokinetics of methylphenidate in children with attention-deficit hyperactivity disorder.
Greenblatt, DJ; Harmatz, JS; Oesterheld, JR; Parmelee, DX; Sallee, FR; Shader, RI, 1999
)
0.59
" Although ADHD has been widely studied, the use of methylphenidate in ADHD still poses a number of unresolved questions, including its pharmacodynamic characteristics (drug concentration-effect relationship) and the effect of long term treatment on the patient's psychopathology later in life."( Pharmacokinetics and clinical effectiveness of methylphenidate.
Abernethy, DR; Cross, JT; Kimko, HC, 1999
)
0.81
" The terminal half-life of methylphenidate was similar for the three formulations."( Single- and multiple-dose pharmacokinetics of an oral once-a-day osmotic controlled-release OROS (methylphenidate HCl) formulation.
Gupta, SK; Lindemulder, B; Modi, NB, 2000
)
0.82
" There was no difference in the plasma elimination half-life of methylphenidate between the fed and fasted state."( Effect of food on the pharmacokinetics of osmotic controlled-release methylphenidate HCl in healthy subjects.
Gupta, SK; Hu, WT; Modi, NB; Wang, B, 2000
)
0.78
"The potential for a pharmacokinetic (PK) drug-drug interaction between modafinil and methylphenidate, each at steady state, was investigated in an open-label, randomized, single-period study in 32 healthy male and female volunteers."( Steady-state pharmacokinetics and tolerability of modafinil given alone or in combination with methylphenidate in healthy volunteers.
Arora, S; Hellriegel, ET; Nelson, M; Robertson, P, 2001
)
0.75
"For plasma d-MPH, there were significant differences (ANOVA) between dl-MPH-IR and dl-MPH-SR in tmax, Cmax (peak exposure), and Cmax/AUC (sensitive to rate of absorption)."( Effects of food on the pharmacokinetics of methylphenidate.
Hubbard, JW; Korchinski, ED; McKay, G; Midha, KK; Rawson, MJ, 2001
)
0.57
" Although the US FDA approved MPH in the 1960s, the pharmacokinetic (PK) properties of serum concentrations of MPH in children with ADHD were not described until the 1980s, and then in only a few cases."( Pharmacokinetic and pharmacodynamic properties of stimulants: implications for the design of new treatments for ADHD.
Swanson, JM; Volkow, ND, 2002
)
0.31
" These values were used to calculate standard noncompartmental pharmacokinetic parameters describing the rate (peak concentration and time to peak concentration) and extent (area under the concentration-time curve, AUC) of absorption of the two formulations."( Pharmacokinetics of methylphenidate after oral administration of two modified-release formulations in healthy adults.
DeVane, CL; Lee, J; Markowitz, JS; Muniz, R; Patrick, KS; Pestreich, L; Straughn, AB; Wang, Y, 2003
)
0.64
" While pharmacokinetic differences appear to exist between some of these new formulations, there are currently no clinical data available to demonstrate clinical efficacy differences between them."( Pharmacokinetic considerations in the treatment of attention-deficit hyperactivity disorder with methylphenidate.
Doffing, MA; Wolraich, ML, 2004
)
0.54
" MPH plasma concentration-time data were used to calculate the pharmacokinetic parameters for each treatment."( Dose-proportional pharmacokinetics of a methylphenidate extended-release capsule.
Dirksen, SJ; González, MA; Rochdi, M, 2004
)
0.59
" This was true for Cmax (maximum observed concentration), AUC(0-last) (area under the plasma concentration curve from time 0 to the last measurable time point) and AUC(0-inf) (area under the plasma concentration curve from time 0 to infinity)."( Dose-proportional pharmacokinetics of a methylphenidate extended-release capsule.
Dirksen, SJ; González, MA; Rochdi, M, 2004
)
0.59
"The technique of microdialysis utilizing three simultaneously implanted probes in the anaesthetized rat enables monitoring of pharmacokinetic (PK) profiles of a tested drug both in blood (1st probe) and brain (2nd probe) compartments and the pharmacodynamic (PD) response of neurotransmitters (3rd probe) released into, or accumulating within the brain extracellular fluid (ECF)."( Application of triple-probe microdialysis for fast pharmacokinetic/pharmacodynamic evaluation of dopamimetic activity of drug candidates in the rat brain.
Egestad, B; Kehr, J; Weikop, P, 2004
)
0.32
" Dose proportionality was shown for all dose-dependent pharmacokinetic parameters."( Dose-proportional pharmacokinetics of d-threo-methylphenidate after a repeated-action release dosage form.
Appel-Dingemanse, S; Maboudian, M; Pommier, F; Sedek, G; Tuerck, D; Wang, Y, 2007
)
0.6
" Pharmacokinetic parameters were compared."( Influence of ethanol and gender on methylphenidate pharmacokinetics and pharmacodynamics.
DeVane, CL; Herrin, AE; Janis, GC; Malcolm, R; Markowitz, JS; Minhinnett, RR; Patrick, KS; Straughn, AB; Yeatts, SD, 2007
)
0.62
" A nonlinear model was used to derive three pharmacokinetic (PK) values for analysis: Peak plasma concentration (C(max)), half-life (t(1/2)), and clearance (CL)."( Pharmacokinetics of methylphenidate in preschoolers with attention-deficit/hyperactivity disorder.
Greenhill, L; Gupta, S; Kapelinski, A; Lerner, M; Martinez, J; Modi, NB; Posner, K; Stehli, A; Steinhoff, K; Swanson, J; Wigal, SB; Wigal, T, 2007
)
0.66
"To use growth mixture modelling (GMM) to identify subgroups of children with attention deficit hyperactive disorder (ADHD) who have different pharmacodynamic profiles in response to extended release methylphenidate as assessed in a laboratory classroom setting."( Heterogeneity in the pharmacodynamics of two long-acting methylphenidate formulations for children with attention deficit/hyperactivity disorder. A growth mixture modelling analysis.
Coghill, D; Hatch, S; Sonuga-Barke, EJ; Swanson, JM; Van Lier, P; Vandenberghe, M; Wigal, S, 2008
)
0.78
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
" Although MPH is a racemic compound composed of a 50:50 mixture of dexmethylphenidate (d-MPH) and l-methylphenidate (l-MPH), animal and human studies have confirmed that the d-MPH isomer is responsible for the pharmacodynamic effect of MPH."( Does chirality matter? pharmacodynamics of enantiomers of methylphenidate in patients with attention-deficit/hyperactivity disorder.
Quinn, D, 2008
)
0.82
"To evaluate the pharmacokinetic properties of the methylphenidate transdermal system (MTS) in pediatric patients diagnosed with ADHD (attention-deficit/hyperactivity disorder) in a laboratory school setting."( Pharmacokinetics of methylphenidate transdermal system (MTS): results from a laboratory classroom study.
Dixon, CM; McGough, JJ; Pierce, D; Wigal, SB, 2008
)
0.92
" Laboratory school evaluations, including pharmacokinetic blood sampling, occurred at the end of each treatment."( Pharmacokinetics of methylphenidate transdermal system (MTS): results from a laboratory classroom study.
Dixon, CM; McGough, JJ; Pierce, D; Wigal, SB, 2008
)
0.67
" The clinical relevance of the MTS pharmacokinetic profile is discussed."( Pharmacokinetics of methylphenidate transdermal system (MTS): results from a laboratory classroom study.
Dixon, CM; McGough, JJ; Pierce, D; Wigal, SB, 2008
)
0.67
" Secondary objectives included assessment of tolerability and determination of further pharmacokinetic parameters."( A pharmacokinetic study of two modified-release methylphenidate formulations under different food conditions in healthy volunteers.
Dietrich, H; Haessler, F; Klatt, J; Stammer, H; Tracik, F, 2008
)
0.6
" Pharmacokinetic evaluations included AUC(0-inf), Cmax, tmax, elimination half life (t1/2) and mean residence time MRT(0-inf))."( A pharmacokinetic study of two modified-release methylphenidate formulations under different food conditions in healthy volunteers.
Dietrich, H; Haessler, F; Klatt, J; Stammer, H; Tracik, F, 2008
)
0.6
" Under fasted condition Ritalin LA(R) showed a consistent bimodal concentration time profile with two tmax peaks."( A pharmacokinetic study of two modified-release methylphenidate formulations under different food conditions in healthy volunteers.
Dietrich, H; Haessler, F; Klatt, J; Stammer, H; Tracik, F, 2008
)
0.6
" Serial blood samples were collected after each MTS application and pharmacokinetic (PK) parameters for d,l-MPH were calculated."( Effects of application to two different skin sites on the pharmacokinetics of transdermal methylphenidate in pediatric patients with attention-deficit/hyperactivity disorder.
Campbell, D; González, MA; Rubin, J, 2009
)
0.57
" MPH and RA were both detected in oral fluid with a pharmacokinetic profile similar to that in plasma."( Pharmacokinetics of methylphenidate in oral fluid and sweat of a pediatric subject.
Farrè, M; García-Algar, O; Marchei, E; Pacifici, R; Pellegrini, M; Pichini, S; Vall, O, 2010
)
0.68
" The pharmacokinetic evaluation showed that methylphenidate concentrations were not markedly affected by ethanol, but ritalinic acid concentrations were lower, especially if ethanol was ingested first."( Influence of ethanol on the pharmacokinetics of methylphenidate's metabolites ritalinic acid and ethylphenidate.
Kauert, GF; Koehm, M; Toennes, SW, 2010
)
0.88
" The pharmacokinetic population consisted of 33 children and 31 adolescents."( Single- and multiple-dose pharmacokinetics of methylphenidate administered as methylphenidate transdermal system or osmotic-release oral system methylphenidate to children and adolescents with attention deficit hyperactivity disorder.
Buckwalter, M; Katic, A; Pierce, D; Webster, K, 2010
)
0.62
" Plasma concentrations of d- and l-MPH were determined and pharmacokinetic parameters were calculated."( The single-dose pharmacokinetics of NWP06, a novel extended-release methylphenidate oral suspension.
Berry, SA; Childress, AC, 2010
)
0.6
" The peak plasma concentration, Cmax (ng/mL), was 13."( The single-dose pharmacokinetics of NWP06, a novel extended-release methylphenidate oral suspension.
Berry, SA; Childress, AC, 2010
)
0.6
" NWP06 has a lower peak concentration than IR MPH."( The single-dose pharmacokinetics of NWP06, a novel extended-release methylphenidate oral suspension.
Berry, SA; Childress, AC, 2010
)
0.6
" Coefficients of variance of pharmacokinetic measures can estimate the levels of pharmacokinetic variability based on the measurable variance between different individuals receiving the same dose of stimulant (interindividual variability) and within the same individual over multiple administrations (intraindividual variability)."( Pharmacokinetic variability of long-acting stimulants in the treatment of children and adults with attention-deficit hyperactivity disorder.
Adeyi, BA; Ermer, JC; Pucci, ML, 2010
)
0.36
" Serial blood samples were obtained before and after drug administration for determination of plasma methylphenidate concentrations and standard pharmacokinetic parameters."( Single-dose pharmacokinetics of NWP06, an extended-release methylphenidate suspension, in children and adolescents with ADHD.
Berry, SA; Childress, AC; Sallee, FR, 2011
)
0.83
" Values for Cmax were observed between 2 and 4 hours after the dose."( Single-dose pharmacokinetics of NWP06, an extended-release methylphenidate suspension, in children and adolescents with ADHD.
Berry, SA; Childress, AC; Sallee, FR, 2011
)
0.61
"There were no age-related pharmacokinetic differences after oral administration of NWP06 to children or adolescents in this small sample."( Single-dose pharmacokinetics of NWP06, an extended-release methylphenidate suspension, in children and adolescents with ADHD.
Berry, SA; Childress, AC; Sallee, FR, 2011
)
0.61
"These results confirm the study hypothesis that central dopamine transporter occupancy parallels peripheral pharmacokinetic findings in orally administered long-acting dexmethylphenidate in later hours after administration."( Understanding the central pharmacokinetics of spheroidal oral drug absorption system (SODAS) dexmethylphenidate: a positron emission tomography study of dopamine transporter receptor occupancy measured with C-11 altropane.
Bonab, AA; Clarke, A; Dougherty, DD; Fischman, AJ; Martin, J; Mirto, T; Spencer, TJ, 2012
)
0.79
"Placebo and pharmacodynamic (PD) models were developed which link temporal measures of efficacy in children with attention deficit hyperactivity disorder (ADHD) and methylphenidate (MPH) plasma concentrations from adults."( Population pharmacodynamic modeling of various extended-release formulations of methylphenidate in children with attention deficit hyperactivity disorder via meta-analysis.
Berwaerts, J; Gibiansky, E; Gibiansky, L; Kimko, H; Massarella, J; Starr, HL; Wiegand, F, 2012
)
0.8
" In the case of complex modified-release formulations, these criteria may not address pharmacokinetic differences with potential therapeutic and tolerability implications."( Differences in the in vitro and in vivo pharmacokinetic profiles of once-daily modified-release methylphenidate formulations in Canada: examination of current bioequivalence criteria.
Chen, N; Endrenyi, L; Faulknor, J; Luong, D; Quinn, AM; Sellers, EM; Shram, MJ, 2012
)
0.6
"This study was performed to characterize in vitro dissolution and in vivo pharmacokinetic profiles of three modified-release formulations of methylphenidate (MPH) marketed in Canada, two of which meet the criteria for assuming bioequivalence as defined by Health Canada: MPH extended-release (ER-C) and osmotic controlled-release oral-delivery-system (OROS-MPH)."( Differences in the in vitro and in vivo pharmacokinetic profiles of once-daily modified-release methylphenidate formulations in Canada: examination of current bioequivalence criteria.
Chen, N; Endrenyi, L; Faulknor, J; Luong, D; Quinn, AM; Sellers, EM; Shram, MJ, 2012
)
0.8
" Twenty-four subjects completed the pharmacokinetic study and were included in the analyses."( Differences in the in vitro and in vivo pharmacokinetic profiles of once-daily modified-release methylphenidate formulations in Canada: examination of current bioequivalence criteria.
Chen, N; Endrenyi, L; Faulknor, J; Luong, D; Quinn, AM; Sellers, EM; Shram, MJ, 2012
)
0.6
"The pharmacokinetic data suggest that in vitro and in vivo profiles of OROS-MPH and MPH ER-C are distinct."( Differences in the in vitro and in vivo pharmacokinetic profiles of once-daily modified-release methylphenidate formulations in Canada: examination of current bioequivalence criteria.
Chen, N; Endrenyi, L; Faulknor, J; Luong, D; Quinn, AM; Sellers, EM; Shram, MJ, 2012
)
0.6
" However, data on the pharmacokinetic profiles and safety of combination treatments in ADHD are needed."( Pharmacokinetics of coadministration of guanfacine extended release and methylphenidate extended release.
Corcoran, M; Ermer, J; Haffey, M; Martin, P; Purkayastha, J; Roesch, B; Stevenson, A; Wang, P, 2013
)
0.62
"The primary objective of this study was to evaluate the pharmacokinetic profiles of guanfacine extended release (GXR) and methylphenidate hydrochloride (MPH) extended release, alone and in combination."( Pharmacokinetics of coadministration of guanfacine extended release and methylphenidate extended release.
Corcoran, M; Ermer, J; Haffey, M; Martin, P; Purkayastha, J; Roesch, B; Stevenson, A; Wang, P, 2013
)
0.83
" Overall, combining GXR and MPH did not alter the pharmacokinetic parameters of either medication."( Pharmacokinetics of coadministration of guanfacine extended release and methylphenidate extended release.
Corcoran, M; Ermer, J; Haffey, M; Martin, P; Purkayastha, J; Roesch, B; Stevenson, A; Wang, P, 2013
)
0.62
"In this short-term, open-label study of healthy adults, coadministration of GXR and MPH did not result in significant pharmacokinetic drug-drug interactions."( Pharmacokinetics of coadministration of guanfacine extended release and methylphenidate extended release.
Corcoran, M; Ermer, J; Haffey, M; Martin, P; Purkayastha, J; Roesch, B; Stevenson, A; Wang, P, 2013
)
0.62
" However, their pharmacokinetic profiles differ with respect to peak plasma levels and the rate at which peak levels are attained and decline."( Comparison of the pharmacokinetics and clinical efficacy of new extended-release formulations of methylphenidate.
Maldonado, R, 2013
)
0.61
" Pharmacodynamic interactions of methylphenidate and MDMA are likely."( Pharmacokinetic and pharmacodynamic effects of methylphenidate and MDMA administered alone or in combination.
Donzelli, M; Grouzmann, E; Hysek, CM; Liechti, ME; Meyer, N; Schillinger, N; Schmid, Y; Simmler, LD, 2014
)
0.94
" The method is suitable for the precisely determination of MPH and for pharmacokinetic study of MPH in human plasma."( [LC-MS/MS assay of methylphenidate: stability and pharmacokinetics in human].
Ding, L; Dong, X; Gu, X; Jiang, LY; Luo, XM, 2014
)
0.73
" For the first time a physiologically based pharmacokinetic (PBPK) model has been developed in juvenile and adult humans and nonhuman primates to quantitatively evaluate species- and age-dependent enantiomer specific pharmacokinetics of MPH and its primary metabolite ritalinic acid."( Development of a physiologically based model to describe the pharmacokinetics of methylphenidate in juvenile and adult humans and nonhuman primates.
Doerge, DR; Fisher, JW; Gearhart, JM; Mattison, DR; Morris, SM; Paule, MG; Ruark, CD; Slikker, W; Twaddle, NC; Vitiello, B; Yang, X; Young, JF, 2014
)
0.63
"The purpose of this study was to evaluate the relative bioavailability and safety of a multilayer extended-release bead methylphenidate (MPH) hydrochloride 80 mg (MPH-MLR) capsule or sprinkles (37% immediate-release [IR]) versus MPH hydrochloride IR(Ritalin(®)) tablets, and to develop a pharmacokinetic (PK) model simulating MPH concentration-time data for different MPH-MLR dosage strengths."( Single-dose pharmacokinetics of methylphenidate extended-release multiple layer beads administered as intact capsule or sprinkles versus methylphenidate immediate-release tablets (Ritalin(®)) in healthy adult volunteers.
Adjei, A; Chang, WW; Connor, DF; Greenhill, L; Kupper, RJ; Newcorn, JH; Teuscher, NS; Wigal, S, 2014
)
0.89
" Based on 90% CIs, total systemic exposure to MPH-MLR 80 mg capsule/sprinkles was similar to that for Ritalin IR 25 mg three times daily, but marked differences in Cmax values indicated that MPH-MLR regimens were not bioequivalent to Ritalin."( Single-dose pharmacokinetics of methylphenidate extended-release multiple layer beads administered as intact capsule or sprinkles versus methylphenidate immediate-release tablets (Ritalin(®)) in healthy adult volunteers.
Adjei, A; Chang, WW; Connor, DF; Greenhill, L; Kupper, RJ; Newcorn, JH; Teuscher, NS; Wigal, S, 2014
)
0.69
"Most animal studies using methylphenidate (MP) do not administer it the same way it is administered clinically (orally), but rather by injection, resulting in an altered pharmacokinetic profile (quicker and higher peak concentrations)."( A pharmacokinetic model of oral methylphenidate in the rat and effects on behavior.
Cooper, T; Hadjiargyrou, M; Hwang, YF; Komatsu, DE; Robison, LS; Steier, J; Swanson, JM; Thanos, PK; Volkow, ND, 2015
)
1
"A new multilayer-bead formulation of extended-release methylphenidate hydrochloride (MPH-MLR) has been evaluated in pharmacokinetic studies in healthy adults and in Phase III efficacy/safety studies in children and adolescents with attention deficit hyperactivity disorder (ADHD)."( Population pharmacokinetics of methylphenidate hydrochloride extended-release multiple-layer beads in pediatric subjects with attention deficit hyperactivity disorder.
Adjei, A; Findling, RL; Greenhill, LL; Kupper, RJ; Teuscher, NS; Wigal, S, 2015
)
0.95
" The validated UFLC-MS/MS method successfully applied to the pharmacokinetic interaction study of oral d-threo-MPH and l-threo-MPH (alone or in combination) in female Sprague Dawley rats."( Development and validation of an UFLC-MS/MS method for enantioselectivity determination of d,l-thero-methylphenidate, d,l-thero-ethylphenidate and d,l-thero-ritalinic acid in rat plasma and its application to pharmacokinetic study.
Lin, G; Luo, H; Wang, H; Wu, Y; Zhang, C; Zhang, F; Zhang, J, 2016
)
0.65
"The purpose of this study was to quantify the amounts of the d- and l-threo enantiomers of methylphenidate in maternal plasma, placenta, and maternal and fetal brain tissue following prenatal exposure and to establish a pharmacokinetic profile for MPH during pregnancy."( The pharmacokinetic profile of methylphenidate use in pregnancy: A study in mice.
Brown, SD; Peters, HT; Pond, BB; Strange, LG,
)
0.64
" This randomized, open-label, crossover trial compared the pharmacokinetic properties and relative bioavailability of MPH ERCT with an MPH chewable immediate-release tablet (IR MPH) formulation in healthy adults."( Single-dose Pharmacokinetic Properties and Relative Bioavailability of a Novel Methylphenidate Extended-release Chewable Tablet Compared With Immediate-release Methylphenidate Chewable Tablet.
Abbas, R; Belden, H; Berry, SA; Palumbo, D; Walters, F, 2016
)
0.66
"A total of 33 participants were enrolled in the study; 31 participants were included in the pharmacokinetic analysis."( Single-dose Pharmacokinetic Properties and Relative Bioavailability of a Novel Methylphenidate Extended-release Chewable Tablet Compared With Immediate-release Methylphenidate Chewable Tablet.
Abbas, R; Belden, H; Berry, SA; Palumbo, D; Walters, F, 2016
)
0.66
"To determine the pharmacokinetic (PK) profile of a proprietary formulation of methylphenidate (MPH) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) in a phase 1 study."( A Single-Dose, Single-Period Pharmacokinetic Assessment of an Extended-Release Orally Disintegrating Tablet of Methylphenidate in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder.
Childress, A; McMahen, R; Newcorn, J; Sikes, C; Stark, JG; Tengler, M, 2016
)
0.87
" The following plasma PK parameters of MPH were determined for participants grouped by age (6-7, 8-9, 10-12, and 13-17 years old): maximum concentration (Cmax), time to maximum concentration (Tmax), elimination half-life (T½), area under the curve from 0 hours to infinity (AUCinf), oral clearance (CL/F), and volume of distribution in the terminal phase (Vz/F)."( A Single-Dose, Single-Period Pharmacokinetic Assessment of an Extended-Release Orally Disintegrating Tablet of Methylphenidate in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder.
Childress, A; McMahen, R; Newcorn, J; Sikes, C; Stark, JG; Tengler, M, 2016
)
0.65
"A previously presented physiologically-based pharmacokinetic model for immediate release (IR) methylphenidate (MPH) was extended to characterize the pharmacokinetic behaviors of oral extended release (ER) MPH formulations in adults for the first time."( Application of Physiologically Based Absorption Modeling to Characterize the Pharmacokinetic Profiles of Oral Extended Release Methylphenidate Products in Adults.
Duan, J; Fisher, J; Yang, X, 2016
)
0.86
"We propose a novel semi-automatic approach to design biomarkers for capturing pharmacodynamic effects induced by pharmacological agents on the spectral power of electroencephalography (EEG) recordings."( Semi-Automated Biomarker Discovery from Pharmacodynamic Effects on EEG in ADHD Rodent Models.
Cichocki, A; Hasegawa, M; Hiroyama, S; Horiuchi, M; Jurica, P; Li, J; Nishitomi, K; Ogawa, K; Struzik, ZR; Takahara, Y; Yokota, T, 2018
)
0.48
" The objectives of the current study were to describe drug concentrations, develop an analytical method that could be used to regulate its use, and describe the pharmacodynamic effects of ethylphenidate in horses."( L- and D-threo ethylphenidate concentrations, pharmacokinetics, and pharmacodynamics in horses.
Benson, D; Hartmann, P; Hovda, L; Knych, HK; McKemie, DS; Seminoff, K, 2018
)
0.48
" This analysis sought to develop a population pharmacokinetic (PK)/pharmacodynamic (PD) model to describe MPH XR-ODT PD-response data in a classroom study and use the model to simulate PD responses for a range of body weights and doses."( Population Pharmacokinetic-Pharmacodynamic Modeling of a Novel Methylphenidate Extended-Release Orally Disintegrating Tablet in Pediatric Patients With Attention-Deficit/Hyperactivity Disorder.
Engelking, D; McMahen, R; Sikes, CR; Teuscher, NS, 2018
)
0.72
" CES1 gene variation only partially explains pharmacokinetic (PK) variability."( Pharmacometabolomics Informs About Pharmacokinetic Profile of Methylphenidate.
Baillie, R; Dalhoff, KP; Hankemeier, T; Harms, A; Jűrgens, G; Kaddurah-Daouk, R; Linnet, K; Motsinger-Reif, AA; Nzabonimpa, GS; Rasmussen, HB; Scholl, EH; Stage, C; Taboureau, O; Thomsen, R, 2018
)
0.72
" The objectives were to evaluate DR/ER-MPH pharmacokinetic (PK) properties in healthy adults, including dose proportionality, food effect, the potential of accumulation using multiple-dose modeling, and bioavailability compared to an immediate-release MPH (IR MPH)."( Pharmacokinetics of HLD200, a Delayed-Release and Extended-Release Methylphenidate: Evaluation of Dose Proportionality, Food Effect, Multiple-Dose Modeling, and Comparative Bioavailability with Immediate-Release Methylphenidate in Healthy Adults.
DeSousa, NJ; Gobburu, JVS; Incledon, B; Liu, T; McLean, A; Po, MD; Sallee, FR, 2019
)
0.75
" The pharmacokinetic (PK) profile of DR/ER-MPH is characterized by an 8- to 10-hour delay in initial methylphenidate absorption and a subsequent gradual increase in plasma concentration, followed by a slow decline."( Effect of Colonic Absorption on the Pharmacokinetic Properties of Delayed-Release and Extended-Release Methylphenidate: In Vivo, In Vitro, and Modeling Evaluations.
Gomeni, R; Incledon, B; Incledon, C; Kapuscinski, J; Morris, A; Perry, K; Uchida, CL, 2022
)
1.15
"As outlined in changes to the US prescribing information for all methylphenidate and risperidone products, health care professionals should be aware that changes to this combination may be associated with a pharmacodynamic drug-drug interaction resulting in acute hyperkinetic movement disorder."( Acute Hyperkinetic Movement Disorders as a Multifactorial Pharmacodynamic Drug Interaction Between Methylphenidate and Risperidone in Children and Adolescents.
Burkhart, K; Chen, Q; Cheng, C; Croteau, D; Demczar, D; Kortepeter, C; Mohamoud, M; Stone, M; Volpe, DA,
)
0.59
" The object of this study is to evaluate CES1 pharmacogenetics as related to MPH metabolism using human liver samples and develop a physiologically-based pharmacokinetic (PBPK) modeling approach to investigate the influence of CES1 genotypes and other factors on MPH PK."( Physiologically-Based Pharmacokinetic Modeling to Predict Methylphenidate Exposure Affected by Interplay Among Carboxylesterase 1 Pharmacogenetics, Drug-Drug Interactions, and Sex.
Shi, J; Smith, DE; Thompson, BR; Xiao, J; Zhang, T; Zhu, HJ, 2022
)
0.97
" While each of these medications have their own distinct pharmacokinetic profile, the extent to which pharmacogenetics effects their pharmacokinetic parameters is best described in atomoxetine, followed by methylphenidate."( The Pharmacogenetic Impact on the Pharmacokinetics of ADHD Medications.
Brown, JT, 2022
)
0.91

Compound-Compound Interactions

Methylphenidate in combination with antiepileptic drugs is gaining acceptance for children with epilepsy who have the symptoms of attention-deficit hyperactivity disorder (ADHD)

ExcerptReferenceRelevance
"Sixty-six children received individual reading instruction for 18 weeks, in combination with methylphenidate (mean daily dose 44."( Children with reading disorders--II. Effects of methylphenidate in combination with reading remediation.
Feingold, I; Gittelman, R; Klein, DF, 1983
)
0.74
" However, none of the measurements showed a significant difference between the conditions when methylphenidate was given with breakfast and the condition when methylphenidate was given 30 minutes before breakfast."( Methylphenidate hydrochloride given with or before breakfast: I. Behavioral, cognitive, and electrophysiologic effects.
Baren, M; Deutsch, C; Sandman, CA; Swanson, JM, 1983
)
1.93
" Often, these agents are used in combination with other medications."( Drug interactions with psychostimulants.
DeVane, CL; Markowitz, JS; Morrison, SD, 1999
)
0.3
"The use of methylphenidate (MPH) in combination with antiepileptic drugs is gaining acceptance for children with epilepsy who have the symptoms of attention-deficit hyperactivity disorder (ADHD)."( Adverse response to methylphenidate in combination with valproic acid.
Gara, L; Roberts, W, 2000
)
1.02
" The present study extends these results by addressing the issue of clinical significance using drug-placebo and drug-drug response curve analyses of the same data."( Efficacy of Adderall and methylphenidate in attention deficit hyperactivity disorder: a reanalysis using drug-placebo and drug-drug response curve methodology.
Biederman, J; Faraone, SV; Olvera, RL; Pliszka, SR; Skolnik, R, 2001
)
0.61
"The potential for a pharmacokinetic (PK) drug-drug interaction between modafinil and methylphenidate, each at steady state, was investigated in an open-label, randomized, single-period study in 32 healthy male and female volunteers."( Steady-state pharmacokinetics and tolerability of modafinil given alone or in combination with methylphenidate in healthy volunteers.
Arora, S; Hellriegel, ET; Nelson, M; Robertson, P, 2001
)
0.75
" Thus, oral MPH-SR is safe in combination with repeated cocaine doses and decreases some of the positive and reinforcing effects of cocaine in cocaine abusers with ADHD."( Response to cocaine, alone and in combination with methylphenidate, in cocaine abusers with ADHD.
Collins, SL; Evans, SM; Foltin, RW; Kleber, HD; Levin, FR, 2006
)
0.59
" We conducted a randomized crossover trial with MPH and placebo (2 weeks each) combined with aripiprazole in children and adolescents (n = 16; 8-17 years old) with JBPD and ADHD who had a significant response in manic symptoms with aripiprazole but still presented clinically significant symptoms of ADHD."( Methylphenidate combined with aripiprazole in children and adolescents with bipolar disorder and attention-deficit/hyperactivity disorder: a randomized crossover trial.
Ketzer, CR; Pheula, GF; Rohde, LA; Tramontina, S; Zeni, CP, 2009
)
1.8
" The risk of adverse drug-drug interaction(s) is present when metabolic inhibitors are combined with known or suspected substrates of a given enzyme."( Identification of selected therapeutic agents as inhibitors of carboxylesterase 1: potential sources of metabolic drug interactions.
Appel, DI; Markowitz, JS; Peterson, YK; Wang, Z; Zhu, HJ, 2010
)
0.36
" We sought to prospectively study the effects of levodopa (LD) and/or methylphenidate (MPH) in combination with physiotherapy on mood and cognition following stroke in human subjects."( Effect of methylphenidate and/or levodopa combined with physiotherapy on mood and cognition after stroke: a randomized, double-blind, placebo-controlled trial.
Delbari, A; Lokk, J; Salman-Roghani, R, 2011
)
1.01
"A 15-day course of daily MPH + LD combined with physiotherapy over a 3-week period was safe and significantly improved mood status in ischemic stroke patients."( Effect of methylphenidate and/or levodopa combined with physiotherapy on mood and cognition after stroke: a randomized, double-blind, placebo-controlled trial.
Delbari, A; Lokk, J; Salman-Roghani, R, 2011
)
0.77
"To investigate the effect of parent training combined with methylphenidate treatment on family relationships in children with attention deficit/hyperactivity disorder (ADHD)."( [Effect of parent training in combination with methylphenidate treatment on family relationships for children with attention deficit/hyperactivity disorder].
Ding, KJ; Kang, CY; Li, XR; Liu, RX; Wan, S; Wang, YJ; Xuan, X; Yang, RX; Zhang, Y; Zhao, XR, 2014
)
0.9
" In this study, we characterized the clinical profile of children and adolescents for whom a once-daily lower dose of OROS-MPH combined with a shorter-acting agent was more tolerable than single higher OROS-MPH dose."( The clinical profile of children with ADHD that require OROS-methylphenidate combined with shorter-acting formulations.
Terkel-Dawer, R; Zelnik, N, 2015
)
0.66
"
 Conclusion: Fluvoxamine combined with MPH-ER is effective in the treatment of refractory obsessive-compulsive disorder."( [Efficacy of fluvoxamine combined with extended-release methylphenidate on treatment-refractory obsessive-compulsive disorder].
Guo, G; Huang, H; Jia, F; Li, G; Quan, D; Zheng, H, 2018
)
0.73
"As outlined in changes to the US prescribing information for all methylphenidate and risperidone products, health care professionals should be aware that changes to this combination may be associated with a pharmacodynamic drug-drug interaction resulting in acute hyperkinetic movement disorder."( Acute Hyperkinetic Movement Disorders as a Multifactorial Pharmacodynamic Drug Interaction Between Methylphenidate and Risperidone in Children and Adolescents.
Burkhart, K; Chen, Q; Cheng, C; Croteau, D; Demczar, D; Kortepeter, C; Mohamoud, M; Stone, M; Volpe, DA,
)
0.59
" Carboxylesterase 1 (CES1) is the primary enzyme metabolizing MPH, and its function is affected by genetic variants, drug-drug interaction (DDI), and sex."( Physiologically-Based Pharmacokinetic Modeling to Predict Methylphenidate Exposure Affected by Interplay Among Carboxylesterase 1 Pharmacogenetics, Drug-Drug Interactions, and Sex.
Shi, J; Smith, DE; Thompson, BR; Xiao, J; Zhang, T; Zhu, HJ, 2022
)
0.97

Bioavailability

Methylphenidate (MPD) is a psychostimulant used for the treatment of ADHD and works by increasing the bioavailability of dopamine (DA) in the brain. Enantioselective hydrolysis of oral racemic methyl phenidate (dl-MPH) by carboxylesterase 1 (CES1) limits the absolute bioavailability to approximately 30%.

ExcerptReferenceRelevance
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
" By measuring the brain function using computer period analysis of cerebral biopotentials, dose-efficacy relations were found (in the range of 25-75 mcg) which suggest the bioavailability of LHM at the CNS level."( Prediction of psychotropic properties of lisuride hydrogen maleate by quantitative pharmaco-electroencephalogram.
Akpinar, S; Herrmann, WM; Itil, TM, 1975
)
0.25
"The pharmacokinetics and bioavailability of methylphenidate (MPH) and a metabolite, ritalinic acid (RA), were studied in normal adults, children with hyperactivity, monkeys and rats."( Pharmacokinetics of methylphenidate in man, rat and monkey.
Breese, GR; Ellington, K; Gualtieri, CT; Kilts, C; Kraemer, G; Mueller, RA; Patrick, K; Wargin, W, 1983
)
0.85
" The bioavailability of methylphenidate and PPA from OROS (methylphenidate HCl) relative to the IR and SR formulations was complete."( Single- and multiple-dose pharmacokinetics of an oral once-a-day osmotic controlled-release OROS (methylphenidate HCl) formulation.
Gupta, SK; Lindemulder, B; Modi, NB, 2000
)
0.83
"To determine the relative bioavailability of two marketed, immediate-release methylphenidate tablets."( Bioequivalence of methylphenidate immediate-release tablets using a replicated study design to characterize intrasubject variability.
Chen, ML; Jarvi, EJ; Meyer, MC; Patnaik, R; Patrick, KS; Pelsor, FR; Shah, VP; Straughn, AB; Williams, RL, 2000
)
0.87
"Food caused a significant increase in extent of absorption but had no effect on rate of absorption of d-MPH after either dl-MPHIR or dl-MPH-SR."( Effects of food on the pharmacokinetics of methylphenidate.
Hubbard, JW; Korchinski, ED; McKay, G; Midha, KK; Rawson, MJ, 2001
)
0.57
"To determine the single-dose bioavailability of 20-mg Metadate CD (methylphenidate HCI, USP) Extended-Release Capsules sprinkled onto 1 level tablespoon (15 mL) of applesauce relative to an intact capsule under fasted conditions in healthy adults."( Methylphenidate bioavailability in adults when an extended-release multiparticulate formulation is administered sprinkled on food or as an intact capsule.
Benedict, MF; Hatch, SJ; Pentikis, HS; Simmons, RD, 2002
)
1.99
"The bioavailability of methylphenidate was not altered when Metadate CD capsules were administered by sprinkling their contents onto a small amount of applesauce."( Methylphenidate bioavailability in adults when an extended-release multiparticulate formulation is administered sprinkled on food or as an intact capsule.
Benedict, MF; Hatch, SJ; Pentikis, HS; Simmons, RD, 2002
)
2.07
"Open-label, randomised, crossover, bioavailability study."( Pharmacokinetics of methylphenidate after oral administration of two modified-release formulations in healthy adults.
DeVane, CL; Lee, J; Markowitz, JS; Muniz, R; Patrick, KS; Pestreich, L; Straughn, AB; Wang, Y, 2003
)
0.64
"The Ritalin LA formulation exhibited more rapid initial absorption and reached significantly higher peak plasma concentrations compared with the Concerta formulation, although the oral bioavailability of MPH was similar between the two formulations."( Pharmacokinetics of methylphenidate after oral administration of two modified-release formulations in healthy adults.
DeVane, CL; Lee, J; Markowitz, JS; Muniz, R; Patrick, KS; Pestreich, L; Straughn, AB; Wang, Y, 2003
)
0.64
" The oral bioavailability of MPH in females may be lower than in males."( Advances in the pharmacotherapy of attention-deficit-hyperactivity disorder: focus on methylphenidate formulations.
Markowitz, JS; Patrick, KS; Straughn, AB, 2003
)
0.54
" In summary, food had no substantial effect on the bioavailability of d-MPH, with an equivalent rate and extent of exposure obtained."( A single-dose, two-way crossover, bioequivalence study of dexmethylphenidate HCl with and without food in healthy subjects.
Khetani, VD; Scheffler, MR; Stirling, DI; Stypinski, D; Teo, SK; Thomas, SD; Wu, A, 2004
)
0.56
" Compared with Ritalin IR, the Ritalin LA formulation demonstrated a similar rate of absorption for the first peak, a lower second Cmax and a higher trough concentration between peaks, as well as similar overall plasma AUC."( In vitro dissolution and in vivo oral absorption of methylphenidate from a bimodal release formulation in healthy volunteers.
Bakhtiar, R; Hossain, M; Lau, H; Lee, J; Lee, L; Rekhi, GS; Sedek, G; Somma, R; Thompson, G; Wang, Y, 2004
)
0.57
" The in vivo biphasic absorption of MPH appeared to be well correlated with the bimodal dissolution characteristics of this new Ritalin LA formulation, and some changes in the dissolution profiles for the DR beads appeared not to affect the overall bioavailability of MPH in humans."( In vitro dissolution and in vivo oral absorption of methylphenidate from a bimodal release formulation in healthy volunteers.
Bakhtiar, R; Hossain, M; Lau, H; Lee, J; Lee, L; Rekhi, GS; Sedek, G; Somma, R; Thompson, G; Wang, Y, 2004
)
0.57
" It has been speculated that l-threo-MP is poorly absorbed in humans when it is given orally because of rapid presystemic metabolism."( Brain kinetics of methylphenidate (Ritalin) enantiomers after oral administration.
Carter, P; Ding, YS; Fowler, JS; Garza, V; Gatley, SJ; King, P; Park, DJ; Pyatt, B; Shea, C; Taintor, NB; Thanos, PK; Volkow, ND; Warner, D; Xu, Y, 2004
)
0.66
"The rate of absorption and elimination of d-MPH was dependent on the pattern of administration, particularly on the initial bolus concentration."( Methylphenidate blood levels and therapeutic response in children with attention-deficit hyperactivity disorder: I. Effects of different dosing regimens.
Chang, WW; Foley, M; McGreenery, CE; McKay, G; Midha, KK; Polcari, A; Teicher, MH; Valente, E, 2006
)
1.78
"This study explores the hypotheses that: (1) ethanol will interact with dl-Methylphenidate (MPH) to enantioselectively elevate plasma d-MPH, and primarily yield l-ethylphenidate as a transesterification metabolite; (2) women will exhibit lower relative bioavailability of MPH than men; and (3) sex-dependent differences in subjective effects will exist."( Influence of ethanol and gender on methylphenidate pharmacokinetics and pharmacodynamics.
DeVane, CL; Herrin, AE; Janis, GC; Malcolm, R; Markowitz, JS; Minhinnett, RR; Patrick, KS; Straughn, AB; Yeatts, SD, 2007
)
0.85
" The relative bioavailability of Ritalin LA(R) and Medikinet retard and the food effect were assessed using a 90% confidence interval (CI) based on the lower and upper endpoints of the CI for the ratios of the geometric means being within the 80 - 125% equivalence criterion."( A pharmacokinetic study of two modified-release methylphenidate formulations under different food conditions in healthy volunteers.
Dietrich, H; Haessler, F; Klatt, J; Stammer, H; Tracik, F, 2008
)
0.6
" Hip and scapular application resulted in quantifiable levels of d,l-MPH, with approximately 31% higher bioavailability upon hip application."( Effects of application to two different skin sites on the pharmacokinetics of transdermal methylphenidate in pediatric patients with attention-deficit/hyperactivity disorder.
Campbell, D; González, MA; Rubin, J, 2009
)
0.57
" Bioavailability of MPH from the same transdermal delivery system appears to differ substantially when applied to two different skin surfaces in young children but with similar overall skin effects assessments."( Effects of application to two different skin sites on the pharmacokinetics of transdermal methylphenidate in pediatric patients with attention-deficit/hyperactivity disorder.
Campbell, D; González, MA; Rubin, J, 2009
)
0.57
" An important assumption in the animal models that have been employed to study methylphenidate's effects on the brain and behavior is that bioavailability of methylphenidate in the animal models reflects that in human subjects."( Plasma and brain concentrations of oral therapeutic doses of methylphenidate and their impact on brain monoamine content in mice.
Balcioglu, A; Bhide, PG; Biederman, J; McCarthy, D; Ren, JQ; Spencer, TJ, 2009
)
0.82
" Bioequivalence could not be demonstrated for the rate of bioavailability (Cmax); both the lower confidence limit and the point estimate were below 80% of the reference."( Lack of bioequivalence between two methylphenidate extended modified release formulations in healthy volunteers.
Ammer, R; Fischer, R; Grossmann, M; Leis, HJ; Mazur, D; Schütz, H, 2009
)
0.63
" The relative bioavailability of the SR formulation was 30."( Pharmacokinetics of methylphenidate following two oral formulations (immediate and sustained release) in the dog.
Giorgi, M; Lavy, E; Neri, D; Prise, U; Soldani, G, 2010
)
0.68
" The relative bioavailability of the SR formulation was 30."( Pharmacokinetics of methylphenidate after oral administration of immediate and sustained-release preparations in Beagle dogs.
Bar Chaim, A; Brandriss, N; Giorgi, M; Lavy, E; Neri, D; Prise, U; Soldani, G, 2011
)
0.69
" Specifically, we asked: (1) will ethanol increase d-MPH biological concentrations, (2) will MTS facilitate the systemic bioavailability of l-MPH, and (3) will l-MPH enantioselectively interact with ethanol to yield l-ethylphenidate (l-EPH)? Mice were dosed with MTS (¼ of a 12."( Transdermal and oral dl-methylphenidate-ethanol interactions in C57BL/6J mice: transesterification to ethylphenidate and elevation of d-methylphenidate concentrations.
Bell, GH; Griffin, WC; Novak, AJ; Patrick, KS, 2011
)
0.68
" Simulations using the fitted parameters determined how changes in fast absorption rate constant (K0Fast) and fraction available (F1) affected curve shape and BE determination using Cmax, AUCINF and PAUC."( Use of partial AUC (PAUC) to evaluate bioequivalence--a case study with complex absorption: methylphenidate.
Fourie Zirkelbach, J; Jackson, AJ; Schuirmann, DJ; Wang, Y, 2013
)
0.61
"Enantioselective hydrolysis of oral racemic methylphenidate (dl-MPH) by carboxylesterase 1 (CES1) limits the absolute bioavailability of the pharmacologically active d-MPH isomer to approximately 30% and that of the inactive l-MPH to only 1-2%."( Differential influences of ethanol on early exposure to racemic methylphenidate compared with dexmethylphenidate in humans.
Anderson, ER; Bell, GH; Bernstein, H; Malcolm, RJ; Patrick, KS; Reeves, OT; Straughn, AB, 2013
)
0.89
" Simulations using the fitted parameters determined how changes in fast absorption rate constant k0fast, and slow absorption rate constant KAslow affected curve shape and BE determination using Cmax, AUCINF and PAUC."( Impact of release mechanism on the pharmacokinetic performance of PAUC metrics for three methylphenidate products with complex absorption.
Jackson, A, 2014
)
0.62
"Current formulations of methylphenidate (MPH) used in treatment of attention-deficit/hyperactivity disorder (ADHD) result in significantly different bioavailability of MPH enantiomers."( Methylphenidate and impulsivity: a comparison of effects of methylphenidate enantiomers on delay discounting in rats.
Katz, JL; Ricaurte, GA; Slezak, JM; Tallarida, RJ, 2014
)
2.15
" MPH is characterized by its low bioavailability and short half-life (2-3 hours)."( Isopropylphenidate: an ester homolog of methylphenidate with sustained and selective dopaminergic activity and reduced drug interaction liability.
Markowitz, JS; Patrick, KS; Zhu, HJ, 2013
)
0.66
" Metabolism of MPH in the small intestine was assumed to account for the low oral bioavailability of MPH."( Development of a physiologically based model to describe the pharmacokinetics of methylphenidate in juvenile and adult humans and nonhuman primates.
Doerge, DR; Fisher, JW; Gearhart, JM; Mattison, DR; Morris, SM; Paule, MG; Ruark, CD; Slikker, W; Twaddle, NC; Vitiello, B; Yang, X; Young, JF, 2014
)
0.63
" Furthermore, it was deduced that the stereoselective cleavage of MPH to produce ritalinic acid (RA) by human carboxylesterase results in a higher oral bioavailability of the d-threo enantiomer."( Chromatographic and electrophoretic strategies for the chiral separation and quantification of d- and l-threo methylphenidate in biological matrices.
Allen, SA; Pond, BB, 2014
)
0.61
"The objective of the study was to determine the relative bioavailability of an extended-release multilayer bead formulation of methylphenidate hydrochloride (MPH-MLR) 80 mg vs."( Steady-state bioavailability of extended-release methylphenidate (MPH-MLR) capsule vs. immediate-release methylphenidate tablets in healthy adult volunteers.
Adjei, A; Childress, A; Greenhill, L; Kollins, SH; Kupper, RJ; Sallee, F; Teuscher, NS; Wigal, S, 2014
)
0.86
"The purpose of this study was to evaluate the relative bioavailability and safety of a multilayer extended-release bead methylphenidate (MPH) hydrochloride 80 mg (MPH-MLR) capsule or sprinkles (37% immediate-release [IR]) versus MPH hydrochloride IR(Ritalin(®)) tablets, and to develop a pharmacokinetic (PK) model simulating MPH concentration-time data for different MPH-MLR dosage strengths."( Single-dose pharmacokinetics of methylphenidate extended-release multiple layer beads administered as intact capsule or sprinkles versus methylphenidate immediate-release tablets (Ritalin(®)) in healthy adult volunteers.
Adjei, A; Chang, WW; Connor, DF; Greenhill, L; Kupper, RJ; Newcorn, JH; Teuscher, NS; Wigal, S, 2014
)
0.89
" Relative bioavailability comparisons included partial area under the plasma concentration-time curves (pAUC0-3 h) for d-MPH."( Absorption Differences between Immediate-Release Dexmethylphenidate and dl-Methylphenidate.
Patrick, KS; Straughn, AB, 2016
)
0.68
" This randomized, open-label, crossover trial compared the pharmacokinetic properties and relative bioavailability of MPH ERCT with an MPH chewable immediate-release tablet (IR MPH) formulation in healthy adults."( Single-dose Pharmacokinetic Properties and Relative Bioavailability of a Novel Methylphenidate Extended-release Chewable Tablet Compared With Immediate-release Methylphenidate Chewable Tablet.
Abbas, R; Belden, H; Berry, SA; Palumbo, D; Walters, F, 2016
)
0.66
"The relative bioavailability of MPH ERCT 40 mg, based on the exposure (AUC), was comparable to that of IR MPH 40 mg administered in 2 equal doses of 20 mg 6 hours apart."( Single-dose Pharmacokinetic Properties and Relative Bioavailability of a Novel Methylphenidate Extended-release Chewable Tablet Compared With Immediate-release Methylphenidate Chewable Tablet.
Abbas, R; Belden, H; Berry, SA; Palumbo, D; Walters, F, 2016
)
0.66
" Deviations from suggested routes of administration such as crushing, chewing, intravenous administration, or snorting stimulant medication may alter the release rate, absorption, and bioavailability of the active drug."( Safety and efficacy considerations due to misuse of extended-release formulations of stimulant medications.
Jain, R; Stark, JG, 2016
)
0.43
" This was a randomized, open-label, 3-period, 3-treatment study comparing the bioavailability and absorption of 2 MPH XR-ODT formulations with an MPH ER reference medication."( A Comparison of the Pharmacokinetics of Methylphenidate Extended-Release Orally Disintegrating Tablets With a Reference Extended-Release Formulation of Methylphenidate in Healthy Adults.
Childress, A; Engelking, D; McMahen, R; Sikes, C; Stark, JG, 2018
)
0.75
" This article evaluates the pharmacokinetic parameters and relative bioavailability of MPH ERCT when chewed versus swallowed whole."( Relative Bioavailability of Methylphenidate Extended-release Chewable Tablets Chewed Versus Swallowed Whole.
Abbas, R; Berry, SA; Childress, AC; Nagraj, P; Palumbo, DR; Rolke, R, 2018
)
0.77
" Food and Drug Administration (FDA) partial area under the curve (pAUC) bioavailability metrics have improved discrimination between specific generic MR-MPH products."( Drug Regimen Individualization for Attention-Deficit/Hyperactivity Disorder: Guidance for Methylphenidate and Dexmethylphenidate Formulations.
Koller, L; Nguyen, LV; Patrick, KS; Radke, JL; Raymond, JR; Rodriguez, W; Straughn, AB, 2019
)
0.74
"Methylphenidate (MPD) is a psychostimulant used for the treatment of ADHD and works by increasing the bioavailability of dopamine (DA) in the brain."( Acute and chronic methylphenidate administration in intact and VTA-specific and nonspecific lesioned rats.
Dafny, N; Ihezie, SA; Thomas, MM, 2019
)
2.29
" The objectives were to evaluate DR/ER-MPH pharmacokinetic (PK) properties in healthy adults, including dose proportionality, food effect, the potential of accumulation using multiple-dose modeling, and bioavailability compared to an immediate-release MPH (IR MPH)."( Pharmacokinetics of HLD200, a Delayed-Release and Extended-Release Methylphenidate: Evaluation of Dose Proportionality, Food Effect, Multiple-Dose Modeling, and Comparative Bioavailability with Immediate-Release Methylphenidate in Healthy Adults.
DeSousa, NJ; Gobburu, JVS; Incledon, B; Liu, T; McLean, A; Po, MD; Sallee, FR, 2019
)
0.75
" The relative bioavailability for DR/ER-MPH compared to IR MPH was 73."( Pharmacokinetics of HLD200, a Delayed-Release and Extended-Release Methylphenidate: Evaluation of Dose Proportionality, Food Effect, Multiple-Dose Modeling, and Comparative Bioavailability with Immediate-Release Methylphenidate in Healthy Adults.
DeSousa, NJ; Gobburu, JVS; Incledon, B; Liu, T; McLean, A; Po, MD; Sallee, FR, 2019
)
0.75
"A tenable hypothesis is presented which explains disparities between older oral dl-MPH bioavailability data generated using chiral derivatization-gas chromatography versus more recent findings using chiral liquid chromatography."( Potential for Underestimation of d-Methylphenidate Bioavailability Using Chiral Derivatization/Gas Chromatography.
Patrick, KS; Rodriguez, W, 2019
)
0.79
" In general, both stimulants are rapidly absorbed with relatively poor bioavailability and short half-lives."( The Pharmacokinetics and Pharmacogenomics of Psychostimulants.
Markowitz, JS; Melchert, PW, 2022
)
0.72
"Adult patients with ADHD, who are not treated with MPH (-MPH), showed varied Arg/NO pathway, but Arg bioavailability seemed to be consistent over the groups."( l-Arginine/nitric oxide pathway and oxidative stress in adults with ADHD: Effects of methylphenidate treatment.
Beckmann, B; Böhme, P; Emons, B; Hanusch, B; Juckel, G; Lücke, T; Sinningen, K; Tsikas, D, 2023
)
1.13

Dosage Studied

OROS methylphenidate, in the flexible dosage range from 36 to 108 mg/d, was well tolerated for up to 1 year in adults with ADHD.

ExcerptRelevanceReference
" These results had been hypothesized from theoretical dose-response curves which indicate different target behaviors would improve at different doses."( Methylphenidate in hyperkinetic children: differences in dose effects on learning and social behavior.
Sleator, EK; Sprague, RL, 1977
)
1.7
" Neither dosage of active medication was found to effect psychomotor or psychological test performance, subjective report, heart rate or blood pressure."( The effect of methylphenidate on test performance in the cognitively impaired aged.
Crook, T; Ferris, S; Gershon, S; Raskin, A; Sathananthan, G, 1977
)
0.62
" No clinical predictors of growth deficits were found; growth in height deficits are not related to total dosage or summer drug holidays, but weight deficits may be related to these factors."( Growth of hyperactive children treated with methylphenidate.
Blaschke, T; Cantwell, DP; Satterfield, JH; Schell, A, 1979
)
0.52
" This temporary effect on growth is present during the first few years of treatment and seems related to drug dosage and to the presence or absence of drug holidays."( The effects of stimulant medication on the growth of hyperkinetic children.
Hung, W; Lipman, RS; Overall, JE; Roche, AF, 1979
)
0.26
"A patient with severe narcolepsy and cataplexy had been treated with a high dosage of methylphenidate hydrochloride, but the drug was not effective."( Successful treatment of narcolepsy with propranolol: a case report.
Cadieux, R; Kales, A; Soldatos, CR; Tan, TL, 1979
)
0.48
"A dose-response analysis was performed on D-amphetamine- and methylphenidate-induced changes in neuronal activity in the neostriatum of immobilized, phenidate-induced changes in neuronal activity in the neostriatum of immobilized, locally anesthetized rats."( Dose-dependent biphasic alterations in the spontaneous activity of neurons in the rat neostriatum produced by d-amphetamine and methylphenidate.
Rebec, GV; Segal, DS, 1978
)
0.71
"A total of twenty-nine patients have thus far been treated with deanol in various dosage levels for periods ranging from five to thirty days."( Deanol acetamidobenzoate (Deaner) in tardive dyskinesia.
Fann, WE; Stafford, JR, 1977
)
0.26
" Dose-response differences were also revealed in "breaking point" comparisons between secobarbital on the one hand, and methylphenidate and cocaine, on the other."( Behavioral procedures for evaluating the relative abuse potential of CNS drugs in primates.
Brady, JV; Griffiths, RR, 1976
)
0.46
" No correlations were found between dosage level and changes in weight and height percentiles."( Growth of hyperkinetic children taking methylphenidate, dextroamphetamine, or imipramine/desipramine.
Gross, MD, 1976
)
0.52
" By repeated dosage a competition is created between receptor-blockade and hypersensitivity, often in favour of the latter."( [Receptor-blockade and receptor-hypersensitivity following neuroleptic treatment (author's transl)].
Christensen, AV; Hyttel, J; Nielsen, IM, 1976
)
0.26
" Methylphenidate dosage was individualized."( Relative efficacy of methylphenidate and behavior modification in hyperkinetic children: an interim report.
Abikoff, H; Gittelman-Klein, R; Gloisten, AC; Kates, W; Katz, S; Klein, DF, 1976
)
1.48
"The development of a suitable formulation and a freeze-dry cycle for a pharmaceutical dosage form requires knowledge of some basic properties such as (1) eutectic temperature, if one exists, (2) temperature effect on solubility, (3) degree of supercooling, (4) heat transfer properties of the frozen product and (5) equipment design and equipment capability."( Research and development of phamaceutical dosage forms.
DeLuca, PP, 1976
)
0.26
" Patients receiving methylphenidate in a dosage of 20 mg daily improved significantly over a period of six weeks as measured by results of tests for mental status, ward behavior (nursis' rating), target-symptom response, and physician's and nurses' global evaluations."( Withdrawn, apathetic geriatric patients responsive to methylphenidate.
Kaplitz, SE, 1975
)
0.82
" A wide range of dosage (0."( Observations on effects of a central stimulant drug (methylphenidate) in children with hyperactive behavior.
Reynard, CL; Schain, RJ, 1975
)
0.5
" Methylphenidate is given in 1-3 daily doses; treatment is commenced with small doses, and after 2-4 days the dosage is increased until behaviour changes."( [Methylphenidat (Ritalin) as a psychotropic drug in children with minimal brain dysfunction and epilepsy].
Kind, CR, 1975
)
1.16
"The dose-response relationships for three stimulants have been explored."( The effects of age and illumination on the dose-response curves for three stimulants.
Isaac, W; Kallman, WM, 1975
)
0.25
" Both groups were divided into three drug dosage levels (0."( Methylphenidate effects on avoidance learning at two ages in the rat.
Gauron, EF; Rowley, VN, 1975
)
1.7
" Dosage should be titrated individually for each patient, and it is best to start with small doses given at least 15 to 30 minutes before meals."( Methylphenidate: a review.
Majovski, LV; Oettinger, L, 1976
)
1.7
" Included are the drugs' putative mechanisms of action, pharmacology, toxicology, indications for their use, short-term and long-term actions, adverse effects, specific dosing regimens, therapeutic monitoring techniques, alternative medications, and drug interactions."( Pharmacologic treatment of attention deficit hyperactivity disorder.
Greenhill, LL, 1992
)
0.28
" Dose-response functions were determined during 5-min extinction sessions."( Discriminative stimulus properties of triadimefon: comparison with methylphenidate.
Eckerman, DA; MacPhail, RC; Perkins, AN, 1991
)
0.52
" The dose-response curve for amphetamine was shifted downward and to the right by reserpine but was flattened by AMPT."( Depletion of catecholamines in the brain of rats differentially affects stimulation of locomotor activity by caffeine, D-amphetamine, and methylphenidate.
Finn, IB; Holtzman, SG; Iuvone, PM, 1990
)
0.48
" Generalization testing then followed in which dose-response curves were determined for the following drugs: d-amphetamine (3."( Discriminative stimulus effects of d-amphetamine, methylphenidate, and diazepam in humans.
Heishman, SJ; Henningfield, JE, 1991
)
0.53
" The groups were also compared in response to two dosage levels of methylphenidate."( Auditory stimulus intensity gradients and response to methylphenidate in ADD children.
Ackerman, PT; Dykman, RA; Oglesby, DM,
)
0.62
" The following were the most significant effects of MDL 19205: a decrease in action potential duration in both ventricular and Purkinje tissues; a cumulative dose-dependent increase in contractile force in ventricular muscle but not in Purkinje strands; no change in aiNa in Purkinje fibers to accompany the positive inotropic effect of this agent; a shift in the dose-response relation by approximately fourfold in the presence of beta-adrenergic blockade with sotalol (10(-7) M); an enhancement of diastolic depolarization in Purkinje fibers resulting in automaticity that is accelerated by overdrive; and a potentiation of the positive inotropic effects of MDL 19205 by 8-bromo-cAMP (1 mM), indicating a potent phosphodiesterase inhibitory action of MDL 19205."( Effects of MDL 19205 (piroximone), a new cardiotonic agent, on electrophysiological, mechanical, and intracellular ionic characteristics of sheep cardiac tissues.
Wasserstrom, JA,
)
0.13
"Investigated the effect of methylphenidate (MPH) on the ability of children with Attention Deficit Disorder with Hyperactivity (ADDH) to learn both trained and untrained complex visual relationships and compared these findings to their school performance under identical dosage parameters."( The effects of methylphenidate on learning in children with ADDH: the stimulus equivalence paradigm.
Rapport, MD; Vyse, SA, 1989
)
0.93
" Among the issues discussed are (a) differences between peer and adult provocation and (b) the roles of medication dosage and multimodality intervention for promoting socially competent behavior in children with ADHD."( Anger control in response to verbal provocation: effects of stimulant medication for boys with ADHD.
Buhrmester, D; Heller, T; Hinshaw, SP, 1989
)
0.28
" Both groups were assessed for dyskinetic symptoms at ten weekly intervals as dosage was phased out in the neuroleptic group."( Dyskinetic symptoms in profoundly retarded residents following neuroleptic withdrawal and during methylphenidate treatment.
Aman, MG; Singh, NN, 1985
)
0.49
" The same low dosage of amphetamine which improved the behavior and learning of hyperkinetic and violent dogs disrupted the behavior and produced disorientation in normal dogs with previously stable conditional responses."( Psychopharmacologic facilitation of psychosocial therapy of violence and hyperkinesis.
Corson, EO; Corson, SA, 1988
)
0.27
" A dose of 5 mg/kg of AMPH, but not 1 mg/kg of AMPH, caused a 2-fold shift to the right in the dose-response curve for DA in stimulating AC activity when compared with saline controls."( Desensitization of rat striatal dopamine-stimulated adenylate cyclase after acute amphetamine administration.
Barnett, JV; Kuczenski, R, 1986
)
0.27
" Significant dose-response relationships were found, indicating enhanced learning from placebo to low to medium to high dose."( Methylphenidate and memory: dissociated effects in hyperactive children.
Amara, I; Evans, RW; Gualtieri, CT, 1986
)
1.71
" The dose-response curves for methylphenidate and d-amphetamine appeared to be quantal in nature."( Effects of chronic amphetamine in BALB/cBy mice, a strain that is not stimulated by acute administration of amphetamine.
Cao, W; Carney, JM; Logan, L; Seale, TW, 1988
)
0.56
" A multi-step analysis was used to examine the dose-response relationship, contribution of pre-stimulus levels of HR (i."( Attention deficit disorder and methylphenidate: a multi-step analysis of dose-response effects on children's cardiovascular functioning.
DuPaul, GJ; Kelly, KL; Rapport, MD, 1988
)
0.56
", complete) so that rats are unresponsive, even to high doses of caffeine, and dose-response curves are displaced downward and flattened; (3) is pharmacologically specific, extending to other methylxanthines but not to nonxanthine psychomotor stimulants."( Tolerance to behavioral effects of caffeine in rats.
Finn, IB; Holtzman, SG, 1988
)
0.27
" The medication trials were double-blind, placebo-controlled, dose-response studies."( Treatment of chronic closed head injury with psychostimulant drugs: a controlled case study and an appropriate evaluation procedure.
Evans, RW; Gualtieri, CT; Patterson, D, 1987
)
0.27
" Dosage should be directly manipulated in pediatric psychopharmacological studies and the practice of using mg/kg dosage schedules may no longer be necessary."( Hyperactivity and methylphenidate: rate-dependent effects on attention.
DuPaul, GJ; Rapport, MD, 1986
)
0.6
" Using signal detection theory methylphenidate significantly increased sensitivity (d) and did not change response bias (beta), independent of the dosage (5 to 20 mg/d)."( [Attention in hyperkinetic children: a signal detection analysis of the effect of methylphenidate].
Rossel, E, 1987
)
0.78
" Dosage effects were assessed on clinic-(PAL--Paired Associates Learning test) and school-(percent on task, teacher ratings, work completion rates, and accuracy) related behaviors."( Methylphenidate in hyperactive children: differential effects of dose on academic, learning, and social behavior.
Birmingham, BK; DuPaul, GJ; Rapport, MD; Stoner, G; Tucker, S, 1985
)
1.71
"The short-term, dose-response effects of methylphenidate hydrochloride were evaluated on academic and social classroom measures in 29 children with attention deficit disorder."( Methylphenidate and children with attention deficit disorder. Dose effects on classroom academic and social behavior.
Bender, ME; Booth, S; Caddell, J; Moorer, SH; Pelham, WE, 1985
)
1.98
" At a dosage of 2 mg/kg, methylphenidate given intraperitoneally decreased shock frequency during FR 4 periods while FR 1 behavior was not affected; at 4 mg/kg, stimulus control of avoidance responding was impaired during both components."( Some effects of methylphenidate on stimulus control of ratio avoidance behavior in the rat.
Alexander, D; Blackman, D; Stretch, R, 1966
)
0.89
" A dose-response analysis of the effect of methylphenidate revealed no differences among the dietary groups."( Effect of dietary lipid on locomotor activity and response to psychomotor stimulants.
Brenneman, DE; Rutledge, CO, 1982
)
0.53
"This research tested the hypothesis that a relatively modest dose of stimulant medication would produce optimal effects on cognitive and impulse control performance when compared to three other dosage levels in hyperactive school children."( How much stimulant medication is appropriate for hyperactive school children?
Brown, RT; Slimmer, LW; Wynne, ME, 1984
)
0.27
" The clinically titrated methylphenidate dosage levels for the subjects were related both to the augmenter-reducer classification and to pretreatment HR levels; that is, subjects who were ERP reducers and/or had higher HR levels, especially under reward conditions, were blindly titrated at higher levels than those who were augmenters and/or had lower HR levels."( Effects of reward and methylphenidate on heart rate response morphology of augmenting and reducing children.
Ackerman, PT; Dykman, RA; Holcomb, PJ, 1984
)
0.89
" The augmenters were blindly titrated at significantly lower dosage levels than the reducers."( Auditory ERP augmentation-reduction and methylphenidate dosage needs in attention and reading disordered children.
Ackerman, PT; Dykman, RA; Holcomb, PJ; McCray, DS, 1983
)
0.53
" Amphetamine induces a dose-response partial reversal of the GBL effect."( gamma-Butyrolactone effects on behavior induced by dopamine agonists.
Dougherty, GG; Ellinwood, EH; Gonzalez, AE, 1983
)
0.27
" However, there was one notable exception; presenting was dramatically increased following dosing with methylphenidate and diethylpropion."( The effects of several anorexigenics on monkey social behavior.
Bedford, JA; Marquis, DK; Wilson, MC, 1984
)
0.48
" The median drug dosage was ."( Effects of methylphenidate (Ritalin) on information processing in hyperactive children.
Borkowski, JG; Reid, MK, 1984
)
0.66
" Active compounds exhibited an inverted U-shaped dose-response curve."( Amnesia-reversal activity of a series of N-[(disubstituted-amino)alkyl] -2-oxo-1-pyrrolidineacetamides, including pramiracetam.
Butler, DE; L'Italien, YJ; Marriott, JG; Nordin, IC; Poschel, PH; Zweisler, L, 1984
)
0.27
" It was concluded that drug effects are likely to be most pronounced in difficult learning situations and that dosage appears to be an important variable for consideration in further studies."( Effects of methylphenidate on learning a 'beginning reading vocabulary' by normal adults.
Gadow, KD; Kupietz, SS; Richardson, E; Winsberg, BG, 1980
)
0.65
" Learning took place under placebo and under the child's regular dosage of methylphenidate."( State-dependent learning in children receiving methylphenidate.
Shea, VT, 1982
)
0.75
" Dosage was significantly associated with the decrease in height and weight percentile."( Growth of hyperactive children on maintenance regimen of methylphenidate.
Gittelman, R; Mattes, JA, 1983
)
0.51
"Four groups of children referred for attention disorders, learning disorders, or both were blindly titrated at statistically equivalent dosage levels of methylphenidate and improved more or less equivalently on several measures of attentiveness (cognitive style tests and reaction time)."( Methylphenidate effects on cognitive style and reaction time in four groups of children.
Ackerman, PT; Dykman, RA; Holcomb, PJ; McCray, DS, 1982
)
1.91
" Results indicated that caffeine in low dosage when added to methylphenidate was superior to all other treatment conditions."( Responses to methylphenidate and varied doses of caffeine in children with attention deficit disorder.
Garfinkel, BD; Sloman, L; Webster, CD, 1981
)
0.87
" The boys also participated in a blind crossover study contrasting placebo and methylphenidate effects; the prescribing physician, who was not informed of the child's nervous system classification, adjusted the dosage levels so that subjects with weaker nervous systems were titrated at higher dosage levels than those with stronger nervous systems."( Studies of nervous system sensitivity in children with learning and attention disorders.
Ackerman, PT; Dykman, RA; Holcomb, PJ; McCray, DS,
)
0.36
" Total milligrams per day dosage, milligrams per kilogram per day dosage and duration of treatment per year were analysed in the medicated hyperactive children and their growth was compared with the other two groups."( Effect of methylphenidate hydrochloride on stature of hyperactive children.
Cohen, MN; Kalachnik, JE; Sleator, EK; Sprague, RL; Ullmann, RK, 1982
)
0.67
" For all dosage groups behavior and attention improved with increased dosage, and the best scores were associated with the highest drug levels."( Optimal dosages of methylphenidate for improving the learning and behavior of hyperactive children.
Charles, L; Schain, R; Zelniker, T, 1981
)
0.59
" Dose-response relationship of methylphenidate thermal effects exhibits a U-shape curve."( A comparison of the hypothermic effects of methylphenidate and d-amphetamine.
Ben-Uriah, Y; Carasso, RL; Yehuda, S, 1981
)
0.81
" All active compounds gave inverted U-shaped dose-response curves."( Cognition-activating properties of 3-(Aryloxy)pyridines.
Butler, DE; Marriott, JG; Poschel, BP, 1981
)
0.26
" Teacher rating data showed equivalent effects of therapy and the low dosage of methylphenidate alone but a stronger effect of the high dose alone; only the high dose resulted in improved behavior after 13 weeks of behavioral intervention."( Behavioral and stimulant treatment of hyperactive children: a therapy study with methylphenidate probes in a within-subject design.
Bologna, NC; Contreras, JA; Pelham, WE; Schnedler, RW, 1980
)
0.71
" The combination of a clinically useful medication in appropriate dosage schedules with relevant psychological treatments simultaneously directed to each of the child's many disabilities were associated with an unexpectedly good outcome at the end of one and two years."( Multimodality treatment. A two-year evaluation of 61 hyperactive boys.
Cantwell, DP; Satterfield, BT; Satterfield, JH, 1980
)
0.26
" Mean dosage levels, individually titrated by the team psychiatrist, were highest for the reading-disabled group, lowest for those with suspected attention disorders."( Effects of methylphenidate on selective and sustained attention in hyperactive, reading-disabled, and presumably attention-disordered boys.
Ackerman, PT; Dykman, RA; McCray, DS, 1980
)
0.65
" Therefore, three-times-a-day dosing should be considered for those children exhibiting ADHD symptoms in the evening."( Effects of late-afternoon methylphenidate administration on behavior and sleep in attention-deficit hyperactivity disorder.
Abikoff, H; Blader, JC; Foley, CA; Kent, JD; Koplewicz, HS, 1995
)
0.59
" Dissociations of dose effects on cognitive function and behavior were demonstrated: Dose-response functions for changes in behavior were linear, whereas the function for response inhibition was U-shaped."( Methylphenidate and cognitive flexibility: dissociated dose effects in hyperactive children.
Logan, G; Schachar, R; Tannock, R, 1995
)
1.73
"A double-blind crossover design was used in an acute dosage trial to assess effects of three dosages (0."( Do high doses of stimulants impair flexible thinking in attention-deficit hyperactivity disorder?
Barr, RG; Desilets, J; Douglas, VI; Sherman, E, 1995
)
0.29
" Twelve attention deficit with hyperactivity disorder (ADHD) children performed a Continuous Performance Test involving a button-press response to the letter X (CPT-X) under the influence of MPH in a double-blind placebo controlled acute dosage design."( Methylphenidate influences on both early and late ERP waves of ADHD children in a continuous performance test.
Buitelaar, J; Koelega, HS; Overtoom, CC; Swaab-Barneveld, H; van der Gaag, RJ; van Engeland, H; Verbaten, MN, 1994
)
1.73
"Methylphenidate (MPD) increased in rats the incidence of sniffing, rearing and locomotion, and this along dose-response curves that had an inverted U-shape; at 40 mg/kg, MPD exclusively induced stereotyped gnawing, which was inhibited by neuroleptics."( Inhibition of methylphenidate-induced behaviors in rats: differences among neuroleptics.
Colpaert, FC; Koek, W, 1993
)
2.09
" Liver injury measured by either method was essentially nonexistent for dosages < or = 50 mg/kg in male mice, and was only minimally evident in female mice at the highest dosage testable."( Methylphenidate-induced hepatotoxicity in mice and its potentiation by beta-adrenergic agonist drugs.
Harbison, RD; James, RC; Roberts, SM; Roth, L, 1994
)
1.73
" Transient sedation lasting 2 to 3 days occurred after initial administration or dosage increase; otherwise, clonidine was well tolerated."( Clonidine therapy for comorbid attention deficit hyperactivity disorder and conduct disorder: preliminary findings in a children's inpatient unit.
Mandoki, MW; Schvehla, TJ; Sumner, GS, 1994
)
0.29
" Personal or family tic history, medication selection, or dosage was not related to onset of T/D."( Tics and dyskinesias associated with stimulant treatment in attention-deficit hyperactivity disorder.
Adesman, AR; Goldstein, IJ; Lipkin, PH, 1994
)
0.29
" The P3a and P3b latencies were significantly longer in the ADHD children on baseline testing; there were no latency differences between the groups of children when the normal controls were compared with the ADHD children on their optimal drug dosage (as determined by extensive behavioural and cognitive assessments)."( Changes in event-related potentials with stimulant medication in children with attention deficit hyperactivity disorder.
Logan, WJ; Malone, MA; Taylor, MJ; Voros, JG, 1993
)
0.29
" No dose-response relationship was found for either stimulant."( Classroom academic performance: improvement with both methylphenidate and dextroamphetamine in ADHD boys.
Elia, J; Gullotta, CS; Rapoport, JL; Welsh, PA, 1993
)
0.53
" Survival was similar in dosed and control groups."( Experimental studies on the long-term effects of methylphenidate hydrochloride.
Dunnick, JK; Hailey, JR, 1995
)
0.55
"Using a computerized infrared activity analysis system, the dose-response relationship, timing, and duration for stimulation of motor activity after a single dose of methylphenidate was studied in Sprague-Dawley rats."( Dose response characteristics of methylphenidate on different indices of rats' locomotor activity at the beginning of the dark cycle.
Dafny, N; Gaytan, O; Ghelani, D; Martin, S; Swann, A, 1996
)
0.77
" Both interventions proved effective for improving neurocognitive test performance and behavior, although broad-band ratings revealed dose-response curves different from those obtained from the neurocognitive tests."( Methylphenidate and attentional training. Comparative effects on behavior and neurocognitive performance in twin girls with attention-deficit/hyperactivity disorder.
Denney, C; Goya, S; Isaacs, P; Loo, S; Rapport, MD; Scanlan, S, 1996
)
1.74
" Although the titration protocol is complex, the study's individual dosing approach and algorithms for openly managing ADHD children's medication over time will be of interest to clinicians in office practice."( Medication treatment strategies in the MTA Study: relevance to clinicians and researchers.
Abikoff, HB; Arnold, LE; Cantwell, DP; Conners, CK; Elliott, G; Greenhill, LL; Hechtman, L; Hinshaw, SP; Hoza, B; Jensen, PS; March, JS; Newcorn, J; Pelham, WE; Severe, JB; Swanson, JM; Vitiello, B; Wells, K, 1996
)
0.29
"To evaluate the short-term efficacy and side effects associated with two methylphenidate hydrochloride (MPH) dosing patterns."( Methylphenidate dosing: twice daily versus three times daily.
Blackwell, B; Blondis, TA; Fishkin, J; O'Brien, T; Roizen, NJ; Schnitzler, ER; Stein, MA; Szumowski, E, 1996
)
1.97
"All dosing conditions resulted in significant effects on ADHD symptoms when compared with baseline."( Methylphenidate dosing: twice daily versus three times daily.
Blackwell, B; Blondis, TA; Fishkin, J; O'Brien, T; Roizen, NJ; Schnitzler, ER; Stein, MA; Szumowski, E, 1996
)
1.74
" dosing may be optimal."( Methylphenidate dosing: twice daily versus three times daily.
Blackwell, B; Blondis, TA; Fishkin, J; O'Brien, T; Roizen, NJ; Schnitzler, ER; Stein, MA; Szumowski, E, 1996
)
1.74
" In Study 1, we examined covert visual spatial orienting in ADHD and comparison boys, Study 2 comprised a dose-response study of methylphenidate for the ADHD group, and Study 3 was an investigation of biological and adoptive parents."( Covert visual spatial attention in boys with attention deficit hyperactivity disorder: lateral effects, methylphenidate response and results for parents.
Hinshaw, SP; Nigg, JT; Swanson, JM, 1997
)
0.72
"Attention-deficit hyperactivity disorder (ADHD) children participated in a double-blind placebo-controlled study in which the effects of a dosage of 15 mg methylphenidate (MPH) on auditory and visual selective attention tasks was determined by presenting frequent (90%) and infrequent (10%) stimuli in both relevant and irrelevant input channels."( Effects of methylphenidate on event-related potentials and performance of attention-deficit hyperactivity disorder children in auditory and visual selective attention tasks.
Buitelaar, JK; Camfferman, G; Jonkman, LM; Kemner, C; Koelega, HS; van Engeland, H; vd Gaag, RJ; Verbaten, MN, 1997
)
0.88
"Dose-response profiles did not differ across children varying incrementally in body mass, nor were systematic variations in dose-response curve parameters observed across discrete groups of children differing in mean body mass."( Titrating methylphenidate in children with attention-deficit/hyperactivity disorder: is body mass predictive of clinical response?
Denney, C; Rapport, MD, 1997
)
0.7
"Rapid-release psychostimulants are commonly used to treat attention-deficit hyperactivity disorder (ADHD), but midday dosing requirements and poor compliance rates have prompted the development of sustained-release formulations."( Optimizing ADHD therapy with sustained-release methylphenidate.
Carson, DS; Lawrence, DB; Lawrence, JD, 1997
)
0.55
" Data obtained from a screening questionnaire, sleep diaries, and medical records showed that 22 of our 43 treated narcoleptic subjects reduced their dosage of stimulant medications or had not taken any stimulant medications during a 24-hour monitoring period during which they were expected to be on medication."( Compliance with stimulant medications in patients with narcolepsy.
Aldrich, MS; Berrios, AM; Rogers, AE; Rosenberg, RS, 1997
)
0.3
" Side effects increased slightly with the high dosage of medication but remained mild."( Effects of methylphenidate on preschool children with ADHD: cognitive and behavioral functions.
Bennett, S; Firestone, P; Mercer, J; Musten, LM; Pisterman, S, 1997
)
0.69
" However, the degree of improvement at times varied substantially across dosage and area of functioning."( Comprehensive school-based behavioral assessment of the effects of methylphenidate.
Gulley, V; Northup, J, 1997
)
0.53
" Further, to investigate the NIE of methamphetamine, the dose-response relations to isoproterenol, histamine, and calcium were measured with or without methamphetamine (2 x 10(-4) M), after adrenergic neuronal blockade with reserpine."( Biphasic inotropic effects of methamphetamine and methylphenidate on ferret papillary muscles.
Ishiguro, Y; Morgan, JP, 1997
)
0.55
"The dose-response relationship and time course of effect on motor activity after a single dose of methylphenidate given at different times of the light/dark cycle was investigated using a computerized infrared activity analysis system."( Methylphenidate: diurnal effects on locomotor and stereotypic behavior in the rat.
Dafny, N; Gaytan, O; Ghelani, D; Martin, S; Swann, A, 1997
)
1.96
" Multiple data analytic methods were used with the goal of (a) describing the shape of the dose-response curves across multiple measures of social functioning, (b) determining the percentage of adolescents whose social behavior improved in response to MPH, and (c) assessing the incremental gains that result from increases in dose."( Dosage effects of methylphenidate on the social behavior of adolescents diagnosed with attention-deficit hyperactivity disorder.
Bukstein, O; Evans, S; Gnagy, E; Greiner, A; Molina, B; Myak, C; Pelham, WE; Presnell, M; Smith, BH; Willoughby, M, 1998
)
0.63
" Since psychostimulant treatment often requires frequent dosing and may be associated with unacceptable side effects and risks, other classes of medication have been studied as possible treatment alternatives."( Psychopharmacology of ADHD: children and adolescents.
Dogin, JW; Findling, RL, 1998
)
0.3
" Side effects were measured after each increase in dosage and weekly."( Methylphenidate in early poststroke recovery: a double-blind, placebo-controlled study.
Blackwell, B; Chrostowski, J; Grade, C; Redford, B; Toussaint, L, 1998
)
1.74
" Higher dosage psychostimulants may be indicated in the last weeks of life of the terminally ill."( Methylphenidate in terminal depression.
Macleod, AD, 1998
)
1.74
" This article presents a technique for evaluating behavioral and cognitive dose-response relationships at the single-subject level of analysis."( Evaluating medication response in ADHD: cognitive, behavioral, and single-subject methodology.
Coury, DL; DeWitt, MB; Hale, JB; Hoeppner, JA; Ritacco, DG; Trommer, B,
)
0.13
" It can assist in optimizing medication dosage for individual children, given its sensitivity to dosage effects."( Use of the restricted academic task in ADHD dose-response relationships.
Fischer, M; Newby, RF,
)
0.13
" For such reasons, the development of a transdermal dosage form of methylphenidate may be useful."( Transdermal iontophoretic delivery of methylphenidate HCl in vitro.
Boniello, S; Dinh, S; Liu, P; Singh, P, 1999
)
0.81
" Subjective ratings by both teachers and parents were examined for dosage level effects and medication type effects."( Differential effectiveness of methylphenidate and Adderall in school-age youths with attention-deficit/hyperactivity disorder.
Findling, RL; Manos, MJ; Short, EJ, 1999
)
0.59
" These results suggest differential dosage effects and a dissociation between dose levels and aspects of processing."( Effect of methylphenidate on attention in children with attention deficit hyperactivity disorder (ADHD): ERP evidence.
Humphries, T; Malone, MA; Roberts, W; Rovet, J; Sunohara, GA; Taylor, MJ, 1999
)
0.71
" The model incorporated each patient's dosage size and schedule, body weight, and time of the plasma sample."( Population pharmacokinetics of methylphenidate in children with attention-deficit hyperactivity disorder.
Greenblatt, DJ; Harmatz, JS; Oesterheld, JR; Parmelee, DX; Sallee, FR; Shader, RI, 1999
)
0.59
" In study I, relative efficacy was determined for three dosing patterns of methylphenidate: a standard twice-daily profile, a flat profile, and an ascending profile."( Acute tolerance to methylphenidate in the treatment of attention deficit hyperactivity disorder in children.
Agler, D; Flynn, D; Guinta, D; Gupta, S; Lerner, M; Shoulson, I; Swanson, J; Wigal, S; Williams, L, 1999
)
0.86
" This should be considered in the design of an optimal dosing regimen for the treatment of children with attention deficit hyperactivity disorder."( Acute tolerance to methylphenidate in the treatment of attention deficit hyperactivity disorder in children.
Agler, D; Flynn, D; Guinta, D; Gupta, S; Lerner, M; Shoulson, I; Swanson, J; Wigal, S; Williams, L, 1999
)
0.63
" Higher dosage was associated with fewer diagnoses of alcoholism or suicide attempts."( Childhood inattention-overactivity, aggression, and stimulant medication history as predictors of young adult outcomes.
Loney, J; Paternite, CE; Salisbury, H; Whaley, MA, 1999
)
0.3
"1) To compare standard twice-daily methylphenidate (MPH) dosing with a single morning dose of MPH and of Adderall during a typical school-day time period, and 2) to conduct a dose-response study of the effects of a late-afternoon (3:30 PM) dose of MPH and Adderall on evening behavior and side effects."( A comparison of morning-only and morning/late afternoon Adderall to morning-only, twice-daily, and three times-daily methylphenidate in children with attention-deficit/hyperactivity disorder.
Aronoff, HR; Burrows-MacLean, L; Chronis, AM; Fabiano, GA; Gnagy, EM; Meichenbaum, DL; Onyango, AN; Pelham, WE; Steiner, RL; Williams, A, 1999
)
0.79
" These results indicate that Adderall may be used as a long-acting stimulant for children for whom midday dosing is a problem."( A comparison of morning-only and morning/late afternoon Adderall to morning-only, twice-daily, and three times-daily methylphenidate in children with attention-deficit/hyperactivity disorder.
Aronoff, HR; Burrows-MacLean, L; Chronis, AM; Fabiano, GA; Gnagy, EM; Meichenbaum, DL; Onyango, AN; Pelham, WE; Steiner, RL; Williams, A, 1999
)
0.51
" The dosage was increased until behavioral change was achieved, using a decrement in scores of less than or equal to 1 on a commonly used rating scale or until the maximum tolerated dose was achieved."( Association of the dopamine transporter gene (DAT1) with poor methylphenidate response.
Comings, DE; Winsberg, BG, 1999
)
0.54
" There is marked individual variability in the dose-response relationship for methylphenidate, and therefore dosage must be titrated for optimal effect and avoidance of toxicity in each child."( Pharmacokinetics and clinical effectiveness of methylphenidate.
Abernethy, DR; Cross, JT; Kimko, HC, 1999
)
0.79
" The single high dose of MPTP produced greater losses of [(11)C]dihydrotetrabenazine binding than did the multiple MPTP dosing regimen."( Rapid and differential losses of in vivo dopamine transporter (DAT) and vesicular monoamine transporter (VMAT2) radioligand binding in MPTP-treated mice.
Kilbourn, MR; Kuszpit, K; Sherman, P, 2000
)
0.31
" Measures of subjective, behavioural, and physiological responses were evaluated at fixed intervals during 72 h after each dosing occasion."( An evaluation of the abuse potential of modafinil using methylphenidate as a reference.
Jasinski, DR, 2000
)
0.55
"In this study we approach problems related to the dosage and specific action of methylphenidate, its effects at cognitive and social levels, possible side-effects and limitations to its usage, and methods for evaluation of the response to treatment in the school environment."( [The evaluation of the effects of pharmacological treatment of children with attention deficit hyperactivity disorder].
Amado, L; Presentación, MJ; Roselló, B, 1999
)
0.53
" An essential component of such studies is the determination of MP plasma levels under chronic and acute dosing conditions."( Analysis of methylphenidate and its metabolite ritalinic acid in monkey plasma by liquid chromatography/electrospray ionization mass spectrometry.
Bajic, S; Doerge, DR; Fogle, CM; McCullagh, M; Paule, MG, 2000
)
0.69
" Thirty-two reports (29 studies) evaluated adverse effects of drug therapy; many of the side effects associated with stimulant use appear to be relatively mild and of short duration and to respond to dosing or timing adjustments."( Treatment of attention-deficit/hyperactivity disorder.
Boyle, M; Cunningham, C; Jadad, AR; Kim, M; Schachar, R, 1999
)
0.3
" Dosage was adjusted at the end of weeks 1 and 2 via an algorithm based on teacher and parent ratings."( A double-blind, placebo-controlled study of Adderall and methylphenidate in the treatment of attention-deficit/hyperactivity disorder.
Browne, RG; Olvera, RL; Pliszka, SR; Wynne, SK, 2000
)
0.55
" Adderall produced significantly more improvements on teacher ratings and the CGI than methylphenidate, although the algorithm may have limited dosing in the methylphenidate group."( A double-blind, placebo-controlled study of Adderall and methylphenidate in the treatment of attention-deficit/hyperactivity disorder.
Browne, RG; Olvera, RL; Pliszka, SR; Wynne, SK, 2000
)
0.77
" It attempts to arrive at a reasonable upper limit of dosage for clinical purposes."( How high a dose of stimulant medication in adult attention deficit hyperactivity disorder?
Sachdev, PS; Trollor, JN, 2000
)
0.31
"5 mg each day with twice-a-day dosing in the morning and at noon until the patient responded or showed side effects."( Treatment of depression with methylphenidate in patients difficult to wean from mechanical ventilation in the intensive care unit.
Ehrentraut, S; Kapfhammer, HP; Kilger, E; Rothenhäusler, HB; Schelling, G; Stoll, C; Tichy, M; von Degenfeld, G; Weis, M, 2000
)
0.6
"The MTA titration protocol validated the efficacy of weekend MPH dosing and established a total daily dose limit of 35 mg of MPH for children weighing less than 25 kg."( Impairment and deportment responses to different methylphenidate doses in children with ADHD: the MTA titration trial.
Abikoff, HB; Arnold, LE; Bukstein, OG; Clevenger, W; Conners, CK; Davies, M; Elliott, GR; Greenhill, LL; Hechtman, L; Hinshaw, SP; Hoza, B; Jensen, PS; Kraemer, HC; March, JS; Newcorn, JH; Severe, JB; Swanson, JM; Vitiello, B; Wells, K; Wigal, T; Wu, M, 2001
)
0.57
"To examine the trajectory of methylphenidate (MPH) dosage over time, following a controlled titration, and to ascertain how accurately the titration was able to predict effective long-term treatment in children with attention-deficit/hyperactivity disorder (ADHD)."( Methylphenidate dosage for children with ADHD over time under controlled conditions: lessons from the MTA.
Abikoff, HB; Arnold, LE; Bukstein, OG; Cantwell, DP; Elliott, GR; Greenhill, LL; Hechtman, L; Hinshaw, SP; Jensen, PS; March, JS; Newcorn, JH; Severe, JB; Swanson, JM; Vitiello, B, 2001
)
2.04
" Of the 230 children for whom titration identified an optimal treatment, 17% continued both the assigned medication and dosage throughout maintenance."( Methylphenidate dosage for children with ADHD over time under controlled conditions: lessons from the MTA.
Abikoff, HB; Arnold, LE; Bukstein, OG; Cantwell, DP; Elliott, GR; Greenhill, LL; Hechtman, L; Hinshaw, SP; Jensen, PS; March, JS; Newcorn, JH; Severe, JB; Swanson, JM; Vitiello, B, 2001
)
1.75
" Results indicated that 3 children were able to accurately report their medication status at levels greater than chance, whereas the accuracy of reports by all children was related to dosage level, differences in behavior, and the presence of adverse effects."( Testing the ability of children with attention deficit hyperactivity disorder to accurately report the effects of medication on their behavior.
Ardoin, SP; Martens, BK, 2000
)
0.31
" Recent studies suggest that Adderall, a psychostimulant indicated for the treatment of ADHD, may provide an efficacious, less frequently dosed alternative to methylphenidate."( Retrospective comparison of Adderall and methylphenidate in the treatment of attention deficit hyperactivity disorder.
Grcevich, S; Marcellino, B; Rowane, WA; Sullivan-Hurst, S, 2001
)
0.77
" Previous long-acting stimulants and preparations have shown effects equivalent to twice-daily dosing of MPH."( Once-a-day Concerta methylphenidate versus three-times-daily methylphenidate in laboratory and natural settings.
Burrows-Maclean, L; Chronis, AM; Coles, EK; Fabiano, GA; Fielbelkorn, K; Forehand, GL; Gnagy, EM; Hoffman, MT; Lock, TM; Meichenbaum, DL; Morrisey, SM; Morse, GD; Nguyen, CA; Onyango, AN; Panahon, CJ; Pelham, WE; Steiner, RL; Williams, A, 2001
)
0.63
" Three dosing levels of medication were used: 5 mg IR MPH tid/18 mg Concerta once a day (qd); 10 mg IR MPH tid/36 mg Concerta qd; and 15 mg IR MPH tid/54 mg Concerta qd."( Once-a-day Concerta methylphenidate versus three-times-daily methylphenidate in laboratory and natural settings.
Burrows-Maclean, L; Chronis, AM; Coles, EK; Fabiano, GA; Fielbelkorn, K; Forehand, GL; Gnagy, EM; Hoffman, MT; Lock, TM; Meichenbaum, DL; Morrisey, SM; Morse, GD; Nguyen, CA; Onyango, AN; Panahon, CJ; Pelham, WE; Steiner, RL; Williams, A, 2001
)
0.63
" However, patients may require dosage adjustment for tolerability of this combination."( Methylphenidate augmentation of citalopram in elderly depressed patients.
Kumar, A; Lavretsky, H, 2001
)
1.75
"Children with attention-deficit/hyperactivity disorder (ADHD; n = 282), all subtypes, ages 6 to 12 years, were randomized to placebo (n = 90), immediate-release methylphenidate (IR MPH) 3 times a day (tid; dosed every 4 hours; n = 97), or OROS MPH once a day (qd; n = 95) in a double-blind, 28-day trial."( Randomized, controlled trial of oros methylphenidate once a day in children with attention-deficit/hyperactivity disorder.
Atkins, M; August, G; Bukstein, O; Greenhill, LL; McBurnett, K; Palumbo, D; Pelham, W; Swanson, J; Wilens, T; Wolraich, ML, 2001
)
0.78
"For the treatment of core ADHD symptoms, OROS MPH dosed qd and IR MPH dosed tid were superior to placebo and were not significantly different from each other."( Randomized, controlled trial of oros methylphenidate once a day in children with attention-deficit/hyperactivity disorder.
Atkins, M; August, G; Bukstein, O; Greenhill, LL; McBurnett, K; Palumbo, D; Pelham, W; Swanson, J; Wilens, T; Wolraich, ML, 2001
)
0.58
" The average daily dosage prescribed differed little among general practitioners, pediatricians and psychiatrists, unlike the mean interval between successive prescriptions: 89."( Prescription of methylphenidate to children and youth, 1990-1996.
Armstrong, RW; Lalonde, CE; McGrail, KM; Miller, AR, 2001
)
0.66
" The differences were attributable to differences in drug-acquisition costs and the need for in-school dosing of twice-daily and thrice-daily medications."( Pharmacotherapies for attention-deficit/hyperactivity disorder: expected-cost analysis.
Carotenuto, I; Conners, CK; Einarson, TR; Findling, R; Iskedjian, M; Jensen, PS; Lau, H; Magar, R; Marchetti, A; Murphy, EL; Wineburg, E, 2001
)
0.31
" Statistical comparisons of specific somatic complaints indicated minimal agreement between parents and children in contrast to the nearly identical parent-child dose-response curves."( Attention-Deficit/Hyperactivity Disorder and methylphenidate: a dose-response analysis and parent-child comparison of somatic complaints.
Moffitt, C; Randall, R; Rapport, MD, 2002
)
0.57
" The conservative dosage levels and relatively brief length of treatment may have contributed to the absence of significant differences among treatment conditions."( An experimental comparison of Pycnogenol and methylphenidate in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).
Dodd, DK; Green, L; Paull, JC; Sparrow, EP; Tenenbaum, S, 2002
)
0.57
" They were dosed with 2, 6, and 20 mg/kg/day D-methylphenidate and 40 mg/kg/day D,L-methylphenidate from gestation Day 7 to lactation Day 20."( The perinatal and postnatal toxicity of D-methylphenidate and D,L-methylphenidate in rats.
Christian, MS; Hoberman, AM; Khetani, VD; Stirling, DI; Teo, SK; Thomas, SD,
)
0.65
" The food effect on early drug exposure and the pharmacokinetic profiles up to 8 h after dosing of the two extended-release stimulants were directly compared using partial area (AUC(p4h), AUC(p6h) and AUC(p8h)) fed/fasted ratios."( Effect of food on early drug exposure from extended-release stimulants: results from the Concerta, Adderall XR Food Evaluation (CAFE) Study.
Auiler, JF; Gelotte, CK; Liu, K; Lynch, JM, 2002
)
0.31
" Overall, the toxicity profile observed in rats with 50 mg/kg per day D-MPH was comparable to that of an equimolar dose of D,L-MPH (100 mg/kg per day) when given repeatedly for 90 days using a twice a day dosing regimen."( A 90-day oral gavage toxicity study of D-methylphenidate and D,L-methylphenidate in Sprague-Dawley rats.
Hoberman, A; Khetani, V; Kiorpes, A; Stirling, D; Teo, S; Thomas, S, 2002
)
0.58
", blood pressure [BP], heart rate [HR], height/weight) are mostly transient, dose-dependent, easily rectified with dosage adjustments, and considered minor from a clinical perspective considering the breadth and level of improvement in behavior and cognitive functioning observed in most children."( Attention deficit/hyperactivity disorder and methylphenidate. A review of height/weight, cardiovascular, and somatic complaint side effects.
Moffitt, C; Rapport, MD, 2002
)
0.57
"To test the effects of a standard dosage of the psychostimulant methylphenidate (MPH) - which significantly enhances intracortical inhibition but had no effects on intracortical facilitation in children with attention-deficit hyperactivity disorder (ADHD) - on intracortical excitability in healthy subjects."( Methylphenidate and intracortical excitability: opposite effects in healthy subjects and attention-deficit hyperactivity disorder.
Heinrich, H; Moll, GH; Rothenberger, A, 2003
)
2
"Examined the impact of late-afternoon stimulant dosing on parent and parent-child domains."( The impact of late-afternoon stimulant dosing for children with ADHD on parent and parent-child domains.
Aronoff, HR; Chronis, AM; Gnagy, EM; Pelham, WE; Roberts, JE, 2003
)
0.32
"The duration of action of the immediate-release formulation of methylphenidate hydrochloride is short (3 to 4 hours), and 3 times daily dosing is thought to maximize effectiveness across a 12-hour day."( Development of a new once-a-day formulation of methylphenidate for the treatment of attention-deficit/hyperactivity disorder: proof-of-concept and proof-of-product studies.
Gupta, S; Lam, A; Lerner, M; Lindemulder, E; Modi, N; Shoulson, I; Swanson, J; Wigal, S, 2003
)
0.82
" In the pharmacodynamic study, OROS-methylphenidate treatment matched the 3 times daily dosing of methylphenidate for onset and duration of efficacy."( Development of a new once-a-day formulation of methylphenidate for the treatment of attention-deficit/hyperactivity disorder: proof-of-concept and proof-of-product studies.
Gupta, S; Lam, A; Lerner, M; Lindemulder, E; Modi, N; Shoulson, I; Swanson, J; Wigal, S, 2003
)
0.85
"The current study was aimed at (a) investigating the effect of three doses methylphenidate (MPH) and placebo on inhibition of a prepotent response, inhibition of an ongoing response, and interference control in Attention Deficit/Hyperactivity Disorder (AD/HD), and (b) studying dose-response relations for the three forms of response inhibition."( The effect of methylphenidate on three forms of response inhibition in boys with AD/HD.
Meiran, N; Morein-Zamir, S; Oosterlaan, J; Scheres, A; Schut, H; Sergeant, JA; Swanson, J; Vlasveld, L, 2003
)
0.91
" Oral clearance was identical between the two dosage forms."( Pharmacokinetics of methylphenidate after oral administration of two modified-release formulations in healthy adults.
DeVane, CL; Lee, J; Markowitz, JS; Muniz, R; Patrick, KS; Pestreich, L; Straughn, AB; Wang, Y, 2003
)
0.64
" Measures of regional cerebral blood flow (rCBF) using positron emission tomography (PET) were acquired at rest for ten adult subjects with ADHD during both an unmedicated state and after a 3-week period of chronic dosing with a clinically optimal dose of MPH."( A positron emission tomography study of methylphenidate in adults with ADHD: alterations in resting blood flow and predicting treatment response.
Grafton, ST; Hanford, RB; Hoffman, JM; Kilts, CD; Lee, DO; Schweitzer, JB; Tagamets, MA, 2003
)
0.59
"Although attention deficit hyperactivity disorder is thought to be present in preschoolers, there are no clear guidelines for dosing stimulant medications in this population."( High-dose methylphenidate treatment of attention deficit hyperactivity disorder in a preschooler.
Butz, AM; Cozen, MA; Lipkin, PH, 2003
)
0.72
" Dogs were orally dosed twice a day in equally divided doses 6 hours apart for total daily doses of 1, 3, and 10 mg/kg/day d-MPH or 20 mg/kg/day d,l-MPH for 90 days, followed by a 30-day recovery period."( A 90-day oral gavage toxicity study of d-methylphenidate and d,l-methylphenidate in beagle dogs.
Evans, MG; Khetani, VD; Stirling, DI; Teo, SK; Thomas, SD,
)
0.4
"Groups of pregnant rats were orally dosed twice daily 6 hr apart from Days 7 to 17 of presumed gestation (DG 7-17) for total daily doses of 2, 6 and 20 mg/kg D-MPH and 40 mg/kg D,L-MPH."( D-methylphenidate and D,L-methylphenidate are not developmental toxicants in rats and rabbits.
Christian, MS; Hoberman, AM; Khetani, VD; Stirling, DI; Teo, SK; Thomas, SD, 2003
)
1.04
" The number of rats with repetitive pawing, dilated pupil and aggression was significantly greater for the 40 mg/kg D,L-MPH compared to the 20 mg/kg D-MPH dosed rats."( D-methylphenidate and D,L-methylphenidate are not developmental toxicants in rats and rabbits.
Christian, MS; Hoberman, AM; Khetani, VD; Stirling, DI; Teo, SK; Thomas, SD, 2003
)
1.04
"Rats and rabbits dosed with D,L-MPH exhibited significantly greater incidence of maternal clinical observations at twice the dose of D-MPH."( D-methylphenidate and D,L-methylphenidate are not developmental toxicants in rats and rabbits.
Christian, MS; Hoberman, AM; Khetani, VD; Stirling, DI; Teo, SK; Thomas, SD, 2003
)
1.04
" A total of 28 children with ADHD as defined by DSM IV were randomized to selegiline or methylphenidate dosed on an age and weight-adjusted basis at selegiline 5 mg/day (under 5 years) and 10 mg/day (over 5 years) (Group 1) and methylphenidate 1 mg/kg/day (Group 2) for a 4-week double-blind clinical trial."( Selegiline in the treatment of attention deficit hyperactivity disorder in children: a double blind and randomized trial.
Akhondzadeh, S; Amini, H; Arabgol, F; Davari-Ashtiani, R; Tavakolian, R, 2003
)
0.54
" We then increased dosage to 15 mg 3 times daily for 2 weeks and administered a complete reassessment on the final day."( The efficacy of 2 different dosages of methylphenidate in treating adults with attention-deficit hyperactivity disorder.
Bouffard, R; Hechtman, L; Iaboni-Kassab, F; Minde, K, 2003
)
0.59
" This notwithstanding, a single-isomer d-MPH immediate-release product is now available for dosing recommended at one-half that of dl-MPH."( Advances in the pharmacotherapy of attention-deficit-hyperactivity disorder: focus on methylphenidate formulations.
Markowitz, JS; Patrick, KS; Straughn, AB, 2003
)
0.54
" This study was conducted to examine dosage effects on ADHD symptoms and stimulant side effects and to explore potential moderating effects of ADHD subtype."( A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder.
Black, DO; Conlon, C; Newcorn, JH; Pearl, PL; Robb, AS; Sarampote, CS; Seymour, KE; Stein, MA; Waldman, ID, 2003
)
0.61
"Children with ADHD combined type (ADHD-CT) or predominantly inattentive type (ADHD-PI; n = 47), ages 5 to 16 years, underwent a placebo-controlled, crossover trial using forced titration with weekly switches at 3 dosage levels."( A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder.
Black, DO; Conlon, C; Newcorn, JH; Pearl, PL; Robb, AS; Sarampote, CS; Seymour, KE; Stein, MA; Waldman, ID, 2003
)
0.61
" For those with ADHD-CT, there was a clear linear dose-response relationship, with clinically significant reductions in ADHD Rating Scale-IV scores occurring in two thirds to three fourths of the subjects during either 36- or 54-mg dose conditions."( A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder.
Black, DO; Conlon, C; Newcorn, JH; Pearl, PL; Robb, AS; Sarampote, CS; Seymour, KE; Stein, MA; Waldman, ID, 2003
)
0.61
"We used a sequential approach to evaluate the relative and combined effects of different types of behavioral treatments, as well as dosage of methylphenidate (MPH), on the disruptive behavior of 3 students who had been diagnosed with attention deficit hyperactivity disorder."( Sequential evaluation of behavioral treatments and methylphenidate dosage for children with attention deficit hyperactivity disorder.
Gulley, V; Hupp, S; LeVelle, J; Northup, J; Ridgway, A; Spera, S, 2003
)
0.77
" There was no clear dose-response relationship."( Effects of once-daily osmotic-release methylphenidate on blood pressure and heart rate in children with attention-deficit/hyperactivity disorder: results from a one-year follow-up study.
Biederman, J; Lerner, M; Wilens, TE, 2004
)
0.59
" The behavioral experiment included dose-response (0."( Dopaminergic ventral tegmental neurons modulated by methylphenidate.
Benitez, MT; Dafny, N; Prieto-Gomez, B; Reyes Vazquez, C; Vazquez-Alvarez, AM; Yang, PB, 2004
)
0.57
" The behavioural responses of individuals are also highly variable, so that it is necessary to start treatment at a low dosage and increase up to a maximally effective dosage (usually starting at 10-15 mg/day with increases of 10-15mg at weekly intervals to a maximum dosage of 60 mg/day, irrespective of formulation)."( Pharmacokinetic considerations in the treatment of attention-deficit hyperactivity disorder with methylphenidate.
Doffing, MA; Wolraich, ML, 2004
)
0.54
"5% of mild complications being resolved by lowering the drug dosage or by withdrawing it altogether."( [The diagnostic evaluation and therapeutic basis of immediate release methylphenidate in attention deficit hyperactivity disorder].
Valdizán, JR,
)
0.37
" A total of 32 children with ADHD as defined by DSM IV were randomized to theophylline and methylphenidate dosed on an age and weight-adjusted basis at 4 mg/kg/day (under 12 years) and 3 mg/kg/day theophylline (over 12 years) (group 1) and 1 mg/kg/day methylphenidate (group 2) for a 6-week double-blind and randomized clinical trial."( Efficacy of theophylline compared to methylphenidate for the treatment of attention-deficit hyperactivity disorder in children and adolescents: a pilot double-blind randomized trial.
Akhondzadeh, S; Izadian, ES; Kashani, L; Mohammadi, MR; Ohadinia, S, 2004
)
0.82
" After having received various dosing levels of a stimulant in a placebo-controlled crossover design, best dose was assigned based on the lowest Abbreviated Symptoms Questionnaire T score received in a given week."( A prospective study of stimulant response in preschool children: insights from ROC analyses.
Findling, RL; Manos, MJ; Schubel, EA; Short, EJ, 2004
)
0.32
" Methylphenidate and amphetamine-based stimulants are now available in longer-acting, once-daily and shorter-acting divided dosing schedules."( Pharmacological management of attention-deficit hyperactivity disorder.
Reeves, G; Schweitzer, J, 2004
)
1.23
" Analysis of dose-response curves revealed significant linear components of trend on measures tapping sustained attention, visual selective attention, auditory selective attention, as well as two tasks tapping inhibition/impulsivity: delay of gratification and match-to-sample."( Treatment effects of methylphenidate on cognitive functioning in children with mental retardation and ADHD.
Casat, CD; Cleveland, LA; Faria, LP; Jerger, SW; Lachar, D; Lane, DM; Loveland, KA; Payne, CD; Pearson, DA; Roache, JD; Santos, CW, 2004
)
0.64
" The 20 mg capsule, the first FDA-approved dosage strength, was used as reference treatment."( Dose-proportional pharmacokinetics of a methylphenidate extended-release capsule.
Dirksen, SJ; González, MA; Rochdi, M, 2004
)
0.59
"Data collected from this study demonstrate the dose proportionality of the new 10 mg and 30 mg dosage strengths of MPH ER capsules with the 20 mg capsule."( Dose-proportional pharmacokinetics of a methylphenidate extended-release capsule.
Dirksen, SJ; González, MA; Rochdi, M, 2004
)
0.59
" The present report describes the determination of plasma concentrations of D-threo- and L-threo-enantiomers of MPH in toxicokinetic (TK) studies in pregnant Wistar Hannover rats and New Zealand white rabbits following repeated daily oral dosing of D,L-MPH (racemate)."( Toxicokinetic assessment of methylphenidate (Ritalin) enantiomers in pregnant rats and rabbits.
Bakhtiar, R; Tse, FL, 2004
)
0.62
"Given the dosing limitations of methylphenidate short-acting preparations in treating ADHD, galenics with longer release of the substance were developed mainly to avoid drug intake during school hours."( Comparative efficacy of once-a-day extended-release methylphenidate, two-times-daily immediate-release methylphenidate, and placebo in a laboratory school setting.
Banaschewski, T; Breuer, D; Döpfner, M; Freisleder, FJ; Gerber, WD; Gerber-von Müller, G; Günter, M; Hässler, F; Lehmkuhl, G; Ose, C; Rothenberger, A; Schmeck, K; Sinzig, J; Stadler, C; Uebel, H, 2004
)
0.86
" The purpose of this study was to examine the acute dose-response characteristics of MPD on three different male rat strains: spontaneously hypertensive/hyperactive rats (SHR), Wistar-Kyoto (WKY) rats, and Sprague-Dawley (SD) rats."( Differential locomotor responses in male rats from three strains to acute methylphenidate.
Amini, B; Dafny, N; Swann, AC; Yang, PB, 2004
)
0.55
" Children were assigned on the basis of their pre-trial dosage to either high (Metadate CD 60 mg; Concerta 54 mg), medium (Metadate CD 40 mg; Concerta 36 mg) or low doses (Metadate CD 20 mg; Concerta 18 mg) of MPH, and attended a laboratory school on the 7th day for assessment at 7 sessions across the day."( Efficacy of two once-daily methylphenidate formulations compared across dose levels at different times of the day: preliminary indications from a secondary analysis of the COMACS study data.
Coghill, D; DeCory, HH; Hatch, SJ; Sonuga-Barke, EJ; Swanson, JM, 2004
)
0.62
" Future studies are needed to confirm these findings and to evaluate chronic dosing with d-MPH."( Open-label study of dexmethylphenidate hydrochloride in children and adolescents with attention deficit hyperactivity disorder.
Cecil, JT; Faleck, H; Khetani, V; Kowalik, S; Patin, J; Silva, R; Tilker, HA, 2004
)
0.63
"These data support the use of XR MPH with its simplified dosing regimen for children with ADHD."( Effect of methylphenidate formulation for attention deficit hyperactivity disorder on patterns and outcomes of treatment.
Hwang, P; Lage, M, 2004
)
0.73
"The newer treatments for ADHD offer advantages over immediate-release methyphenidate in dosing schedule and duration of action that may be of particular benefit to adolescent and adult patients."( Review of new compounds available in Australia for the treatment of attention-deficit hyperactivity disorder.
Hazell, P, 2004
)
0.32
" (total daily MPH IR dosage 45 mg)."( [Long-acting methylphenidate. An alternative medical therapy for adult patients with attention deficit hyperactivity disorder].
Alm, B; Sobanski, E, 2005
)
0.7
"02 years), underwent a 4-week, double-blinded, crossover trial with forced weekly dosage changes."( Dopamine transporter genotype and methylphenidate dose response in children with ADHD.
Conlon, C; Cook, EH; Kim, SJ; Robb, AS; Sarampote, CS; Seymour, KE; Stein, MA; Waldman, ID, 2005
)
0.61
" In an attempt to understand these behavioral differences at the neuronal level, the dose-response characteristics of these two psychostimulants on electrophysiologically identified VTA-DA neurons at the glutamatergic synapse were investigated."( Methylphenidate and amphetamine modulate differently the NMDA and AMPA glutamatergic transmission of dopaminergic neurons in the ventral tegmental area.
Dafny, N; Martínez-Peña, JL; Prieto-Gómez, B; Reyes-Vázquez, C; Vázquez-Alvarez, AM; Yang, PB, 2005
)
1.77
" This paper draws upon data from a qualitative empirical study to investigate parents' use of the moral ideal of authenticity as part of their narrative justifications for dosing decisions and actions."( Will the "real boy" please behave: dosing dilemmas for parents of boys with ADHD.
Singh, I, 2005
)
0.33
" After adjustment of the dosage for body weight, the pharmacokinetic parameters are similar across all age and gender groups."( [Current evidence about atomoxetine. A therapeutic alternative for the treatment of attention deficit hyperactivity disorder].
Peña, JA; Velásquez-Tirado, JD,
)
0.13
" Subjects successfully completing the dose titration phase (n = 177) (ie, tolerated and responded to treatment and adhered to the protocol) were randomized to receive 2 weeks' treatment with their individualized dosage of OROS methylphenidate (18, 36, 54, or 72 mg once daily) or placebo."( Multisite controlled study of OROS methylphenidate in the treatment of adolescents with attention-deficit/hyperactivity disorder.
Bailey, CE; Bloom, L; Bukstein, O; Casat, C; Conners, CK; Cooper, KM; Coury, D; Denisco, MJ; Duby, J; Greenhill, L; Gu, J; Halstead, P; Kratochvil, CJ; Lerner, M; Lynch, JM; McBurnett, K; McGough, J; Newcorn, J; Stein, MA; Wilens, TE; Zimmerman, BA, 2006
)
0.79
" Thirty-seven percent of subjects required the maximum dosage of 72 mg/d."( Multisite controlled study of OROS methylphenidate in the treatment of adolescents with attention-deficit/hyperactivity disorder.
Bailey, CE; Bloom, L; Bukstein, O; Casat, C; Conners, CK; Cooper, KM; Coury, D; Denisco, MJ; Duby, J; Greenhill, L; Gu, J; Halstead, P; Kratochvil, CJ; Lerner, M; Lynch, JM; McBurnett, K; McGough, J; Newcorn, J; Stein, MA; Wilens, TE; Zimmerman, BA, 2006
)
0.61
"The thrice daily dosing regimen of immediate release methylphenidate (IR-MPH) for Attention Deficit/Hyperactivity Disorder (ADHD) requires in-school dosing, leading to issues surrounding dispensing and storage of controlled substances by school personnel and concerns over children?s privacy and the embarrassment associated with taking medication in public at school."( A randomized, controlled effectiveness trial of OROS-methylphenidate compared to usual care with immediate-release methylphenidate in attention deficit-hyperactivity disorder.
Binder, CE; Prinzo, RS; Steele, M; Swanson, J; Wang, J; Weiss, M, 2006
)
0.83
" The objectives of the present study were to investigate the MPD dose-response characteristics on locomotor activity and sensory inputs using acoustic stimuli."( Sensory-evoked potentials recordings from the ventral tegmental area, nucleus accumbens, prefrontal cortex, and caudate nucleus and locomotor activity are modulated in dose-response characteristics by methylphenidate.
Dafny, N; Swann, AC; Yang, PB, 2006
)
0.52
" Members of the high-dose group (n = 58) had received at least 1 stimulant at a dosage > or = 120% of the maximum recommended by the American Academy of Sleep Medicine Standards of Practice Committee."( Risks of high-dose stimulants in the treatment of disorders of excessive somnolence: a case-control study.
Auger, RR; Goodman, SH; Krahn, LE; Pankratz, VS; Silber, MH; Slocumb, NL, 2005
)
0.33
"All 12 dosed subjects finished both treatment periods and were included in pharmacokinetic and safety analyses."( Bioequivalence of a methylphenidate hydrochloride extended-release preparation: comparison of an intact capsule and an opened capsule sprinkled on applesauce.
Ammer, R; Fischer, R; Grossmann, M; Leis, HJ; Schütz, H, 2006
)
0.66
" Therefore, experiments were carried out in P-gp knockout (KO) mice versus wild-type (WT) mice after intraperitoneal dosing (2."( The role of the polymorphic efflux transporter P-glycoprotein on the brain accumulation of d-methylphenidate and d-amphetamine.
DeVane, CL; Donovan, JL; Gibson, BB; Markowitz, JS; Middaugh, LD; Patrick, KS; Wang, JS; Williard, RL; Zhu, HJ, 2006
)
0.55
"Findings indicate that multiple daily dosing of MPH increases the likelihood of poor adherence, particularly in adolescents, and that poor adherence is associated with impaired maternal/family process."( Determinants of adherence to methylphenidate and the impact of poor adherence on maternal and family measures.
Chiu, YN; Chou, MC; Gau, CS; Gau, SS; Shen, HY; Tang, CS, 2006
)
0.63
" Results showed that repeated administration of MPD increased locomotion in dose-response manner and elicited behavioral sensitization, while the amplitude of the sensory evoked field responses of the VTA and NAc exhibited dose-response attenuation on both recording days (days 1 and 10)."( Chronic methylphenidate modulates locomotor activity and sensory evoked responses in the VTA and NAc of freely behaving rats.
Dafny, N; Swann, AC; Yang, PB, 2006
)
0.77
" Flexible d-MPH-ER dosing (30 mg/day) was permitted for 5 weeks, then patients remained on their optimal dose during the last 2 study weeks."( Efficacy and safety of dexmethylphenidate extended-release capsules in children with attention-deficit/hyperactivity disorder.
Ball, RR; Greenhill, LL; Jiang, H; Levine, A; Muniz, R; Pestreich, L, 2006
)
0.63
" Since therapeutic MPH in humans is typically administered orally, oral dosing methods that have been verified in the rodent model are of value."( A novel method for oral stimulant administration in the neonate rat and similar species.
Eppolito, AK; Huff, TB; Smith, LN; Smith, RF; Wheeler, TL, 2007
)
0.34
" The development of ideal long-acting preparations requires detailed understanding of the pharmacokinetic and pharmacodynamic consequences of complex dosing regimens."( Methylphenidate blood levels and therapeutic response in children with attention-deficit hyperactivity disorder: I. Effects of different dosing regimens.
Chang, WW; Foley, M; McGreenery, CE; McKay, G; Midha, KK; Polcari, A; Teicher, MH; Valente, E, 2006
)
1.78
"This study does not support the expectation that optimally dosed stimulant treated children with ADHD should routinely receive psychosocial treatment to further reduce ADHD- and related symptoms."( Does brief, clinically based, intensive multimodal behavior therapy enhance the effects of methylphenidate in children with ADHD?
Emmelkamp, PM; Oosterlaan, J; Prins, PJ; van der Oord, S, 2007
)
0.56
" Clinical trials have shown OROS MPH to have a continued action over a 12-h period, to be superior to placebo and to be as effective as immediate-release MPH dosed three times daily, in reducing symptoms of attention-deficit hyperactivity disorder, with similar incidence of side effects."( Osmotic, controlled-release methylphenidate for the treatment of ADHD.
Coghill, D; Seth, S, 2006
)
0.63
" The dosage of Concerta was adjusted by the investigators based on symptoms and safety assessments performed on a weekly basis."( Efficacy and tolerability of OROS methylphenidate in Korean children with attention-deficit/hyperactivity disorder.
Cheong, S; Cho, IH; Choi, JW; Hong, SD; Kim, EJ; Kim, JH; Kim, SY; Lee, SI; Lim, TS; Oh, EY; Park, JH; Park, MK; Park, S, 2007
)
0.62
" An automated, computerized, open-field activity monitoring system was used to study the dose-response characteristics of acute and repeated MPD administration throughout the 11-day experimental protocol."( Acute and chronic methylphenidate dose-response assessment on three adolescent male rat strains.
Dafny, N; Swann, AC; Yang, PB, 2006
)
0.67
" Trial length, dosing schedule and efficacy assessment differed per physician."( Use of double-blind placebo-controlled N-of-1 trials among stimulant-treated youths in The Netherlands: a descriptive study.
de Jong-van den Berg, LT; Faber, A; Keizer, RJ; Tobi, H; van den Berg, PB, 2007
)
0.34
" Overall distribution of CGI-I ratings at final visit was significantly better with each d-MPH-ER dosage than with placebo."( Efficacy and safety of dexmethylphenidate extended-release capsules in adults with attention-deficit/hyperactivity disorder.
Adler, LA; Jiang, H; McGough, JJ; Muniz, R; Pestreich, L; Spencer, TJ, 2007
)
0.64
" The present study was designed to investigate the dose-response effects of MPD on sensory evoked potentials recorded from the PFC and CN in freely behaving rats previously implanted with permanent electrodes, as well as their behavioral (locomotor) activities."( Chronic administration of methylphenidate produces neurophysiological and behavioral sensitization.
Dafny, N; Swann, AC; Yang, PB, 2007
)
0.64
"05), with significant linear dose-response relationships evident for both domains."( Preliminary evidence of beneficial effects of methylphenidate on listening comprehension in children with attention-deficit/hyperactivity disorder.
Bedard, AC; Hogg-Johnson, S; McInnes, A; Tannock, R, 2007
)
0.6
"To determine if repeated dosing with methylphenidate hydrochloride (MPD) (Ritalin; Novartis Pharmaceuticals, East Hanover, NJ), an inhibitor of the dopamine transporter, would augment the effects of oral levodopa in patients with Parkinson disease."( Effects of methylphenidate on response to oral levodopa: a double-blind clinical trial.
Carlson, NE; Carter, JH; Nutt, JG, 2007
)
1
" Oral levodopa dosage was decreased as clinically feasible during the first 4 days in the GCRC during open-label administration of MPD and hourly monitoring of parkinsonism and vital signs between 7 am and 8 pm."( Effects of methylphenidate on response to oral levodopa: a double-blind clinical trial.
Carlson, NE; Carter, JH; Nutt, JG, 2007
)
0.73
" These data suggest additional studies should be performed to characterize age-related differences in PK properties of MPH that may inform practitioners about dosing strategies based on the age and size of children being treated."( Pharmacokinetics of methylphenidate in preschoolers with attention-deficit/hyperactivity disorder.
Greenhill, L; Gupta, S; Kapelinski, A; Lerner, M; Martinez, J; Modi, NB; Posner, K; Stehli, A; Steinhoff, K; Swanson, J; Wigal, SB; Wigal, T, 2007
)
0.66
" However there are gender specific drug differences in behavioral performance and sensitivity to treatment with MPH that may have implications for treatment efficacy and dosing clinically after TBI."( Gender associations with chronic methylphenidate treatment and behavioral performance following experimental traumatic brain injury.
Dixon, CE; Kline, AE; Ren, D; Wagner, AK; Wenger, MK; Willard, LA; Zafonte, RD, 2007
)
0.62
" Patients were treated with a gradually increasing dosage of a psychostimulant over two weeks, followed by a similar two-week period of gradually diminishing dosage."( Methylphenidate effect on hemispheric attentional imbalance in patients with traumatic brain injury: a psychophysical study.
Groswasser, Z; Hochstein, S; Keren, O; Mordvinov, E; Pavlovskaya, M, 2007
)
1.78
" These issues include: (1) sequencing and dosage of treatments being combined and compared; (2) difficulty drawing valid conclusions about individual components of treatment when treatment packages are employed; (3) differing results emerging from measurement tools that purportedly measure the same domain; and (4) the resultant difficulty in reaching a summary conclusion when multiple outcome measures yielding conflicting results are used."( Multimodal treatments for childhood attention-deficit/hyperactivity disorder: interpreting outcomes in the context of study designs.
Hoza, B; Hurt, E; Kaiser, NM, 2007
)
0.34
" Regarding a minimum requirement of 5 days weekly dosage and drug holidays, cases that took more than 70% of the recommended methylphenidate dose at the end of the first year were described as compliant."( [Sociodemographic and clinical factors associated with compliance to methylphenidate treatment in children with attention deficit hyperactivity disorder].
Aysev, A; Bilgiç, A; Gürkan, K; Kiliç, BG, 2007
)
0.78
" Data available from prescriptions and analyzed were: age, sex and place of residence of the patient, dosage prescribed, date of prescription, place of practice and medical specialization of doctors."( [Hyperactivity and prescription of Ritalin in the canton of Vaud (Switzerland), 2002].
Dubois-Arber, F; Huissoud, T; Jeannin, A, 2007
)
0.34
" Dosage complies with the recommendations of the Swiss Medic Compendium."( [Hyperactivity and prescription of Ritalin in the canton of Vaud (Switzerland), 2002].
Dubois-Arber, F; Huissoud, T; Jeannin, A, 2007
)
0.34
" Subjects were randomly assigned to receive one of six possible dosing orders."( Methylphenidate in the treatment of children and adolescents with bipolar disorder and attention-deficit/hyperactivity disorder.
Calabrese, JR; Demeter, CA; Findling, RL; Gracious, BL; Manos, MJ; McNamara, NK; Short, EJ; Stansbrey, RJ; Whipkey, R, 2007
)
1.78
" Increased locomotor activity and cage biting/chewing occurred at > or =5 mpkd (females) and > or =50 mpkd (males) and were absent after dosing ceased."( Juvenile toxicity assessment of d,l-methylphenidate in rats.
Beckman, DA; Schneider, M; Tse, FL; Youreneff, M, 2008
)
0.62
"Given that poor adherence to medication may be an important reason for suboptimal outcome in ADHD treatment, physicians should ensure adherence with therapy before adjusting dosage or switching medication."( National survey of adherence, efficacy, and side effects of methylphenidate in children with attention-deficit/hyperactivity disorder in Taiwan.
Chang, HL; Chen, SJ; Cheng, H; Chou, MC; Chou, WJ; Gau, SS; Hsu, YC; Huang, YF; Huang, YS; Liang, HY; Lu, HH; Tang, CS; Tzang, RF; Wu, YY, 2008
)
0.59
"In these healthy young subjects, MLR methylphenidate was associated with a concentration-time profile that resulted in a higher proportion of the administered methylphenidate dose being delivered in the first 4 hours after dosing compared with OROS methylphenidate while maintaining comparable levels of drug in the latter portion of the dosing interval."( Comparative bioavailability of single-dose methylphenidate from a multilayer-release bead formulation and an osmotic system: a two-way crossover study in healthy young adults.
Donnelly, GA; Michalko, K; Reiz, JL, 2008
)
0.88
" The methylphenidate transdermal system (MTS) is the first stimulant patch dosage formulation to be approved by the US Food and Drug Administration for the treatment of the symptoms of ADHD in children aged 6 to 12 years."( Practical management of cutaneous reactions to the methylphenidate transdermal system: recommendations from a dermatology expert panel consensus meeting.
Fowler, JF; Paller, AS; Warshaw, EM; Zirwas, MJ, 2008
)
1.11
" There was no significant relationship between dosage and severity or frequency of sleep problems."( Effects of once-daily oral and transdermal methylphenidate on sleep behavior of children with ADHD.
Arnold, LE; Bukstein, OG; Faraone, SV; Findling, RL; Glatt, SJ; Lopez, FA, 2009
)
0.62
"4 mg/kg, aripiprazole decreased rates of cocaine self-administration without shifting the peak of the dose-response function."( Aripiprazole blocks acute self-administration of cocaine and is not self-administered in mice.
Brennum, LT; Fink-Jensen, A; Hee Bengtsen, C; Petersen, JH; Sager, TN; Sørensen, G; Thomsen, M; Thøgersen, P; Woldbye, DP; Wörtwein, G, 2008
)
0.35
" Therefore, we dosed subjects with methylphenidate at 1 or 3 mg/kg/day via gastric intubation from postnatal day 22 to 59 and assessed the effects of the drug on performance on the radial arm maze each day."( Methylphenidate improves performance on the radial arm maze in periadolescent rats.
Dow-Edwards, DL; Hellmann, E; Weedon, JC,
)
1.85
" The disadvantages of such formulations include the need for multiple daily dosing and a potential for abuse."( Evolution of the treatment of attention-deficit/hyperactivity disorder in children: a review.
Findling, RL, 2008
)
0.35
"Currently available treatments for ADHD in children are efficacious and well tolerated, but many of them are limited by the requirement for multiple daily dosing and abuse potential."( Evolution of the treatment of attention-deficit/hyperactivity disorder in children: a review.
Findling, RL, 2008
)
0.35
" The relationship between dosage and effect size was explored by weighted regression analysis."( Limits of meta-analysis: methylphenidate in the treatment of adult attention-deficit hyperactivity disorder.
Becker, T; Fegert, JM; Kilian, R; Koesters, M; Weinmann, S, 2009
)
0.66
" Staggered, double blind dosing was used to examine eating and smoking behavior during the peak effects of varenicline and methylphenidate."( The influence of acute varenicline administration on smoking and eating behavior in humans.
Glaser, PE; Rush, CR; Stoops, WW; Vansickel, AR, 2008
)
0.55
" This study compared the cognitive consequences following chronic treatment with two doses (5 and 10 mg/kg) of methylphenidate on recognition and spatial memory in adult male Long-Evans rats using an established oral dosing procedure."( Chronic oral methylphenidate induces post-treatment impairment in recognition and spatial memory in adult rats.
LeBlanc-Duchin, D; Taukulis, HK, 2009
)
0.93
"The studies presented in this work were designed to evaluate the genetic toxicity of methylphenidate hydrochloride (MPH) in non-human primates (NHP) using a long-term, chronic dosing regimen."( The genetic toxicology of methylphenidate hydrochloride in non-human primates.
Bishop, ME; Chen, JJ; Dobrovolsky, VN; Doerge, DR; Hotchkiss, CE; Lin, CJ; Manjanatha, MG; Mattison, DR; Mittelstaedt, RA; Morris, SM; Paule, MG; Petibone, D; Shaddock, JG; Shelton, SD; Slikker, W; Tucker, JD; Twaddle, NC, 2009
)
0.88
" The dose-response protocol of MPD (0."( Methylphenidate treated at the test cage--dose-dependent sensitization or tolerance depend on the behavioral assay used.
Dafny, N; Swann, AC; Yang, PB, 2007
)
1.78
"Following a 5-week, randomized, controlled, fixed-dose study of d-MPH-ER 20 to 40 mg/d, 170 adults entered a 6-month open-label extension (OLE) to assess long-term safety, with flexible dosing of 20 to 40 mg/d."( Long-term effectiveness and safety of dexmethylphenidate extended-release capsules in adult ADHD.
Adler, LA; Jiang, H; McGough, JJ; Muniz, R; Spencer, T, 2009
)
0.62
"To evaluate stimulant dosing patterns in the community treatment of children with attention-deficit/hyperactivity disorder (ADHD)."( Stimulant dosing for children with ADHD: a medical claims analysis.
Marcus, S; Olfson, M; Wan, G, 2009
)
0.35
"Among children with ADHD who continue stimulants through the first 3 months of treatment, dosing in the community treatment of ADHD tends to be lower than doses used in clinical trials."( Stimulant dosing for children with ADHD: a medical claims analysis.
Marcus, S; Olfson, M; Wan, G, 2009
)
0.35
" Medication dosing was flexible, with titration to a maximum of 30 mg/day."( The open-label treatment of attention-deficit/hyperactivity disorder in 4- and 5-year-old children with beaded methylphenidate.
Fried, J; Greenhill, L; Gugga, SS; Maayan, L; Paykina, N; Strauss, T, 2009
)
0.56
"To review recent literature on the different stimulant preparations regarding efficacy and safety in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) and describe advantages and disadvantages of the many available dosage formulations."( An update on central nervous system stimulant formulations in children and adolescents with attention-deficit/hyperactivity disorder.
Angstadt, K; Bogart, GT; Chavez, B; Ehret, MJ; Goldberg, KR; Paulino, RE; Sopko, MA, 2009
)
0.35
" Daytrana gives patients more control over their dosing by being able to choose when the patch is removed; it is also a feasible alternative for children who cannot swallow pills."( An update on central nervous system stimulant formulations in children and adolescents with attention-deficit/hyperactivity disorder.
Angstadt, K; Bogart, GT; Chavez, B; Ehret, MJ; Goldberg, KR; Paulino, RE; Sopko, MA, 2009
)
0.35
" The multiple available dosage forms allow for individualization of treatment."( An update on central nervous system stimulant formulations in children and adolescents with attention-deficit/hyperactivity disorder.
Angstadt, K; Bogart, GT; Chavez, B; Ehret, MJ; Goldberg, KR; Paulino, RE; Sopko, MA, 2009
)
0.35
" Additional population-based studies that address manifestation of serious heart disease, especially after long-term use, dosage comparisons, and interactions with preexisting cardiac risk factors are needed to inform psychiatric treatment decisions."( Cardiac safety of methylphenidate versus amphetamine salts in the treatment of ADHD.
Gerhard, T; Saidi, A; Shuster, J; Winterstein, AG, 2009
)
0.69
" All 3 reports had identical dosing schedules and symptom assessments."( Methylphenidate side effects in advanced cancer: a retrospective analysis.
Davis, MP; Khoshknabi, DS; Lasheen, W; Mahmoud, F; Rivera, N; Walsh, D, 2010
)
1.8
"Children (ages 6-18 years) with ADHD were recruited for a prospective 12-week, open-labeled, multicenter study to examine optimal dosage of OROS methylphenidate."( Variability of response time as a predictor of methylphenidate treatment response in korean children with attention deficit hyperactivity disorder.
Cheon, KA; Ha, EH; Joung, YS; Kim, BN; Lee, SH; Shin, DW; Shin, YJ; Song, DH; Yoo, HJ, 2009
)
0.81
" Children whose aggressive behavior persisted at the conclusion of the lead-in phase were randomly assigned to receive double-blind, flexibly dosed divalproex or a placebo adjunctive to stimulant for 8 weeks."( Adjunctive divalproex versus placebo for children with ADHD and aggression refractory to stimulant monotherapy.
Blader, JC; Jensen, PS; Kafantaris, V; Pliszka, SR; Schooler, NR, 2009
)
0.35
"All dosed subjects finished both treatment periods and were included in pharmacokinetic and safety analyses."( Lack of bioequivalence between two methylphenidate extended modified release formulations in healthy volunteers.
Ammer, R; Fischer, R; Grossmann, M; Leis, HJ; Mazur, D; Schütz, H, 2009
)
0.63
" MPH was administered in a dosage of 1 mg/kg body weight, maximum 60 mg."( Modulation of motorcortical excitability by methylphenidate in adult voluntary test persons performing a go/nogo task.
Buchmann, J; Dueck, A; Gierow, W; Haessler, F; Heinicke, S; Heinrich, H; Hoeppner, J; Klauer, T; Reis, O; Zamorski, H, 2010
)
0.62
" Larger studies with higher doses combined with individual dosage and longer follow-up periods are warranted."( Sustained release methylphenidate for the treatment of ADHD in amphetamine abusers: a pilot study.
Beck, O; Franck, J; Jayaram-Lindström, N; Konstenius, M, 2010
)
0.69
" Dexmethylphenidate XR is a stimulant treatment in a single isomer form, and has an efficacy and tolerability similar to two doses of immediate-release (IR) dexmethylphenidate when taken 4 hours apart, but is dosed at half of the usual d,l-methylphenidate dose."( Attention-deficit hyperactivity disorder: recent advances in paediatric pharmacotherapy.
Kratochvil, CJ; May, DE, 2010
)
0.92
"This study compared the methylphenidate (MPH) dose-response profiles of children with the Predominantly Inattentive (PI) and Combined (CB) subtypes of attention-deficit/hyperactivity disorder (ADHD)."( Stimulant drug response in the predominantly inattentive and combined subtypes of attention-deficit/hyperactivity disorder.
Gilbert, S; Ivanov, I; Lara, R; Newcorn, J; Solanto, M; Vail, L, 2009
)
0.66
") dosage regimens of immediate-release MPH, administered in random order."( Stimulant drug response in the predominantly inattentive and combined subtypes of attention-deficit/hyperactivity disorder.
Gilbert, S; Ivanov, I; Lara, R; Newcorn, J; Solanto, M; Vail, L, 2009
)
0.35
"5 hours after dosing), but not, by and large, immediately after dosing or in the evening."( Measuring methylphenidate response in attention-deficit/hyperactvity disorder: how are laboratory classroom-based measures related to parent ratings?
Coghill, D; DeBacker, M; Sonuga-Barke, EJ; Swanson, J, 2009
)
0.76
" Unfortunately, results of current ADHD pharmacogenetic studies have not been entirely consistent, possibly due to differences in study design, medication dosing regimens and outcome measures."( Progress and promise of attention-deficit hyperactivity disorder pharmacogenetics.
Froehlich, TE; McGough, JJ; Stein, MA, 2010
)
0.36
"Pharmacological treatment for attention deficit hyperactivity disorder, although highly effective, presents a marked variability in clinical response, optimal dosage needed and tolerability."( A current update on ADHD pharmacogenomics.
Genro, JP; Hutz, MH; Kieling, C; Rohde, LA, 2010
)
0.36
"Modified-release products are complex dosage forms designed to release drug in a controlled manner to achieve desired efficacy and safety."( Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: workshop summary report.
Abrahamsson, B; Caro, J; Chen, ML; Conner, D; Davit, B; Fackler, P; Farrell, C; Ganes, D; Gupta, S; Katz, R; Mehta, M; Midha, KK; Nambiar, P; Preskorn, SH; Rocci, ML; Sanderink, G; Shah, VP; Stavchansky, S; Temple, R; Thombre, AG; Wang, Y; Winkle, H; Yu, L, 2010
)
0.36
" Plasma level-dependent effects of psychostimulants can be modelled on an inverted U-shaped dose-response relationship, which is highly relevant to predict cognitive enhancing and detrimental effects of psychostimulants in patients with cognitive deficits (e."( Effects of modafinil and methylphenidate on visual attention capacity: a TVA-based study.
Baumann, F; Bublak, P; Dodds, CM; Finke, K; Manly, T; Müller, U; Regenthal, R, 2010
)
0.66
" In conclusion, the tested dosage appears to be too low for clinical application in canines, and an increase in dosing is suggested."( Pharmacokinetics of methylphenidate following two oral formulations (immediate and sustained release) in the dog.
Giorgi, M; Lavy, E; Neri, D; Prise, U; Soldani, G, 2010
)
0.68
" A total of 34 children with ADHD as defined by DSM-IV-TR were randomized to buspirone or methylphenidate dosed on weight-adjusted basis at buspirone (0."( Buspirone versus methylphenidate in the treatment of attention deficit hyperactivity disorder: a double-blind and randomized trial.
Amini, H; Davari-Ashtiani, R; Mazhabdar, H; Razjouyan, K; Shahrbabaki, ME, 2010
)
0.92
" Future studies should address the issue of the optimal therapeutic window and dosage of medications to identify those patients who would benefit most."( Effect of methylphenidate and/or levodopa coupled with physiotherapy on functional and motor recovery after stroke--a randomized, double-blind, placebo-controlled trial.
Delbari, A; Lokk, J; Salman Roghani, R, 2011
)
0.77
" Attentional performance increased differentially as a function of MPH dose, with some tasks showing linear improvement with higher dosage whereas more complex tasks in particular showed inverse U-shaped patterns of MPH effects."( Sex differences in attentional performance and their modulation by methylphenidate in children with attention-deficit/hyperactivity disorder.
Günther, T; Herpertz-Dahlmann, B; Konrad, K, 2010
)
0.6
"The aim of this study was to evaluate dose-response characteristics in adolescents with attention-deficit/hyperactivity disorder (ADHD) treated with once-daily OROS methylphenidate (OROS MPH) during the 4-week, open-label, escalating dose-titration phase of a larger multisite, placebo-controlled trial."( Dose-response characteristics in adolescents with attention-deficit/hyperactivity disorder treated with OROS methylphenidate in a 4-week, open-label, dose-titration study.
Cooper, KM; Newcorn, JH; Stein, MA, 2010
)
0.77
"MLN8054 dosing for up to 14 days of a 28-day cycle was feasible."( Phase 1 study of MLN8054, a selective inhibitor of Aurora A kinase in patients with advanced solid tumors.
Burris, H; Cohen, RB; Danaee, H; Dees, EC; Ecsedy, J; Eton, O; Fingert, H; Galvin, K; Infante, JR; Jones, S; Lee, Y; Liu, H; Manfredi, M; O'Neil, BH; Stringer, B; von Mehren, M, 2011
)
0.37
"This was a 1-month, multicenter, open-label, randomized study to determine single- and multiple-dose pharmacokinetics of d,l-methylphenidate (MPH) after MPH transdermal system (MTS) and osmotic-release oral system MPH (OROS MPH) dosing in children (6-12 years) and adolescents (13-17 years) who had a diagnosis of attention deficit hyperactivity disorder."( Single- and multiple-dose pharmacokinetics of methylphenidate administered as methylphenidate transdermal system or osmotic-release oral system methylphenidate to children and adolescents with attention deficit hyperactivity disorder.
Buckwalter, M; Katic, A; Pierce, D; Webster, K, 2010
)
0.83
" The mean daily dosage at phase 1 endpoint was 78."( A randomized, 3-phase, 34-week, double-blind, long-term efficacy study of osmotic-release oral system-methylphenidate in adults with attention-deficit/hyperactivity disorder.
Biederman, J; Doyle, R; Hammerness, P; Kotarski, M; Mick, E; Spencer, T; Surman, C, 2010
)
0.58
"25), diagnosed with ADHD and treated with methylphenidate at a minimal dosage of 10 mg per day."( Increased dental trauma in children with attention deficit hyperactivity disorder treated with methylphenidate--a pilot study.
Brinsky-Rapoport, T; Katz-Sagi, H; Matot, I; Ram, D; Redlich, M, 2010
)
0.84
"3%) of 65 children was reduced sufficiently after stimulant dosage adjustment and behavioral therapy to preclude adjunctive medication."( Stimulant-responsive and stimulant-refractory aggressive behavior among children with ADHD.
Blader, JC; Jensen, PS; Kafantaris, V; Pliszka, SR; Schooler, NR, 2010
)
0.36
"MPH and ATM generally produced inverted-U dose-response curves, with improvement occurring at moderate doses, but not at higher doses."( Methylphenidate and atomoxetine enhance prefrontal function through α2-adrenergic and dopamine D1 receptors.
Arnsten, AF; Gamo, NJ; Wang, M, 2010
)
1.8
"To determine the single-dose pharmacokinetics of 60 mg NWP06, a novel extended-release (ER) liquid formulation of methylphenidate (MPH) compared with 30 mg immediate-release (IR) liquid MPH, dosed at Hours 0 and 6, in adults."( The single-dose pharmacokinetics of NWP06, a novel extended-release methylphenidate oral suspension.
Berry, SA; Childress, AC, 2010
)
0.81
"Attainment of a stable dosing regimen was defined as no change in type of drug (including a switch from an immediate release (IR) to a long-acting (LA) formulation), strength, and number of pills per day for five consecutive dispensings."( Treatment stabilization in children and adolescents with attention-deficit/hyperactivity disorder: data from the Netherlands.
Hodgkins, P; Meijer, W; Sasané, R, 2010
)
0.36
" The proposed method was successfully applied to the analysis of rat plasma, where the rats were separately dosed with D2PM and MPH (Ritalin)."( HPLC enantioseparation of α,α-diphenyl-2-pyrrolidinemethanol and methylphenidate using a chiral fluorescent derivatization reagent and its application to the analysis of rat plasma.
Goda, Y; Higashi, T; Hirashima, H; Inagaki, S; Kikura-Hanajiri, R; Min, JZ; Taniguchi, S; Toyo'oka, T, 2010
)
0.6
" The objective of the present study is to investigate the dose-response effects of repeated MPD administration (0."( Age and genetic strain differences in response to chronic methylphenidate administration.
Cuellar, DO; Dafny, N; Swann, AC; Yang, PB, 2011
)
0.61
" Compared with WKY and WIS rats, SHRs with previous methylphenidate treatment acquired cocaine self-administration faster, identified cocaine as a highly efficacious reinforcer by displaying an upward shift in the cocaine dose-response function, and showed the greatest motivation to self-administer cocaine by exhibiting the highest progressive ratio breakpoints."( Methylphenidate treatment in adolescent rats with an attention deficit/hyperactivity disorder phenotype: cocaine addiction vulnerability and dopamine transporter function.
Deaciuc, A; Dwoskin, LP; Harvey, RC; Kantak, KM; Sen, S, 2011
)
2.06
"5 mg/kg), and dose-response tests established appropriate reductions in discrimination with declining dose."( The discriminative stimulus properties of methylphenidate in C57BL/6J mice.
Griffin, WC; McGovern, RW; Middaugh, LD; Patrick, KS, 2011
)
0.63
" Dosing began at 36 mg/d, with titration in 18-mg increments every 7 days until a predefined outcome (efficacy threshold, maximum dosage of 108 mg/d, or limiting adverse event)."( Long-term safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: an open-label, dose-titration, 1-year study.
Adler, LA; Berwaerts, J; Cooper, K; Harrison, DD; Orman, C; Palumbo, J; Silber, S; Starr, HL, 2011
)
0.67
"OROS methylphenidate, in the flexible dosage range from 36 to 108 mg/d, was well tolerated for up to 1 year in adults with ADHD."( Long-term safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: an open-label, dose-titration, 1-year study.
Adler, LA; Berwaerts, J; Cooper, K; Harrison, DD; Orman, C; Palumbo, J; Silber, S; Starr, HL, 2011
)
1.19
" Specifically, we asked: (1) will ethanol increase d-MPH biological concentrations, (2) will MTS facilitate the systemic bioavailability of l-MPH, and (3) will l-MPH enantioselectively interact with ethanol to yield l-ethylphenidate (l-EPH)? Mice were dosed with MTS (¼ of a 12."( Transdermal and oral dl-methylphenidate-ethanol interactions in C57BL/6J mice: transesterification to ethylphenidate and elevation of d-methylphenidate concentrations.
Bell, GH; Griffin, WC; Novak, AJ; Patrick, KS, 2011
)
0.68
" After determining individualized OROS MPH dosing (18-54 mg/day), 71 subjects received blinded treatment (OROS MPH or placebo then vice versa) on each of 2 laboratory school days, separated by 1 week."( Academic, behavioral, and cognitive effects of OROS® methylphenidate on older children with attention-deficit/hyperactivity disorder.
Armstrong, RB; Brams, M; Schuck, S; Starr, HL; Wigal, SB; Wigal, T; Williamson, D, 2011
)
0.62
"OROS MPH dosed to reduce core symptoms of ADHD to within the normal range also improved performance on a variety of academic tasks in school-aged children compared to placebo."( Academic, behavioral, and cognitive effects of OROS® methylphenidate on older children with attention-deficit/hyperactivity disorder.
Armstrong, RB; Brams, M; Schuck, S; Starr, HL; Wigal, SB; Wigal, T; Williamson, D, 2011
)
0.62
" During the treatment period the investigators titrated the OROS-MPH dosage on the basis of symptom severity and side effects."( Norepinephrine transporter -3081(A/T) and alpha-2A-adrenergic receptor MspI polymorphisms are associated with cardiovascular side effects of OROS-methylphenidate treatment.
Bellgrove, MA; Cho, SC; Cummins, TD; Kim, BN; Kim, JW, 2012
)
0.58
"To examine the pharmacokinetics (PKs) and pharmacodynamics (PDs) of OROS methylphenidate (OROS MPH) dosed once daily (QD) versus an early standard regimen (immediate-release [IR] MPH dosed three times daily [TID]) under various breakfast conditions."( Pharmacokinetics and therapeutic effect of OROS methylphenidate under different breakfast conditions in children with attention-deficit/hyperactivity disorder.
Gupta, S; Heverin, E; Starr, HL; Wigal, SB, 2011
)
0.86
" Patients were assigned to 1 of 3 dosage levels (OROS MPH 18, 36, and 54 mg QD, and an assumed equivalent regimen of IR MPH 5, 10, and 15 mg given TID) based on their prestudy established clinical dose of IR MPH."( Pharmacokinetics and therapeutic effect of OROS methylphenidate under different breakfast conditions in children with attention-deficit/hyperactivity disorder.
Gupta, S; Heverin, E; Starr, HL; Wigal, SB, 2011
)
0.62
" Future studies are needed which determine the optimal therapeutic window for and dosage of psychostimulants as well as identify those stroke patients who might benefit the most from treatment."( Effect of methylphenidate and/or levodopa combined with physiotherapy on mood and cognition after stroke: a randomized, double-blind, placebo-controlled trial.
Delbari, A; Lokk, J; Salman-Roghani, R, 2011
)
0.77
" Recently a transdermal delivery system has been developed which can allow symptom control all day long but with greater dosing flexibility."( Methylphenidate delivery mechanisms for the treatment of children with attention deficit hyperactivity disorder: heterogeneity in parent preferences.
Dewilde, S; Falconer, S; Hodgkins, P; Lloyd, A; Sasané, R; Sonuga Barke, E, 2011
)
1.81
" At each daily visit, signs and symptoms were assessed, and medications and dosing instructions were given for the following 24 hours."( A nonopioid procedure for outpatient opioid detoxification.
Baier, AR; Coons, EE; Fingesten, A; Ockert, DM; Volpicelli, JR, 2011
)
0.37
" Further, exploratory analyses on teacher and parent ratings on attention-deficit/hyperactivity disorder and on externalizing symptoms during the day revealed no evidence for the superiority of Concerta over Medikinet retard in an equivalent daily dosage throughout the day."( Comparison of the efficacy of two different modified release methylphenidate preparations for children and adolescents with attention-deficit/hyperactivity disorder in a natural setting: comparison of the efficacy of Medikinet(®) retard and Concerta(®)--a
Ammer, R; Döpfner, M; Fischer, R; Ose, C; Scherag, A, 2011
)
0.61
" The open field assay was used to assess the dose-response of acute and chronic MPD administration."( Sex differences in the behavioral response to methylphenidate in three adolescent rat strains (WKY, SHR, SD).
Chelaru, MI; Dafny, N; Yang, PB, 2012
)
0.64
" Limited observations suggest a potentially different dose-sensitivity of prefrontal cortex (PFC)-dependent function (narrow inverted-U-shaped dose-response curves) versus classroom/overt behavior (broad inverted U) in children with ADHD."( Differential sensitivity to psychostimulants across prefrontal cognitive tasks: differential involvement of noradrenergic α₁ - and α₂-receptors.
Andrzejewski, ME; Berridge, CW; Devilbiss, DM; McGaughy, JA; Shumsky, JS; Spencer, RC; Waterhouse, BD, 2012
)
0.38
" Choice of therapy is increasingly influenced by treatment satisfaction and patient preference, with once-daily modified-release methylphenidate (MPH-MR) formulations offering clear benefits compared with immediate-release (IR) dosage forms."( An observational study of once-daily modified-release methylphenidate in ADHD: quality of life, satisfaction with treatment and adherence.
Becker, A; Breuer, D; Döpfner, M; Rothenberger, A, 2011
)
0.82
"Locomotor activity of C57BL/6J mice was recorded for 3 h following dosing with either oral DL-methylphenidate (7."( Oral and transdermal DL-methylphenidate-ethanol interactions in C57BL/6J mice: potentiation of locomotor activity with oral delivery.
Bell, GH; Griffin, WC; Patrick, KS, 2011
)
0.9
" A dose-response study was performed to test for methylphenidate-induced restoration of righting during continuous isoflurane general anesthesia."( Methylphenidate actively induces emergence from general anesthesia.
Brown, EN; Chemali, JJ; Cimenser, A; Cotten, JF; Solt, K; Wong, KF, 2011
)
2.07
" Patients were followed for 1 year for dosage change, switch (change to non-MPH treatment), augmentation, persistence (number days on index medication) and adherence (days supplied/days persistent)."( Treatment outcomes with methylphenidate formulations among patients with ADHD: retrospective claims analysis of a managed care population.
Christensen, L; Harley, C; Hodgkins, P; Liu, F; Sasané, R, 2011
)
0.68
"4% had a dosing change, 14% switched to a non-MPH agent, and 4% augmented MPH therapy."( Treatment outcomes with methylphenidate formulations among patients with ADHD: retrospective claims analysis of a managed care population.
Christensen, L; Harley, C; Hodgkins, P; Liu, F; Sasané, R, 2011
)
0.68
" Parents and teachers assessed each child's response on placebo and three MPH dosage levels using the Vanderbilt ADHD rating scales."( Pharmacogenetic predictors of methylphenidate dose-response in attention-deficit/hyperactivity disorder.
Brinkman, WB; Epstein, JN; Froehlich, TE; Graham, AJ; Kahn, RS; Langberg, JM; Melguizo Castro, MS; Nick, TG; Stein, MA, 2011
)
0.66
"5 hr before dosing and 1, 2, 4, 10, 11, and 12."( Time course of treatment effect of OROS® methylphenidate in children with ADHD.
Armstrong, RB; Ascher, S; Damaraju, CV; O'Neill, J; Schwarzman, L; Starr, HL, 2012
)
0.64
"OROS-MPH treatment at the adequate dosage can achieve higher remission and recovery rates, produce greater functional improvement, and result in better treatment adherence than IR-MPH treatment."( Naturalistic exploration of the effect of osmotic release oral system-methylphenidate on remission rate and functional improvement in Taiwanese children with attention-deficit-hyperactivity disorder.
Chang, HL; Cheng, H; Hsu, CD; Hsu, YC; Huang, CF; Huang, YF; Huang, YH; Huang, YS; Liang, HY; Liu, HC; Liu, HJ; Liu, SI; Pan, CH; Tzang, RF; Wang, YC; Wu, YY; Yang, PC; Yeh, CB, 2012
)
0.61
" However, repeat dosing has not been examined."( Importance of pharmacokinetic profile and timing of coadministration of short- and long-acting formulations of methylphenidate on patterns of subjective responses and abuse potential.
Batchelder, H; Biederman, J; Clarke, A; Faraone, SV; Martin, JM; Mirto, T; Moorehead, TM; Spencer, TJ, 2012
)
0.59
" Such knowledge provides important information for clinicians about the safety and tolerability of the timing of repeat dosing of various permutations of coadministration of MPH formulations."( Importance of pharmacokinetic profile and timing of coadministration of short- and long-acting formulations of methylphenidate on patterns of subjective responses and abuse potential.
Batchelder, H; Biederman, J; Clarke, A; Faraone, SV; Martin, JM; Mirto, T; Moorehead, TM; Spencer, TJ, 2012
)
0.59
" Dosage was inversely associated with risk."( Methylphenidate and risk of serious cardiovascular events in adults.
Bilker, WB; Cziraky, MJ; Daniel, GW; Guevara, JP; Hennessy, S; Kimmel, SE; Newcomb, C; Schelleman, H; Strom, BL, 2012
)
1.82
"8-fold increase in risk of sudden death or ventricular arrhythmia, the lack of a dose-response relationship suggests that this association may not be a causal one."( Methylphenidate and risk of serious cardiovascular events in adults.
Bilker, WB; Cziraky, MJ; Daniel, GW; Guevara, JP; Hennessy, S; Kimmel, SE; Newcomb, C; Schelleman, H; Strom, BL, 2012
)
1.82
" This dosage of MPH also induced a significant increase in the number of activated microglia in the SNpc."( Methylphenidate exposure induces dopamine neuron loss and activation of microglia in the basal ganglia of mice.
Jiao, Y; Pani, AK; Pond, BB; Qu, C; Sadasivan, S; Smeyne, RJ, 2012
)
1.82
" We have not found examples of ADHD in children who use increased dosage of sustained release of methylphenidate leading to depressive symptomatology."( Depressive symptoms as a side effect of the sustained release form of methylphenidate in a 7-year-old boy with attention-deficit hyperactivity disorder.
Lakić, A, 2012
)
0.83
" The two lower dosages showed a good tolerability profile, but the higher dosage of bavisant was less well tolerated, as evidenced by the incidence of total TEAEs (61."( Randomized clinical study of a histamine H3 receptor antagonist for the treatment of adults with attention-deficit hyperactivity disorder.
Cooper, K; Daly, EJ; Gassmann-Mayer, C; Pandina, GJ; Weisler, RH, 2012
)
0.38
" Clinicians should carefully follow patients' improvements and titrate the MPH dosage during long-term treatment."( No beneficial effects of adding parent training to methylphenidate treatment for ADHD + ODD/CD children: a 1-year prospective follow-up study.
Ardic, UA; Durak, S; Ercan, ES; Kutlu, A, 2014
)
0.65
"The purpose of this study was to identify the optimal dose of osmotic release oral system methylphenidate (OROS-MPH) using a dosage forced-titration scheme to achieve symptomatic remission in children with attention- deficit/hyperactivity disorder (ADHD)."( Remission in children and adolescents diagnosed with attention-deficit/hyperactivity disorder via an effective and tolerable titration scheme for osmotic release oral system methylphenidate.
Chan, CH; Chang, HL; Chen, SJ; Chen, YS; Chou, MC; Chou, WJ; Hou, PH; Hsu, JW; Huang, CF; Huang, YF; Huang, YS; Hwang, KL; Liang, HY; Lin, CC; Lin, DY; Liu, HJ; Pan, CH; Tang, CS; Wu, YY; Yeh, CB, 2012
)
0.79
" Determinants for remission included less severe ADHD symptoms (SNAP-IV score < 40), no family history of ADHD, and an appropriate dosage of medication according to the patient's weight."( Remission in children and adolescents diagnosed with attention-deficit/hyperactivity disorder via an effective and tolerable titration scheme for osmotic release oral system methylphenidate.
Chan, CH; Chang, HL; Chen, SJ; Chen, YS; Chou, MC; Chou, WJ; Hou, PH; Hsu, JW; Huang, CF; Huang, YF; Huang, YS; Hwang, KL; Liang, HY; Lin, CC; Lin, DY; Liu, HJ; Pan, CH; Tang, CS; Wu, YY; Yeh, CB, 2012
)
0.57
"The findings suggest remission as a treatment goal for ADHD therapy by providing an optimal dosage of medication for children and adolescents with ADHD through using an effective and tolerable forced-titration scheme."( Remission in children and adolescents diagnosed with attention-deficit/hyperactivity disorder via an effective and tolerable titration scheme for osmotic release oral system methylphenidate.
Chan, CH; Chang, HL; Chen, SJ; Chen, YS; Chou, MC; Chou, WJ; Hou, PH; Hsu, JW; Huang, CF; Huang, YF; Huang, YS; Hwang, KL; Liang, HY; Lin, CC; Lin, DY; Liu, HJ; Pan, CH; Tang, CS; Wu, YY; Yeh, CB, 2012
)
0.57
" We report a case of a prepubertal child who developed unwanted erections after commencing a response-adjusted dosing regimen of sustained release methylphenidate."( Methylphenidate-induced erections in a prepubertal child.
Brady, CM; Kelly, BD; Lundon, DJ; McGuinness, D, 2013
)
2.03
" Previous research has suggested stimulants are less effective than in typically developing children but no studies have titrated medication for individual optimal dosing or tested the effects for longer than 4 weeks."( Randomized controlled double-blind trial of optimal dose methylphenidate in children and adolescents with severe attention deficit hyperactivity disorder and intellectual disability.
Baird, G; Bernard, S; Chadwick, O; Golaszewski, A; Jichi, F; Kelly, J; Kennedy, J; Liang, H; Riemer, K; Rodney, L; Sharma, K; Sharma, SP; Simonoff, E; Taylor, E; Walwyn, R; West, N; Whitwell, S; Wood, N, 2013
)
0.64
"Optimal dosing of methylphenidate is practical and effective in some children with hyperkinetic disorder and intellectual disability."( Randomized controlled double-blind trial of optimal dose methylphenidate in children and adolescents with severe attention deficit hyperactivity disorder and intellectual disability.
Baird, G; Bernard, S; Chadwick, O; Golaszewski, A; Jichi, F; Kelly, J; Kennedy, J; Liang, H; Riemer, K; Rodney, L; Sharma, K; Sharma, SP; Simonoff, E; Taylor, E; Walwyn, R; West, N; Whitwell, S; Wood, N, 2013
)
0.97
" In seeking to optimize individual response and outcomes to stimulant therapy, important considerations include the selection of stimulant class, the choice of long- or short-acting stimulant formulations, addressing effectively any emergent adverse effects and strategies aimed at enhancing adherence to dosing regimen and persistence on therapy."( Amfetamine and methylphenidate medications for attention-deficit/hyperactivity disorder: complementary treatment options.
Coghill, D; Hechtman, L; Hodgkins, P; Shaw, M, 2012
)
0.73
" The LC-MS/MS assay was validated for entomotoxicological use and initially applied to male Sprague-Dawley rats (n=6) that were dosed with MPH (20mg/kg) ante-mortem."( Determination of methylphenidate in Calliphorid larvae by liquid-liquid extraction and liquid chromatography mass spectrometry--forensic entomotoxicology using an in vivo rat brain model.
Bushby, SK; Coulter, CV; Kieser, JA; Priemel, PA; Rades, T; Thomas, N, 2012
)
0.72
" This review provides an overview of current understanding of MPH efficacy, safety, and dosage in adult and pediatric ADHD patients, as well as adult animal studies and pioneering studies in juvenile animals treated with MPH."( Evolution of the Study of Methylphenidate and Its Actions on the Adult Versus Juvenile Brain.
Gao, WJ; Urban, KR, 2015
)
0.72
" The CEPAC members and clinical experts recommended the increased use of parent behavior training as first-line therapy for preschoolers and emphasized the importance of proper monitoring of and dosing for all children who receive medication for their ADHD symptoms."( Management strategies for attention-deficit/hyperactivity disorder: a regional deliberation on the evidence.
Colby, JA; Emond, SK; Ollendorf, DA; Pearson, SD; Reed, SJ, 2012
)
0.38
" Furthermore, since a single dosage resulted in significant changes in NMDA receptors, off-label usage by healthy individuals, especially children and adolescents, may result in altered potential for plastic learning."( Treatment with a clinically-relevant dose of methylphenidate alters NMDA receptor composition and synaptic plasticity in the juvenile rat prefrontal cortex.
Gao, WJ; Li, YC; Urban, KR, 2013
)
0.65
" Additional studies are needed to further investigate these findings and examine short-versus long-acting stimulant medications and dosage effects."( Caregiver survey of pharmacotherapy to treat attention deficit/hyperactivity disorder in individuals with Williams syndrome.
Andridge, RR; Coury, DL; Foster, JE; Martens, MA; McClure, KE; Seyfer, DL, 2013
)
0.39
" The doses identified as best doses from two nicotine dose-response curve determinations were unrelated, and the improvement associated with the best dose observed during the first dose-response curve determination was not reliable when the dose was administered repeatedly."( A critical examination of best dose analysis for determining cognitive-enhancing potential of drugs: studies with rhesus monkeys and computer simulations.
Ator, NA; Dallery, J; Katz, BR; Soto, PL, 2013
)
0.39
") dose-response curves were determined, self-administration sessions were suspended and MPD (0."( Effects of chronic methylphenidate on cocaine self-administration under a progressive-ratio schedule of reinforcement in rhesus monkeys.
Czoty, PW; Gould, RW; Martelle, SE; Nader, MA, 2013
)
0.72
"In the author's opinion, Concerta, Equasym XL/Metadate CD, Medikinet Retard and Ritalin LA offer the convenience of once-daily administration with absorption characteristics resembling two or three times daily dosing with IR MPH preparations."( Comparison of the pharmacokinetics and clinical efficacy of new extended-release formulations of methylphenidate.
Maldonado, R, 2013
)
0.61
"To psychometrically assess cognitive domains in adolescents with ADHD during long-term open treatment with robust dosing of extended-release methylphenidate (OROS MPH)."( Assessment of cognitive domains during treatment with OROS methylphenidate in adolescents with ADHD.
Biederman, J; Fried, R; Hammerness, P; Meller, B; Petty, C, 2014
)
0.85
" The former, on sale without prescription, presents a varied symptomatology, dosage and dependent metabolic action, ranging from euphoria to hallucinations."( [Emergent drugs (II): the Pharming phenomenon].
Aldea-Perona, A; Burillo-Putze, G; Climent, B; Dueñas, A; García-Sáiz, MM; Hoffman, RS; Munné, P; Nogué, S; Rodríguez-Jiménez, C,
)
0.13
" To evaluate the efficacy of LDX throughout the day, symptoms and behaviors of ADHD were evaluated using an abbreviated version of the Conners' Parent Rating Scale-Revised (CPRS-R) at 1000, 1400 and 1800 hours following early morning dosing (0700 hours)."( Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial.
Banaschewski, T; Bloomfield, R; Civil, R; Coghill, DR; Dittmann, RW; Lecendreux, M; Otero, IH; Squires, LA; Zuddas, A, 2014
)
0.4
" ADHD and associated psychiatric symptoms, medication status and dosage frequency, treatment adherence and adverse events were assessed at baseline and after a median treatment length with Medikinet(®) retard of 70 days."( A non-interventional study of extended-release methylphenidate in the routine treatment of adolescents with ADHD: effectiveness, safety and adherence to treatment.
Döpfner, M; Fischer, R; Ose, C; Sobanski, E, 2013
)
0.65
"Clinical pharmacology as an interdisciplinary science is unique in its capacity and the diversity of the methods and approaches it can provide to derive dosing recommendations in various subpopulations."( An integrated clinical pharmacology approach for deriving dosing recommendations in a regulatory setting: review of recent cases in psychiatry drugs.
Mehta, MU; Rogers, H; Uppoor, RS; Younis, IR; Zhang, H; Zhu, H, 2013
)
0.39
" The objective of this study was to investigate the repetitive dose-response effects of MPD on circadian rhythm of locomotor activity pattern of female WKY rats."( Adult female rats' altered diurnal locomotor activity pattern following chronic methylphenidate treatment.
Burau, KD; Dafny, N; Kohllepel, SR; Trinh, TN; Yang, PB, 2013
)
0.62
" Because of its short duration of effect, MPH-IR had to be dosed multiple times daily."( The use of methylphenidate hydrochloride extended-release oral suspension for the treatment of ADHD.
Childress, A; Sallee, FR, 2013
)
0.78
" Owing to the short half-life and the issues associated with multiple daily dosing of immediate-release MPH formulations, a new generation of long-acting MPH formulations has emerged."( Long-acting methylphenidate formulations in the treatment of attention-deficit/hyperactivity disorder: a systematic review of head-to-head studies.
Banaschewski, T; Coghill, D; Doepfner, M; Gagliano, A; Pelaz, A; Zuddas, A, 2013
)
0.77
" Recent studies have suggested that early life exposure of healthy rodent models to methylphenidate resulted in altered sleep/wake cycle, heightened stress reactivity, and, in fact, a dosage previously thought of as therapeutic depressed neuronal function in juvenile rats."( Methylphenidate and the juvenile brain: enhancement of attention at the expense of cortical plasticity?
Gao, WJ; Urban, KR, 2013
)
2.06
"At baseline and at weeks 4 and 8, the parents evaluated their children, who were receiving treatment with osmotic-release oral system methylphenidate (mean dosage 36."( Parental quality of life and depressive mood following methylphenidate treatment of children with attention-deficit hyperactivity disorder.
Chang, JS; Cho, SC; Hwang, JW; Kim, B; Kim, BN; Kim, Y, 2014
)
0.85
" To evaluate whether the dose-response relationship follows an inverted-U-shaped curve, MPH effects on cognition are also quantified for low, medium and high doses, respectively."( Cognitive effects of methylphenidate in healthy volunteers: a review of single dose studies.
Linssen, AM; Riedel, WJ; Sambeth, A; Vuurman, EF, 2014
)
0.72
" Whereas there was a linear dose-response curve for medication in NBM, the dose-response curves flattened considerably in LBM and HBM."( A dose-ranging study of behavioral and pharmacological treatment in social settings for children with ADHD.
Burrows-MacLean, L; Chacko, A; Coles, EK; Fabiano, GA; Garefino, A; Gnagy, EM; Hoffman, MT; Pelham, WE; Walker, KS; Waschbusch, DA; Waxmonsky, JG; Wymbs, BT; Wymbs, F, 2014
)
0.4
"5, 5 or 10mg/kg for its physical dependence potential in a repeated dose non-precipitated withdrawal test, for its drug profiling in a drug discrimination learning procedure (single escalating doses), and for its reinforcing properties in a conditioned place preference test (alternate dosing days) and an intravenous self-administration procedure (0."( Abuse liability assessment in preclinical drug development: predictivity of a translational approach for abuse liability testing using methylphenidate in four standardized preclinical study models.
Geuens, SM; Geys, HM; Meert, TF; Stinissen, P; Teuns, GB,
)
0.33
"Cessation of subchronic dosing up to 10mg/kg methylphenidate led to sustained or even exacerbated effects on locomotion and behavior, body temperature, body weight, food consumption, and alteration of the diurnal rhythm during withdrawal."( Abuse liability assessment in preclinical drug development: predictivity of a translational approach for abuse liability testing using methylphenidate in four standardized preclinical study models.
Geuens, SM; Geys, HM; Meert, TF; Stinissen, P; Teuns, GB,
)
0.59
"These findings may help clinicians assess factors upon initiation of ADHD treatment to improve course prediction, proper dosing and treatment adherence and persistence."( Predictors of pharmacological treatment outcomes with atomoxetine or methylphenidate in patients with attention-deficit/hyperactivity disorder from China, Egypt, Lebanon, Russian Federation, Taiwan, and United Arab Emirates.
Altin, M; Desaiah, D; El-Shafei, A; Faries, D; Feng, Q; Gado, M; Serebryakova, E; Treuer, T; Wu, S, 2014
)
0.64
" After changing the dosage of methylphenidate and additionally using dog appeasing pheromone, the behavior of the bitch became normal after 8 days."( [Methylphenidate use in dogs with attention deficit hyperactivity disorder (ADHD). A case report of a Weimaraner bitch].
Piturru, P, 2014
)
1.6
" Specifically, while methylphenidate at this dosage enhances connectivity to the motor cortex and memory circuits, it dampens prefrontal cortical connectivity perhaps by increasing catecholaminergic signalling past the 'optimal' level."( The effects of methylphenidate on resting-state striatal, thalamic and global functional connectivity in healthy adults.
Abdelghany, O; Farr, OM; Hu, S; Li, CS; Malison, RT; Matuskey, D; Zhang, S, 2014
)
1.07
" Considerable clinical expertise is required to identify an individually well-adapted dosage which will produce the optimal clinical effects with potential side effects minimized."( An evaluation of the pharmacokinetics of methylphenidate for the treatment of attention-deficit/ hyperactivity disorder.
Banaschewski, T; Döpfner, M; Frölich, J; Görtz-Dorten, A, 2014
)
0.67
" Comparing the acute MPD effect to the repetitive MPD effect revealed that the acute response to MPD exhibited dose-response characteristics: an increase in behavioral activity correlated with increasing MPD doses."( Behavioral and neuronal recording of the nucleus accumbens in adolescent rats following acute and repetitive exposure to methylphenidate.
Dafny, N; Frolov, A; Reyes-Vasquez, C, 2015
)
0.62
" In the present study, we used a regimen of MPH (8 mg/kg daily×14 days) in C57BL/6J mice to determine whether establishing locomotor sensitization to MPH influenced the acquisition and the dose-response function of MPH in a classic drug discrimination procedure."( Influence of sensitization on the discriminative stimulus effects of methylphenidate in mice.
Griffin, WC; Knecht, K; Luderman, L; McGovern, R, 2014
)
0.64
" Patterns of medication selection and dosing were compared with CMAP guidelines."( Treatment receipt and outcomes from a clinic employing the attention-deficit/hyperactivity disorder treatment guideline of the children's medication algorithm project.
McLennan, JD; Vallerand, IA; Wagner, DJ, 2014
)
0.4
" Eligibility and dosing were determined by the physician based on the drug label."( Effectiveness and safety of a long-acting, once-daily, two-phase release formulation of methylphenidate (Ritalin ® LA) in school children under daily practice conditions.
Bilke-Hentsch, O; Haertling, F; Mueller, B, 2015
)
0.64
" The ideal dosing regimen of methylphenidate is debatable with daily use being considered harmful by many."( Drug holiday utilisation in ADHD-diagnosed children and adolescents in South Africa.
McCartney, J; Regnart, J; Truter, I, 2014
)
0.69
"The purpose of this study was to evaluate the relative bioavailability and safety of a multilayer extended-release bead methylphenidate (MPH) hydrochloride 80 mg (MPH-MLR) capsule or sprinkles (37% immediate-release [IR]) versus MPH hydrochloride IR(Ritalin(®)) tablets, and to develop a pharmacokinetic (PK) model simulating MPH concentration-time data for different MPH-MLR dosage strengths."( Single-dose pharmacokinetics of methylphenidate extended-release multiple layer beads administered as intact capsule or sprinkles versus methylphenidate immediate-release tablets (Ritalin(®)) in healthy adult volunteers.
Adjei, A; Chang, WW; Connor, DF; Greenhill, L; Kupper, RJ; Newcorn, JH; Teuscher, NS; Wigal, S, 2014
)
0.89
" The PK modeling in adults suggested that differences in MPH pharmacokinetics between MPH-MLR and Ritalin are the result of dosage form design attributes and the associated absorption profiles of MPH."( Single-dose pharmacokinetics of methylphenidate extended-release multiple layer beads administered as intact capsule or sprinkles versus methylphenidate immediate-release tablets (Ritalin(®)) in healthy adult volunteers.
Adjei, A; Chang, WW; Connor, DF; Greenhill, L; Kupper, RJ; Newcorn, JH; Teuscher, NS; Wigal, S, 2014
)
0.69
" A dose-response study was performed to monitor caloric intake, liquid intake and growth rate in rats following repeated administration of human oral therapeutic doses 2 mg/kg/day, 5mg/kg/day and 8mg/kg/day of methylphenidate."( Effect of repeated oral therapeutic doses of methylphenidate on food intake and growth rate in rats.
Alam, N; Najam, R, 2015
)
0.86
" The acquisition of cocaine self-administration was faster, and cocaine dose-response functions were shifted upward under fixed-ratio and progressive ratio schedules compared to adult SHR that received adolescent vehicle treatment or to control strains that received adolescent methylphenidate treatment."( Methylphenidate treatment beyond adolescence maintains increased cocaine self-administration in the spontaneously hypertensive rat model of attention deficit/hyperactivity disorder.
Baskin, BM; Dwoskin, LP; Kantak, KM, 2015
)
2.04
"The age, sex, leading diagnosis, prescribed medication, and dosage of each patient were recorded anonymously twice a year."( [Hyperkinetic disorders in childhood and adolescence- an analysis of KinderAGATE 2009-2012].
Haen, E; Rexroth, CA; Stegmann, B; Wenzel-Seifert, K, 2015
)
0.42
" Knowledge of the relationship between dose, body weight, and clinical response following the administration of MPH-MLR in children and adolescents may be useful for clinicians selecting initial dosing of MPH-MLR."( Population pharmacokinetics of methylphenidate hydrochloride extended-release multiple-layer beads in pediatric subjects with attention deficit hyperactivity disorder.
Adjei, A; Findling, RL; Greenhill, LL; Kupper, RJ; Teuscher, NS; Wigal, S, 2015
)
0.7
"For psychostimulants, a marked individual variability in the dose-response relationship and large differences in plasma concentrations after similar doses are known."( Quantification of Methylphenidate, Dexamphetamine, and Atomoxetine in Human Serum and Oral Fluid by HPLC With Fluorescence Detection.
Dörfelt, A; Haen, E; Stegmann, B, 2016
)
0.77
" The entire sample (N = 14) demonstrated a reduction in the mean score on the Inattention Scale from clinically significant (T-score > 65) to not clinically significant (T-score < 65) when patients were changed from non-OROS to OROS at the same dosage (mean T-score reduction = 23, p < ."( Not All Generic Concerta Is Created Equal: Comparison of OROS Versus Non-OROS for the Treatment of ADHD.
Boan, AD; Kral, MC; Lally, MD, 2016
)
0.43
" The AUC0-3 h difference reported here points to the potential limitations of using bioequivalence for sound predictions of dose-response relationships."( Absorption Differences between Immediate-Release Dexmethylphenidate and dl-Methylphenidate.
Patrick, KS; Straughn, AB, 2016
)
0.68
" Recent products offer convenience in terms of dosing and timing of drug administration to improve symptom control, but efficacy is similar among all MPH-ER products."( Methylphenidate HCL for the treatment of ADHD in children and adolescents.
Childress, AC, 2016
)
1.88
" Methylphenidate extended-release orally disintegrating tablets (MPH XR-ODTs) combine two technologies in a single-tablet formulation-an extended-release profile that was designed for once-daily dosing in an ODT that does not require water or chewing for ingestion."( A Single-Dose, Single-Period Pharmacokinetic Assessment of an Extended-Release Orally Disintegrating Tablet of Methylphenidate in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder.
Childress, A; McMahen, R; Newcorn, J; Sikes, C; Stark, JG; Tengler, M, 2016
)
1.56
" To minimize the acute effects of MPH on FDG uptake, microPET/CT scans were scheduled on Mondays before their first daily dosing of the week (approximately 68h since their last treatment)."( MicroPET/CT assessment of FDG uptake in brain after long-term methylphenidate treatment in nonhuman primates.
Apana, SM; Berridge, MS; Callicott, R; Liu, S; Newport, GD; Paule, MG; Slikker, W; Thompson, J; Wang, C; Zhang, X,
)
0.37
" This dose-response pattern is commonly observed with psychostimulant cognitive modulation."( Methylphenidate has nonlinear dose effects on cued response inhibition in adults but not adolescents.
Moghaddam, B; Simon, NW, 2017
)
1.9
" A marked individual variability in the dose-response has been observed, and therefore dosage must be titrated for optimal therapeutic effect with minimal toxicity."( Metabolomics of Methylphenidate and Ethylphenidate: Implications in Pharmacological and Toxicological Effects.
Dinis-Oliveira, RJ, 2017
)
0.8
" For patients with pre-existing tic disorders, the usual recommended dosing of stimulants should be used because supratherapeutic doses of this class of medications, specifically dextroamphetamine, have shown to exacerbate tic disorders."( Attention Deficit Hyperactive Disorder and Occurrence of Tic Disorders in Children and Adolescents-What is the Verdict.
Cooke, T; So, TY, 2016
)
0.43
"To evaluate the efficacy and safety of individualized dosing within the approved dose range for osmotic-release oral system (OROS) methylphenidate hydrochloride in adults with attention-deficit/hyperactivity disorder (ADHD)."( Randomized, 6-Week, Placebo-Controlled Study of Treatment for Adult Attention-Deficit/Hyperactivity Disorder: Individualized Dosing of Osmotic-Release Oral System (OROS) Methylphenidate With a Goal of Symptom Remission.
Armstrong, RB; Ascher, S; Goodman, DW; Ma, YW; Rostain, AL; Starr, HL, 2017
)
0.85
" The model provides a quantitative tool to predict the biphasic plasma time course data for ER MPH, helping elucidate factors responsible for the diverse plasma MPH concentration profiles following oral dosing of different ER formulations."( Application of Physiologically Based Absorption Modeling to Characterize the Pharmacokinetic Profiles of Oral Extended Release Methylphenidate Products in Adults.
Duan, J; Fisher, J; Yang, X, 2016
)
0.64
" The goal of this study is to investigate the effects of acute and chronic dose-response characteristics following MPD exposure on both the PFC neuronal population and behavioral activity in freely behaving animals implanted previously with permanent electrodes within the PFC."( Concomitant behavioral and PFC neuronal activity recorded following dose-response protocol of MPD in adult male rats.
Claussen, C; Dafny, N; Joseph, M; Venkataraman, SS, 2017
)
0.46
" Given that immediate-release and/or tablet/capsule formulations may decrease adherence to methylphenidate treatment, several drug companies have been developing novel long-acting and/or liquid/chewable formulations that may improve adherence as well as (for long-acting formulations) reduce abuse potential, decrease stigma associated with multiple administrations per day, and decrease the potential for adverse effects related to dosage peak."( New Formulations of Methylphenidate for the Treatment of Attention-Deficit/Hyperactivity Disorder: Pharmacokinetics, Efficacy, and Tolerability.
Cortese, S; D'Acunto, G; Konofal, E; Masi, G; Vitiello, B, 2017
)
1
"In this article, accounting for day-to-day children's activities and using up-to-date pharmacokinetic knowledge of methylphenidate, we propose a computational approach for the identification of the most suitable dosing regimens of immediate-release formulations of methylphenidate based on constraints on drug concentration and time frame of activities, defined through therapeutic boxes."( An Evaluation Approach for the Performance of Dosing Regimens in Attention-Deficit/Hyperactivity Disorder Treatment.
Barrière, O; Bonnefois, G; Li, J; Nekka, F; Robaey, P, 2017
)
0.67
"A web-based interface that can serve as an educational tool for clinicians and patients has been developed based on the proposed approach for the evaluation of dosing regimens."( An Evaluation Approach for the Performance of Dosing Regimens in Attention-Deficit/Hyperactivity Disorder Treatment.
Barrière, O; Bonnefois, G; Li, J; Nekka, F; Robaey, P, 2017
)
0.46
" After 3 months 2/8 (25%, CI 95%: 8-65%) showed improvements, remaining 75% has been increased dosage of methylphenidate."( Attention-deficit/hyperactivity disorder and enuresis: a study about effectiveness of treatment with methylphenidate or desmopressin in a pediatric population.
Ferrara, P; Ianniello, F; Mariotti, P; Petitti, T; Quattrocchi, E; Sannicandro, V; Sbordone, A, 2019
)
0.94
" The anorexigenic effect of methylphenidate has been demonstrated in preclinical studies although the dosage and the administration routes differ in animals from those used for human beings."( [The effect of methylphenidate on appetite and weight].
Bou Khalil, R; Fares, N; Richa, S; Saliba, Y; Tamraz, J, 2017
)
1.1
" We explored differences in test scores between current methylphenidate users versus never users and methylphenidate users who stopped treatment at least 6 months before the test, early versus late starters, different dosage of methylphenidate, and concurrent antipsychotic or asthma treatment."( Methylphenidate use and school performance among primary school children: a descriptive study.
Bos, JH; Çiçek, R; de Vries, TW; Hak, E; Hoekstra, PJ; van der Schans, J; Vardar, S, 2017
)
2.14
" Unfortunately, there is little information regarding changes in drug absorption after bariatric surgeries, limiting the ability of medical professionals to produce clear recommendations on what changes should be made to the formulations and dosing regimens of drugs after bariatric surgery."( Impaired oral absorption of methylphenidate after Roux-en-Y gastric bypass.
Azran, C; Dahan, A; Langguth, P, 2017
)
0.75
"6 g/kg), dosed 4 hours later."( Ethanol Interactions With Dexmethylphenidate and dl-Methylphenidate Spheroidal Oral Drug Absorption Systems in Healthy Volunteers.
Bernstein, H; Johnson, HJ; Knight, JM; Malcolm, RJ; Markowitz, JS; Patrick, KS; Reeves, OT; Shi, J; Smith, AT; Straughn, AB; Zhu, HJ, 2017
)
0.75
" Lack of longitudinal follow-up studies of dosing and adverse effects has resulted in conflicting treatment guidelines."( Methylphenidate doses in Attention Deficit/Hyperactivity Disorder and comorbid substance use disorders.
Brandt, L; D'Onofrio, B; Franck, J; Larsson, H; Skoglund, C, 2017
)
1.9
"6 mg/kg of immediate-release MPH dosed TID)."( How do stimulant treatments for ADHD work? Evidence for mediation by improved cognition.
Colder, CR; Fosco, WD; Hawk, LW; Pelham, WE; Rosch, KS; Waxmonsky, JG, 2018
)
0.48
" The dose-response (0."( How do stimulant treatments for ADHD work? Evidence for mediation by improved cognition.
Colder, CR; Fosco, WD; Hawk, LW; Pelham, WE; Rosch, KS; Waxmonsky, JG, 2018
)
0.48
" These comprised comparative and non-comparative cohort studies, patient-control studies, patient reports/series and cross-sectional studies of methylphenidate administered at any dosage or formulation."( Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of adverse events in non-randomised studies.
Aagaard, L; Buch Rasmussen, K; Gauci, D; Gerner, T; Gillies, D; Gluud, C; Groth, C; Håkonsen, SJ; Holmskov, M; Kielsholm, ML; Kirubakaran, R; Krogh, HB; Magnusson, FL; Moreira-Maia, CR; Nielsen, SS; Pedersen, N; Ramstad, E; Rosendal, S; Simonsen, E; Skoog, M; Storebø, OJ; Zwi, M, 2018
)
2.12
" Therefore, the aim of this retrospective observational study is to evaluate the influence of psychostimulants on BMI-sds and height-sds in a pediatric cohort with ADHD from an outpatient clinic, and to study the correlation between psychostimulant dosage and BMI-sds and height-sds change."( Psychostimulants: Influence on Body Mass Index and Height in a Pediatric Population with Attention-Deficit/Hyperactivity Disorder?
Knibbe, CAJ; Lentferink, YE; van de Garde, EMW; van der Vorst, MMJ, 2018
)
0.48
" However, the correlation with psychostimulant dosage was weak, and the decline was not observed in all subgroups."( Psychostimulants: Influence on Body Mass Index and Height in a Pediatric Population with Attention-Deficit/Hyperactivity Disorder?
Knibbe, CAJ; Lentferink, YE; van de Garde, EMW; van der Vorst, MMJ, 2018
)
0.48
" Neither acute nor chronic dosing produced a change in locomotion during the EPM, indicating that the anxiolytic effects of MPH are independent of changes in locomotor behavior."( A recreational dose of methylphenidate, but not methamphetamine, decreases anxiety-like behavior in female rats.
Boyette-Davis, JA; Gonzalez, CMF; Guarraci, FA; Kunkel, MN; Lucero, DA; Rice, HR; Shoubaki, RI; Womble, PD, 2018
)
0.79
" In one study, tics limited further dosage increases of methylphenidate."( Pharmacological treatment for attention deficit hyperactivity disorder (ADHD) in children with comorbid tic disorders.
Osland, ST; Pringsheim, T; Steeves, TD, 2018
)
0.73
" If the decision is made to initiate treatment, it is started at the lowest dosage and followed by a titration phase."( [Supervised off-label prescribing of methylphenidate in adult ADHD].
Amad, A; Bordet, R; Brigadeau, F; Carton, L; Cottencin, O; Danel, T; Deheul, S; Devos, D; Dondaine, T; Gautier, S; Marquié, C; Ménard, O, 2019
)
0.79
" Multivariate regression analysis confirmed an inverse dose-response association between MP and fractures in men (p < 0."( Lower risk of fractures under methylphenidate treatment for ADHD: A dose-response effect.
Ankory, R; Gurel, R; Kadar, A; Karakis, I; Schermann, H; Snir, N; Sternheim, A; Yoffe, V, 2018
)
0.77
" The adverse effects may limit optimal dosing and patients' compliance with treatment leading to the discontinuation of treatment."( Preventive effect of cyproheptadine on sleep and appetite disorders induced by methylphenidate: an exploratory randomised, double-blinded, placebo-controlled clinical trial.
Elyasi, S; Kadkhoda Mezerji, F; Mohammadpour, AH; Moharreri, F, 2019
)
0.74
" Further, transdermal, suspension, and orally disintegrating tablet products are now available to overcome any solid dosage form swallowing difficulties."( Drug Regimen Individualization for Attention-Deficit/Hyperactivity Disorder: Guidance for Methylphenidate and Dexmethylphenidate Formulations.
Koller, L; Nguyen, LV; Patrick, KS; Radke, JL; Raymond, JR; Rodriguez, W; Straughn, AB, 2019
)
0.74
"Whether long-term methylphenidate (MPH) results in any changes in cardiovascular function or structure can only be properly addressed through a randomized trial using an animal model which permits elevated dosing over an extended period of time."( A randomized controlled laboratory study on the long-term effects of methylphenidate on cardiovascular function and structure in rhesus monkeys.
Bodien, A; Callicott, R; Czachor, J; Dauphin, DD; Davis, K; Greenhaw, J; Jones, Y; Lipshultz, SE; Paredes, A; Paule, MG; Rusconi, PG; Salminen, WF; Sandhu, SK; Slikker, W; Westphal, JA; Wilkinson, JD, 2019
)
1.08
" Dosage groups were compared on serum cardiovascular and inflammatory biomarkers, electrocardiograms (ECGs), echocardiograms, myocardial biopsies, and clinical pathology parameters following 5 years of uninterrupted dosing."( A randomized controlled laboratory study on the long-term effects of methylphenidate on cardiovascular function and structure in rhesus monkeys.
Bodien, A; Callicott, R; Czachor, J; Dauphin, DD; Davis, K; Greenhaw, J; Jones, Y; Lipshultz, SE; Paredes, A; Paule, MG; Rusconi, PG; Salminen, WF; Sandhu, SK; Slikker, W; Westphal, JA; Wilkinson, JD, 2019
)
0.75
"With the exception of serum myoglobin, there were no statistical differences or apparent dose-response trends in clinical pathology, cardiac inflammatory biomarkers, ECGs, echocardiograms, or myocardial biopsies."( A randomized controlled laboratory study on the long-term effects of methylphenidate on cardiovascular function and structure in rhesus monkeys.
Bodien, A; Callicott, R; Czachor, J; Dauphin, DD; Davis, K; Greenhaw, J; Jones, Y; Lipshultz, SE; Paredes, A; Paule, MG; Rusconi, PG; Salminen, WF; Sandhu, SK; Slikker, W; Westphal, JA; Wilkinson, JD, 2019
)
0.75
" The optimization of the benefit-risk ratio can be achieved by identifying the most adequate dose (and/or dosage regimen) jointly with the best-performing in vivo release properties of a drug."( A General Framework for Assessing In vitro/In vivo Correlation as a Tool for Maximizing the Benefit-Risk Ratio of a Treatment Using a Convolution-Based Modeling Approach.
Babiskin, A; Bressolle-Gomeni, F; Fang, LL; Faraone, SV; Gomeni, R; Spencer, TJ, 2019
)
0.51
" Importantly, the dose-response curve for this action was right-shifted relative to working memory, as seen with systemic administration."( Receptor and circuit mechanisms underlying differential procognitive actions of psychostimulants.
Berridge, CW; Spencer, RC, 2019
)
0.51
" A high-fat meal immediately preceding evening dosing did not affect total MPH exposure but lowered peak MPH exposure by 14% and 11% versus fasted and sprinkled states, and time to peak exposure was delayed by ∼2."( Pharmacokinetics of HLD200, a Delayed-Release and Extended-Release Methylphenidate: Evaluation of Dose Proportionality, Food Effect, Multiple-Dose Modeling, and Comparative Bioavailability with Immediate-Release Methylphenidate in Healthy Adults.
DeSousa, NJ; Gobburu, JVS; Incledon, B; Liu, T; McLean, A; Po, MD; Sallee, FR, 2019
)
0.75
" We investigated the effect of OT, delivered intraperitoneally, on the methylphenidate (MP) dose-response function for self-administration in rats."( Effect of systemically administered oxytocin on dose response for methylphenidate self-administration and mesolimbic dopamine levels.
Coggiano, MA; Lee, MR; Leggio, L; Rohn, MCH; Tanda, G; Zanettini, C, 2019
)
0.98
" However, further studies are needed to provide more robust evidence on efficacy, dosage and safety for this population."( Amphetamine Use in the Elderly: A Systematic Review of the Literature.
Colpo, GD; John, V; Rocha, NP; Sassi, KLM; Teixeira, AL, 2020
)
0.56
" This study is unique in that it investigated acute and chronic, dose-response MPD exposure on animals' behavior activity concomitantly with PFC and CN neuronal circuitry in freely behaving adult animals without the interference of anesthesia."( The prefrontal cortex and the caudate nucleus respond conjointly to methylphenidate (Ritalin). Concomitant behavioral and neuronal recording study.
Claussen, CM; Dafny, N; Kharas, N; Venkataraman, SS, 2020
)
0.79
" We used mixed-effects logistic regression models to personalize the dosage of Methylphenidate (MPH) in ADHD."( Individualizing the dosage of Methylphenidate in children with attention deficit hyperactivity disorder.
Fotouhi, A; Hoseini, M; Mahmoudi-Gharaei, J; Mozaffarpur, SA; Shirafkan, H; Yaseri, M, 2020
)
1.07
" In multivariable mixed logit model, three variables (severity of ADHD, time duration receiving MPH, and dosage of MPH) had a significant relationship with improvement."( Individualizing the dosage of Methylphenidate in children with attention deficit hyperactivity disorder.
Fotouhi, A; Hoseini, M; Mahmoudi-Gharaei, J; Mozaffarpur, SA; Shirafkan, H; Yaseri, M, 2020
)
0.85
"To determine the dosage of MPH for a new patient, the more the severity of baseline is, the more of an initial dose is required."( Individualizing the dosage of Methylphenidate in children with attention deficit hyperactivity disorder.
Fotouhi, A; Hoseini, M; Mahmoudi-Gharaei, J; Mozaffarpur, SA; Shirafkan, H; Yaseri, M, 2020
)
0.85
" Studies using standardized dosing schemes for longer durations and evaluating sleep with objective measurements may clarify the differential effects of treatments on sleep among children with ADHD."( Sleep habits of children diagnosed with attention/ deficit/ hyperactivity disorder and effects of treatment on sleep related parameters.
Sarıgedik, E; Tufan, AE; Yektaş, Ç, 2020
)
0.56
" An important consequence of this study finding is that it may be important to adjust MPH dosage depending on learning effects in a specific setting to constantly increase cognitive control functions in that setting."( Task experience eliminates catecholaminergic effects on inhibitory control - A randomized, double-blind cross-over neurophysiological study.
Beste, C; Mückschel, M; Roessner, V, 2020
)
0.56
" Further investigations containing larger sample sizes, longer supplementation periods, and dose-response evaluations are required to replicate these findings in ADHD children more confidently."( Resveratrol adjunct to methylphenidate improves symptoms of attention-deficit/hyperactivity disorder: a randomized, double-blinded, placebo-controlled clinical trial.
Akhondzadeh, S; Ashraf-Ganjouei, A; Bagheri, S; Mohammadi, MR; Moradi, K; Rafeiy-Torghabeh, M, 2021
)
0.93
" Participants (N = 12; 33% female) completed a within-subject, outpatient, acute dosing study."( Acute methylphenidate administration reduces cocaine-cue attentional bias.
Alcorn, JL; Lile, JA; Rush, CR; Stoops, WW; Strickland, JC, 2020
)
1.04
" The results from the literature underline the necessity of caution and patient monitoring when risperidone dosing is modified during methylphenidate therapy."( Movement disorders and use of risperidone and methylphenidate: a review of case reports and an analysis of the WHO database in pharmacovigilance.
Burden, AM; Stämpfli, D; Weiler, S, 2021
)
1.08
" Secondary endpoints comprise patient evaluation (Wender-Reimherr self-report, WR-SR), safety, tolerability, and dosage of MPH."( Methylphenidate treatment of adult ADHD patients improves the degree of ADHD severity under routine conditions.
Ammer, R; Fischer, R; Ose, C; Retz, W; Rösler, M, 2020
)
2
" PRC-063 (100 mg/d) was compared with immediate-release methylphenidate (20 mg, 3 times daily) when administered on a single day under fasted and fed conditions and at steady state (day 5 of repeat dosing under fasted conditions)."( Randomized Controlled Crossover Trials of the Pharmacokinetics of PRC-063, a Novel Multilayer Extended-Release Formulation of Methylphenidate, in Healthy Adults.
Cataldo, MJ; Donnelly, GAE; Katzman, MA; Klassen, LJ; Mattingly, G,
)
0.58
"Although the relationship between attention-deficit/hyperactivity disorder (ADHD) and transport accidents has been shown, there is limited information on the relationship between medication and dose-response effects and transport accident risk."( Association of psychiatric comorbidities with the risk of transport accidents in ADHD and MPH.
Chen, VC; Chen, YL; Gossop, M; Liu, YC; Yang, YH, 2021
)
0.62
" MPH treatment lowered the accident risk with a dose-response relationship."( Association of psychiatric comorbidities with the risk of transport accidents in ADHD and MPH.
Chen, VC; Chen, YL; Gossop, M; Liu, YC; Yang, YH, 2021
)
0.62
" The participants had drug dosage adjustment based on body weight/dose (mg/kg)."( Methylphenidate decreases the EEG mu power in the right primary motor cortex in healthy adults during motor imagery and execution.
Aprigio, D; Basile, LF; Bastos, VH; Bittencourt, J; Budde, H; Cagy, M; Gongora, M; Marinho, V; Ribeiro, P; Teixeira, S; Velasques, B, 2021
)
2.06
" The effectiveness of MP for cognitive enhancement is well documented along a dose-response curve."( The Use of Methylphenidate for Cognitive Enhancement in Young Healthy Adults: The Clinical and Ethical Debates.
Koren, G; Korn, L,
)
0.52
"Accurate estimation of daily dosage and duration of medication use is essential to pharmacoepidemiological studies using electronic healthcare databases."( Prediction of treatment dosage and duration from free-text prescriptions: an application to ADHD medications in the Swedish prescribed drug register.
Chang, Z; Chen, Q; D'Onofrio, BM; Ghirardi, L; Lagerberg, T; Larsson, H; Viktorin, A; Zhang, L, 2021
)
0.62
"To develop and validate an algorithm for predicting prescribed daily dosage and treatment duration from free-text prescriptions, and apply the algorithm to ADHD medication prescriptions."( Prediction of treatment dosage and duration from free-text prescriptions: an application to ADHD medications in the Swedish prescribed drug register.
Chang, Z; Chen, Q; D'Onofrio, BM; Ghirardi, L; Lagerberg, T; Larsson, H; Viktorin, A; Zhang, L, 2021
)
0.62
"We developed an algorithm to predict daily dosage from free-text prescriptions using 8000 ADHD medication prescriptions as the training sample, and estimated treatment periods while taking into account several features including titration, stockpiling and non-perfect adherence."( Prediction of treatment dosage and duration from free-text prescriptions: an application to ADHD medications in the Swedish prescribed drug register.
Chang, Z; Chen, Q; D'Onofrio, BM; Ghirardi, L; Lagerberg, T; Larsson, H; Viktorin, A; Zhang, L, 2021
)
0.62
"In the validation sample, the overall accuracy for predicting daily dosage was 96."( Prediction of treatment dosage and duration from free-text prescriptions: an application to ADHD medications in the Swedish prescribed drug register.
Chang, Z; Chen, Q; D'Onofrio, BM; Ghirardi, L; Lagerberg, T; Larsson, H; Viktorin, A; Zhang, L, 2021
)
0.62
"The algorithm provides a flexible approach to estimate prescribed daily dosage and treatment duration from free-text prescriptions using register data."( Prediction of treatment dosage and duration from free-text prescriptions: an application to ADHD medications in the Swedish prescribed drug register.
Chang, Z; Chen, Q; D'Onofrio, BM; Ghirardi, L; Lagerberg, T; Larsson, H; Viktorin, A; Zhang, L, 2021
)
0.62
" Study durations ranged from 8 to 16 weeks and MPH dosing ranged from 5 to 90 mg per day."( Methylphenidate use in geriatric depression: A systematic review.
Britt, RB; Brown, JN; Kahlon, CH; Smith, KR, 2021
)
2.06
"The findings suggest that the IN-DA treatment has potential for use in the treatment of ADHD; however, caution must be exercised when determining the dosage to be administered, because too much dopamine may have negative effects."( Acute intranasal dopamine application counteracts the reversal learning deficit of spontaneously hypertensive rats in an attentional set-shifting task.
Chao, OY; Huston, JP; Li, JS; Mattern, C; Yang, SS; Yang, YM, 2021
)
0.62
" Determining the dosing effects of methylphenidate (MPH) on a broad range of neurocognitive functions and investigating possible impairing effects of high doses is therefore important."( Meta-analysis: Dose-Dependent Effects of Methylphenidate on Neurocognitive Functioning in Children With Attention-Deficit/Hyperactivity Disorder.
Bet, P; de Vries, R; Luman, M; Oosterlaan, J; Staff, A; Twisk, J; Vertessen, K, 2022
)
1.26
"Placebo-controlled trials were included that investigated MPH dosing effects on neurocognitive functions in children and adolescents (aged 5-18 years) diagnosed with ADHD."( Meta-analysis: Dose-Dependent Effects of Methylphenidate on Neurocognitive Functioning in Children With Attention-Deficit/Hyperactivity Disorder.
Bet, P; de Vries, R; Luman, M; Oosterlaan, J; Staff, A; Twisk, J; Vertessen, K, 2022
)
0.99
" Significant linear dosing effects were found for ADHD symptoms and lower-order neurocognitive functions (baseline speed, variability in responding, nonexecutive memory), with greater enhancement of functioning with increasing dose."( Meta-analysis: Dose-Dependent Effects of Methylphenidate on Neurocognitive Functioning in Children With Attention-Deficit/Hyperactivity Disorder.
Bet, P; de Vries, R; Luman, M; Oosterlaan, J; Staff, A; Twisk, J; Vertessen, K, 2022
)
0.99
" A physiologically-based pharmacokinetic modeling simulation revealed that the CES1-based individualized dosing strategy might significantly reduce d-methylphenidate exposure variability in pediatric patients relative to conventional trial and error fixed dosing regimens."( Plasma Carboxylesterase 1 Predicts Methylphenidate Exposure: A Proof-of-Concept Study Using Plasma Protein Biomarker for Hepatic Drug Metabolism.
Bleske, BE; Jung, SM; Markowitz, JS; Patrick, KS; Shi, J; Wang, X; Xiao, J; Zhu, HJ, 2022
)
1.2
" However, robust evidence-base regarding the effects of doses and dosing strategies of stimulants on clinical outcomes in the treatment of children/adolescents with ADHD is currently lacking and stimulants are often underdosed in clinical practice."( The effects of stimulant dose and dosing strategy on treatment outcomes in attention-deficit/hyperactivity disorder in children and adolescents: a meta-analysis.
Avila-Quintero, VJ; Behling, E; Bloch, MH; Cortese, S; Farhat, LC; Flores, JM; Lombroso, A; Polanczyk, GV, 2022
)
0.72
" Heart rate and blood pressure were measured at dosing and 1, 2, and 3 hours afterwards."( Acute Tolerability of Methylphenidate in Treatment-Naïve Children with ADHD: An Analysis of Naturalistically Collected Data from Clinical Practice.
Amianto, F; D'Acunto, G; Davico, C; Falcone, F; Fantozzi, P; Favole, I; Lenzi, F; Levantini, V; Liboni, F; Masi, G; Muratori, P; Pfanner, C; Simonelli, V; Villafranca, A; Vitiello, B, 2022
)
1.04
"A simple, robust stability indicating RP-HPLC method was developed for simultaneous quantification of serdexmethyl phenidate and dexmethyl phenidate in a fixed capsule dosage form."( A Novel Stability Indicating RP-HPLC Method for Simultaneous Quantification of Serdexmethylphenidate and Dexmethylphenidate in Fixed Dosage Form.
Gollu, G; Gummadi, S, 2023
)
1.13
" Nonetheless, patients' growth and the appropriateness of drug dosage should be closely monitored."( Growth Hormone and Thyroid Function in Children With Attention Deficit Hyperactivity Disorder Undergoing Drug Therapy.
Chou, WJ; Huang, YH; Lee, SY; Wang, LJ, 2022
)
0.72
" The syrup dosage is 5cc every 8 h, and MP will have a stabilized dose for 8 weeks during the study."( The effect of Rosa canina L. and a polyherbal formulation syrup in patients with attention-deficit/hyperactivity disorder: a study protocol for a multicenter randomized controlled trial.
Abniki, E; Bahrami, M; Dadmehr, M; Golsorkhi, H; Kamalinejad, M; Montazerlotfelahi, H; Qorbani, M; Sabbaghzadegan, S; Vafaee-Shahi, M, 2022
)
0.72
" Further research is needed to evaluate effects of higher average dosing and adherence to treatment, multi-modal treatments and preventative interventions in the community."( Randomised controlled trial of the short-term effects of osmotic-release oral system methylphenidate on symptoms and behavioural outcomes in young male prisoners with attention deficit hyperactivity disorder: CIAO-II study.
Asherson, PJ; Bedding, M; Forrester, A; Giannulli, L; Ginsberg, Y; Holland, R; Howitt, S; Johansson, L; Kelly, C; Khan, K; Kretzschmar, I; Landau, S; Lawrie, SM; Mansfield, M; Marsh, C; McCafferty, C; Müller-Sedgwick, U; Strang, J; Thomson, LDG; Williamson, G; Wilson, L; Young, S, 2023
)
1.13
" At present, pharmacogenomic testing as an aid to guide dosing and personalized treatment cannot be recommended for either agent."( The Pharmacokinetics and Pharmacogenomics of Psychostimulants.
Markowitz, JS; Melchert, PW, 2022
)
0.72
" A high dosage of methylphenidate diminished both behavioral inflexibility and improved learning abilities in adult rats."( Former Training Relieves the Later Development of Behavioral Inflexibility in an Animal Model Overexpressing the Dopamine Transporter.
Akinola, EO; Bernhardt, N; Edemann-Callesen, H; Glienke, M; Habelt, B; Hadar, R; Lieser, MK; Winter, C, 2022
)
1.06
" Human mesenchymal stem cells (hMSCs) were incubated with a therapeutic plasma dosage of modafinil, atomoxetine and guanfacine."( Psychostimulants Modafinil, Atomoxetine and Guanfacine Impair Bone Cell Differentiation and MSC Migration.
Böker, KO; Di Fazio, P; Jäckle, K; Lehmann, W; Schilling, AF; Wagener, N; Weiser, L, 2022
)
0.72
" It is important that future research addresses the current weaknesses in this area, which include small sample sizes, variability of selection criteria, variability of the type and dosage of supplementation, and short follow-up times."( Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents.
Gillies, D; Leach, MJ; Perez Algorta, G, 2023
)
0.91
" HC received 30 mg methylphenidate (MPH) and ADHD patients received either MPH or lisdexamphetamine (LDX) as selected by their clinician, with dosage individually determined for optimal effect."( Salience and hedonic experience as predictors of central stimulant treatment response in ADHD - A resting state fMRI study.
Msghina, M; Rode, J; Runnamo, R; Thunberg, P, 2023
)
1.24
"The aim of this study is to characterize children with GI and evaluate their response to methylphenidate, as well as describe treatment duration, dosage of methylphenidate, relapse rates after discontinuation of medication, and side effects."( The effect of methylphenidate for giggle incontinence in children.
Arvad, M; Borch, L; Hagstroem, S; Kamperis, K; Svendsen, AM; Thorsteinsson, KN, 2023
)
1.49
" Results underscore the need to consider dosing as well as parent preference when utilizing combined treatment approaches."( Single and Combined Effects of Multiple Intensities of Behavioral Modification and Methylphenidate for Children with ADHD in the Home Setting.
Burrows-MacLean, L; Chacko, A; Coles, EK; Fabiano, GA; Garefino, A; Gnagy, EM; Macphee, FL; Massetti, GM; Merrill, BM; Pelham, WE; Robb Mazzant, J; Walker, K; Waschbusch, DA; Waxmonsky, JG; Wymbs, BT; Wymbs, F, 2023
)
1.14
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (3)

ClassDescription
piperidines
methyl esterAny carboxylic ester resulting from the formal condensation of a carboxy group with methanol.
beta-amino acid esterAn amino acid ester resulting from the formal condensation of the carboxy group of a beta-amino acid with the hydroxy group of an alcohol or phenol.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (14)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency37.90830.01237.983543.2770AID1645841
GVesicular stomatitis virusPotency10.68400.01238.964839.8107AID1645842
Interferon betaHomo sapiens (human)Potency10.68400.00339.158239.8107AID1645842
HLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)Potency10.68400.01238.964839.8107AID1645842
Inositol hexakisphosphate kinase 1Homo sapiens (human)Potency10.68400.01238.964839.8107AID1645842
cytochrome P450 2C9, partialHomo sapiens (human)Potency10.68400.01238.964839.8107AID1645842
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Fatty-acid amide hydrolase 1Homo sapiens (human)IC50 (µMol)0.46300.00020.59827.0000AID1363884; AID1363885; AID1798724; AID1798725; AID1798726; AID1798727; AID430491
Fatty-acid amide hydrolase 1Rattus norvegicus (Norway rat)Ki0.03300.00060.16192.0000AID412539
Transient receptor potential cation channel subfamily V member 1Homo sapiens (human)IC50 (µMol)10.00000.00020.606010.0000AID470070
Sodium-dependent noradrenaline transporter Homo sapiens (human)IC50 (µMol)0.06100.00081.541620.0000AID275446
Sodium-dependent noradrenaline transporter Homo sapiens (human)Ki0.50000.00031.465610.0000AID1184915; AID275445
Sodium-dependent dopamine transporterRattus norvegicus (Norway rat)IC50 (µMol)0.08300.00070.97749.7000AID65807
Sodium-dependent serotonin transporterHomo sapiens (human)IC50 (µMol)5.10000.00010.86458.7096AID275444
Sodium-dependent serotonin transporterHomo sapiens (human)Ki37.50000.00000.70488.1930AID1184913; AID275443
Sodium-dependent dopamine transporter Homo sapiens (human)IC50 (µMol)0.07900.00071.841946.0000AID275442
Sodium-dependent dopamine transporter Homo sapiens (human)Ki0.07200.00021.11158.0280AID1184914; AID275441
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Transient receptor potential cation channel subfamily A member 1Homo sapiens (human)EC50 (µMol)25.00000.00033.166210.0000AID470071
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (148)

Processvia Protein(s)Taxonomy
fatty acid catabolic processFatty-acid amide hydrolase 1Homo sapiens (human)
arachidonic acid metabolic processFatty-acid amide hydrolase 1Homo sapiens (human)
positive regulation of vasoconstrictionFatty-acid amide hydrolase 1Homo sapiens (human)
monoacylglycerol catabolic processFatty-acid amide hydrolase 1Homo sapiens (human)
monoatomic ion transportTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
intracellular calcium ion homeostasisTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
cell surface receptor signaling pathwayTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
response to coldTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
response to xenobiotic stimulusTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
response to organic substanceTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
response to organic cyclic compoundTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
sensory perception of painTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
calcium-mediated signalingTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
response to painTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
thermoceptionTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
detection of mechanical stimulus involved in sensory perception of painTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
detection of chemical stimulus involved in sensory perception of painTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
protein homotetramerizationTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
cellular response to hydrogen peroxideTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
calcium ion transmembrane transportTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
cellular response to organic substanceTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell activation involved in immune responseInterferon betaHomo sapiens (human)
cell surface receptor signaling pathwayInterferon betaHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to virusInterferon betaHomo sapiens (human)
positive regulation of autophagyInterferon betaHomo sapiens (human)
cytokine-mediated signaling pathwayInterferon betaHomo sapiens (human)
natural killer cell activationInterferon betaHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylation of STAT proteinInterferon betaHomo sapiens (human)
cellular response to interferon-betaInterferon betaHomo sapiens (human)
B cell proliferationInterferon betaHomo sapiens (human)
negative regulation of viral genome replicationInterferon betaHomo sapiens (human)
innate immune responseInterferon betaHomo sapiens (human)
positive regulation of innate immune responseInterferon betaHomo sapiens (human)
regulation of MHC class I biosynthetic processInterferon betaHomo sapiens (human)
negative regulation of T cell differentiationInterferon betaHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIInterferon betaHomo sapiens (human)
defense response to virusInterferon betaHomo sapiens (human)
type I interferon-mediated signaling pathwayInterferon betaHomo sapiens (human)
neuron cellular homeostasisInterferon betaHomo sapiens (human)
cellular response to exogenous dsRNAInterferon betaHomo sapiens (human)
cellular response to virusInterferon betaHomo sapiens (human)
negative regulation of Lewy body formationInterferon betaHomo sapiens (human)
negative regulation of T-helper 2 cell cytokine productionInterferon betaHomo sapiens (human)
positive regulation of apoptotic signaling pathwayInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell differentiationInterferon betaHomo sapiens (human)
natural killer cell activation involved in immune responseInterferon betaHomo sapiens (human)
adaptive immune responseInterferon betaHomo sapiens (human)
T cell activation involved in immune responseInterferon betaHomo sapiens (human)
humoral immune responseInterferon betaHomo sapiens (human)
positive regulation of T cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
adaptive immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class I via ER pathway, TAP-independentHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of T cell anergyHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
defense responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
detection of bacteriumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-12 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-6 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protection from natural killer cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
innate immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of dendritic cell differentiationHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class IbHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
thermoceptionTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
negative regulation of transcription by RNA polymerase IITransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
fever generationTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
microglial cell activationTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
diet induced thermogenesisTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
peptide secretionTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
negative regulation of systemic arterial blood pressureTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
lipid metabolic processTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
cell surface receptor signaling pathwayTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
positive regulation of cytosolic calcium ion concentrationTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
chemosensory behaviorTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
negative regulation of heart rateTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
negative regulation of mitochondrial membrane potentialTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
glutamate secretionTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
calcium-mediated signalingTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
cellular response to heatTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
positive regulation of apoptotic processTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
response to peptide hormoneTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
positive regulation of nitric oxide biosynthetic processTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
behavioral response to painTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
sensory perception of mechanical stimulusTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
detection of temperature stimulus involved in thermoceptionTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
detection of temperature stimulus involved in sensory perception of painTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
detection of chemical stimulus involved in sensory perception of painTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
protein homotetramerizationTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
excitatory postsynaptic potentialTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
smooth muscle contraction involved in micturitionTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
calcium ion transmembrane transportTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
cellular response to alkaloidTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
cellular response to ATPTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
cellular response to tumor necrosis factorTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
cellular response to acidic pHTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
cellular response to temperature stimulusTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
negative regulation of establishment of blood-brain barrierTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
calcium ion import across plasma membraneTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
response to capsazepineTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
cellular response to nerve growth factor stimulusTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
inositol phosphate metabolic processInositol hexakisphosphate kinase 1Homo sapiens (human)
phosphatidylinositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
negative regulation of cold-induced thermogenesisInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
monoamine transportSodium-dependent noradrenaline transporter Homo sapiens (human)
neurotransmitter transportSodium-dependent noradrenaline transporter Homo sapiens (human)
chemical synaptic transmissionSodium-dependent noradrenaline transporter Homo sapiens (human)
response to xenobiotic stimulusSodium-dependent noradrenaline transporter Homo sapiens (human)
response to painSodium-dependent noradrenaline transporter Homo sapiens (human)
norepinephrine uptakeSodium-dependent noradrenaline transporter Homo sapiens (human)
neuron cellular homeostasisSodium-dependent noradrenaline transporter Homo sapiens (human)
amino acid transportSodium-dependent noradrenaline transporter Homo sapiens (human)
norepinephrine transportSodium-dependent noradrenaline transporter Homo sapiens (human)
dopamine uptake involved in synaptic transmissionSodium-dependent noradrenaline transporter Homo sapiens (human)
sodium ion transmembrane transportSodium-dependent noradrenaline transporter Homo sapiens (human)
monoamine transportSodium-dependent serotonin transporterHomo sapiens (human)
response to hypoxiaSodium-dependent serotonin transporterHomo sapiens (human)
neurotransmitter transportSodium-dependent serotonin transporterHomo sapiens (human)
response to nutrientSodium-dependent serotonin transporterHomo sapiens (human)
memorySodium-dependent serotonin transporterHomo sapiens (human)
circadian rhythmSodium-dependent serotonin transporterHomo sapiens (human)
response to xenobiotic stimulusSodium-dependent serotonin transporterHomo sapiens (human)
response to toxic substanceSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of gene expressionSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of serotonin secretionSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of cerebellar granule cell precursor proliferationSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of synaptic transmission, dopaminergicSodium-dependent serotonin transporterHomo sapiens (human)
response to estradiolSodium-dependent serotonin transporterHomo sapiens (human)
social behaviorSodium-dependent serotonin transporterHomo sapiens (human)
vasoconstrictionSodium-dependent serotonin transporterHomo sapiens (human)
sperm ejaculationSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of neuron differentiationSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of cell cycleSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of organ growthSodium-dependent serotonin transporterHomo sapiens (human)
behavioral response to cocaineSodium-dependent serotonin transporterHomo sapiens (human)
enteric nervous system developmentSodium-dependent serotonin transporterHomo sapiens (human)
brain morphogenesisSodium-dependent serotonin transporterHomo sapiens (human)
serotonin uptakeSodium-dependent serotonin transporterHomo sapiens (human)
membrane depolarizationSodium-dependent serotonin transporterHomo sapiens (human)
platelet aggregationSodium-dependent serotonin transporterHomo sapiens (human)
cellular response to retinoic acidSodium-dependent serotonin transporterHomo sapiens (human)
cellular response to cGMPSodium-dependent serotonin transporterHomo sapiens (human)
regulation of thalamus sizeSodium-dependent serotonin transporterHomo sapiens (human)
conditioned place preferenceSodium-dependent serotonin transporterHomo sapiens (human)
sodium ion transmembrane transportSodium-dependent serotonin transporterHomo sapiens (human)
amino acid transportSodium-dependent serotonin transporterHomo sapiens (human)
monoamine transportSodium-dependent dopamine transporter Homo sapiens (human)
neurotransmitter transportSodium-dependent dopamine transporter Homo sapiens (human)
lactationSodium-dependent dopamine transporter Homo sapiens (human)
sensory perception of smellSodium-dependent dopamine transporter Homo sapiens (human)
locomotory behaviorSodium-dependent dopamine transporter Homo sapiens (human)
response to xenobiotic stimulusSodium-dependent dopamine transporter Homo sapiens (human)
response to iron ionSodium-dependent dopamine transporter Homo sapiens (human)
dopamine transportSodium-dependent dopamine transporter Homo sapiens (human)
adenohypophysis developmentSodium-dependent dopamine transporter Homo sapiens (human)
response to nicotineSodium-dependent dopamine transporter Homo sapiens (human)
positive regulation of multicellular organism growthSodium-dependent dopamine transporter Homo sapiens (human)
regulation of dopamine metabolic processSodium-dependent dopamine transporter Homo sapiens (human)
response to cocaineSodium-dependent dopamine transporter Homo sapiens (human)
dopamine biosynthetic processSodium-dependent dopamine transporter Homo sapiens (human)
dopamine catabolic processSodium-dependent dopamine transporter Homo sapiens (human)
response to ethanolSodium-dependent dopamine transporter Homo sapiens (human)
cognitionSodium-dependent dopamine transporter Homo sapiens (human)
dopamine uptake involved in synaptic transmissionSodium-dependent dopamine transporter Homo sapiens (human)
response to cAMPSodium-dependent dopamine transporter Homo sapiens (human)
norepinephrine uptakeSodium-dependent dopamine transporter Homo sapiens (human)
prepulse inhibitionSodium-dependent dopamine transporter Homo sapiens (human)
dopamine uptakeSodium-dependent dopamine transporter Homo sapiens (human)
hyaloid vascular plexus regressionSodium-dependent dopamine transporter Homo sapiens (human)
amino acid transportSodium-dependent dopamine transporter Homo sapiens (human)
norepinephrine transportSodium-dependent dopamine transporter Homo sapiens (human)
sodium ion transmembrane transportSodium-dependent dopamine transporter Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (61)

Processvia Protein(s)Taxonomy
protein bindingFatty-acid amide hydrolase 1Homo sapiens (human)
phospholipid bindingFatty-acid amide hydrolase 1Homo sapiens (human)
fatty acid amide hydrolase activityFatty-acid amide hydrolase 1Homo sapiens (human)
identical protein bindingFatty-acid amide hydrolase 1Homo sapiens (human)
acylglycerol lipase activityFatty-acid amide hydrolase 1Homo sapiens (human)
amidase activityFatty-acid amide hydrolase 1Homo sapiens (human)
calcium channel activityTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
channel activityTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
intracellularly gated calcium channel activityTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
identical protein bindingTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
temperature-gated cation channel activityTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
cytokine activityInterferon betaHomo sapiens (human)
cytokine receptor bindingInterferon betaHomo sapiens (human)
type I interferon receptor bindingInterferon betaHomo sapiens (human)
protein bindingInterferon betaHomo sapiens (human)
chloramphenicol O-acetyltransferase activityInterferon betaHomo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
signaling receptor bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
peptide antigen bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein-folding chaperone bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
transmembrane signaling receptor activityTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
extracellular ligand-gated monoatomic ion channel activityTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
excitatory extracellular ligand-gated monoatomic ion channel activityTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
voltage-gated calcium channel activityTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
calcium channel activityTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
protein bindingTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
calmodulin bindingTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
ATP bindingTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
intracellularly gated calcium channel activityTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
chloride channel regulator activityTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
phosphatidylinositol bindingTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
identical protein bindingTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
metal ion bindingTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
phosphoprotein bindingTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
temperature-gated ion channel activityTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
inositol-1,3,4,5,6-pentakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol heptakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
protein bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
ATP bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 1-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 3-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol 5-diphosphate pentakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol diphosphate tetrakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
actin bindingSodium-dependent noradrenaline transporter Homo sapiens (human)
neurotransmitter transmembrane transporter activitySodium-dependent noradrenaline transporter Homo sapiens (human)
neurotransmitter:sodium symporter activitySodium-dependent noradrenaline transporter Homo sapiens (human)
dopamine:sodium symporter activitySodium-dependent noradrenaline transporter Homo sapiens (human)
norepinephrine:sodium symporter activitySodium-dependent noradrenaline transporter Homo sapiens (human)
protein bindingSodium-dependent noradrenaline transporter Homo sapiens (human)
monoamine transmembrane transporter activitySodium-dependent noradrenaline transporter Homo sapiens (human)
alpha-tubulin bindingSodium-dependent noradrenaline transporter Homo sapiens (human)
metal ion bindingSodium-dependent noradrenaline transporter Homo sapiens (human)
beta-tubulin bindingSodium-dependent noradrenaline transporter Homo sapiens (human)
integrin bindingSodium-dependent serotonin transporterHomo sapiens (human)
monoatomic cation channel activitySodium-dependent serotonin transporterHomo sapiens (human)
neurotransmitter transmembrane transporter activitySodium-dependent serotonin transporterHomo sapiens (human)
serotonin:sodium:chloride symporter activitySodium-dependent serotonin transporterHomo sapiens (human)
protein bindingSodium-dependent serotonin transporterHomo sapiens (human)
monoamine transmembrane transporter activitySodium-dependent serotonin transporterHomo sapiens (human)
antiporter activitySodium-dependent serotonin transporterHomo sapiens (human)
syntaxin-1 bindingSodium-dependent serotonin transporterHomo sapiens (human)
cocaine bindingSodium-dependent serotonin transporterHomo sapiens (human)
sodium ion bindingSodium-dependent serotonin transporterHomo sapiens (human)
identical protein bindingSodium-dependent serotonin transporterHomo sapiens (human)
nitric-oxide synthase bindingSodium-dependent serotonin transporterHomo sapiens (human)
actin filament bindingSodium-dependent serotonin transporterHomo sapiens (human)
serotonin bindingSodium-dependent serotonin transporterHomo sapiens (human)
protease bindingSodium-dependent dopamine transporter Homo sapiens (human)
signaling receptor bindingSodium-dependent dopamine transporter Homo sapiens (human)
neurotransmitter transmembrane transporter activitySodium-dependent dopamine transporter Homo sapiens (human)
dopamine:sodium symporter activitySodium-dependent dopamine transporter Homo sapiens (human)
protein bindingSodium-dependent dopamine transporter Homo sapiens (human)
monoamine transmembrane transporter activitySodium-dependent dopamine transporter Homo sapiens (human)
dopamine bindingSodium-dependent dopamine transporter Homo sapiens (human)
amine bindingSodium-dependent dopamine transporter Homo sapiens (human)
protein-containing complex bindingSodium-dependent dopamine transporter Homo sapiens (human)
metal ion bindingSodium-dependent dopamine transporter Homo sapiens (human)
protein phosphatase 2A bindingSodium-dependent dopamine transporter Homo sapiens (human)
heterocyclic compound bindingSodium-dependent dopamine transporter Homo sapiens (human)
norepinephrine:sodium symporter activitySodium-dependent dopamine transporter Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (42)

Processvia Protein(s)Taxonomy
endoplasmic reticulum membraneFatty-acid amide hydrolase 1Homo sapiens (human)
cytoskeletonFatty-acid amide hydrolase 1Homo sapiens (human)
organelle membraneFatty-acid amide hydrolase 1Homo sapiens (human)
plasma membraneTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
stereocilium bundleTransient receptor potential cation channel subfamily A member 1Homo sapiens (human)
extracellular spaceInterferon betaHomo sapiens (human)
extracellular regionInterferon betaHomo sapiens (human)
Golgi membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
endoplasmic reticulumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
Golgi apparatusHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
cell surfaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
ER to Golgi transport vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
secretory granule membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
phagocytic vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
early endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
recycling endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular exosomeHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
lumenal side of endoplasmic reticulum membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
MHC class I protein complexHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular spaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
external side of plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
plasma membraneTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
external side of plasma membraneTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
membraneTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
dendritic spine membraneTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
neuronal cell bodyTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
postsynaptic membraneTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
plasma membraneTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
fibrillar centerInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
cytosolInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleusInositol hexakisphosphate kinase 1Homo sapiens (human)
cytoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
plasma membraneSodium-dependent noradrenaline transporter Homo sapiens (human)
cell surfaceSodium-dependent noradrenaline transporter Homo sapiens (human)
membraneSodium-dependent noradrenaline transporter Homo sapiens (human)
neuronal cell body membraneSodium-dependent noradrenaline transporter Homo sapiens (human)
presynaptic membraneSodium-dependent noradrenaline transporter Homo sapiens (human)
plasma membraneSodium-dependent noradrenaline transporter Homo sapiens (human)
axonSodium-dependent noradrenaline transporter Homo sapiens (human)
plasma membraneSodium-dependent serotonin transporterHomo sapiens (human)
focal adhesionSodium-dependent serotonin transporterHomo sapiens (human)
endosome membraneSodium-dependent serotonin transporterHomo sapiens (human)
endomembrane systemSodium-dependent serotonin transporterHomo sapiens (human)
presynaptic membraneSodium-dependent serotonin transporterHomo sapiens (human)
membrane raftSodium-dependent serotonin transporterHomo sapiens (human)
synapseSodium-dependent serotonin transporterHomo sapiens (human)
postsynaptic membraneSodium-dependent serotonin transporterHomo sapiens (human)
serotonergic synapseSodium-dependent serotonin transporterHomo sapiens (human)
synapseSodium-dependent serotonin transporterHomo sapiens (human)
plasma membraneSodium-dependent serotonin transporterHomo sapiens (human)
neuron projectionSodium-dependent serotonin transporterHomo sapiens (human)
cytoplasmSodium-dependent dopamine transporter Homo sapiens (human)
plasma membraneSodium-dependent dopamine transporter Homo sapiens (human)
cell surfaceSodium-dependent dopamine transporter Homo sapiens (human)
membraneSodium-dependent dopamine transporter Homo sapiens (human)
axonSodium-dependent dopamine transporter Homo sapiens (human)
neuron projectionSodium-dependent dopamine transporter Homo sapiens (human)
neuronal cell bodySodium-dependent dopamine transporter Homo sapiens (human)
axon terminusSodium-dependent dopamine transporter Homo sapiens (human)
membrane raftSodium-dependent dopamine transporter Homo sapiens (human)
postsynaptic membraneSodium-dependent dopamine transporter Homo sapiens (human)
dopaminergic synapseSodium-dependent dopamine transporter Homo sapiens (human)
flotillin complexSodium-dependent dopamine transporter Homo sapiens (human)
axonSodium-dependent dopamine transporter Homo sapiens (human)
presynaptic membraneSodium-dependent dopamine transporter Homo sapiens (human)
plasma membraneSodium-dependent dopamine transporter Homo sapiens (human)
neuronal cell body membraneSodium-dependent dopamine transporter Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (122)

Assay IDTitleYearJournalArticle
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347160Primary screen NINDS Rhodamine qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347159Primary screen GU Rhodamine qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1798726FAAH Inhibition Assay (30 min Preincubation) from Article 10.1021/bi701378g: \\Novel mechanistic class of fatty acid amide hydrolase inhibitors with remarkable selectivity.\\2007Biochemistry, Nov-13, Volume: 46, Issue:45
Novel mechanistic class of fatty acid amide hydrolase inhibitors with remarkable selectivity.
AID1798724FAAH Inhibition Assay (5 min Preincubation) from Article 10.1021/bi701378g: \\Novel mechanistic class of fatty acid amide hydrolase inhibitors with remarkable selectivity.\\2007Biochemistry, Nov-13, Volume: 46, Issue:45
Novel mechanistic class of fatty acid amide hydrolase inhibitors with remarkable selectivity.
AID1798725FAAH Inhibition Assay (15 min Preincubation) from Article 10.1021/bi701378g: \\Novel mechanistic class of fatty acid amide hydrolase inhibitors with remarkable selectivity.\\2007Biochemistry, Nov-13, Volume: 46, Issue:45
Novel mechanistic class of fatty acid amide hydrolase inhibitors with remarkable selectivity.
AID1798727FAAH Inhibition Assay (60 min Preincubation) from Article 10.1021/bi701378g: \\Novel mechanistic class of fatty acid amide hydrolase inhibitors with remarkable selectivity.\\2007Biochemistry, Nov-13, Volume: 46, Issue:45
Novel mechanistic class of fatty acid amide hydrolase inhibitors with remarkable selectivity.
AID470070Antagonist activity at human TRPV1 expressed in HEK293 cells assessed as decrease in intracellular calcium level2009Bioorganic & medicinal chemistry letters, Dec-01, Volume: 19, Issue:23
Synthesis and biological evaluation of piperazinyl carbamates and ureas as fatty acid amide hydrolase (FAAH) and transient receptor potential (TRP) channel dual ligands.
AID470069Inhibition of FAAH-mediated hydrolysis of [3H]AEA in rat brain membrane at 50 uM2009Bioorganic & medicinal chemistry letters, Dec-01, Volume: 19, Issue:23
Synthesis and biological evaluation of piperazinyl carbamates and ureas as fatty acid amide hydrolase (FAAH) and transient receptor potential (TRP) channel dual ligands.
AID470071Antagonist activity at human TRPA1 expressed in HEK293 cells assessed as decrease in intracellular calcium level2009Bioorganic & medicinal chemistry letters, Dec-01, Volume: 19, Issue:23
Synthesis and biological evaluation of piperazinyl carbamates and ureas as fatty acid amide hydrolase (FAAH) and transient receptor potential (TRP) channel dual ligands.
AID470068Inhibition of FAAH-mediated hydrolysis of [3H]AEA in rat brain membrane2009Bioorganic & medicinal chemistry letters, Dec-01, Volume: 19, Issue:23
Synthesis and biological evaluation of piperazinyl carbamates and ureas as fatty acid amide hydrolase (FAAH) and transient receptor potential (TRP) channel dual ligands.
AID1363885Inhibition of recombinant human N-terminal -His6 tagged FAAH (32 to 579 residues) expressed in Escherichia coli BL21-AI preincubated for 5 mins followed by olamide substrate addition measured every 10 sec intervals for 30 mins by spectrophotometry2017Journal of medicinal chemistry, 01-12, Volume: 60, Issue:1
Therapeutic Potential of Fatty Acid Amide Hydrolase, Monoacylglycerol Lipase, and N-Acylethanolamine Acid Amidase Inhibitors.
AID412539Inhibition of rat cortex FAAH by [3H]anandamide carbon filtration assay2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Synthesis and evaluation of benzothiazole-based analogues as novel, potent, and selective fatty acid amide hydrolase inhibitors.
AID430491Inhibition of FAAH2009Bioorganic & medicinal chemistry letters, Aug-01, Volume: 19, Issue:15
Fatty acid amide hydrolase inhibitors. Surprising selectivity of chiral azetidine ureas.
AID1363884Inhibition of recombinant human N-terminal -His6 tagged FAAH (32 to 579 residues) expressed in Escherichia coli BL21 preincubated for 60 mins followed by olamide substrate addition measured every 10 sec intervals for 30 mins by spectrophotometry2017Journal of medicinal chemistry, 01-12, Volume: 60, Issue:1
Therapeutic Potential of Fatty Acid Amide Hydrolase, Monoacylglycerol Lipase, and N-Acylethanolamine Acid Amidase Inhibitors.
AID496828Antimicrobial activity against Leishmania donovani2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID275447Selectivity for human DAT over human NET in radio ligand binding assay2007Journal of medicinal chemistry, Jan-25, Volume: 50, Issue:2
Slow-onset, long-duration, alkyl analogues of methylphenidate with enhanced selectivity for the dopamine transporter.
AID120997Compound was tested at subtoxic dose of 25 mg/kg in mice; Symptoms are hyperactivity, irritability, stereotypy.2003Journal of medicinal chemistry, Jan-02, Volume: 46, Issue:1
New benzo[h][1,6]naphthyridine and azepino[3,2-c]quinoline derivatives as selective antagonists of 5-HT4 receptors: binding profile and pharmacological characterization.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1184914Displacement of [3H]WIN 35,428 from human DAT expressed in HEK293E cells after 1 hr by liquid scintillation counting2014ACS medicinal chemistry letters, Jul-10, Volume: 5, Issue:7
Design and synthesis of 4-heteroaryl 1,2,3,4-tetrahydroisoquinolines as triple reuptake inhibitors.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID195887Ability to inhibit the uptake of dopamine [3H]DA in to rat brain synaptosomes1998Journal of medicinal chemistry, Feb-12, Volume: 41, Issue:4
Asymmetric synthesis and pharmacology of methylphenidate and its para-substituted derivatives.
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID65807Tested for the ability to bind stereoselectively and enantioselectively to the dopamine transporter (DAT); Value ranges from 34 - 83 nM2003Journal of medicinal chemistry, Apr-10, Volume: 46, Issue:8
Synthesis and evaluation of dopamine and serotonin transporter inhibition by oxacyclic and carbacyclic analogues of methylphenidate.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID64208Inhibition of [3H]WIN-35428 Binding to the Dopamine Transporter in Rhesus (Macaca mulatta) orCynomolgus Monkey (Macaca fascicularis) Caudate-Putamen2003Journal of medicinal chemistry, Apr-10, Volume: 46, Issue:8
Synthesis and evaluation of dopamine and serotonin transporter inhibition by oxacyclic and carbacyclic analogues of methylphenidate.
AID111826Ability to reverse electroconvulsive shock induced amnesia in mice, after administering intraperitoneally at a dose of 1.25 mg/kg1984Journal of medicinal chemistry, May, Volume: 27, Issue:5
Amnesia-reversal activity of a series of N-[(disubstituted-amino)alkyl] -2-oxo-1-pyrrolidineacetamides, including pramiracetam.
AID275448Selectivity for human DAT over human NET in radio ligand uptake assay2007Journal of medicinal chemistry, Jan-25, Volume: 50, Issue:2
Slow-onset, long-duration, alkyl analogues of methylphenidate with enhanced selectivity for the dopamine transporter.
AID275444Inhibition of [3H]5-HT uptake into human SERT expressing HEK293 cells2007Journal of medicinal chemistry, Jan-25, Volume: 50, Issue:2
Slow-onset, long-duration, alkyl analogues of methylphenidate with enhanced selectivity for the dopamine transporter.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID603953In-vivo plasma to lung partition coefficients of the compound, logP(lung) in rat2008European journal of medicinal chemistry, Mar, Volume: 43, Issue:3
Air to lung partition coefficients for volatile organic compounds and blood to lung partition coefficients for volatile organic compounds and drugs.
AID275443Displacement of [125I]RTI-55 from human SERT expressing HEK293 cells2007Journal of medicinal chemistry, Jan-25, Volume: 50, Issue:2
Slow-onset, long-duration, alkyl analogues of methylphenidate with enhanced selectivity for the dopamine transporter.
AID1597737Half life in human at 20 mg2019Bioorganic & medicinal chemistry letters, 08-15, Volume: 29, Issue:16
Sleep modulating agents.
AID395325Lipophilicity, log P by microemulsion electrokinetic chromatography2009Journal of medicinal chemistry, Mar-26, Volume: 52, Issue:6
Relationship between brain tissue partitioning and microemulsion retention factors of CNS drugs.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID497005Antimicrobial activity against Pneumocystis carinii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID118787Retention for passive avoidance learning in mice at dose 1.25 mg/kg1981Journal of medicinal chemistry, Mar, Volume: 24, Issue:3
Cognition-activating properties of 3-(Aryloxy)pyridines.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID118790Retention for passive avoidance learning in mice at dose 20 mg/kg1981Journal of medicinal chemistry, Mar, Volume: 24, Issue:3
Cognition-activating properties of 3-(Aryloxy)pyridines.
AID496826Antimicrobial activity against Entamoeba histolytica2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID111828Ability to reverse electroconvulsive shock (ECS) induced amnesia in mice, after administering intraperitoneally, at a dose of 10.0 mg/kg1984Journal of medicinal chemistry, May, Volume: 27, Issue:5
Amnesia-reversal activity of a series of N-[(disubstituted-amino)alkyl] -2-oxo-1-pyrrolidineacetamides, including pramiracetam.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID496827Antimicrobial activity against Leishmania amazonensis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496832Antimicrobial activity against Trypanosoma brucei rhodesiense2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID496820Antimicrobial activity against Trypanosoma brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID118789Retention for passive avoidance learning in mice at dose 2.5 mg/kg1981Journal of medicinal chemistry, Mar, Volume: 24, Issue:3
Cognition-activating properties of 3-(Aryloxy)pyridines.
AID111834Ability to reverse electroconvulsive shock induced amnesia in mice, after administering intraperitoneally at a dose of 20.0 mg/kg1984Journal of medicinal chemistry, May, Volume: 27, Issue:5
Amnesia-reversal activity of a series of N-[(disubstituted-amino)alkyl] -2-oxo-1-pyrrolidineacetamides, including pramiracetam.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID275445Displacement of [125I]RTI-55 from human NET expressing HEK293 cells2007Journal of medicinal chemistry, Jan-25, Volume: 50, Issue:2
Slow-onset, long-duration, alkyl analogues of methylphenidate with enhanced selectivity for the dopamine transporter.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496817Antimicrobial activity against Trypanosoma cruzi2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID588210Human drug-induced liver injury (DILI) modelling dataset from Ekins et al2010Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 38, Issue:12
A predictive ligand-based Bayesian model for human drug-induced liver injury.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496818Antimicrobial activity against Trypanosoma brucei brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID496830Antimicrobial activity against Leishmania major2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID539464Solubility of the compound in 0.1 M phosphate buffer at 600 uM at pH 7.4 after 24 hrs by LC/MS/MS analysis2010Bioorganic & medicinal chemistry letters, Dec-15, Volume: 20, Issue:24
Experimental solubility profiling of marketed CNS drugs, exploring solubility limit of CNS discovery candidate.
AID111830Ability to reverse electroconvulsive shock induced amnesia in mice, after administering intraperitoneally at a dose of 2.5 mg/kg1984Journal of medicinal chemistry, May, Volume: 27, Issue:5
Amnesia-reversal activity of a series of N-[(disubstituted-amino)alkyl] -2-oxo-1-pyrrolidineacetamides, including pramiracetam.
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID395327Dissociation constant, pKa by capillary electrophoresis2009Journal of medicinal chemistry, Mar-26, Volume: 52, Issue:6
Relationship between brain tissue partitioning and microemulsion retention factors of CNS drugs.
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID496819Antimicrobial activity against Plasmodium falciparum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID395324Lipophilicity, log D at pH 7.4 by liquid chromatography2009Journal of medicinal chemistry, Mar-26, Volume: 52, Issue:6
Relationship between brain tissue partitioning and microemulsion retention factors of CNS drugs.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID496831Antimicrobial activity against Cryptosporidium parvum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID409956Inhibition of mouse brain MAOB2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID420090Ratio of Ki for [3H]dopamine uptake at rat dopamine transporter expressed in CHO cells to Ki for displacement of [3H]WIN-35428 from rat dopamine transporter expressed in CHO cells2009Bioorganic & medicinal chemistry, Jun-01, Volume: 17, Issue:11
A novel photoaffinity ligand for the dopamine transporter based on pyrovalerone.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID275446Inhibition of [3H]NE uptake into human NET expressing HEK293 cells2007Journal of medicinal chemistry, Jan-25, Volume: 50, Issue:2
Slow-onset, long-duration, alkyl analogues of methylphenidate with enhanced selectivity for the dopamine transporter.
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID496825Antimicrobial activity against Leishmania mexicana2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID298031Lipophilicity, log D at pH7.42007Journal of medicinal chemistry, Sep-20, Volume: 50, Issue:19
High-throughput screening of drug-brain tissue binding and in silico prediction for assessment of central nervous system drug delivery.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID275441Displacement of [125I]RTI-55 from human DAT expressing HEK293 cells2007Journal of medicinal chemistry, Jan-25, Volume: 50, Issue:2
Slow-onset, long-duration, alkyl analogues of methylphenidate with enhanced selectivity for the dopamine transporter.
AID1184915Displacement of [3H]Nisoxetine from human NET expressed in HEK293E cells after 1 hr by liquid scintillation counting2014ACS medicinal chemistry letters, Jul-10, Volume: 5, Issue:7
Design and synthesis of 4-heteroaryl 1,2,3,4-tetrahydroisoquinolines as triple reuptake inhibitors.
AID111841Ability to reverse electroconvulsive shock induced amnesia in mice, after administering intraperitoneally at a dose of 5 mg/kg1984Journal of medicinal chemistry, May, Volume: 27, Issue:5
Amnesia-reversal activity of a series of N-[(disubstituted-amino)alkyl] -2-oxo-1-pyrrolidineacetamides, including pramiracetam.
AID496829Antimicrobial activity against Leishmania infantum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496824Antimicrobial activity against Toxoplasma gondii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID203945Inhibition of [3H]citalopram Binding to the Serotonin Transporter in Rhesus (Macaca mulatta) or Cynomolgus Monkey (Macaca fascicularis) Caudate-Putamen2003Journal of medicinal chemistry, Apr-10, Volume: 46, Issue:8
Synthesis and evaluation of dopamine and serotonin transporter inhibition by oxacyclic and carbacyclic analogues of methylphenidate.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID118793Retention for passive avoidance learning in mice at dose 5 mg/kg1981Journal of medicinal chemistry, Mar, Volume: 24, Issue:3
Cognition-activating properties of 3-(Aryloxy)pyridines.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID588209Literature-mined public compounds from Greene et al multi-species hepatotoxicity modelling dataset2010Chemical research in toxicology, Jul-19, Volume: 23, Issue:7
Developing structure-activity relationships for the prediction of hepatotoxicity.
AID275442Inhibition of [3H]DA uptake at human DAT expressing HEK293 cells2007Journal of medicinal chemistry, Jan-25, Volume: 50, Issue:2
Slow-onset, long-duration, alkyl analogues of methylphenidate with enhanced selectivity for the dopamine transporter.
AID416532Acute toxicity in NMRI mouse assessed as behavioral changes at 25 mg/kg, ip by CNS activity test2009Bioorganic & medicinal chemistry, Mar-15, Volume: 17, Issue:6
Novel antagonists of serotonin-4 receptors: synthesis and biological evaluation of pyrrolothienopyrazines.
AID496823Antimicrobial activity against Trichomonas vaginalis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID118788Compound was tested for cognitive activity by measuring retention for passive avoidance learning in mice at dose 10 mg/kg1981Journal of medicinal chemistry, Mar, Volume: 24, Issue:3
Cognition-activating properties of 3-(Aryloxy)pyridines.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID298032Acid dissociation constant, pKa of the compound2007Journal of medicinal chemistry, Sep-20, Volume: 50, Issue:19
High-throughput screening of drug-brain tissue binding and in silico prediction for assessment of central nervous system drug delivery.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID195888Ability to inhibit the uptake of norepinephrine [3H]-NE in to rat brain synaptosomes1998Journal of medicinal chemistry, Feb-12, Volume: 41, Issue:4
Asymmetric synthesis and pharmacology of methylphenidate and its para-substituted derivatives.
AID1184913Displacement of [3H]Citolapram from human SERT expressed in HEK293E cells after 1 hr by liquid scintillation counting2014ACS medicinal chemistry letters, Jul-10, Volume: 5, Issue:7
Design and synthesis of 4-heteroaryl 1,2,3,4-tetrahydroisoquinolines as triple reuptake inhibitors.
AID640615Clearance in human liver microsomes at 1 uM measured after 60 mins by HPLC analysis2012Bioorganic & medicinal chemistry letters, Jan-15, Volume: 22, Issue:2
Capture hydrolysis signals in the microsomal stability assay: molecular mechanisms of the alkyl ester drug and prodrug metabolism.
AID409954Inhibition of mouse brain MAOA2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID496821Antimicrobial activity against Leishmania2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1346963Human DAT (Monoamine transporter subfamily)2007Journal of medicinal chemistry, Jan-25, Volume: 50, Issue:2
Slow-onset, long-duration, alkyl analogues of methylphenidate with enhanced selectivity for the dopamine transporter.
AID493017Wombat Data for BeliefDocking2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Synthesis of methylphenidate analogues and their binding affinities at dopamine and serotonin transport sites.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (7,354)

TimeframeStudies, This Drug (%)All Drugs %
pre-19901804 (24.53)18.7374
1990's732 (9.95)18.2507
2000's1882 (25.59)29.6817
2010's2334 (31.74)24.3611
2020's602 (8.19)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 122.09

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index122.09 (24.57)
Research Supply Index9.16 (2.92)
Research Growth Index4.72 (4.65)
Search Engine Demand Index232.48 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (122.09)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials0 (0.00%)5.53%
Trials1,698 (21.82%)5.53%
Reviews1 (11.11%)6.00%
Reviews932 (11.97%)6.00%
Case Studies0 (0.00%)4.05%
Case Studies721 (9.26%)4.05%
Observational0 (0.00%)0.25%
Observational51 (0.66%)0.25%
Other8 (88.89%)84.16%
Other4,381 (56.29%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (408)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomized, Open-label, Single-dose, Three-way Crossover Study to Determine the Relative Pharmacokinetic Profile of Oral Doses of CONCERTA Tablets, Ritalin-SR Tablets and Novo-Methylphenidate ER-CTablets Under Fasted Condition in Healthy Subjects [NCT01118702]Phase 130 participants (Actual)Interventional2010-05-31Completed
COST-EFFECTIVENESS STUDY OF THE TREATMENT OF ATTENTION DEFICIT/HYPERACTIVITY DISORDER IN BRAZIL [NCT01228604]Phase 423 participants (Actual)Interventional2010-12-31Completed
ADHD Treatment: Comparative and Combined Dosage Effects [NCT00050622]154 participants (Actual)Interventional2001-09-30Completed
Randomized Controlled Trial of Osmotic-Release Methylphenidate (OROS-MPH) for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD) [NCT00264797]Phase 3303 participants (Actual)Interventional2006-02-28Completed
Phase 1, Single-dose, Double-blind, Rand., Placebo- and Active-controlled, 4-period, 4-sequence Crossover, Proof-of-Concept Study to Evaluate Effect of Naltrexone on Abuse Potential of Methylphenidate in Healthy Recreational Stimulant Users [NCT03769064]Phase 194 participants (Actual)Interventional2018-03-27Completed
Effect of Central Nervous System Stimulants on Physical Function in Children With Cerebral Palsy: A Pilot Randomized Controlled Trial [NCT05675098]Early Phase 130 participants (Anticipated)Interventional2023-05-01Not yet recruiting
Bariatric Surgery and Pharmacokinetics Methylphenidate: BAR-MEDS Methylphenidate [NCT03440190]12 participants (Anticipated)Observational2018-01-02Recruiting
Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance During the Quantified Behavior Test in Patients With Untreated ADHD and Substance Use Disorder [NCT02477280]Phase 439 participants (Actual)Interventional2016-09-30Completed
A Novel Drug Combination for Alcohol-Use Disorders: A Human Laboratory Study [NCT03575403]Phase 119 participants (Actual)Interventional2018-09-01Completed
Phase Ia/Ib Study of Normal Healthy Volunteer Clinical Trial of a Novel Ondansetron Formulation [NCT01290276]Phase 16 participants (Actual)Interventional2010-12-31Completed
Amantadine VS Ritalin in the Treatment of ADHD: a Double Blind Randomized Trial [NCT01099059]Phase 240 participants (Anticipated)Interventional2010-04-30Recruiting
Efficacy and Learning Skill After OROS Methylphenidate Treatment in Adolescents With Attention-Deficit/Hyperactivity Disorder: A 12-week, Multi-center, Open-label Study [NCT01060150]Phase 4115 participants (Actual)Interventional2008-07-31Completed
Electroencephalogram Study of Intravenous Methylphenidate-Induced Emergence From Propofol Sedation [NCT03610282]Phase 1/Phase 20 participants (Actual)Interventional2019-11-30Withdrawn(stopped due to We have decided to withdraw the study prior to enrollment of the first participant in order to pursue other research studies.)
Genetic Modulation of Functional Brain Activity of Attention-deficit/Hyperactivity Disorder-related Working Memory Processes [NCT01351272]Phase 341 participants (Actual)Interventional2011-05-31Completed
Adaptive Response to Intervention (RTI) for Students With ADHD [NCT03511976]Phase 4300 participants (Anticipated)Interventional2018-05-14Recruiting
Multimodal Therapy for the Treatment of Sleep Disturbance in Patients With Cancer [NCT01628029]Phase 268 participants (Actual)Interventional2014-01-15Active, not recruiting
Stimulant Effects on Brain Activity During the Stop Signal Task [NCT02453698]Phase 119 participants (Actual)Interventional2011-01-31Completed
Stimulant Therapy Targeted to Individualized Connectivity Maps to Promote ReACTivation of Consciousness - A Phase 1 Study [NCT03814356]Phase 122 participants (Anticipated)Interventional2020-08-24Recruiting
TAME-PD - Physical Therapy, Atomoxetine and, Methylphenidate, to Enhance Gait and Balance in Parkinson's Disease: A Single Center, Randomized Pilot Study [NCT02879136]Early Phase 142 participants (Anticipated)Interventional2016-12-31Recruiting
Patient Controlled Administration of Methylphenidate for Cancer Related Fatigue [NCT02361125]Phase 131 participants (Actual)Interventional2002-08-01Completed
A Study to Identify the Peripheral Biomarkers of Symptomatology, Neurocognitive Functions, and Medication Response in Attention Deficit Hyperactivity Disorder [NCT02074228]Phase 4120 participants (Anticipated)Interventional2012-08-31Recruiting
Effects of Modulation of the Dopaminergic System Using Methylphenidate on Memory and Executive Processes in Individuals With 22q11.2 Deletion Syndrome [NCT04647500]45 participants (Actual)Interventional2016-08-26Completed
Methylphenidate for Depressed Cancer Patients in Hospice [NCT00129467]47 participants (Actual)Interventional2005-02-28Completed
A Phase 4, Open-label, Safety, Tolerability And Pharmacokinetic Study Of Methylphenidate Hydrochloride (Hcl) Extended Release Chewable Tablet (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd) [NCT03546400]Phase 40 participants (Actual)Interventional2018-09-25Withdrawn(stopped due to The study was cancelled prior to the enrollment of any participants.)
Investigating the Impact of Methylphenidate on Neural Response in Disruptive Behavioral Disorder [NCT02247986]Phase 1/Phase 20 participants (Actual)Interventional2014-09-04Withdrawn
A 6-month, Open-label Extension to a 40-week, Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in the Treatment of Adult Patients With Childhood-onset ADHD [NCT01338818]Phase 3299 participants (Actual)Interventional2011-04-30Completed
Efficacy of Careful Medication and Tailored Case Management Follow up Treatment for Children With Attention Deficit Hyperactivity Disorder [NCT02142140]326 participants (Anticipated)Interventional2012-12-31Active, not recruiting
An Open-label, Single-Ascending-Dose Study to Investigate the Pharmacokinetics and Safety of CONCERTA in Healthy Japanese Adult Male Subjects [NCT01202734]Phase 110 participants (Actual)Interventional2010-09-30Completed
Evaluating Safety and Potential Benefit of Methylphenidate as a Symptomatic Treatment for Apathy in Veterans With Parkinson's Disease. [NCT05669170]Phase 260 participants (Anticipated)Interventional2024-01-31Not yet recruiting
Oxytocin and Social Cognition in Children With Attention Deficit Hyperactivity Disorder: Impact of Methylphenidate [NCT03788902]90 participants (Actual)Interventional2014-02-01Completed
Assessing the Efficacy of Immediate Release Methylphenidate, Sustained Release Methylphenidate and Modafinil for Patients With Brain Tumors [NCT00418691]Phase 334 participants (Actual)Interventional2004-02-29Terminated(stopped due to Closed early due to slow accrual.)
Étude Pilote de Phase II Sur l'Effet du méthylphénidate Sur la Fonction Cognitive Des Patientes en rémission d'un Cancer du Sein [NCT02970500]Phase 220 participants (Actual)Interventional2017-10-09Terminated(stopped due to We decided to close recruitment in December 2022 as we were having trouble recruiting participants who met our inclusion criteria and the study funding was coming to an end.)
A Six-month, Open-label, Multi-center Study of the Safety and Efficacy of PRC-063 in Adults and Adolescents With ADHD [NCT02168127]Phase 3360 participants (Actual)Interventional2014-05-31Completed
The Effects of Long-acting Methylphenidate on Academic Activity and Related Constructs in Children With ADHD: A Randomised Placebo Controlled Trial [NCT02501798]Phase 461 participants (Anticipated)Interventional2013-01-31Completed
The Effects of Methylphenidate on the Cognitive Function of Older People With Mild Cognitive Impairment: a Randomized, Placebo Controlled, Double-blind Trial. [NCT02180529]16 participants (Actual)Interventional2015-11-30Terminated(stopped due to recruiting difficulties)
Brain Connectivity in Attention Deficit Hyperactivity Disorder (ADHD): a Biomarker to Predict Treatment Response [NCT03709940]60 participants (Actual)Interventional2013-05-03Completed
Precision Functional Brain Mapping to Understand the Mechanisms of Psilocybin [NCT04501653]Early Phase 125 participants (Anticipated)Interventional2021-06-01Active, not recruiting
Repetitive Transcranial Magnetic Stimulation for Apathy Clinical Trial (REACT) [NCT05561205]8 participants (Anticipated)Interventional2023-02-09Recruiting
Neuropsychological, Genetic and Neuroimaging Markers and Treatment Response Predictors of Attention-Deficit/Hyperactivity Disorder (ADHD) [NCT02430896]600 participants (Anticipated)Observational2015-02-28Recruiting
Ph 3 Multicenter DBRCT Parallel Group Study to Evaluate Safety & Efficacy of Evening-dosed HLD200, a Novel Delayed & Extended Release Formulation (DELEXIS) of MPH HCl, on Post-waking, Early Morning Function in Children Aged 6-12 With ADHD [NCT02520388]Phase 3163 participants (Actual)Interventional2015-08-31Completed
Diagnostic Utility of ADHD by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials [NCT01063153]Phase 471 participants (Actual)Interventional2009-09-30Completed
The Characteristics of Prepulse Inhibition in Children and Adolescents Suffering From Attention Deficit Disorder: With and Without Medication. [NCT02344784]46 participants (Actual)Observational2015-01-31Active, not recruiting
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants [NCT03511118]1,600 participants (Anticipated)Observational2018-10-04Recruiting
A Phase 4, Double-blind, Randomized, Parallel Group, Placebo-controlled Study Of The Efficacy And Safety Of Methylphenidate Hydrochloride (Hcl) Extended Release Chewable Tablet (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder [NCT03536390]Phase 40 participants (Actual)Interventional2018-09-19Withdrawn(stopped due to The study was cancelled prior to the enrollment of any participants.)
PHASE IIA: Randomized, Double Blind, Placebo Controlled, Single Center Clinical Trial of a Combination of a Novel Ondansetron Formulation (OND-PR002) and Immediate-Release Methylphenidate (Ritalin®) [NCT01377662]Phase 230 participants (Actual)Interventional2011-08-31Completed
A Novel Drug Combination as a Pharmacotherapeutic for Methamphetamine-Use Disorder [NCT04178993]Phase 18 participants (Actual)Interventional2019-09-01Completed
Symptomatic Treatment of Vascular Cognitive Impairment [NCT02098824]Phase 2/Phase 330 participants (Anticipated)Interventional2014-02-28Recruiting
A Randomized Controlled Trial of Methylphenidate and a Nursing Telephone Intervention (NTI) for Fatigue in Advanced Cancer Patients [NCT00424099]Phase 2/Phase 3197 participants (Actual)Interventional2007-01-09Completed
Does Serotonin System Stimulation Increase Pro-social Behavior? - A Comparative Pharmacological Neuroscientific Study in Healthy Humans [NCT06081179]Phase 1120 participants (Anticipated)Interventional2023-10-24Recruiting
A Phase 4, Double-blind, Randomized, Parallel Group, Placebo-controlled Study Of The Efficacy And Safety Of Quillichew (Methylphenidate Hydrochloride (Hcl)) Extended Release Chewable Tablets (Erct) In 4-5 Year Old Children With Attention Deficit Hyperacti [NCT03580005]Phase 40 participants (Actual)Interventional2018-10-31Withdrawn(stopped due to The study was cancelled prior to the enrollment of any participants.)
Effect of Methylphenidate on Ecologic Function in Paediatric Acquired Brain Injury Population [NCT02227056]Phase 234 participants (Actual)Interventional2014-01-31Completed
Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk [NCT03781765]Phase 444 participants (Anticipated)Interventional2019-06-04Recruiting
Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD [NCT03781752]Phase 4500 participants (Anticipated)Interventional2018-03-04Enrolling by invitation
Added Value of the Oculomotor and Cognitive Examination in the Management of Patients With Attention Deficit Disorder With or Without Hyperactivity. Interventional Study to Evaluate Current Care [NCT03411434]90 participants (Anticipated)Interventional2014-02-17Recruiting
A Phase I/II, Single Center, Single-Treatment, Open-Label, Adaptive Clinical Trial Design Examining the Pharmacokinetic Effects of up to Two Separate HLD200 Modified Release Formulations of Methylphenidate in Adolescent and Pediatric Subjects With ADHD [NCT01907360]Phase 1/Phase 229 participants (Actual)Interventional2013-08-31Completed
Impact of CES1 Genotype on Metabolism of Methylphenidate [NCT02147535]Phase 478 participants (Actual)Interventional2014-03-31Completed
Dopamine Receptor Imaging to Predict Response to Stimulant Therapy in Chronic TBI [NCT02148783]Phase 211 participants (Actual)Interventional2014-09-30Terminated(stopped due to Recruitment was slower than anticipated. Incomplete neuropsychological outcome measures obtained.)
Efficacy and Safety of Transdermal Methylphenidate for Cancer-Related Fatigue [NCT01124500]0 participants (Actual)Interventional2010-05-31Withdrawn
Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD [NCT01220440]Phase 436 participants (Actual)Interventional2006-01-31Completed
[NCT01124032]30 participants (Anticipated)Interventional2010-05-31Not yet recruiting
Efficacy of Cognitive Behavioral Therapy in Treatment of Adults With Attention Deficit Hyperactivity Disorder [NCT02210728]200 participants (Anticipated)Interventional2006-04-30Active, not recruiting
A Randomized, Double Blind, Placebo Controlled Trial To Study Difference In Cognitive Learning Associated With Repeated Self-administration Of Remote Computer Tablet-based Application Assessing Dual-task Performance Based On Amyloid Status In Healthy Elde [NCT02265718]97 participants (Actual)Observational2014-09-30Completed
A Phase II, Open-Label Co-Administration Study of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD) [NCT00151996]Phase 275 participants (Actual)Interventional2004-08-16Completed
Randomized Placebo-Controlled Trial of Methylphenidate for the Treatment of Post-Traumatic Stress Disorder With Associated Neurocognitive Complaints [NCT05776056]Phase 470 participants (Anticipated)Interventional2023-12-04Not yet recruiting
[NCT01130467]150 participants (Anticipated)Observational2009-09-30Recruiting
Influence of Methylphenidate and Duloxetine Maintenance on Pharmacodynamic Effects of Cocaine [NCT03519022]Early Phase 19 participants (Actual)Interventional2018-06-01Completed
The Influence of Dopamine Activity on Neuromuscular Function During Passive Heat Stress [NCT03515668]6 participants (Actual)Interventional2018-04-20Active, not recruiting
Train Your Brain? Exercise and Neurofeedback Intervention for ADHD [NCT01363544]Phase 2/Phase 3112 participants (Actual)Interventional2010-06-30Completed
The Neuroprotective Effects of Methylphenidate and Atomoxetine in Children With Attention Deficit Hyperactivity Disorder: A Lipidomic Study [NCT03936491]105 participants (Anticipated)Interventional2019-08-01Not yet recruiting
Dopaminergic Modulation of Cognition and Psychomotor Function [NCT01218425]20 participants (Actual)Interventional2010-11-30Completed
Large-scale Brain Organization During Cognitive Control in ADHD [NCT04349917]Phase 437 participants (Actual)Interventional2016-12-16Completed
Quality Assurance of Administering Methylphenidate in Adults With ADHD [NCT00730249]Phase 3150 participants (Anticipated)Interventional2008-09-30Completed
Comparison of Modafinil and Methylphenidate in Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's Disease [NCT00393562]0 participants (Actual)Interventional2006-03-31Withdrawn(stopped due to Unable to recruit any subjects for this study)
Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Methamphetamine and Osmotic-Release Methylphenidate (OROS-MPH) [NCT00603434]Phase 116 participants (Anticipated)Interventional2008-01-31Completed
A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study to Evaluate Efficacy and Safety of Prolonged Release (PR) OROS Methylphenidate (54 and 72 mg/Day) in Adults With Attention Deficit/Hyperactivity Disorder [NCT00714688]Phase 3279 participants (Actual)Interventional2008-02-29Completed
Placebo Controlled Double Blind Study With Methylphenidate in Treatment of Adults With Cancer-Related Fatigue [NCT00758407]Phase 2/Phase 366 participants (Anticipated)Interventional2006-08-31Completed
EEG-MRI Study of the Effect of Methylphenidate on Neural Mechanisms in Adult Patients With ADHD With or Without Mood Disorders: a Randomized Controlled Trial Versus Placebo [NCT05832489]Phase 380 participants (Anticipated)Interventional2023-10-01Not yet recruiting
Differences by Sex and Genotype in the Effects of Stress on Executive Functions [NCT04273880]Phase 1146 participants (Anticipated)Interventional2018-04-28Recruiting
Studying the Role of Brain Molecules for Decision Making [NCT04384562]160 participants (Anticipated)Interventional2020-12-17Recruiting
NWP06 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)- A Laboratory Classroom Study [NCT00904670]Phase 345 participants (Actual)Interventional2009-04-30Completed
Stimulant Drug Treatment of AD/HD, Inattentive Type [NCT00824317]25 participants (Actual)Interventional2001-10-31Completed
The Reinforcing Mechanisms of Smoking in Adult ADHD [NCT00573859]Phase 1/Phase 227 participants (Actual)Interventional2006-09-30Completed
Targeting Neural, Behavioral and Pharmacological Mechanisms of Drug Memories in Drug Addiction With Methylphenidate [NCT05978167]Early Phase 150 participants (Anticipated)Interventional2023-07-05Recruiting
Irritability in Children With ADHD and Emotion Dysregulation: Clinical Profiles, Neuropsychological Characteristics , and Pharmacological Treatment: A Cross-over Study [NCT05974241]Phase 436 participants (Actual)Interventional2017-04-21Completed
Methylphenidate Effect on Performing Humphrey Visual Fields [NCT02162381]32 participants (Actual)Interventional2014-06-30Completed
Effectiveness of a Personalized Neurofeedback Training Device (ADHD@Home) as Compared With Methylphenidate in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: A Multicentre Randomized Clinical Study [NCT02778360]Phase 1/Phase 2179 participants (Anticipated)Interventional2016-08-31Recruiting
Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance During the Quantified Behavior Test in Patients With Untreated ADHD [NCT02473185]Phase 440 participants (Actual)Interventional2015-09-30Completed
Assessing Cognitive Performance Among Adults With Attention Disorders Working on Treadmill [NCT05243186]Phase 2/Phase 330 participants (Anticipated)Interventional2021-10-01Recruiting
Effects of Modafinil, Caffeine and Methylphenidate on Functional Brain Activity and Cognitive Performance in Healthy Volunteers: a Randomized, Placebo-controlled, Double-blind fMRI Study [NCT02071615]48 participants (Actual)Interventional2013-08-31Completed
Metabolism of Methylphenidate and Enalapril Based on CES1 Genotype [NCT02135263]Phase 444 participants (Actual)Interventional2012-04-30Completed
The Assessment of Efficacy and Tolerability of Methylphenidate vs. Risperidone in the Treatment of Children and Adolescents With ADHD and Disruptive Disorders [NCT02063945]Phase 45 participants (Actual)Interventional2017-02-01Terminated(stopped due to Major difficulties recruiting participants)
Exploration of the Metabolic Mechanisms of the Electrophysiological Biomarkers for Response to Methylphenidate Treatment in Children With Attention-Deficit/Hyperactivity Disorder [NCT06073470]160 participants (Anticipated)Observational2024-01-01Not yet recruiting
Dopaminergic Modulation of Brain Activation Using Simultaneous PET/Pharmacological MRI [NCT03326245]Phase 140 participants (Anticipated)Interventional2018-01-29Enrolling by invitation
A Double-Blind Comparison of Concerta and Placebo in Adults With Attention Deficit Hyperactivity Disorder [NCT00181571]Phase 4297 participants (Actual)Interventional2003-06-30Completed
[NCT02194075]Phase 460 participants (Actual)Interventional2013-10-31Completed
Biomarkers of ADHD Treatment Response [NCT05650775]Phase 130 participants (Anticipated)Interventional2023-02-17Recruiting
Measuring and Predicting Response to Atomoxetine and Methylphenidate [NCT00183391]Phase 4232 participants (Actual)Interventional2005-07-31Completed
Applied Physiology of Oxygen Toxicity: Mechanisms in Humans [NCT05761756]62 participants (Anticipated)Interventional2024-02-29Not yet recruiting
Concerta in the Treatment of Adult ADHD and a Comparison of Four Adult ADHD Scales and Effects on Personality [NCT02215538]Phase 2/Phase 347 participants (Actual)Interventional2004-11-30Completed
A Phase IIIb, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Efficacy and Safety of MTS in Adolescents Aged 13-17 Years With ADHD [NCT00499863]Phase 3217 participants (Actual)Interventional2007-07-31Completed
Phase III Study of Autism Co-Morbid for Attention Deficit Hyperactivity Disorder [NCT00541346]Phase 316 participants (Actual)Interventional2007-09-30Completed
An Open-label, Behavioral-treatment-controlled Evaluation of the Effects of Extended Release Methylphenidate on the Frequency of Cytogenetic Abnormalities in Children 6 - 12 Years of Age With Attention Deficit Hyperactivity Disorder (ADHD) [NCT00409708]Phase 2142 participants (Actual)Interventional2006-11-30Completed
Sustained-Release Methylphenidate for Management of Methamphetamine Dependence [NCT01044238]Phase 290 participants (Anticipated)Interventional2010-10-31Active, not recruiting
Methylphenidate (Ritalin) and Memory/Attention in Traumatic Brain Injury (TBI) [NCT00453921]76 participants (Actual)Interventional2007-02-28Completed
Evaluating Assessment and Medication Treatment of ADHD in Children With Down Syndrome [NCT04219280]Phase 4100 participants (Anticipated)Interventional2020-10-02Recruiting
A Phase IV, Multi-center, Open-label Study of DAYTRANA (Methylphenidate Transdermal System [MTS]) to Characterize the Dermal Reactions in Pediatric Patients Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD). [NCT00434213]Phase 4309 participants (Actual)Interventional2007-01-31Completed
Carnitine as an Adjunct to Methylphenidate for the Treatment of Attention Deficit Hyperactivity Disorder Children and Adolescents in the Placebo Control Double -Blind Randomized Clinical Trail [NCT01099072]Phase 240 participants (Anticipated)Interventional2010-04-30Enrolling by invitation
The Effects of Methylphenidate on the Reduction of Food Energy Intake and on the Augmentation of Energy Expenditure [NCT02754258]Phase 340 participants (Anticipated)Interventional2017-01-31Recruiting
Early Interventions in Children With Attention Deficit/Hyperactivity Disorder: Randomized Controlled Trial Comparing Methylphenidate Parental Training in Treating Preschool Children With Attention Deficit / Hyperactivity Disorder [NCT02807870]Phase 4153 participants (Actual)Interventional2016-06-30Completed
Comparison of the Effects of Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control on Executive Functions and Clinical Symptoms of Attention Deficit/ Hyperactivity Disorder [NCT02780102]48 participants (Actual)Interventional2015-09-30Completed
Concerta-to-Generic Switch Study [NCT02730572]1,464 participants (Actual)Observational2015-09-30Completed
Imaging of Dopamine Systems in Anorexia Nervosa [NCT00670293]50 participants (Actual)Observational2008-07-31Completed
Does Methylphenidate, Prescribed for Attention Deficit Disorder, Influence Primary Enuresis in These Children? [NCT02699528]50 participants (Anticipated)Observational2016-05-31Recruiting
Treatments for Fathers With Attention Deficit/Hyperactivity Disorder (ADHD) and Their At-Risk Children (Fathers Too) [NCT02675400]Phase 419 participants (Actual)Interventional2015-12-31Completed
Fatigue in Sarcoidosis - A Feasibility Study Investigating the Treatment of Fatigue in Stable Sarcoidosis Patients Using Methylphenidate [NCT02643732]30 participants (Anticipated)Interventional2016-11-30Recruiting
Acute Effect of Three Neuroactive Drugs on Brain Activity Measured by MEG, EEG and the Synchronous Neural Interaction Test [NCT00972985]15 participants (Anticipated)Interventional2009-09-30Completed
Suicidality, Psychosis or Substance Abuse With Methylphenidate, Atomoxetine, Amphetamine/Dextroamphetamine or Lisdexamfetamine, a Post-authorization Safety Study [NCT04132557]430,000 participants (Actual)Observational2019-10-09Completed
Pediatric Attention Deficit Hyperactivity Disorder: Predicting Clinical Response to Stimulant Medication From Single-dose Changes in Event Related Potentials [NCT02695355]Phase 287 participants (Actual)Interventional2006-10-31Completed
Effect of Methylphenidate Formulation on ADHD-patients' Adherence to Medical Treatment. A Comparison of Medikinet Retard® (ER) Once Daily and Medikinet® (IR) Twice Daily in Children and Adolescents Diagnosed With ADHD [NCT00852059]Phase 432 participants (Actual)Interventional2009-03-31Terminated(stopped due to Diffculties to recruit anticipated study size, now analysis)
Investigating Fundamental Mechanisms of Mental and Physical Fatigue Using Neurotransmitter Reuptake Inhibitors and Electroencephalography: a Randomized Counterbalanced Crossover Trial [NCT05880342]Phase 362 participants (Anticipated)Interventional2023-05-03Recruiting
An Eight-Week, Randomized, Double-Blind Comparison of Guanfacine, Focalin XR, and the Combination, With a Twelve Month Open-Label Extension for the Treatment of ADHD in Pediatric Subjects Aged 7 to 14 Years [NCT00429273]Phase 4212 participants (Actual)Interventional2007-01-31Completed
An Open International Multicentre Long-Term Follow Up Study to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder [NCT00307684]Phase 3155 participants (Actual)Interventional2006-01-31Completed
Medications Development for Drug Abuse Disorders [NCT00499746]Phase 1/Phase 220 participants (Actual)Interventional2007-11-30Completed
A Double-blind, Randomized, Placebo-controlled, Crossover Study of Repeat Dosing of OROS® Methylphenidate Hydrochloride (CONCERTA®) and Immediate Release Methylphenidate Hydrochloride in Healthy Adults [NCT00302458]Phase 444 participants (Actual)Interventional2006-01-31Completed
Randomized, Observer-blind, Placebo-controlled, Four-way Cross-over Study to Study the Ability of Functional Magnetic Resonance Imaging (fMRI) of the Brain to Detect and Characterize the Effects of Single Doses of a Selective Serotonin Reuptake Inhibitor [NCT01045083]Phase 125 participants (Actual)Interventional2010-01-31Completed
A Controlled Trial of Citalopram Added to Methylphenidate in Youth With Severe Mood Dysregulation [NCT00794040]Phase 2103 participants (Actual)Interventional2008-11-17Completed
Further Studies of Attention Deficit Disorder - Residual Type [NCT00693212]Phase 3116 participants (Actual)Interventional1986-02-28Completed
A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity [NCT00763971]Phase 3336 participants (Actual)Interventional2008-11-17Completed
From Immediate-release MPH to OROS MPH: The Impact Upon Family of Children and Adolescents With ADHD [NCT00758160]Phase 4296 participants (Actual)Interventional2008-03-31Completed
A Double-Blind, Double-Dummy, Placebo-Controlled, Dose Ranging Study of 7.5, 15, and 30 mg of Sublingual Lobeline in Adult ADHD Patients [NCT00664703]Phase 213 participants (Actual)Interventional2008-07-31Completed
A Phase IV, Real World, Open-label, Multi-centre Study on the Use of FOQUEST® (Methylphenidate Hydrochloride Controlled-release Capsules) for the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Pediatric and Adult Patients [NCT04152629]Phase 4257 participants (Actual)Interventional2019-09-19Completed
Comparative Crossover Study of OROS (Methylphenidate HCl), Ritalin, and Placebo in Children With ADHD [NCT00269789]Phase 30 participants Interventional1998-03-31Completed
Learning Impairments Among Survivors of Childhood Cancer [NCT00576472]Phase 4469 participants (Actual)Interventional2000-01-31Completed
A Randomized, Multi-center, Double-blind, Placebo-controlled, Cross-over Study Evaluating the Safety and Efficacy of Dex-Methylphenidate Extended Release 30 mg vs. 20 mg as Measured by SKAMP-Combined Scores in Children With Attention-Deficit/Hyperactivity [NCT00776009]Phase 4165 participants (Actual)Interventional2008-10-31Completed
Effects of Methylphenidate on Postural Stability of Old Adults Under Single and Dual Task Conditions. [NCT00817960]30 participants (Actual)Interventional2011-07-31Completed
Neurobiological Principles Applied to the Rehabilitation of Stroke Patients [NCT00715520]33 participants (Actual)Interventional2007-04-30Completed
Association Between Norepinephrine Transporter Polymorphism and Response of Methylphenidate [NCT00757029]Phase 4150 participants (Anticipated)Interventional2005-10-31Completed
A Single-Center, Single-Blind, Randomized, Oral Dose Cross-Over Study in Prepuberal Boys With ADHD to Investigate Efficacy and Bioequivalence of 20 mg Ritalin LA Compared to 20 mg Medikinet Retard After Treatment With o.d. Doses Over 7 Days Each. [NCT00772161]Phase 1/Phase 224 participants (Actual)Interventional2008-10-31Completed
A 12-Month Open Label Safety Study of Methylphenidate Hydrochloride Extended-Release Capsules (Aptensio XR®) in Children Ages 4-5 Years Diagnosed With Attention-Deficit/Hyperactivity Disorder (ADHD) [NCT02677519]Phase 4120 participants (Anticipated)Interventional2016-09-30Not yet recruiting
Double-Blind Randomized Trial of Methylphenidate for Alleviation of Fatigue and Lethargy Associated With Interferon Alpha 2b [NCT00003266]Phase 3200 participants (Anticipated)Interventional1999-10-12Completed
Assessing the Effect of Missing Doses (Off-Days) of Daily Medication in Patients Stable on Pharmacotherapy for ADHD Receiving Atomoxetine or OROS Methylphenidate: A Parallel Matched Group Clinical Study (On/Off Study) [NCT01127646]Phase 423 participants (Actual)Interventional2010-06-30Terminated(stopped due to Due to lack of availability of study participants to accommodate the study design)
The Role of Methylphenidate on Performance in the Cold [NCT04283877]Phase 424 participants (Anticipated)Interventional2019-12-15Active, not recruiting
Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy [NCT01410942]Phase 2175 participants (Anticipated)Interventional2012-02-29Active, not recruiting
Methylphenidate and Response to Alcohol Cues (MARA) Pilot Study [NCT06063200]Early Phase 130 participants (Anticipated)Interventional2023-10-31Not yet recruiting
Functional Brain Markers and Predictors of Treatment Response Associated With Norepinephrine System Genes in ADHD [NCT00862108]Phase 450 participants (Anticipated)Interventional2008-09-30Recruiting
Near-infrared Spectroscopy Neurofeedback as a Treatment for Children With Attention Deficit Hyperactivity Disorder [NCT04065906]90 participants (Anticipated)Interventional2019-01-15Recruiting
Orexin's Role in The Neurobiology of Substance Use Disorder [NCT05630781]140 participants (Anticipated)Interventional2023-02-15Recruiting
[NCT00815841]Phase 450 participants (Anticipated)Interventional2009-01-31Not yet recruiting
A Cognitive Behavioral Therapy Group Intervention for Adolescents With Attention-Deficit / Hyperactivity Disorder [NCT02566824]Phase 4216 participants (Anticipated)Interventional2010-10-31Recruiting
Title: Eye Tracking as a Predictor of Methylphenidate Response in Autism With Co-morbid Attention Deficit Hyperactivity Disorder [NCT02874690]Early Phase 140 participants (Actual)Interventional2016-02-19Completed
Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth [NCT01109849]Phase 3230 participants (Actual)Interventional2010-11-30Completed
Apathy in Dementia Methylphenidate Trial (ADMET) [NCT01117181]Phase 260 participants (Actual)Interventional2010-06-30Completed
The Effect of the Drug Methylphenidate on Physiological Stress and Function During Exposure to Exercise and Heat Stress in ADD/ADHD Treated Patients [NCT02704546]20 participants (Anticipated)Interventional2016-04-30Not yet recruiting
Genetic Polymorphism of Drug Transporters in OROS-Methylphenidate Treatment in Children and Adolescents With Attention Deficit Hyperactivity Disorder(ADHD) [NCT00842127]Phase 4150 participants (Actual)Interventional2006-03-31Completed
Phase 1,Randomized,Open-Label,Two Period Single Dose Crossover Bioequivalence Study of Two Capsule Strengths of SPD544 In Healthy Volunteers. [NCT01183234]Phase 128 participants (Actual)Interventional2010-08-27Completed
International Study to Predict Optimised Treatment Response to Short or Long Acting Methylphenidate in Children and Adolescents With Attention Deficit/Hyperactivity Disorder. [NCT00863499]Phase 41,344 participants (Anticipated)Interventional2009-10-31Active, not recruiting
Efficacy of Methylphenidate for Treating Tobacco Dependence [NCT00549640]Phase 280 participants (Actual)Interventional2008-01-31Completed
The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome (VCFS), Williams Syndrome (WS)and Fragile X Syndrome Characterization, Treatment and Examining the Connection to Developmental and Molecular Factors [NCT00768820]Phase 4400 participants (Anticipated)Interventional2001-05-31Recruiting
Long Acting Methylphenidate (Concerta™) for Cancer-Related Fatigue: A Phase III, Randomized, Double-Blind Placebo Controlled Study [NCT00376675]Phase 3148 participants (Actual)Interventional2008-02-29Completed
Comprehensive Pathophysiological Study Based on the Core Neurocognitive Deficits and Development of Biological Markers of Treatment Response in Attention Deficit Hyperactivity Disorder [NCT02623114]Phase 4400 participants (Anticipated)Interventional2012-05-31Recruiting
[NCT00773916]Phase 4130 participants (Anticipated)Interventional2006-03-31Completed
A Multicenter Open Trial to Evaluate the Effectiveness and Quality of Life in Adults With Attention Deficit /Hyperactivity Disorder (ADHD) Treated With Long Acting Methylphenidate (CONCERTA) [NCT00783835]Phase 460 participants (Actual)Interventional2008-02-29Completed
A Study to Assess the Sensitivity of Project: EVO Monitor Cognitive Function Measurements to Methylphenidate and Triazolam in Adults 40-55 Years Old [NCT02822937]18 participants (Actual)Interventional2016-07-31Completed
The Effects of ADHD Medication (TEAM) Study: Neurobehavioral Effects of Abrupt Methylphenidate Discontinuation [NCT02293655]Phase 4204 participants (Actual)Interventional2015-01-12Completed
A Randomized Placebo-controlled Trial of Methylphenidate in Veterans With a Diagnosis of Post Traumatic Stress Disorder and Recent Cerebral Stroke. [NCT04885257]Phase 260 participants (Anticipated)Interventional2022-01-14Recruiting
Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity [NCT03481959]Phase 33 participants (Actual)Interventional2019-05-07Terminated(stopped due to insufficient recrutement in the study)
An Open-label Prospective Trial to Evaluate Functional Outcomes of OROS Methylphenidate in Children With ADHD (FOSCO) [NCT01012622]Phase 4142 participants (Actual)Interventional2008-09-30Completed
Randomized Clinical Trial: 03 (Methylphenidate and Duloxetine) [NCT02700711]Phase 113 participants (Actual)Interventional2016-02-29Completed
Methylphenidate for the Treatment of Gain Impairment in Parkinson's Disease: a Randomized Double-Blind, Placebo-Controlled, Cross-over Study [NCT00526630]Phase 423 participants (Actual)Interventional2007-12-31Completed
The Relation Between Attentional, Sensory and Emotional Dysregulation in Adults With Posttraumatic Stress Disorder: a Double-blind, Placebo-controlled Randomized Controlled Trial of the Combined Treatment With Reboxetine and Methylphenidate [NCT05133804]Phase 253 participants (Anticipated)Interventional2022-06-01Recruiting
A 7 Week Multicenter, Double-Blind, Randomized, Placebo-Controlled Cross-Over Evaluation of the Efficacy and Safety of Two Different Brands of Modified-Release Oral Dosage Forms of Methylphenidate-HCl (20 mg, q.d.) in Children With Attention Deficit Hyper [NCT00254878]Phase 3130 participants Interventional2005-10-31Completed
Cocaine-Methylphendidate Interaction Study [NCT00015067]Phase 18 participants Interventional1997-12-31Completed
Methyphendidate in the Treatment of Cocaine Dependent Patients With Adult ADHD [NCT00015223]Phase 20 participants Interventional1997-06-30Completed
Methylphenidate Raclopride PET Test [NCT00015301]Phase 40 participants Interventional2003-12-31Completed
Methylphenidate Study in Young Children With Developmental Disorders [NCT00517504]Phase 448 participants (Actual)Interventional2001-05-31Completed
A Prospective, Open-Label, Multi-Center Study Evaluating the Safety and Tolerability of Methylphenidate Transdermal System (MTS) in Children Aged 6-12 Previously Treated With Extended-Release Methylphenidate Product. [NCT00151983]Phase 3175 participants (Actual)Interventional2005-06-30Completed
Efficacy and Safety/Tolerability of Methylphenidate Transdermal System (MTS) for Before-School Dysfunction in Children With Attention Deficit Hyperactivity Disorder (ADHD) [NCT00586157]Phase 436 participants (Actual)Interventional2006-09-30Completed
Long-Duration Stimulant Treatment of ADHD in Young Children-Feasibility Study [NCT00257725]Phase 411 participants (Actual)Interventional2005-03-31Completed
Comportemental and Neuropsychologic Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate. A Double-blind Randomised Study Methylphenidate Versus Placebo [NCT00169611]Phase 480 participants (Anticipated)Interventional2004-01-31Completed
A Phase IIB, Randomized, Double-blind, Multi-Center, Placebo-Controlled, Dose-Optimization, 3-way Cross-Over, Analog Classroom Study to Assess the Efficacy, Duration of Effect, Tolerability and Safety of 4- and 6- Hour Wear Times of Methylphenidate Transd [NCT00151970]Phase 2128 participants (Actual)Interventional2005-06-30Completed
A Pilot Study of Osmotic-Release Methylphenidate in Initiating and Maintaining Abstinence in Smokers With ADHD [NCT00253747]Phase 3255 participants (Actual)Interventional2005-11-30Completed
Treatment of College Students With ADHD Using OROS Methylphenidate [NCT00931398]Phase 40 participants (Actual)Interventional2010-04-30Withdrawn(stopped due to Study was not initiated due to lack of funding by the sponsor)
An Open-label, Randomized, Rater-blinded, Cross-over, Multicenter Study Comparing the Clinical Efficacy of Methylphenidate (Immediate Release/Extended Release) Treatment (20 or 40 mg Orally od) in Children With Attention-Deficit Hyperactivity Disorder (AD [NCT00428792]Phase 3150 participants (Actual)Interventional2007-04-30Completed
The Effect of Methylphenidate on Decision-making Ability of ADHD Adults [NCT01040702]Phase 158 participants (Actual)Interventional2008-01-31Completed
A Randomized, Double Blind, Two Period, Placebo-Controlled Crossover Trial of a Sustained Release Methylphenidate in the Treatment of Fatigue in Cancer Patients [NCT00516269]Phase 342 participants (Actual)Interventional2004-08-31Terminated(stopped due to Slow Accrual)
Methylphenidate Transdermal System (MTS) in the Treatment of Adult ADHD [NCT00506285]Phase 392 participants (Actual)Interventional2007-06-30Completed
A Phase IIIb, Long-Term, Open-Label, Multi-Center, Extension Study Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD) [NCT00501293]Phase 3163 participants (Actual)Interventional2007-08-31Completed
Methylphenidate Modified-release as Treatment of MS-associated Fatigue. A Single-center Randomized Double-blind Placebo-controlled Study. [NCT01879202]Phase 296 participants (Anticipated)Interventional2012-12-31Recruiting
The Effect of Ritalin (Methylphenidate Hydrochloride) on Pain and Auditory Sensitivity: an Exploratory Double-blind Randomized Controlled Trial on Healthy Subjects [NCT01914822]Phase 241 participants (Actual)Interventional2013-07-31Completed
A Double-Blind Placebo-Controlled Study of Combination Therapy in Children With ADHD [NCT01940978]Phase 499 participants (Actual)Interventional2014-03-31Completed
Efficacy and Safety of Generic Methylphenidate Prolong-released Comparison With Original in Child With Attention-deficit-hyperactive Disorders [NCT05410626]78 participants (Anticipated)Interventional2022-06-01Not yet recruiting
Effects of Methylphenidate, Modafinil, and MDMA on Emotion-processing in Humans: A Pharmaco-fMRI Study [NCT01951508]Early Phase 124 participants (Actual)Interventional2013-10-31Completed
Clinical Study Protocol: Evaluation of the Efficiency of Ritalin in Multiple Sclerosis Patients [NCT00220493]Phase 180 participants Interventional2003-06-30Recruiting
Identifying Characteristic Signature of Brain Activity of Electroencephalogram Records in Attention Deficit / Hyperactivity Disorder (ADHD) and Ritalin Treatment [NCT01962181]40 participants (Anticipated)Interventional2013-10-31Not yet recruiting
Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Methylphenidate Hydrochloride as a Treatment for Chronic Fatigue Syndrome in Patients Taking a CFS-Specific Nutrient Formula [NCT01966276]Phase 2134 participants (Actual)Interventional2013-11-30Active, not recruiting
The Effects of a Single Dose of Methylphenidate on Motor Performance [NCT04283604]Phase 4200 participants (Anticipated)Interventional2021-05-27Recruiting
Preschool Supplement to Clonidine in ADHD (Kiddie-CAT) [NCT00414921]Phase 230 participants (Actual)Interventional2003-09-30Completed
Evaluation and Treatment of Autonomic Failure. [NCT00223691]Phase 1389 participants (Actual)Interventional2002-03-31Completed
The Control of Brain Networks After Traumatic Brain Injury: a Neuroimaging and Neuropsychological Study of Dopamine and Cognition [NCT02015949]Phase 440 participants (Actual)Interventional2014-02-28Completed
A Crossover Study on the Effect of Methylphenidate (MPH) on Cognitive Abilities of Adults With Bipolar Disorder (BD), During Remission or Depressed State, Compared With Healthy Adults and Adults With Attention Deficit Hyperactivity Disorder (ADHD). [NCT02020200]40 participants (Anticipated)Interventional2014-01-31Not yet recruiting
Effects of Methylphenidate (Ritalin®) on the Neural Basis of Anxiety: a Placebo-controlled fMRI Study in Healthy Male Subjects [NCT02021214]Early Phase 124 participants (Actual)Interventional2014-03-31Completed
The Role of Dopamine in the Central Neural Signature of Chronic Pain [NCT05285683]Phase 210 participants (Anticipated)Interventional2023-01-01Recruiting
Brain Dopamine Function in Adults With ADHD [NCT00580814]24 participants (Actual)Interventional2006-02-28Completed
[NCT01683032]38 participants (Actual)Interventional2012-10-31Completed
A Phase II, Randomized, Double-blind, Placebo Controlled Trial of Methylphenidate Hydrochloride for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH-Agonist Therapy [NCT00593853]Phase 233 participants (Actual)Interventional2008-01-31Terminated(stopped due to Slow Accrual)
A Randomized Open-label Study of Dopamine Transporter Receptor Occupancy With Long-acting Dex-methylphenidate (20 mg, 30 mg, and 40 mg) as Measured With C-11 Altropane in Healthy Adult Volunteers [NCT00593138]Phase 1/Phase 223 participants (Actual)Interventional2006-12-31Completed
Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral and Cognitive Effects of CONCERTA on Older Children With ADHD (The ABC Study) [NCT00799487]Phase 489 participants (Actual)Interventional2009-01-02Completed
The ABC Study: A Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral, and Cognitive Effects of CONCERTA on Older Children With ADHD [NCT00799409]Phase 478 participants (Actual)Interventional2008-12-31Completed
Attention Deficit/Hyperactivity Disorder (ADHD) Medications in Japan: A Retrospective Cohort Study of Label Compliance [NCT04113551]17,418 participants (Actual)Observational2019-10-01Completed
Effect of OROS-Methylphenidate (Concerta) on Different Domains of Attention and Working Memory in Children With Attention-Deficit/Hyperactivity Disorder [NCT00530257]Phase 430 participants (Actual)Interventional2004-06-30Completed
A Pilot Study of Proton Magnetic Spectroscopy in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) Before and After Treatment With Osmotic-controlled Release Oral Delivery System (OROS) Methylphenidate [NCT00593112]Phase 439 participants (Actual)Interventional2006-11-30Completed
Benefits of In-prison OROS-methylphenidate vs. Placebo Treatment in Detained People With Attention-deficit/Hyperactivity Disorder: A Randomized Controlled Trial [NCT05842330]Phase 3150 participants (Anticipated)Interventional2023-12-01Not yet recruiting
Effect of a Polyphenol-rich Plant Extract on Attention-Deficit Hyperactivity Disorder (ADHD): A Randomized, Double Blind, Placebo and Active Product Controlled Multicenter Trial. [NCT02700685]Phase 388 participants (Actual)Interventional2017-09-01Completed
A 40-week, Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy and Safety Study of Methylphenidate HCl Extended Release in the Treatment of Adult Patients With Childhood-onset ADHD [NCT01259492]Phase 3725 participants (Actual)Interventional2010-11-30Completed
A Fixed-Dose, Randomized, Double-Blind, Placebo-Controlled Study of LY2216684 in Pediatric Patients With Attention Deficit/Hyperactivity Disorder [NCT00922636]Phase 2/Phase 3340 participants (Actual)Interventional2009-06-30Completed
A Phase 1, Open-label, Randomized, Three-period Crossover Drug Interaction Study Evaluating the Pharmacokinetic Profiles of SPD503 and CONCERTA, Administered Alone and in Combination in Healthy Adult Volunteers [NCT00901576]Phase 138 participants (Actual)Interventional2009-05-18Completed
Evaluation of the Ability for Monitoring Dynamics in ADD/ADHD With an Easy to Use EEG [NCT02625805]30 participants (Actual)Interventional2016-04-30Completed
Effects of Methylphenidate on Neuropsychological Functioning in Children With Attention Deficits Secondary to Childhood Cancer [NCT01100658]1 participants (Actual)Interventional2010-05-31Terminated(stopped due to Due to slow accrual)
Placebo-Controlled Multi-Centre Double-Blind Trial for Adults With Extended-Release Methylphenidate for ADHD [NCT00619840]Phase 3363 participants (Actual)Interventional2004-11-30Completed
Methylphenidate for Cancer-Related Fatigue: A Pilot N-of-1 Study [NCT01164956]Phase 13 participants (Actual)Interventional2011-07-31Terminated(stopped due to Insufficient Resources)
Intervention for Teens With ADHD and Substance Use [NCT02502799]Phase 3158 participants (Actual)Interventional2015-07-31Terminated
Dose Response Pharmacogenetic Study of ADHD [NCT00663442]Phase 448 participants (Actual)Interventional1999-12-31Completed
Study of Methylphenidate to Treat Gait Disorders And Attention Deficit In Parkinson's Disease: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentric Trial [NCT00914095]Phase 469 participants (Actual)Interventional2009-10-31Completed
Response Variability in Children With ADHD [NCT01238822]Phase 496 participants (Actual)Interventional2006-06-30Completed
Comparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties [NCT01393574]Phase 446 participants (Anticipated)Interventional2011-06-30Recruiting
Ameliorating Attention Problems in Children With SCD [NCT01411280]Phase 334 participants (Actual)Interventional2006-06-30Completed
Randomized Controlled Trial of Galantamine, Methylphenidate, and Placebo for the Treatment of Cognitive Symptoms in Patients With Traumatic Brain Injury (TBI) and/or Posttraumatic Stress Disorder (PTSD) [NCT01416948]Phase 232 participants (Actual)Interventional2011-08-31Terminated(stopped due to The funding agency, DoD, determined that the study could not meet its enrollment numbers by the end of the grant.)
Phase 2/3 Study of Efficacy and Tolerability of Methylphenidate in the Treatment of Excessive Daytime Sleepiness in Myotonic Dystrophy Type 1 [NCT01421992]Phase 2/Phase 328 participants (Actual)Interventional2008-06-30Completed
A Double Blind Crossover Study on the Effect of Methylphenidate on Decision-making Ability of Adults With Borderline Personality Disorder (BPD) Compared to Adults With Attention Deficit Hyperactivity Disorder (ADHD) and Healthy Adults [NCT01426984]20 participants (Anticipated)Interventional2012-05-31Recruiting
Cognitive vs. Emotional Psycho-Pharmacological Manipulations of Fear vs. Anxiety [NCT02153944]Phase 4142 participants (Actual)Interventional2014-06-16Completed
A Multi-center Randomized Parallel Group Study Evaluating Treatment Outcomes of Concerta (Extended Release Methylphenidate) and Strattera (Atomoxetine) in Children With Attention-deficit/Hyperactivity Disorder [NCT00866996]Phase 41,323 participants (Actual)InterventionalCompleted
Methylphenidate for Apathy in Alzheimer's Dementia: A Controlled Study [NCT00495820]Phase 460 participants (Actual)Interventional2007-08-31Completed
The Relative Efficacy of Aerobic Exercise in the Treatment of Adults With Attention Deficit Hyperactivity Disorder (ADHD) Versus Medication Only and the Combination of the Two: A Pilot Study [NCT02788851]70 participants (Anticipated)Interventional2016-04-30Active, not recruiting
A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Incomplete Block, Two-period, Crossover Clinical Trial to Study the Safety and Efficacy of MK0249, 10 mg, for Adult Patients, Ages 18 to 55, With Attention Deficit Hyperactivity Disorder (ADHD) [NCT00475735]Phase 272 participants (Actual)Interventional2007-07-31Completed
Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Patients With ADHD [NCT04781972]Phase 430 participants (Anticipated)Interventional2021-07-27Recruiting
Naturalistic Study of ADHD Medication and Predictors of Treatment Outcome [NCT02136147]632 participants (Actual)Observational [Patient Registry]2015-06-30Completed
An Assessment of the Drug Interaction Potential Between Oral Cannabidiol (Epidiolex®) and the CES1 Substrate Methylphenidate in Healthy Volunteers [NCT04603391]Phase 412 participants (Actual)Interventional2021-02-25Completed
A Single Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy of PR OROS Methylphenidate Followed by Open-Label Extension, in Swedish Male Prison Inmates With ADHD [NCT00482313]Phase 330 participants (Actual)Interventional2007-05-31Completed
Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients: a Randomized, Mono-blind Pilot Trial [NCT00599287]Phase 380 participants (Anticipated)Interventional2008-02-29Terminated(stopped due to Inclusion rate too low due to a lack of eligible patients and difficulties obtaining informed consent.)
A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride Augmented With Either Extended-Release Methylphenidate Hydrochloride (Concerta-TM) or Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) Who Have Not Responded to Sti [NCT00485550]Phase 314 participants (Actual)Interventional2004-01-31Completed
Combination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer [NCT05474846]Phase 2/Phase 3188 participants (Anticipated)Interventional2022-11-21Recruiting
Single and Combined Effects of Positive Behavior Support, Medication and Academic Accommodation for Children With ADHD [NCT05469386]Phase 4288 participants (Anticipated)Interventional2022-06-13Recruiting
Methylphenidate Treatment of Children and Adolescents Diagnosed With ADHD and Its Influence on Comorbid Trichotillomania [NCT00552266]Phase 430 participants (Anticipated)Interventional2007-10-31Recruiting
Adjunctive Methylphenidate Extended Release in Patients With Schizophrenia: a Single-centre Fixed Dose Cross-over Open-label Trial to Improve Functional and Cognitive Outcomes [NCT05414058]Phase 224 participants (Anticipated)Interventional2022-09-09Recruiting
[NCT00446537]Early Phase 10 participants InterventionalNot yet recruiting
Acoustic and Vestibular Noise as Possible Non-pharmacological Treatments of ADHD in School Children [NCT03425669]70 participants (Anticipated)Interventional2019-05-01Recruiting
[NCT01821170]51 participants (Actual)Interventional2013-04-01Completed
Double-Blind, Placebo-Controlled Trial of Flexible Dose Divalproex Sodium Adjunctive to Stimulant Treatment for Aggressive Children With Attention-Deficit Hyperactivity Disorder [NCT00228046]Phase 440 participants (Anticipated)Interventional2004-01-31Completed
A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study To Evaluate the Safety And Efficacy Of Prolonged Release OROS Methylphenidate Hydrochloride (18, 36 and 72 mg/Day), With Open-Label Extension, In Adults With [NCT00246220]Phase 3402 participants (Actual)Interventional2005-03-31Completed
Screening, Efficacy, and Safety Study Evaluating OROS (Methylphenidate HCl), Ritalin and Placebo in Children With ADHD [NCT00269776]Phase 30 participants Interventional1998-11-30Completed
Long-term Safety and Effectiveness of OROS (Methylphenidate HCl) in Children With ADHD [NCT00269815]Phase 30 participants InterventionalCompleted
A PET Study Examining Pharmacokinetics and Dopamine Transporter Receptor Occupancy Of Two Long-Acting Formulations of Methylphenidate in Adults [NCT00301639]Phase 340 participants Interventional2005-03-31Completed
The Effectiveness of CONCERTA® vs. Usual Clinical Care With Immediate Release Methylphenidate (IR MPH) in Children (6-12 Years) With Attention Deficit Hyperactivity Disorder (ADHD): A Randomized, Open-Label Trial [NCT00304681]Phase 3147 participants (Actual)InterventionalCompleted
Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits: a Randomized, Double-blind, Placebo-controlled Trial [NCT04419272]Phase 4226 participants (Anticipated)Interventional2023-08-14Recruiting
Double Blind, Placebo Controlled, Crossover Study of Extended Release Methylphenidate for Treatment of ADHD in Children With Epilepsy [NCT00323947]Phase 433 participants (Actual)Interventional2003-05-31Completed
Methylphenidate Treatment for Cocaine Abuse and ADHD [NCT00136734]Phase 1124 participants (Actual)Interventional1998-04-30Completed
Psychostimulants for Fatigue in Advanced Prostate Cancer [NCT00138138]Phase 2120 participants Interventional2002-10-31Completed
Methylphenidate Treatment of ADHD in Children With Tourette Syndrome [NCT00441649]71 participants Interventional2000-02-29Completed
A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) vs. CONCERTA® in Pediatric Patients Aged 6-12 With A [NCT00444574]Phase 3282 participants (Actual)Interventional2004-09-30Completed
Clinical and Pharmacogenetic Study of Attention Deficit With Hyperactivity Disorder (ADHD) [NCT00483106]Phase 4885 participants (Actual)Interventional1999-11-30Completed
Effects of Methylphenidate on Postural Stability of Children Suffer From Attention Deficit Hyperactivity Disorder (ADHD) Under Single and Dual Task Conditions. [NCT00485797]30 participants (Actual)Interventional2007-10-31Completed
Two-phase Randomized Controlled Trial of Low and Moderate Dose Methylphenidate for Non-motor and Postural Symptoms in Parkinson's Disease. [NCT01244269]Phase 46 participants (Actual)Interventional2010-12-31Terminated(stopped due to Inadequate enrolment, protocol too challenging for participants, lack of observable benefit after analysis of 6 patients.)
Effects of Methylphenidate on Resting State Connectivity in Healthy Controls and in Adults With Attention Deficit Hyperactivity Disorder. [NCT01764672]Phase 40 participants (Actual)Interventional2013-04-30Withdrawn
Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Children and Adolescents With ADHD [NCT06077669]Phase 480 participants (Anticipated)Interventional2024-01-20Not yet recruiting
Efficacy of Concerta in Treating ADHD in Mothers of Children With ADHD [NCT00318981]Phase 440 participants Interventional2004-12-31Completed
A Randomized, Multi-center, Double-blind, Cross-over Study Comparing the Efficacy and Safety of Focalin® XR 20 mg Versus Placebo at the 0.5 Hour Timepoint (Post-dose) in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Labor [NCT00564954]Phase 486 participants (Actual)Interventional2007-10-31Completed
Stimulant and Risperidone in Children With Severe Physical Aggression [NCT00796302]Phase 4168 participants (Actual)Interventional2008-08-31Completed
Enhancing Attention in Adults With Compulsive Hoarding: A Pilot Study [NCT01100268]Phase 24 participants (Actual)Interventional2010-04-30Completed
Association Between Motorcycle Accidents, Attention Deficit/Hyperactivity Disorder and Substance Use Disorder and Motorcycle Accidents [NCT00536419]Phase 453 participants (Anticipated)Interventional2007-09-30Recruiting
An Open-label Study Evaluating the Safety and Effectiveness of OROS Methylphenidate Hydrochloride (CONCERTA) in Adults With Attention Deficit Hyperactivity Disorder [NCT00246207]Phase 332 participants (Actual)Interventional2005-03-31Completed
Enhancing ADHD Driving Performance With Stimulant Medication [NCT00572026]14 participants (Anticipated)Interventional2007-07-31Recruiting
Reading ICARD: Interventions for Children With Attention and Reading Disorders [NCT01133847]Phase 4222 participants (Actual)Interventional2010-11-30Completed
A Phase II, Randomized, Double-blind, Multi-center, Placebo-controlled, Dose Optimization, Analog Classroom, Crossover Study Designed to Assess the Time Course of Treatment Effect, Tolerability and Safety of Methylphenidate Transdermal System (MTS) in Ped [NCT00466791]Phase 293 participants (Actual)Interventional2004-08-31Completed
A Randomized, Double-Blind Comparison, Safety and Efficacy Trial of Atomoxetine Hydrochloride and Methylphenidate Hydrochloride in Pediatric Outpatients With DSM-IV Attention-Deficit/Hyperactivity Disorder [NCT00486083]Phase 3330 participants (Actual)Interventional2003-12-31Completed
Methylphenidate in Adults With Attention Deficit/Hyperactivity Disorder [NCT02951754]Phase 4600 participants (Anticipated)Interventional2002-02-28Recruiting
The Effective and Tolerable Titration Scheme and Dosage in Children With Attention-deficit Hyperactivity Disorder Treated With OROS-Methylphenidate [NCT00518232]Phase 4520 participants (Actual)Interventional2006-09-30Completed
A Combination Therapy to Treat Cancer-Related Fatigue - NCI R01 [NCT03772834]Phase 2/Phase 3200 participants (Anticipated)Interventional2019-03-25Recruiting
The Role of Apathy in Glycemic Control [NCT00844090]106 participants (Actual)Interventional2009-07-31Completed
International Randomised Double-blind Placebo-controlled Study on the Initial Treatment of Acute Mania With Methylphenidate [NCT01541605]Phase 342 participants (Actual)Interventional2012-03-31Completed
A Randomized, Double-Blind Comparison of the Time Course of Response to Two Extended-Release Oral Delivery Systems for Methylphenidate in Pediatric Patients With Attention Deficit Hyperactivity Disorder in an Analog Classroom Setting: The CoMACS Study [NCT00381758]Phase 4184 participants Interventional2002-05-31Completed
Methylphenidats Betydning for motoriskindlæring Hos Patienter Med Apopleksi [NCT00396058]Phase 413 participants (Anticipated)Interventional2006-11-30Terminated(stopped due to Recruitment of patients proved much too difficult based on the chosen criteria.)
A Phase III, Double-Blind, Prospective Randomized Clinical Trial of the Effect of D-threo-methylphenidate HCl (d-MPH) on Quality of Life in Brain Tumor Patients Receiving Radiation Therapy [NCT00031798]Phase 30 participants Interventional2002-04-01Terminated(stopped due to low accrual; loss of funding)
MPD04961-Methylphendidate Treatment of Cocaine Dependent ADHD Patients [NCT00015054]Phase 220 participants Interventional1998-09-30Completed
Treatment of Adult ADHD in Methadone Patients [NCT00061087]Phase 2/Phase 3115 participants (Actual)Interventional1998-02-28Completed
A Treatment Study of Youth With Comorbid Attention Deficit Hyperactivity Disorder (ADHD) and Anxiety Disorders [NCT00012584]120 participants Interventional2000-11-30Completed
Methylphenidate for Hyperactivity and Impulsiveness in Children and Adolescents With Pervasive Developmental Disorders [NCT00025779]60 participants Interventional2001-10-31Completed
Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) Treatment (CAT) [NCT00031395]Phase 3122 participants (Actual)Interventional1999-09-30Completed
Pediatric Traumatic Brain Injury: Methylphenidate Effects on Early Recovery [NCT00035139]Phase 40 participants InterventionalCompleted
Emotional Effects of Methylphenidate and MDMA in Healthy Subjects [NCT01465685]Phase 116 participants (Actual)Interventional2011-12-31Completed
A Study of Cancer Related Fatigue in Patients With Metastatic Cancer Receiving Anti-PD1 Immunotherapy [NCT03525873]Phase 3212 participants (Actual)Interventional2018-08-02Active, not recruiting
Methylphenidate Efficacy and Safety in ADHD Preschoolers [NCT00018863]Phase 3165 participants Interventional2001-04-01Completed
Adderall-XR Versus Concerta For Cancer Treatment-Related Neurocognitive Sequelae And Depression In Pediatric Patients: A Randomized Phase II Study [NCT00069927]Phase 212 participants (Actual)Interventional2003-08-31Terminated(stopped due to Only 12 subjects enrolled. DSMB recommended closing due to lack of feasibility)
A Phase III, Multi-center, Open-label Study of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) [NCT00151957]Phase 3450 participants (Actual)Interventional2004-10-31Completed
Open-Label Study of Concerta in the Treatment of ADHD in Youth and Adults With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder [NCT00181987]Phase 429 participants (Actual)Interventional2002-08-31Completed
A Double Blind, Placebo-Controlled Crossover Study to Determine the Effects of Methylphenidate on Driving Ability in Adult Patients With Attention-Deficit Hyperactivity Disorder [NCT00223561]Phase 418 participants Interventional2003-02-28Completed
Long Acting Stimulant Treatment of ADHD in Young Children [NCT00754208]Phase 47 participants (Actual)Interventional2008-09-18Completed
A Double Blind Randomized Crossover Study of the Effect of Methylphenidate Versus Placebo on State Anxiety in Children With Attention Deficit Hyperactivity Disorder. [NCT01798459]30 participants (Anticipated)Interventional2013-02-28Recruiting
Virtual Reality a Novel Screening and Treatment Aid in Attention Deficit Disorder [NCT00364702]Phase 240 participants (Anticipated)Interventional2006-08-31Completed
Effects of Evening Dose of Immediate Release Methylphenidate on Sleep in Children With Attention Deficit Hyperactivity Disorder: A Randomized Placebo-controlled Pilot Study [NCT02638168]Phase 43 participants (Actual)Interventional2016-01-31Terminated(stopped due to challenge in recruitment)
The Effects of Methylphenidate (MPH) and Non-invasive Brain Stimulation (tDCS) on Inhibitory Control Children With Attention-Deficit/Hyperactivity Disorder (ADHD) [NCT04964427]26 participants (Actual)Interventional2021-02-08Completed
A Randomized Controlled Trial of Methylphenidate Transdermal System (Daytrana), Lisdexamfetamine Dimesylate (Vyvanse), OROS MPH (Concerta), and Mixed Amphetamine Salts Extended Release (Adderall XR) in Children and Adolescents With ADHD [NCT00889915]Phase 4228 participants (Actual)Interventional2009-04-30Completed
Behavioral Differences in Effortful Control [NCT01852344]108 participants (Actual)Interventional2012-06-30Completed
A Randomized, Parallel, Double-Blind Efficacy and Safety Study of Biphentin Methylphenidate HCl Extended Release Capsules Compared to Placebo in Children and Adolescents 6 to 18 Years With Attention Deficit Hyperactivity Disorder (ADHD) [NCT01239030]Phase 3230 participants (Actual)Interventional2010-11-30Completed
Dopamine Receptor Imaging to Predict Response to Stimulant Therapy in Chronic TBI [NCT02225106]Phase 211 participants (Actual)Interventional2014-08-06Completed
Multicenter Study Comparing the Efficacy and Safety of OROS (Methylphenidate HCl), Ritalin, and Placebo in Children With ADHD [NCT00269802]Phase 30 participants InterventionalCompleted
Randomized Study Evaluating the Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients [NCT00273741]Phase 339 participants (Actual)Interventional2007-01-31Terminated(stopped due to difficulty of recrutement)
A Double-blind, Placebo-controlled, Randomized Trial to Evaluate the Safety, Tolerability and Efficacy of CONCERTA® (Methylphenidate Hydrochloride) Augmentation of SSRI/SNRI Monotherapy in Adult Patients With Major Depressive Disorder. [NCT00246233]Phase 3145 participants (Actual)Interventional2005-06-30Completed
An Evaluation of the Safety and Effectiveness of CONCERTA® (Methylphenidate Hydrochloride), up to 72 mg Daily, in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) [NCT00249353]Phase 3220 participants (Actual)Interventional2002-03-31Completed
The Role of the Dopaminergic Brain Reward System in Apathy Associated With Alzheimer's Disease [NCT00254033]Phase 440 participants Interventional2003-10-31Completed
Treatment of Patients With Alcoholism and Attention Deficit Disorder [NCT00261872]Phase 4100 participants Interventional2005-12-01Completed
An Open Label Phase I/II Study of Dopamine Transporter Receptor Occupancy With OROS and Immediate Release Methylphenidate as Measured With C-11 Altropane in Human Subjects [NCT00302367]Phase 420 participants Interventional2004-01-31Completed
Naturalistic Substitution of Concerta in Adult Subject With ADHD Receiving Immediate Release Methylphenidate [NCT00302406]Phase 450 participants (Anticipated)Interventional2003-07-31Completed
A Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Titration Study to Evaluate the Efficacy and Safety of CONCERTA (Methylphenidate HCl) Extended-release Tablets in Adults With Attention Deficit Hyperactivity Disorder at Doses of 36 mg, 54 mg, 72 mg [NCT00326391]Phase 3229 participants (Actual)Interventional2006-04-30Completed
A Double-blind Randomized, Placebo-controlled, Crossover Study of Single Doses of OROS Methylphenidate Hydrochloride (CONCERTA) and Long-acting Methylphenidate Hydrochloride (RITALIN LA) in Healthy Adults [NCT00302354]Phase 450 participants Interventional2004-12-31Completed
A PET Study Examining Pharmacokinetics and Dopamine Transporter Receptor Occupancy of Repeat Dosing of OROS® Methylphenidate (CONCERTA®) and Immediate Release Methylphenidate in Healthy Adults [NCT00302393]Phase 320 participants (Actual)Interventional2006-06-30Completed
A Parallel-group, Double-blind, Placebo-controlled Study of Methylphenidate as an Add on Therapy for Mirtazapine in the Treatment of Major Depressive Disorder in Cancer Patients Under Palliative Care [NCT01497548]Phase 3120 participants (Anticipated)Interventional2011-03-31Recruiting
Prospective Follow-Up Observational Study to Examine the Progression of ADHD Drug Treatment and to Analyze Associated Factors [NCT01624649]289 participants (Actual)Observational2012-02-29Completed
Evaluating the Effect of Methylphenidate on Intracortical Inhibition in Methamphetamine Abusers Comorbid With Attention Deficit Disorder With Hyperactivity(ADHD) in TMS Unit, Neurcognitive Lab, Iranian National Center for Addiction Studies (INCAS), in 201 [NCT01651169]30 participants (Anticipated)Interventional2012-09-30Enrolling by invitation
A 14 Week, Randomized, Placebo-Controlled Cross-Over Study of Methylphenidate Hydrochloride Controlled Release Capsules in Adult ADHD With and Without Anxiety Disorder Comorbidity [NCT03785223]Phase 460 participants (Actual)Interventional2019-04-20Completed
Double-blind, Placebo-controlled, Multicenter Randomized Clinical Trial to Evaluate Short-term Efficacy of Palliative Treatment With Methylphenidate in Asthenia in Advanced Cancer Patients [NCT01773837]Phase 3100 participants (Actual)Interventional2012-01-31Terminated(stopped due to Slow accrual. 100 patients included)
A Phase III Clinical Endpoint Evaluation Study Examining the Safety and Efficacy of HLD200 in Pediatric Subjects With Attention-Deficit Hyperactivity Disorder. [NCT02255513]Phase 343 participants (Actual)Interventional2014-05-31Completed
Psychopharmacology of Novel Medications for Cocaine Dependence - Buspirone [NCT01267292]Phase 250 participants (Actual)Interventional2011-03-31Completed
Impulsivity and Stimulant Administration [NCT01978431]Phase 129 participants (Actual)Interventional2012-11-30Completed
A Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Titration Study of Aptensio XR® in Children Ages 4 to Under 6 Years Diagnosed With Attention Deficit-Hyperactivity Disorder (ADHD) [NCT02683265]Phase 4158 participants (Actual)Interventional2016-04-25Completed
[NCT01740206]50 participants (Actual)Interventional2012-11-30Completed
Medication Response in Children With Predominately Inattentive Type ADHD [NCT01727414]Phase 4171 participants (Actual)Interventional2006-06-30Completed
A Phase 4, Randomized, Double-blind, Multicenter, Parallel-group, Active-controlled, Forced-dose Titration, Safety and Efficacy Study of SPD489 (VYVANSE®) Compared With OROS-MPH (CONCERTA®) With a Placebo Reference Arm, in Adolescents Aged 13-17 Years Wit [NCT01552902]Phase 4549 participants (Actual)Interventional2012-04-03Completed
The Effect of Methylphenidate (Ritalin IR) Treatment in Familial Attention Deficit/Hyperactivity Disorder (ADHD) [NCT01554046]40 participants (Actual)Interventional2011-10-31Completed
Subacute Trial of Methylphenidate in Parkinson's Disease [NCT00359723]Phase 213 participants (Actual)Interventional2004-07-31Completed
Gene-environment Interactions and Brain Functional Connectivity Associated With Norepinephrine System Genes in Attention Deficit Hyperactivity Disorder [NCT01912352]83 participants (Actual)Interventional2010-05-31Completed
Real-world Evidence of Duration of Adhansia XR for Treatment of ADHD (RE-DAX): An Open-label Pragmatic Study to Assess the Real-world Effectiveness of Adhansia XR in Treatment of Adult and Adolescent Patients With ADHD in the United States [NCT04507204]Phase 4267 participants (Actual)Interventional2020-07-30Terminated(stopped due to (due to administrative reasons not related to efficacy or safety.))
A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Multicenter Study of 3 Dosages of JNJ-31001074 in the Treatment of Adult Subjects With Attention-Deficit/Hyperactivity Disorder [NCT00880217]Phase 2430 participants (Actual)Interventional2009-05-31Completed
Imaging Stimulant and Non Stimulant Treatments for ADHD: A Network Based Approach [NCT01678209]Phase 4127 participants (Actual)Interventional2012-10-31Completed
Anomalous Motor System Physiology in Attention Deficit Hyperactivity Disorder: Biomarker Validation and Modeling Domains of Function [NCT04421248]Phase 4214 participants (Anticipated)Interventional2020-09-01Recruiting
Understanding the Mechanism of Action of Methylphenidate in ADHD: A Computational Psychiatry Approach [NCT05600881]35 participants (Anticipated)Observational2023-06-30Not yet recruiting
Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With DESR Traits: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial [NCT01399827]Phase 22 participants (Actual)Interventional2012-02-29Completed
The Evaluation of the Safety and Efficacy of the Methylphenidate Patch in Former Stimulant Users With ADHD [NCT00780208]14 participants (Actual)Interventional2007-04-30Completed
LAMAinDiab - Lisdexamphetamine vs Methylphenidate for Pediatric Patients With ADHD and Type 1 Diabetes - a Randomized Cross-over Clinical Trial [NCT05957055]Phase 2150 participants (Anticipated)Interventional2024-01-01Not yet recruiting
Electroencephalogram Studies of Intravenous Methylphenidate-Induced Emergence From General Anesthesia [NCT02429076]Phase 1/Phase 20 participants (Actual)Interventional2017-06-30Withdrawn(stopped due to We are not going to complete this study with healthy volunteers at this time.)
A Pharmacokinetic Study of Aptensio XR® (Methylphenidate Hydrochloride (HCl) Extended-release) Capsules in Male or Female Pre-School Children 4 to Under 6 Years of Age With Attention Deficit Hyperactivity Disorder (ADHD) in Fed Condition [NCT02470234]Phase 410 participants (Actual)Interventional2016-07-30Completed
Ph 3 Multicenter OL Treatment-optimized RDBPC Forced-withdrawal, Parallel Grp Study to Evaluate Safety & Efficacy of Evening Dosed HLD200, a Novel DR/ER Formulation (DELEXIS) of MPH HCl in Children Aged 6-12 With ADHD in Classroom Setting [NCT02493777]Phase 3125 participants (Actual)Interventional2015-07-31Completed
Phase I Study About Effects of Caffeine, Methylphenidate, Modafinil and Placebo on Cognitive Performance of Chess Players. [NCT01834547]Phase 140 participants (Actual)Interventional2011-05-31Completed
The Relationship Between CES1 Genotype and Methylphenidate Response in Children With ADHD - INDICES Work Package 6 [NCT04366609]207 participants (Actual)Observational2012-05-01Completed
Novel Cross-Species Neurophysiological Assays of Reward and Cognitive Domains [NCT02855229]222 participants (Actual)Observational2020-08-15Completed
Phase III, Placebo-Controlled, Double-Blind Crossover Study of Slow-Release Methylphenidate (Concerta ™) for Treatment of HIV Associated Neurocognitive Disorder [NCT01599975]Phase 340 participants (Anticipated)Interventional2012-05-31Recruiting
Effects of MDMA (Ecstasy) and Methylphenidate (Ritalin) on Social Cognition [NCT01616407]Early Phase 130 participants (Actual)Interventional2012-08-31Completed
An Open-Label, Dose-Titration, Long-Term Safety Study to Evaluate CONCERTA (Methylphenidate HCL) Extended-release Tablets at Doses of 36 mg, 54 mg, 72 mg, 90 mg, and 108 mg Per Day in Adults With Attention Deficit Hyperactivity Disorder [NCT00326300]Phase 3560 participants (Actual)Interventional2006-04-30Completed
Quillivant XR in Children With Attention Deficit/Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD): A Pilot Study [NCT02255565]Phase 436 participants (Actual)Interventional2014-09-30Completed
Open-Label Treatment Trial to Assess the Short-Term Tolerability, Safety, and Efficacy of Methylphenidate Hydrochloride Extended-Release Liquid Formulation in High-Functioning Autism Spectrum Disorder Adults With Attention-Deficit/Hyperactivity Disorder [NCT02096952]Phase 415 participants (Actual)Interventional2014-05-31Completed
Methylphenidate to Improve Balance and Walking in MS [NCT01896700]Phase 2/Phase 324 participants (Actual)Interventional2013-07-31Completed
An Open-Label Study of Quetiapine Added to Oros Methylphenidate in the Treatment of ADHD and Aggressive Behavior [NCT00550147]Phase 230 participants (Actual)Interventional2004-02-29Completed
Active Emergence of From Isoflurane General Anesthesia Induced by Methylphenidate [NCT02327195]Phase 154 participants (Actual)Interventional2014-05-31Completed
A Phase II Proof-of-concept Trial of Methylphenidate in Children With Apraxia of Speech: a Double-blind, Randomised, Placebo-controlled, Cross-over Trial [NCT05185583]Phase 224 participants (Anticipated)Interventional2022-03-14Recruiting
Sensitivity of the NIH Toolbox Cognition Battery to Stimulant Treatment in Intellectual Disabilities [NCT05301361]Phase 168 participants (Anticipated)Interventional2023-02-01Enrolling by invitation
Improving Function, Quality of Life, Glycemia in Diabetics With Dementia [NCT00792662]Phase 40 participants (Actual)Interventional2008-11-18Withdrawn(stopped due to No Subjects enrolled)
Attention Management Trial for Children With FASD - a N-of-1 Control Trial of Prescribed Stimulants for ADHD in FASD [NCT04968522]Phase 420 participants (Anticipated)Interventional2022-02-14Recruiting
Randomized, Double-Blind, Placebo-Controlled Study of Dexmethylphenidate Hydrochloride, (d-MPH) in the Treatment of Fatigue in Sarcoidosis Subjects. [NCT00361387]Phase 412 participants (Anticipated)Interventional2006-06-30Completed
Pharmacokinetic Pharmacodynamic Studies of Methylphenidate Extended Release Products in Pediatric Attention Deficit Hyperactivity Disorder [NCT02536105]88 participants (Actual)Interventional2016-05-31Completed
Motivated Behavior in Adults With and Without ADHD [NCT02630017]Phase 251 participants (Actual)Interventional2016-03-07Completed
[NCT02152670]1 participants (Actual)Interventional2014-05-31Terminated(stopped due to Study drug became unaffordable for the purposes of the research.)
Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis [NCT03185065]Phase 3141 participants (Actual)Interventional2017-10-04Completed
Memantine for Executive Dysfunction in Adults With ADHD: A Pilot Study [NCT01533493]33 participants (Actual)Interventional2012-05-31Completed
A Phase 4, Randomized, Double-blind, Multicenter, Parallel-group, Active-controlled, Dose-optimization Safety and Efficacy Study of SPD489 (VYVANSE®) Compared With OROS-MPH (CONCERTA®) With a Placebo Reference Arm, in Adolescents Aged 13-17 Years With Att [NCT01552915]Phase 4464 participants (Actual)Interventional2012-04-17Completed
Can Methylphenidate (Ritalin) Improve Memory and Attention in Mild Cognitive Impairment? A Combined Behaviour-EEG Study [NCT02326038]Phase 440 participants (Anticipated)Interventional2014-11-30Recruiting
Equine-Assisted Activities and Therapy for Treating Children With Attention-Deficit/Hyperactivity Disorder [NCT02482649]46 participants (Anticipated)Interventional2013-01-31Recruiting
WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring [NCT05536011]1,329 participants (Anticipated)Observational [Patient Registry]2021-08-24Recruiting
Examining Tolerance to CNS Stimulants in ADHD [NCT02039908]Phase 4267 participants (Actual)Interventional2013-04-30Completed
Multi Neuro-functional Biomarkers for Monitoring the Effects of Treatments in ADHD Children [NCT04272021]Phase 420 participants (Anticipated)Interventional2018-04-13Recruiting
Relationship Between the Neuroendocrine Substrates, Candidate Genes and Endophenotypes in Patients With Attention-deficit/Hyperactivity Disorder [NCT02392169]300 participants (Anticipated)Observational2013-08-31Recruiting
Etude Comparative Monocentrique, randomisée, en Cross-over, en Double Aveugle, Contre Placebo, de l'Action du méthylphénidate Sur Les paramètres Cognitifs de la Motivation [NCT03190681]Early Phase 124 participants (Anticipated)Interventional2017-07-01Not yet recruiting
Pilot Study to Evaluate the Benefits and the Risks of Methylphenidate for the Treatment of Cocaine Dependence [NCT03090269]Phase 20 participants (Actual)Interventional2018-06-01Withdrawn(stopped due to feasibility reasons.)
Efficacy of Pharmacologic Management of ADHD in Children and Youth With Autism Spectrum Disorder [NCT05916339]Phase 4500 participants (Anticipated)Interventional2023-10-01Not yet recruiting
The Interaction of Cognitive Control Mechanisms and Language Processing: An Investigation With Methylphenidate [NCT05272397]36 participants (Actual)Interventional2019-11-26Completed
Influence of Stimulant Medication on Brain Processes for Decision Making in Attention Deficit Hyperactivity Disorder [NCT01831622]Phase 4131 participants (Actual)Interventional2013-06-30Completed
The Role of Dopaminergic and Noradrenergic Neurotransmission in Value- and Salience-based Decision-Making [NCT04371146]120 participants (Actual)Interventional2019-07-03Completed
An Extension Study to Evaluate the Long-term Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD [NCT02704390]Phase 364 participants (Actual)Interventional2016-01-31Completed
A Randomized Clinical Trial Comparing Computer-assisted Cognitive Rehabilitation (CACR), Psycho-stimulants, and Placebo CACR in the Treatment of Attention Deficit/ Hyperactivity Disorder [NCT01675804]Phase 334 participants (Actual)Interventional2011-11-30Completed
The Impact of Genetic Variation In Nicotinic Cholinergic Receptors on Functional Brain Networks Underlying Addiction Susceptibility [NCT01924468]Phase 176 participants (Actual)Interventional2013-08-14Completed
Open Label Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children 6-12 Years Old With Attention Deficit Hyperactivity Disorder (ADHD) [NCT00989950]26 participants (Actual)Interventional2009-12-31Completed
A Randomized Comparison of Osmotic Release Oral System Methylphenidate and Cognitive Behavioural Therapy for the Treatment of Obese Patients With Binge Eating Disorder [NCT01921582]Phase 251 participants (Actual)Interventional2013-08-31Completed
Prevention of Cigarette Smoking in ADHD Youth With Concerta [NCT00181714]Phase 4203 participants (Actual)Interventional2003-11-30Completed
Efficacy and Safety/Tolerability of OROS MPH (Concerta) Plus Atomoxetine (ATMX) in Children and Adolescents (Age 6-17) With Attention Deficit Hyperactivity Disorder (ADHD) [NCT00585910]Phase 494 participants (Actual)Interventional2004-01-31Completed
The Use of Methylphenidate to Improve Clinical Outcomes in Geriatric Depression: A Double-blind Placebo-Controlled Trial of Methylphenidate (Ritalin) Augmentation of Citalopram (Celexa) in Depressed Elderly Patients [NCT00602290]Phase 4181 participants (Actual)Interventional2008-02-29Completed
Efficacy of Methylphenidate for Management of Long-Term Attention Problems After Pediatric Traumatic Brain Injury (TBI) [NCT01933217]Phase 426 participants (Actual)Interventional2013-11-30Completed
MethylphenIdate for Fatigue in Haematological Cancer. A Randomized, Double-blind, Placebo-controlled, CROssover Trial - the MICRO Trial [NCT03218254]Phase 3150 participants (Anticipated)Interventional2018-06-08Recruiting
Potentiation of Cognitive Functions in Healthy Elderly by Association of Methylphenidate and Cognitive Training: Proof of Concept Study in Order to Develop a Synergic Symptomatic Treatment for the Cognitive Disorders Before Dementia [NCT03280251]Phase 2120 participants (Anticipated)Interventional2018-09-19Recruiting
The Roles of Endocrine Disrupting Chemicals, Growth Hormone and Thyroid Function in Attention-deficit/Hyperactivity Disorder [NCT04970303]240 participants (Anticipated)Observational2019-07-12Enrolling by invitation
L-methylfolate Supplementation to OROS-Methylphenidate Pharmacotherapy in ADHD Adults: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial [NCT01853280]Phase 2/Phase 347 participants (Actual)Interventional2014-05-31Completed
Apathy in Dementia Methylphenidate Trial 2 [NCT02346201]Phase 3200 participants (Actual)Interventional2016-01-31Completed
Patient Controlled Methylphenidate for Cancer Related Fatigue: A Double Blind, Randomized, Placebo Controlled Trial [NCT05041946]Phase 3112 participants (Actual)Interventional2003-07-16Completed
Functional Neuroimaging of Acute Concerta Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD): Differences Across Development [NCT00778310]Phase 476 participants (Actual)Interventional2008-11-30Completed
A Randomized, Phase II Placebo-controlled Study of the Use of Extended-release Methylphenidate or Modafinil for the Treatment of Excessive Daytime Sleepiness in Children Following Cancer Therapy [NCT01348607]Phase 21 participants (Actual)Interventional2010-07-31Terminated(stopped due to Study only randomized 1 subject and was determined not feasible by DSMB)
An Open, Self-Controlled, Prospective Study of Concerta on Cognitive Functions, Efficacy and Tolerance in the Pediatric Patients With Attention Deficit Hyperactivity Disorder (ADHD) [NCT01933880]Phase 4194 participants (Actual)Interventional2009-12-31Completed
Exploring the Use of Transdermal Methylphenidate to Reduce Fall Risk in Patients With Dementia. [NCT01825577]Phase 414 participants (Actual)Interventional2012-11-30Terminated(stopped due to Administrative Reasons)
Control of Cognition: Naltrexone, Methylphenidate, and ADHD Study [NCT01993108]Phase 423 participants (Actual)Interventional2013-10-31Completed
Effects of Atomoxetine and Oros-mph on Executive Functions in Patients With Combined Type Attention Deficit Hyperactivity Disorder [NCT02352051]Phase 443 participants (Actual)Interventional2014-02-28Completed
An Electroencephalography Study of the Effects of Psychostimulants on Dynamic Patterns of Cognitive Task-based Functional Connectivity in Youths With Attention Deficit Hyperactivity Disorder [NCT02318017]75 participants (Anticipated)Interventional2014-12-31Not yet recruiting
A Pilot Study of Omega-3 Fatty Acid Supplementation to ADHD Medication in Children With ADHD and Deficits in Emotional Self-Regulation [NCT02204410]Phase 421 participants (Actual)Interventional2014-07-31Completed
Multimodal Magnetic Resonance Imaging Study on the Neural Mechanisms of Remission in Children With ADHD Treated With Methylphenidate or Atomoxetine [NCT05229627]250 participants (Anticipated)Observational2016-01-31Enrolling by invitation
The Neural Correlates of and Effects of Methylphenidate on Acute Pain Dynamics [NCT05669924]Phase 230 participants (Anticipated)Interventional2022-09-19Recruiting
Methylphenidate Treatment of Attentional and Cognitive Deficits in Epilepsy [NCT02178995]Phase 455 participants (Actual)Interventional2014-08-31Completed
A Pilot, Multiple Crossover, Randomized Block Sequence, Double-Blind, Placebo-Controlled Trial for Use of Methylphenidate for Cognitive and Behavioral Symptoms in Mild Cognitive Impairment and Dementia [NCT03811847]Phase 411 participants (Actual)Interventional2019-11-01Completed
Use of Methylphenidate in Children and Adolescents in France [NCT03371069]1 participants (Actual)Observational2015-09-30Completed
Aripiprazole Added on Methylphenidate in the Treatment of Youths With Comorbid ADHD and DMDD [NCT03358277]58 participants (Actual)Interventional2014-11-19Completed
A Randomized, Double-Blind Study of the Time Course of Response to Biphentin® Methylphenidate Hydrochloride ER Capsules Compared to Placebo in Children 6 to 12 Years With Attention Deficit Hyperactivity Disorder in Analog Classroom Setting [NCT01269463]Phase 326 participants (Actual)Interventional2011-01-19Completed
ADHD Symptoms in Autism: Cognition, Behavior, Treatment [NCT00178503]Phase 2/Phase 324 participants (Actual)Interventional2005-09-30Completed
Reversal of General Anesthesia With Intravenous Methylphenidate [NCT02051452]Phase 1/Phase 232 participants (Actual)Interventional2014-11-30Completed
Stimulant Medication Effects on Auditory Sensitivity and Acoustic Reflex in Adolescents With ADHD [NCT04577417]70 participants (Actual)Observational2020-09-13Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00050622 (3) [back to overview]Classroom Behavior
NCT00050622 (3) [back to overview]Social Behavior-Negative Verbalizations
NCT00050622 (3) [back to overview]Treatment Satisfaction
NCT00129467 (1) [back to overview]Days to Remission of Depression
NCT00151996 (5) [back to overview]Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Scores at 6 Weeks
NCT00151996 (5) [back to overview]Number of Participants With Improvement on Parent Global Assessment (PGA) Scores
NCT00151996 (5) [back to overview]Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
NCT00151996 (5) [back to overview]Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks
NCT00151996 (5) [back to overview]Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Total Score at 6 Weeks
NCT00178503 (3) [back to overview]Mean Conners' Parent ADHD Index T Score by Week
NCT00178503 (3) [back to overview]Mean Conners' Teacher ADHD Index T Score by Dose
NCT00178503 (3) [back to overview]Mean Continuous Performance Test (CPT)-Commission Errors by Dose
NCT00181714 (1) [back to overview]Cigarette Smoking
NCT00183391 (16) [back to overview]Assessment of Affective Range (AAR)
NCT00183391 (16) [back to overview]Child Conflict Index (CCI)
NCT00183391 (16) [back to overview]Children's Sleep Questionnaire
NCT00183391 (16) [back to overview]Clinical Global Impressions (CGI)- Severity
NCT00183391 (16) [back to overview]Continuous Performance Test (CPT)
NCT00183391 (16) [back to overview]Social Skills Rating Scale (SSRS)- Parent Version
NCT00183391 (16) [back to overview]Tics: Total Impairment
NCT00183391 (16) [back to overview]Tics: Total Motor
NCT00183391 (16) [back to overview]Tics: Total Phonic
NCT00183391 (16) [back to overview]Vital Signs - Diastolic Blood Pressure
NCT00183391 (16) [back to overview]Vital Signs - Pulse
NCT00183391 (16) [back to overview]Vital Signs - Systolic Blood Pressure
NCT00183391 (16) [back to overview]ADHD - H/I
NCT00183391 (16) [back to overview]ADHD-RS Inattention
NCT00183391 (16) [back to overview]ADHD-RS Total Score
NCT00183391 (16) [back to overview]Treatment Preference Survey
NCT00253747 (3) [back to overview]Prolonged Abstinence
NCT00253747 (3) [back to overview]Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale
NCT00253747 (3) [back to overview]Point-prevalence Abstinence
NCT00257725 (3) [back to overview]Swanson, Nolan, and Pelham Questionnaire (SNAP-IV)
NCT00257725 (3) [back to overview]Children's Global Assessment Scale (C-GAS)
NCT00257725 (3) [back to overview]Clinical Global Impressions-Severity (CGI-S)
NCT00264797 (4) [back to overview]ADHD Severity
NCT00264797 (4) [back to overview]OROS-MPH Abuse Liability
NCT00264797 (4) [back to overview]Substance Use
NCT00264797 (4) [back to overview]Substance Use Outcomes
NCT00302458 (1) [back to overview]Peak Plasma Concentration of d-Methylphenidate
NCT00307684 (7) [back to overview]Change From OL Baseline in Clinical Global Impression Scale (CGI-S) Score at OL Endpoint
NCT00307684 (7) [back to overview]Change From OL Baseline in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score at OL Endpoint
NCT00307684 (7) [back to overview]Change From OL Baseline to OL Endpoint in Conners' Adult ADHD Rating Scale (CAARS) Total and Subscale Scores
NCT00307684 (7) [back to overview]Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00307684 (7) [back to overview]Change From DB Baseline to DB Endpoint in CGI-S Score
NCT00307684 (7) [back to overview]Change From DB Baseline to DB Endpoint in CAARS Self Rated Scale (CAARS-S:S) Total Score
NCT00307684 (7) [back to overview]Change From DB Baseline in Conners' Adult ADHD Rating Scale (CAARS) Total Score at DB Endpoint
NCT00376675 (9) [back to overview]AUC of Sleep Quality as Measured by the Pittsburgh Sleep Quality Index at Baseline and at Weeks 1-4
NCT00376675 (9) [back to overview]AUC of Vitality as Measured by the Short Form-36 Vitality Subscale at Baseline and at Weeks 1-4
NCT00376675 (9) [back to overview]Prorated AUC of Total Fatigue as Measured by the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4
NCT00376675 (9) [back to overview]AUC of Other Fatigue Scores as Measured by Items of the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4
NCT00376675 (9) [back to overview]AUC of Overall Quality of Life (QOL) and QOL Domains as Measured by the Linear Analogue Self Assessment at Baseline and at Weeks 1-4
NCT00376675 (9) [back to overview]Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4
NCT00376675 (9) [back to overview]Anchor-based Minimally Important Difference in SGIC Overall Quality of Life Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue
NCT00376675 (9) [back to overview]Anchor-based Minimally Important Difference in SGIC Physical Condition Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue
NCT00376675 (9) [back to overview]Anchor-based Minimally Important Difference in SGIC Emotional State Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue
NCT00409708 (6) [back to overview]Number of Sister Chromatoid Exchanges Per Cell
NCT00409708 (6) [back to overview]The Number of Chromosomal Aberrations Per 100 Cells Excluding Gaps at Baseline and at the End of Treatment i.e Day 84 (Week 12)
NCT00409708 (6) [back to overview]The Number of Micronuclei Per 1000 Binucleated Cells Endpoints at Baseline and at the End of Treatment i.e Day 84 (Week 12)
NCT00409708 (6) [back to overview]Change From Baseline to End of Treatment (Week 12) on the Conners' ADHD/DSM-IV Scale for Parents (CADS-P)
NCT00409708 (6) [back to overview]Change From Baseline to the End of Treatment (Week 12) on the Global Improvement Rating of the Clinical Global Impression Scale (CGI-I)
NCT00409708 (6) [back to overview]Change From Baseline to the End of Treatment (Week 12) on the Severity of Illness Rating of the Clinical Global Impression Scale (CGI-S)
NCT00418691 (1) [back to overview]Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score
NCT00424099 (2) [back to overview]Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Fatigue Subscale Score
NCT00424099 (2) [back to overview]Change in Edmonton Symptom Assessment System (ESAS) Fatigue Score
NCT00428792 (10) [back to overview]Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating
NCT00428792 (10) [back to overview]Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating
NCT00428792 (10) [back to overview]Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating
NCT00428792 (10) [back to overview]Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population
NCT00428792 (10) [back to overview]Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Per Protocol (PP) Population
NCT00428792 (10) [back to overview]Clinical Global Impression (CGI-I) Scale Score - Physician Rating of Improvement (Change in State)
NCT00428792 (10) [back to overview]Clinical Global Impression Severity (CGI-S) Scale Score - Physician Rating of Severity
NCT00428792 (10) [back to overview]Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating
NCT00428792 (10) [back to overview]10-Minute Math Test - Problems Attempted
NCT00428792 (10) [back to overview]10-Minute Math Test - Problems Solved
NCT00429273 (1) [back to overview]ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale)
NCT00434213 (2) [back to overview]Contact Sensitization to Methylphenidate
NCT00434213 (2) [back to overview]Dermal Reactions
NCT00453921 (7) [back to overview]Self Report Questionnaire - MASQ
NCT00453921 (7) [back to overview]Neuropsychological Assessment, CVLT-II
NCT00453921 (7) [back to overview]Neuropsychological Assessment - CPT, Distractibility Condition (Reaction Time)
NCT00453921 (7) [back to overview]Functional MRI Task Performance and Brain Activation (Change From Baseline to Post-treatment)
NCT00453921 (7) [back to overview]Change in Right Inferior Frontal Activation During Working Memory Processing (3-back > 0-back Condition) From Baseline to Post-intervention
NCT00453921 (7) [back to overview]Change in Left Middle/Inferior Frontal Activation During Working Memory Processing (3-back > 0-back Condition) From Baseline to Post-intervention
NCT00453921 (7) [back to overview]Change in Anterior Cingulate Gyrus Activation During Working Memory Processing (3-back > 0-back Condition) From Baseline to Post-intervention
NCT00475735 (2) [back to overview]Baseline AISRS
NCT00475735 (2) [back to overview]Mean Change From Baseline in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) Total Score After 4 Weeks of Treatment
NCT00495820 (3) [back to overview]Apathy Evaluation Scale Score at 12 Weeks
NCT00495820 (3) [back to overview]Clinical Global Impression
NCT00495820 (3) [back to overview]Mini-mental State Examination (MMSE) at 12 Weeks
NCT00499746 (8) [back to overview]Physiologic Effects Assessed by the Pharmacological Class Questionnaire
NCT00499746 (8) [back to overview]Discrimination Effects Assessed by Point Distribution
NCT00499746 (8) [back to overview]Discrimination Effects Assessed by Operant Responses
NCT00499746 (8) [back to overview]Discrimination Effects Assessed by Discrete Choice
NCT00499746 (8) [back to overview]Physiological Effects Assessed by Peak Change From Baseline Pupil Diameter
NCT00499746 (8) [back to overview]Peak Change From Baseline Stimulant Effects Assessed by the Visual Analog Scale (VAS)
NCT00499746 (8) [back to overview]Peak Change From Baseline Opioid Agonist Effects Assessed by the Visual Analog Scale (VAS)
NCT00499746 (8) [back to overview]Acquisition of Discrimination Assessed by Accuracy of the Discrimination Test
NCT00499863 (12) [back to overview]Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint
NCT00499863 (12) [back to overview]Change From Baseline in Weight at Endpoint
NCT00499863 (12) [back to overview]Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint
NCT00499863 (12) [back to overview]Dermal Response Scale (DRS) Scores
NCT00499863 (12) [back to overview]Improvement in Clinical Global Impressions-Improvement (CGI-I) Score
NCT00499863 (12) [back to overview]Improvement in Parent Global Assessment (PGA) Score
NCT00499863 (12) [back to overview]Post Sleep Questionnaire (PSQ) Quality of Sleep
NCT00499863 (12) [back to overview]Change From Baseline in Diastolic Blood Pressure at Endpoint
NCT00499863 (12) [back to overview]Change From Baseline in Electrocardiogram Results(QTcF Interval) at Endpoint
NCT00499863 (12) [back to overview]Change From Baseline in Pulse Rate at Endpoint
NCT00499863 (12) [back to overview]Change From Baseline in Systolic Blood Pressure at Endpoint
NCT00499863 (12) [back to overview]Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint
NCT00501293 (12) [back to overview]Electrocardiogram Results (QTcF Interval)
NCT00501293 (12) [back to overview]Diastolic Blood Pressure
NCT00501293 (12) [back to overview]Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at 6 Months
NCT00501293 (12) [back to overview]Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
NCT00501293 (12) [back to overview]Number of Participants With Improvement on Parent Global Assessment (PGA) Scores.
NCT00501293 (12) [back to overview]Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Scores at 6 Months
NCT00501293 (12) [back to overview]Dermal Reactions
NCT00501293 (12) [back to overview]Weight
NCT00501293 (12) [back to overview]Pulse Rate
NCT00501293 (12) [back to overview]Post Sleep Questionnaire (PSQ) Quality of Sleep
NCT00501293 (12) [back to overview]Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) at 6 Months
NCT00501293 (12) [back to overview]Systolic Blood Pressure
NCT00506285 (2) [back to overview]Conners' Adult ADHD Rating Scales (CAARS)
NCT00506285 (2) [back to overview]Wender Reimherr Adult Attention Deficit Disorder Scale
NCT00516269 (1) [back to overview]Mean Difference Between Post-Methylphenidate and Post-Placebo Measurement
NCT00526630 (8) [back to overview]Duration of Freezing and Shuffling Episodes Between Groups at 12 and 27 Weeks.
NCT00526630 (8) [back to overview]Montgomery-Åsberg Depression Rating Scale (MADRS) Between Groups at 12 and 27 Weeks.
NCT00526630 (8) [back to overview]The 5-item EuroQoL (EQ-5D) Quality of Life Generic Instrument Between Groups at 12 and 27 Weeks.
NCT00526630 (8) [back to overview]The Epworth Sleepiness Scale (ESS) Between Groups at 12 and 27 Weeks
NCT00526630 (8) [back to overview]The Primary Outcome Measure Was Change in a Gait Stride Length Between Groups at 12 and 27 Weeks.
NCT00526630 (8) [back to overview]The Primary Outcome Measure Was Change in Gait Velocity Between Groups at 12 and 27 Weeks.
NCT00526630 (8) [back to overview]The Unified Parkinson Disease Rating Scale (UPDRS) Between Groups at 12 and 27 Weeks
NCT00526630 (8) [back to overview]Freezing of Gait Questionnaire (FOGQ) Scores Between Groups at 12 and 27 Weeks.
NCT00530257 (11) [back to overview]Test of Everyday Attention for Children: Sky Search
NCT00530257 (11) [back to overview]Test of Everyday Attention for Children: Walk, Don't Walk
NCT00530257 (11) [back to overview]Wechsler Intelligence Scale for Children-IV, Digit Span Subtest
NCT00530257 (11) [back to overview]ADHD Rating Scale-IV, Parent and Teacher Version
NCT00530257 (11) [back to overview]Gordon Diagnostic System Continuous Performance Test
NCT00530257 (11) [back to overview]Test of Everyday Attention for Children: Map Mission
NCT00530257 (11) [back to overview]Test of Everyday Attention for Children: Creature Counting
NCT00530257 (11) [back to overview]Test of Everyday Attention for Children-Sky Search Dual Task
NCT00530257 (11) [back to overview]Stimulant Side Effect Rating Scale
NCT00530257 (11) [back to overview]Test of Everyday Attention for Children: Opposite Worlds
NCT00530257 (11) [back to overview]Test of Everyday Attention for Children: Score Dual Task (DT)
NCT00541346 (11) [back to overview]Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit
NCT00541346 (11) [back to overview]Change in Pediatric Evaluation Disability Inventory (PEDI) Social Function From Baseline to 8-week Follow-up Visit
NCT00541346 (11) [back to overview]Change in Pediatric Evaluation Disability Inventory (PEDI) Caregiver Assistance: Self-Care From Baseline to 8-week Follow-up Visit
NCT00541346 (11) [back to overview]Change in Lifetime Participation Scale (LPS) Total Scores From Baseline to 8-week Follow-up Visit
NCT00541346 (11) [back to overview]Change in Family III General Scale Summed Score From Baseline to 8-week Follow-up Visit
NCT00541346 (11) [back to overview]Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit
NCT00541346 (11) [back to overview]Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit
NCT00541346 (11) [back to overview]Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit
NCT00541346 (11) [back to overview]Change in Attention Deficit Hyperactivity Disorder Rating Scale IV: Teacher Assessment Total Scores From Baseline to 8-week Follow-up Visit
NCT00541346 (11) [back to overview]Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit
NCT00541346 (11) [back to overview]Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit
NCT00549640 (3) [back to overview]Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Study
NCT00549640 (3) [back to overview]Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Treatment.
NCT00549640 (3) [back to overview]The Change in the Average Nicotine Withdrawal Symptom Score From Baseline to 14 Days Post Target Quit Date.
NCT00550147 (5) [back to overview]Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent Version)
NCT00550147 (5) [back to overview]CGI-S: Clinical Global Improvement Scale
NCT00550147 (5) [back to overview]Modified Overt Aggression Scale (MOAS)
NCT00550147 (5) [back to overview]RAAPP: Rating of Aggression Against People and/or Property Scale
NCT00550147 (5) [back to overview]Swanson, Nolan and Pelham IV (SNAP-IV) Oppositional-Defiant Disorder Subscale
NCT00564954 (6) [back to overview]Change From Pre-dose in SKAMP Deportment Score
NCT00564954 (6) [back to overview]Change From Pre-dose (0 hr) in SKAMP Combined Score at All Times Excluding the 0.5 Hour Timepoint (Hours 1, 2, 4, 6, 8)
NCT00564954 (6) [back to overview]Change From Pre-dose (0 hr.) in Permanent Product Measure of Performance (PERMP) Math Test-Attempted Scores at All Timepoints (0.5, 1, 2, 4, 6, 8)
NCT00564954 (6) [back to overview]Change From Pre-dose (0 hr [Hour]) on the Swanson, Kotkin, Agler, M-Flynn & Pelham (SKAMP) Rating Scale Combined Score at 0.5 Hour During the 8- Hour Laboratory Classroom Day
NCT00564954 (6) [back to overview]Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8)
NCT00564954 (6) [back to overview]Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test
NCT00573859 (3) [back to overview]The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission.
NCT00573859 (3) [back to overview]The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire.
NCT00573859 (3) [back to overview]The Effects of ADHD Medication Versus Placebo on Cotinine Levels
NCT00576472 (34) [back to overview]Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conner's Parent Rating Scale (CPRS: Cognitive Problem T Score)
NCT00576472 (34) [back to overview]Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Parent Rating Scale (CPRS: ADHD T Score)
NCT00576472 (34) [back to overview]Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: Cognitive Problem T Score)
NCT00576472 (34) [back to overview]Change From Maintenance Phase Baseline to Completion of Phase as Measured by Social Skill Rating System (SSRS-P)
NCT00576472 (34) [back to overview]Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Math: Composite Standard Score
NCT00576472 (34) [back to overview]Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Reading: Composite Standard Score
NCT00576472 (34) [back to overview]Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Spelling: Standard Score
NCT00576472 (34) [back to overview]Change From Methylphenidate (MPH) Home Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: ADHD T Score)
NCT00576472 (34) [back to overview]Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Parent (SSRS-P) - Problem Behavior.
NCT00576472 (34) [back to overview]Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Teacher (SSRS-T) - Problem Behavior.
NCT00576472 (34) [back to overview]Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Teacher (SSRS-T) - Social Skill.
NCT00576472 (34) [back to overview]Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Parent Rating Scale (CPRS) ADHD Index.
NCT00576472 (34) [back to overview]Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Parent Rating Scale (CPRS) Cognitive Problem/Inattention Scale.
NCT00576472 (34) [back to overview]Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Parent Rating Scale (CPRS) Hyperactivity Scale.
NCT00576472 (34) [back to overview]Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Teacher Rating Scale (CTRS) ADHD Index.
NCT00576472 (34) [back to overview]Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Teacher Rating Scale (CTRS) Cognitive Problem/Inattention Scale.
NCT00576472 (34) [back to overview]Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Teacher Rating Scale (CTRS) Hyperactivity Scale.
NCT00576472 (34) [back to overview]Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Color Naming Time.
NCT00576472 (34) [back to overview]Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Ink Color Naming Time.
NCT00576472 (34) [back to overview]Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Interference Score.
NCT00576472 (34) [back to overview]Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Word Naming Time.
NCT00576472 (34) [back to overview]Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) for Long Delay Free Recall.
NCT00576472 (34) [back to overview]Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) for Short Delay Free Recall.
NCT00576472 (34) [back to overview]Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) Over Five Learning Trials.
NCT00576472 (34) [back to overview]Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Commission Errors.
NCT00576472 (34) [back to overview]Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for d' (Sensitivity).
NCT00576472 (34) [back to overview]Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Hit Reaction Time.
NCT00576472 (34) [back to overview]Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Omission Errors.
NCT00576472 (34) [back to overview]Best Weekly Score Measured by Conners' Parent Rating Scale (CPRS: ADHD T Score) During the 3-week Home Crossover Phase.
NCT00576472 (34) [back to overview]Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Beta (Risk Taking).
NCT00576472 (34) [back to overview]Brain White Matter Volume for Patients Versus Sibling Controls
NCT00576472 (34) [back to overview]Brain White Matter Volume for Patients With Acute Lymphoblastic Leukemia Versus Brain Tumors
NCT00576472 (34) [back to overview]Brain White Matter Volume for Treatment Intensity Groups and Sibling Controls
NCT00576472 (34) [back to overview]Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Parent (SSRS-P) - Social Skill.
NCT00585910 (2) [back to overview]Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)
NCT00585910 (2) [back to overview]Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders
NCT00586157 (3) [back to overview]Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires
NCT00586157 (3) [back to overview]Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM.
NCT00586157 (3) [back to overview]Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day.
NCT00593112 (3) [back to overview]H MRS Scan Results - Glutamate & Glutamine (Glx)/Ino
NCT00593112 (3) [back to overview]H MRS Scan Results - Glutamine (Gln)/Ino
NCT00593112 (3) [back to overview]Proton Magnetic Resonance Spectroscopy (H MRS) Scan Results - Glutamate(Glu)/Myo-inositol-containing Compounds (Ino)
NCT00602290 (2) [back to overview]Hamilton Depression Rating Scale (HDRS) Maintained Scores at Week 16
NCT00602290 (2) [back to overview]Quality of Life Assessment
NCT00714688 (4) [back to overview]Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS)
NCT00714688 (4) [back to overview]Change in Clinical Global Impression-Severity (CGI-S) From Baseline to End of Treatment
NCT00714688 (4) [back to overview]Clinical Global Impression-Change (CGI-C)
NCT00714688 (4) [back to overview]Change in Conners Adult ADHD Rating Scale Self Report Short Version (CAARS-S:S) Total Score
NCT00715520 (6) [back to overview]Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)
NCT00715520 (6) [back to overview]Aim 1: Mean Peak Acceleration of Wrist Extension Movements
NCT00715520 (6) [back to overview]Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency
NCT00715520 (6) [back to overview]Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse
NCT00715520 (6) [back to overview]Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency
NCT00715520 (6) [back to overview]Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse
NCT00754208 (3) [back to overview]Change in Children's Global Assessment Scale (CGAS) Score
NCT00754208 (3) [back to overview]Change in Clinical Global Impression-Severity
NCT00754208 (3) [back to overview]Change in Attention Deficit Hyperactivity Disorder Rating Scale-IV Parent Version Investigator-Scored (ADHD-IV-Parent: Inv) Total Score.
NCT00758160 (12) [back to overview]Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4
NCT00758160 (12) [back to overview]Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score
NCT00758160 (12) [back to overview]Clinical Global Impression-Severity (CGI-S) Score
NCT00758160 (12) [back to overview]Global Assessment of Satisfaction by Parents/Caregivers
NCT00758160 (12) [back to overview]Global Assessment of Satisfaction by Participant
NCT00758160 (12) [back to overview]Social Adjustment Scale Score for Children and Adolescents (SAICA)
NCT00758160 (12) [back to overview]Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8
NCT00758160 (12) [back to overview]Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4
NCT00758160 (12) [back to overview]Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8
NCT00758160 (12) [back to overview]Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
NCT00758160 (12) [back to overview]Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score
NCT00758160 (12) [back to overview]Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2
NCT00763971 (8) [back to overview]Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks
NCT00763971 (8) [back to overview]Columbia-Suicide Severity Rating Scale (C-SSRS)
NCT00763971 (8) [back to overview]Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks
NCT00763971 (8) [back to overview]Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 Weeks
NCT00763971 (8) [back to overview]Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks
NCT00763971 (8) [back to overview]Change From Baseline in the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks
NCT00763971 (8) [back to overview]Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 Weeks
NCT00763971 (8) [back to overview]Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
NCT00776009 (5) [back to overview]Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Attention Score at 10, 11, and 12 Hour (Averaged) Post-dose
NCT00776009 (5) [back to overview]Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Correctly Answered Score at 10, 11, and 12 Hours (Averaged) Post-dose
NCT00776009 (5) [back to overview]Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Attempted Score at 10, 11, and 12 Hours (Averaged) Post-dose
NCT00776009 (5) [back to overview]Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose
NCT00776009 (5) [back to overview]Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Deportment Score at 10, 11, and 12 Hour (Averaged) Post-dose
NCT00778310 (1) [back to overview]Brain Oxygenation Level Dependent Signal in the Fusiform Gyrus and the Amygdala on Concerta vs. Placebo
NCT00780208 (2) [back to overview]Number of Participants With Positive Drug Screen
NCT00780208 (2) [back to overview]ADHD Symptom Severity
NCT00783835 (9) [back to overview]Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale
NCT00783835 (9) [back to overview]Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 12
NCT00783835 (9) [back to overview]Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 4
NCT00783835 (9) [back to overview]Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 8
NCT00783835 (9) [back to overview]Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 12
NCT00783835 (9) [back to overview]Clinical Global Impression-Improvement (CGI-I) Score
NCT00783835 (9) [back to overview]Change From Screening in the Hamilton Depression Rating (HAM-D) Scale Score at Week 4 and 12
NCT00783835 (9) [back to overview]Change From Screening in Clinical Global Impression-Severity of Illness (CGI-S) Score at Weeks 4, 8 and 12
NCT00783835 (9) [back to overview]Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 4
NCT00794040 (5) [back to overview]"Percentage of Participants That Much Improved (Score of 2) in, or Completely Recovered (Score of 1) From Their Irritability Severity, as Measured With the Clinical Global Impression-Improvement (CGI-I)."
NCT00794040 (5) [back to overview]Functional Impairment at 8th Week of Trial
NCT00794040 (5) [back to overview]Depressive Symptoms at 8th Week of Trial
NCT00794040 (5) [back to overview]Irritability Severity at 8th Week of Trial.
NCT00794040 (5) [back to overview]Anxiety Symptoms at 8th Week of Trial
NCT00796302 (4) [back to overview]NCBRF-TIQ D-Total Score
NCT00796302 (4) [back to overview]Clinical Global Impressions Scale for Severity of Illness
NCT00796302 (4) [back to overview]Antisocial Behavior Scale - Reactive Aggression Subscale
NCT00796302 (4) [back to overview]Clinical Global Impressions Scale for Improvement
NCT00799409 (25) [back to overview]Hour 7.5 Test of Handwriting Skills (Revised) (THS-R) Standard Score
NCT00799409 (25) [back to overview]Hour 8.75 Gray Silent Reading Test (GSRT) Reading Quotient
NCT00799409 (25) [back to overview]Hour 8.75 Packet Activity Alphabetize List of Words
NCT00799409 (25) [back to overview]Hour 8.75 Packet Activity Complete Sentences Using Words Provided
NCT00799409 (25) [back to overview]Hour 8.75 Packet Activity Decode the Mystery Sentence
NCT00799409 (25) [back to overview]Hour 8.75 Packet Activity Identify Multiple Meanings for Words
NCT00799409 (25) [back to overview]Hour 8.75 Packet Activity Identify Root Word
NCT00799409 (25) [back to overview]Hour 8.75 Packet Activity Short Story With Questions for Comprehension
NCT00799409 (25) [back to overview]Hour 8.75 Packet Activity Word Search
NCT00799409 (25) [back to overview]Hour 3.0 Grammar Task
NCT00799409 (25) [back to overview]Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS)
NCT00799409 (25) [back to overview]Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)
NCT00799409 (25) [back to overview]Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct)
NCT00799409 (25) [back to overview]Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention)
NCT00799409 (25) [back to overview]Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite)
NCT00799409 (25) [back to overview]Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment)
NCT00799409 (25) [back to overview]Hour 5.5 Test of Variables of Attention (TOVA) ADHD Composite Cutoff Score
NCT00799409 (25) [back to overview]Hour 5.5 Test of Variables of Attention (TOVA) Commissions Standard Score
NCT00799409 (25) [back to overview]Hour 5.5 Test of Variables of Attention (TOVA) Omissions Standard Score
NCT00799409 (25) [back to overview]Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Standard Score
NCT00799409 (25) [back to overview]Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Variability Standard Score
NCT00799409 (25) [back to overview]Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards
NCT00799409 (25) [back to overview]Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards
NCT00799409 (25) [back to overview]Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards
NCT00799409 (25) [back to overview]Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards
NCT00799487 (25) [back to overview]Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards
NCT00799487 (25) [back to overview]Hour 8.75 Packet Activity - Decode the Mystery Sentence
NCT00799487 (25) [back to overview]Hour 8.75 Packet Activity - Complete Sentences Using Words Provided
NCT00799487 (25) [back to overview]Hour 8.75 Packet Activity - Alphabetize List of Words
NCT00799487 (25) [back to overview]Hour 8.75 Gray Silent Reading Test (GSRT)
NCT00799487 (25) [back to overview]Hour 7.5 Test of Handwriting Skills (Revised) (THS-R)
NCT00799487 (25) [back to overview]Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)
NCT00799487 (25) [back to overview]Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards
NCT00799487 (25) [back to overview]Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards
NCT00799487 (25) [back to overview]Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards
NCT00799487 (25) [back to overview]Hour 5.5 Test of Variables of Attention(TOVA) Reaction Time Variability (Standard Deviation in Milliseconds (Msecs))
NCT00799487 (25) [back to overview]Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS)
NCT00799487 (25) [back to overview]Hour 5.5 Test of Variables of Attention (TOVA) Omissions
NCT00799487 (25) [back to overview]Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment)
NCT00799487 (25) [back to overview]Hour 8.75 Packet Activity - Identify Multiple Meanings for Words
NCT00799487 (25) [back to overview]Hour 8.75 Packet Activity - Identiy Root Word
NCT00799487 (25) [back to overview]Hour 8.75 Packet Activity - Short Story With Questions for Comprehension
NCT00799487 (25) [back to overview]Hour 8.75 Packet Activity - Word Search
NCT00799487 (25) [back to overview]Hour 5.5 Test of Variables of Attention (TOVA) ADHD Score
NCT00799487 (25) [back to overview]Hour 5.5 Test of Variables of Attention (TOVA) Commissions
NCT00799487 (25) [back to overview]Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time (Msec)
NCT00799487 (25) [back to overview]Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite)
NCT00799487 (25) [back to overview]Hour 3.0 Grammar Task
NCT00799487 (25) [back to overview]Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention)
NCT00799487 (25) [back to overview]Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct)
NCT00844090 (1) [back to overview]Change in HbA1c Over Baseline
NCT00889915 (3) [back to overview]Clinical Global Improvements-Acceptability (CGI-A) Scale
NCT00889915 (3) [back to overview]Clinical Global Impressions-Improvement (CGI-I) Scale
NCT00889915 (3) [back to overview]Dichotomized Clinical Global Impression-Effectiveness (CGI-E) Scale
NCT00901576 (8) [back to overview]Time of Plasma Half-Life(T 1/2) of Guanfacine
NCT00901576 (8) [back to overview]Time of Maximum Plasma Concentration (Tmax) of Guanfacine
NCT00901576 (8) [back to overview]T 1/2 of d-Methylphenidate
NCT00901576 (8) [back to overview]Maximum Plasma Concentration (Cmax) of Guanfacine
NCT00901576 (8) [back to overview]Cmax of d-Methylphenidate
NCT00901576 (8) [back to overview]AUC of d-Methylphenidate
NCT00901576 (8) [back to overview]Tmax of d-Methylphenidate
NCT00901576 (8) [back to overview]Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine
NCT00904670 (7) [back to overview]Permanent Product Measure of Performance (PERMP) Score Over 12 Hours
NCT00904670 (7) [back to overview]SKAMP Quality of Work Subscale Score Over 12 Hours
NCT00904670 (7) [back to overview]SKAMP Deportment Subscale Score Over 12 Hours
NCT00904670 (7) [back to overview]Onset and Duration of Clinical Effect Based on SKAMP-Combined Scale
NCT00904670 (7) [back to overview]SKAMP Compliance Subscale Score Over 12 Hours
NCT00904670 (7) [back to overview]SKAMP Attention Subscale Score Over 12 Hours
NCT00904670 (7) [back to overview]Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose
NCT00922636 (52) [back to overview]Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Oppositional Defiant Disorder (ODD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Total Score at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Total Score at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Conduct Disorder Symptom Subscale Score at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Conduct Disorder Symptom Subscale Score at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Major Depressive Episode Score at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Major Depressive Episode Score at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Manic Episode - Total Score at 8 Weeks in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Manic Episode - Total Score at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Oppositional Defiant Disorder (ODD) Total Score at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Swanson, Nolan and Pelham (SNAP-IV) Oppositional Defiant Disorder (ODD) Total Score at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Swanson, Nolan and Pelham (SNAP-IV) Oppositional Defiant Disorder (ODD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Total Score at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Total Score at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Child Health and Illness Profile - Child Edition (CHIP-CE) at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Child Health and Illness Profile-Adolescent Edition (CHIP-AE) Domain Scores at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Content Subscales - Total Score at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Child Health and Illness Profile-Adolescent Edition (CHIP-AE) Domain Scores at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Generalized Anxiety Disorder (GAD) and Separation Anxiety Disorder Symptom Subscales at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Generalized Anxiety Disorder (GAD) and Separation Anxiety Disorder Symptom Subscales at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Academic Difficulties Total Score and the Language and Math Subscales at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Academic Difficulties Total Score and the Language and Math Subscales at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Hyperactivity-Impulsivity and Inattention Subtotal Scores at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Content Subscales - Total Score at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Child Health and Illness Profile - Child Edition (CHIP-CE) at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR ADHD) Predominantly Hyperactive-Impulsive Type and Predominantly Inattentive Type Total Score and Symptom Scores at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Impairment Items Subscales-Total Score at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Impairment Items Subscales-Total Score at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the CP-CBRS DSM-IV-TR ADHD Predominantly Hyperactive-Impulsive Type and Predominantly Inattentive Type Total Score and Symptom Scores at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Rapid Automatized Naming/Rapid Alternating Stimulus Test (RAN/RAS) Subtotal Scores at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Rapid Automatized Naming/Rapid Alternating Stimulus Test (RAN/RAS) Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Subtotal Scores at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 8
NCT00922636 (52) [back to overview]Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the ADHDRS-IV-Parent:Inv Hyperactivity-Impulsivity and Inattention Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8
NCT00922636 (52) [back to overview]Number of Participants With a Response (Response Rate) up to Week 8
NCT00922636 (52) [back to overview]Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Endpoint Score During the Treatment Phase (Weeks 1-8) in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Endpoint Score During the Treatment Phase (Weeks 1-8)
NCT00922636 (52) [back to overview]Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Total Score at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Total Score at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Letter-Number Sequencing Score at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Morning Summary Score at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Morning Summary Score at Week 8
NCT00922636 (52) [back to overview]Number of Participants With a Response (Response Rate) up to Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R ) Evening Summary Score at Week 8 in Stimulant Naive Methylphenidate Group
NCT00922636 (52) [back to overview]Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R ) Evening Summary Score at Week 8
NCT00922636 (52) [back to overview]Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Letter-Number Sequencing Score at Week 8 in Stimulant Naive Methylphenidate Group
NCT00989950 (1) [back to overview]Sleep Latency
NCT01012622 (16) [back to overview]Change From Baseline in Parenting Stress Index (PSI) Total Score at Week 12
NCT01012622 (16) [back to overview]Change From Baseline in Korean Version of the Attention-Deficit Hyperactivity Disorder (K-ADHD) Rating Scale (K-ARS) Total Score at Week 12
NCT01012622 (16) [back to overview]Change From Baseline in Interference-Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12
NCT01012622 (16) [back to overview]Change From Baseline in Inhibition-Sustained Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12
NCT01012622 (16) [back to overview]Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 12
NCT01012622 (16) [back to overview]Number of Participants With Remission Based on K-ARS Total Score and Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 12
NCT01012622 (16) [back to overview]Change From Baseline in Working Memory Forward Subtest of Comprehensive Attention Test (CAT) at Week 12
NCT01012622 (16) [back to overview]Change From Baseline in Academic Performance Rating Scale (APRS) Score at Week 12
NCT01012622 (16) [back to overview]Change From Baseline in Auditory Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12
NCT01012622 (16) [back to overview]Change From Baseline in Beck Depression Inventory (BDI) Score at Week 12
NCT01012622 (16) [back to overview]Change From Baseline in Child Health and Illness Profile-Child Edition (CHIP) Total Score and 5 Sub-domains Score at Week 12
NCT01012622 (16) [back to overview]Change From Baseline in Clinical Global Impression-severity (CGI-S) Score at Week 12
NCT01012622 (16) [back to overview]Change From Baseline in Divided Attention Subtest of Comprehensive Attention Test (CAT) at Week 12
NCT01012622 (16) [back to overview]Change From Baseline in Working Memory Backward Subtest of Comprehensive Attention Test (CAT) at Week 12
NCT01012622 (16) [back to overview]Change From Baseline in Visual Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12
NCT01012622 (16) [back to overview]Number of Participants With Response Based on K-ARS Total Score at Week 12
NCT01060150 (12) [back to overview]Clinical Global Impression - Severity (CGI-S) Score
NCT01060150 (12) [back to overview]Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score
NCT01060150 (12) [back to overview]Learning Skill Test (LST) Total Score
NCT01060150 (12) [back to overview]Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors
NCT01060150 (12) [back to overview]Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability
NCT01060150 (12) [back to overview]Controlled Oral Words Association Test (COWAT) Score
NCT01060150 (12) [back to overview]Digit Span Test Score
NCT01060150 (12) [back to overview]Finger Window (FW) Test Score
NCT01060150 (12) [back to overview]Stroop Test Result for False Reaction
NCT01060150 (12) [back to overview]Stroop Test Result for Reaction Time
NCT01060150 (12) [back to overview]Stroop Test Score for Ratio Interference
NCT01060150 (12) [back to overview]Clinical Global Impression - Improvement (CGI-I) Score
NCT01063153 (2) [back to overview]Adult ADHD Investigator Symptom Rating Scale (AISRS)
NCT01063153 (2) [back to overview]Percent Errors in Visual Go/NoGo Task
NCT01100268 (2) [back to overview]Number of Patients Who Met and Exceeded Response Criteria of Attention Deficit Hyperactivity Disorder Symptom Scale
NCT01100268 (2) [back to overview]Number of Patients Who Met Response Criteria for the Saving Inventory-Revised.
NCT01109849 (18) [back to overview]Change Score for z Weight
NCT01109849 (18) [back to overview]Change Score for Z-height Baseline to Endpoint
NCT01109849 (18) [back to overview]Change in Weight z Score During Weight Recovery Phase (Second Randomization) Based on Actual Usage
NCT01109849 (18) [back to overview]Number of Behavior Therapy Sessions
NCT01109849 (18) [back to overview]Change in zBody Mass Index (BMI)
NCT01109849 (18) [back to overview]Change in Zscore for BMI During Weight Recovery Phase (Second Randomization)
NCT01109849 (18) [back to overview]Change in BMI z Score by Actual Medication Usage
NCT01109849 (18) [back to overview]Change Score for Zheight Months 0 to 6
NCT01109849 (18) [back to overview]Treatment Adherence for Caloric Supplement
NCT01109849 (18) [back to overview]Medication Adherence
NCT01109849 (18) [back to overview]ADHD Symptoms- Parent Rated
NCT01109849 (18) [back to overview]ADHD Symptoms- Teacher Rated
NCT01109849 (18) [back to overview]Change in BMI z Score During Weight Recovery Period (Second Randomization) Based on Actual Usage
NCT01109849 (18) [back to overview]Change in Height z Score by Actual Medication Usage
NCT01109849 (18) [back to overview]Change in Height z Score During Weight Recovery Phase (Second Randomization)
NCT01109849 (18) [back to overview]Change in Weight z Score by Actual Medication Usage
NCT01109849 (18) [back to overview]Difference in Height z Score During Weight Recovery Phase (Second Randomization) by Actual Usage
NCT01109849 (18) [back to overview]Change in Weight z Score During Weight Recovery Phase (Second Randomization)
NCT01117181 (8) [back to overview]Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change
NCT01117181 (8) [back to overview]Apathy Evaluation Scale (AES)
NCT01117181 (8) [back to overview]Digit Span
NCT01117181 (8) [back to overview]Electrocardiogram (ECG)
NCT01117181 (8) [back to overview]Mini-Mental State Exam (MMSE)
NCT01117181 (8) [back to overview]Neuropsychiatric Inventory (NPI): Apathy Subscale
NCT01117181 (8) [back to overview]Electrolytes
NCT01117181 (8) [back to overview]Vital Status
NCT01127646 (2) [back to overview]Change From Baseline in Heart Rate up to 5 Weeks
NCT01127646 (2) [back to overview]Change From Baseline in Systolic and Diastolic Blood Pressure up to 5 Weeks
NCT01133847 (11) [back to overview]Test of Silent Reading Fluency and Comprehension (TOSREC)
NCT01133847 (11) [back to overview]Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest
NCT01133847 (11) [back to overview]Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)
NCT01133847 (11) [back to overview]Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity
NCT01133847 (11) [back to overview]Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention
NCT01133847 (11) [back to overview]Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity
NCT01133847 (11) [back to overview]Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention
NCT01133847 (11) [back to overview]Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency
NCT01133847 (11) [back to overview]Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency
NCT01133847 (11) [back to overview]Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest
NCT01133847 (11) [back to overview]Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest
NCT01164956 (3) [back to overview]Rate of Receiving Clinically Definite Answer Regarding the Ability of Experimental Treatment to Reduce Fatigue Using the N-1-T Design
NCT01164956 (3) [back to overview]Completion Rate of Two Treatment Pairs Using the N-1-T Design
NCT01164956 (3) [back to overview]Change Over Treatment Pairs in pedsFACIT-F Score
NCT01183234 (3) [back to overview]Maximum Plasma Concentration (Cmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD)
NCT01183234 (3) [back to overview]Area Under the Steady-state Plasma Concentration-time Curve (AUC 0-t) for Methylphenidate Hydrochloride (MPH) Using Two Different Formulations (Equasym XL and Metadate CD)
NCT01183234 (3) [back to overview]Time of Maximum Plasma Concentration (Tmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD)
NCT01238822 (1) [back to overview]Attention Deficit / Hyperactivity Disorder Total Sum Score of All 18 ADHD Symptom Items
NCT01239030 (1) [back to overview]Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3)
NCT01259492 (13) [back to overview]Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment
NCT01259492 (13) [back to overview]Change From Baseline of Period 1 (Baseline 1) to End of Period 1 on Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score by Treatment
NCT01259492 (13) [back to overview]Change From Baseline Period 3 (Baseline 2) to End of Period 3 in ASRS Total Score by Treatment
NCT01259492 (13) [back to overview]Number of Participants With Clinical Global Impression - Improvement Scale Severity of Illness (CGI-S) Rating at the End of Period 2 (Visit 13/ Week 14)
NCT01259492 (13) [back to overview]Percentage of Participants With Treatment Failures During Period 3
NCT01259492 (13) [back to overview]Number of Participants With Clinical Global Impression - Improvement Scale (CGI-I) Rating at the End of Period 2 (Visit 13/ Week 14)
NCT01259492 (13) [back to overview]Change From Baseline 1 in DSM-IVADHD RS Total Score, SDS Total Score, The Conners' Adult ADHD Rating Scale Observer Short Version (CAARS-O:S) Total Score and Adult Self-Report Scale (ASRS) Total Score at the End of Period 2 (Visit 13/ Week 14)
NCT01259492 (13) [back to overview]Percentage of Patients With Improvement on Clinical Global Impression - Improvement Scale (CGI-I) From Baseline Period 1 (Baseline 1) to End of Period 1
NCT01259492 (13) [back to overview]Number of Patients With Worsening on CGI-S Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment
NCT01259492 (13) [back to overview]Number of Patients With Worsening on CGI-I Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment
NCT01259492 (13) [back to overview]Change From Baseline Period 3 (Baseline 2) to End of Period 3 on SDS Total Score by Treatment
NCT01259492 (13) [back to overview]Change From Baseline Period 3 (Baseline 2) to End of Period 3 on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale ADHD RS Total Score by Treatment
NCT01259492 (13) [back to overview]Change From Baseline Period 3 (Baseline 2) to End of Period 3 in Conners Adult ADHD Rating Scales Observer: Short Version (CAARS-O:S:) Total Score by Treatment
NCT01267292 (14) [back to overview]Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task
NCT01267292 (14) [back to overview]Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task
NCT01267292 (14) [back to overview]Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)
NCT01267292 (14) [back to overview]Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)
NCT01267292 (14) [back to overview]Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task
NCT01267292 (14) [back to overview]Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)
NCT01267292 (14) [back to overview]Diastolic Blood Pressure
NCT01267292 (14) [back to overview]Systolic Blood Pressure
NCT01267292 (14) [back to overview]Subjective Effects as Assessed by Score on the Vigor Subscale of the Profile of Mood States (POMS)
NCT01267292 (14) [back to overview]Risky Decision Making as Assessed by Score on the Risky Decision Making Task
NCT01267292 (14) [back to overview]Heart Rate
NCT01267292 (14) [back to overview]Attentional Bias as Assessed by Score on the Stroop Task
NCT01267292 (14) [back to overview]"Subjective Effects as Assessed by the Elated Subscale of the Visual Analogue Scale (VAS)"
NCT01267292 (14) [back to overview]"Subjective Effects as Assessed by Score on the Feel High Subscale of the Drug Effects Questionnaire (DEQ)"
NCT01269463 (2) [back to overview]Comparison Following Treatment Between Drug and Placebo Using Evaluation by SKAMP Combined, Attention, and Deportment Scales
NCT01269463 (2) [back to overview]Comparison Following Treatment With Drug or Placebo Using PERMP (Permanent Product of Arithmetic) Evaluations
NCT01338818 (3) [back to overview]Change From Extension Baseline (Week 40) to End of Study (Week 66) on Sheehan Disability Scale (SDS) Total Score
NCT01338818 (3) [back to overview]Number of Participants With Adverse Events, Serious Adverse Events and Deaths.
NCT01338818 (3) [back to overview]Change From Extension Baseline (Week 40) to End of Study (Week 66) in on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score.
NCT01348607 (2) [back to overview]Average Daytime Napping Minutes in a Week
NCT01348607 (2) [back to overview]Adverse Events
NCT01399827 (5) [back to overview]Efficacy Measured by Mean Change From Baseline to Endpoint on Clinical Global Impression (CGI) Scale
NCT01399827 (5) [back to overview]Efficacy Measured by Mean Change From Baseline to Endpoint on the Global Assessment of Functioning (GAF) Scale
NCT01399827 (5) [back to overview]Efficacy Measured by Mean Change From Baseline to Endpoint on Adult ADHD Investigator Rating Scale (AISRS) Total Score
NCT01399827 (5) [back to overview]Mean Change From Baseline to Endpoint on the BRIEF-A Emotional Control Scale
NCT01399827 (5) [back to overview]Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales
NCT01533493 (1) [back to overview]Percent Change in Global Executive Composite T-Score on the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
NCT01552902 (5) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
NCT01552902 (5) [back to overview]Change From Baseline in Blood Pressure at Week 6
NCT01552902 (5) [back to overview]Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6
NCT01552902 (5) [back to overview]Change From Baseline in Pulse Rate at Week 6
NCT01552902 (5) [back to overview]Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6
NCT01552915 (5) [back to overview]Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment
NCT01552915 (5) [back to overview]Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment
NCT01552915 (5) [back to overview]Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF)
NCT01552915 (5) [back to overview]Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment
NCT01552915 (5) [back to overview]Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8
NCT01678209 (7) [back to overview]Finger Windows
NCT01678209 (7) [back to overview]Digit Span
NCT01678209 (7) [back to overview]Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (ADHD-RS)
NCT01678209 (7) [back to overview]Clinical Global Impressions-Severity (CGI-S)
NCT01678209 (7) [back to overview]Continuous Performance Test (CPT)
NCT01678209 (7) [back to overview]Response Time in Attention Networks Test (ANT)
NCT01678209 (7) [back to overview]Percentage of Correct Inhibition in Participants Assessed With the Go-No go Task
NCT01727414 (1) [back to overview]Attention Deficit Hyperactivity Disorder Total Symptom Score
NCT01740206 (6) [back to overview]mYPAS Measurement in Patients Not Receiving Midazolam
NCT01740206 (6) [back to overview]Heart Rate
NCT01740206 (6) [back to overview]Diastolic Blood Pressure
NCT01740206 (6) [back to overview]mYPAS Measurement in Patients Receiving Midazolam
NCT01740206 (6) [back to overview]Mean Blood Pressure
NCT01740206 (6) [back to overview]Systolic Blood Pressure
NCT01825577 (2) [back to overview]Timed Get Up and Go Test - Measure of Mobility
NCT01825577 (2) [back to overview]POMA -Performance Oriented Mobility Assessment - Measure of Gait and Balance.
NCT01852344 (3) [back to overview]Accuracy on the Multi-Source Interference Task.
NCT01852344 (3) [back to overview]Reaction Time on the Multi-Source Interference Task
NCT01852344 (3) [back to overview]Reaction Time Variability on the Multi-Source Interference Task.
NCT01853280 (1) [back to overview]Adult ADHD Investigator Symptom Rating Scale (AISRS)
NCT01896700 (8) [back to overview]Change From Baseline in Timed 25 Foot Walk (T25FW) at 6 Weeks
NCT01896700 (8) [back to overview]Change From Baseline in Pittsburgh Sleep Quality Assessment Questionnaire Score at 6 Weeks
NCT01896700 (8) [back to overview]Change From Baseline in Modified Fatigue Index Scale Score at 6 Weeks
NCT01896700 (8) [back to overview]Change From Baseline in Automatic Postural Response (APR) Latency at 6 Weeks
NCT01896700 (8) [back to overview]Change From Baseline in Vestibular-Ocular Reflex (VOR) Gain at 6 Weeks
NCT01896700 (8) [back to overview]Change From Baseline in Vestibular Ocular Reflex (VOR) Phase (in Degrees) at 6 Weeks
NCT01896700 (8) [back to overview]Change From Baseline in Vestibular Ocular Reflex (VOR) Asymmetry (Percentage Asymmetric) at 6 Weeks
NCT01896700 (8) [back to overview]Change From Baseline in Timed Up and Go (TUG) Test Time at 6 Weeks
NCT01907360 (6) [back to overview]PK Parameters for Rate and Extent of Absorption of MPH in Plasma: Plasma Concentration-time Curve
NCT01907360 (6) [back to overview]PK Parameters for Rate and Extent of Absorption of MPH: Lag Time
NCT01907360 (6) [back to overview]PK Parameters for Rate and Extent of Absorption of MPH: Cmax
NCT01907360 (6) [back to overview]PK Parameters for Rate and Extent of Absorption of MPH: AUC0-tz
NCT01907360 (6) [back to overview]PK Parameters for Rate and Extent of Absorption of MPH: AUC0-inf
NCT01907360 (6) [back to overview]PK Parameters for Rate and Extent of Absorption of MPH: Tmax
NCT01912352 (2) [back to overview]Change From Baseline ADHD Rating Scale-IV Scores at 8 Weeks
NCT01912352 (2) [back to overview]Clinical Global Impression-Improvement Scale at 8 Weeks
NCT01933217 (3) [back to overview]Parent Outcome-Behavior Rating Inventory of Executive Functioning (BRIEF)
NCT01933217 (3) [back to overview]Neuropsychological Outcome- Wechsler Intelligence Scale for Children, 4th Edition Processing Speed Index (WISC-IV-PSI)
NCT01933217 (3) [back to overview]Parent Outcome-Vanderbilt ADHD Parent Rating Scales (VADPRS)
NCT01933880 (29) [back to overview]WCST: Percentage of Correct Responses (Rc%)
NCT01933880 (29) [back to overview]WCST: Percentage of Perseverative Error Responses (Rpe%)
NCT01933880 (29) [back to overview]WCST: Perseverative Error Responses (Rpe)
NCT01933880 (29) [back to overview]WCST: Perseverative Responses (Rp)
NCT01933880 (29) [back to overview]Wisconsin Card Sorting Test (WCST): Administered Responses (Ra) of Completed Examination
NCT01933880 (29) [back to overview]WCST: Percentage of Conceptual Level Responses (Rf%)
NCT01933880 (29) [back to overview]Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 2
NCT01933880 (29) [back to overview]Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale at Week 12
NCT01933880 (29) [back to overview]Academic Achievement
NCT01933880 (29) [back to overview]Change From Baseline in Completion Time of Stroop Color-word Test at Week 12
NCT01933880 (29) [back to overview]Change From Baseline in Digit Span Test Total Score at Week 12
NCT01933880 (29) [back to overview]Change From Baseline in I/O Score of IOWA Conners Behavior Rating Scale at Week 12
NCT01933880 (29) [back to overview]Change From Baseline in Inattention/Overactivity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 1
NCT01933880 (29) [back to overview]Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 12
NCT01933880 (29) [back to overview]Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 3
NCT01933880 (29) [back to overview]Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 7
NCT01933880 (29) [back to overview]Change From Baseline in Total Scores of Digit Span Test at Week 12
NCT01933880 (29) [back to overview]Coding Test
NCT01933880 (29) [back to overview]Number of Participants Compliant With Treatment
NCT01933880 (29) [back to overview]Number of Participants With Clinical Global Impression - CGI Scale Score
NCT01933880 (29) [back to overview]Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale.
NCT01933880 (29) [back to overview]Stroop Color Word Naming Test
NCT01933880 (29) [back to overview]WCST: Completed Categories (Cc)
NCT01933880 (29) [back to overview]WCST: Correct Responses (Rc)
NCT01933880 (29) [back to overview]WCST: Error Responses (Re)
NCT01933880 (29) [back to overview]WCST: Failure to Maintain Set (Fm)
NCT01933880 (29) [back to overview]WCST: First Response (Rf)
NCT01933880 (29) [back to overview]WCST: Learning to Learn (L-C)
NCT01933880 (29) [back to overview]WCST: Non-Persistent Error Responses (nRpe)
NCT01993108 (4) [back to overview]Reaction Time on the Multi-Source Interference Task
NCT01993108 (4) [back to overview]Characterize the Effects of Methylphenidate and Naltrexone on Neural Circuits in Prefrontal Cortex Associated With Top-down Control.
NCT01993108 (4) [back to overview]Accuracy on the Multi-Source Interference Task
NCT01993108 (4) [back to overview]Reaction Time Variability on the Multi-Source Interference Task
NCT02039908 (3) [back to overview]Endpoint Medication Dose
NCT02039908 (3) [back to overview]Time to First Dose Increase
NCT02039908 (3) [back to overview]Number of Dose Changes Required Per Protocol
NCT02051452 (2) [back to overview]Number of Participants With Adverse Events
NCT02051452 (2) [back to overview]Time to Emergence From General Anesthesia
NCT02096952 (1) [back to overview]Change in Adult ADHD Investigator Symptom Report Scale (AISRS) Score
NCT02153944 (28) [back to overview]Measure of Heart Rate
NCT02153944 (28) [back to overview]Reaction Time to Stimuli: Threat Condition - 3BACK - Run 1
NCT02153944 (28) [back to overview]Reaction Time to Stimuli: Threat Condition - 3BACK - Run 2
NCT02153944 (28) [back to overview]Magnitude of Startle Reflex During Safe Condition
NCT02153944 (28) [back to overview]Magnitude of Startle Reflex During Threat Condition
NCT02153944 (28) [back to overview]Measure of BOLD Response in Brain Cluster - Threat Condition - 1BACK
NCT02153944 (28) [back to overview]Measure of BOLD Response in Brain Cluster - Threat Condition - 3BACK
NCT02153944 (28) [back to overview]Measure of BOLD Response in Brain Clusters - Safe Condition - 1BACK
NCT02153944 (28) [back to overview]Measure of BOLD Response in Brain Clusters - Safe Condition - 3BACK
NCT02153944 (28) [back to overview]Reaction Time to Stimuli: Safe Condition - 3BACK - Run 1
NCT02153944 (28) [back to overview]Reaction Time to Stimuli: Safe Condition - 1BACK - Run 2
NCT02153944 (28) [back to overview]Proportion of Correct Responses in the Working Memory Task (N-back): Safe Condition - 1BACK - Run 2
NCT02153944 (28) [back to overview]Measure of Heart Rate
NCT02153944 (28) [back to overview]Measure of Level of Anxiety
NCT02153944 (28) [back to overview]Measure of Level of Anxiety
NCT02153944 (28) [back to overview]Proportion of Correct Responses in the Working Memory Task (N-back) - Safe Condition
NCT02153944 (28) [back to overview]Proportion of Correct Responses in the Working Memory Task (N-back) - Threat Condition
NCT02153944 (28) [back to overview]Proportion of Correct Responses in the Working Memory Task (N-Back): Safe Condition - 1BACK - Run 1
NCT02153944 (28) [back to overview]Proportion of Correct Responses in the Working Memory Task (N-back): Threat Condition - 3BACK - Run 2
NCT02153944 (28) [back to overview]Proportion of Correct Responses in the Working Memory Task (N-back): Threat Condition - 3BACK - Run 1
NCT02153944 (28) [back to overview]Proportion of Correct Responses in the Working Memory Task (N-back): Threat Condition - 1BACK - Run 2
NCT02153944 (28) [back to overview]Reaction Time to Stimuli: Threat Condition - 1BACK - Run 2
NCT02153944 (28) [back to overview]Proportion of Correct Responses in the Working Memory Task (N-back): Threat Condition - 1BACK - Run 1
NCT02153944 (28) [back to overview]Reaction Time to Stimuli: Threat Condition - 1BACK - Run 1
NCT02153944 (28) [back to overview]Reaction Time to Stimuli: Safe Condition - 3BACK - Run 2
NCT02153944 (28) [back to overview]Proportion of Correct Responses in the Working Memory Task (N-back): Safe Condition - 3BACK - Run 1
NCT02153944 (28) [back to overview]Proportion of Correct Responses in the Working Memory Task (N-back): Safe Condition - 3BACK - Run 2
NCT02153944 (28) [back to overview]Reaction Time to Stimuli: Safe Condition - 1BACK - Run 1
NCT02178995 (20) [back to overview]Symbol-digit Matching Test (Double-blind Portion)
NCT02178995 (20) [back to overview]Neuropsychiatric Questionnaires
NCT02178995 (20) [back to overview]CPT Scores (Double-blind Portion) (Secondary Variables)
NCT02178995 (20) [back to overview]CPT Outcomes (Secondary Variables) (Open-label Portion)
NCT02178995 (20) [back to overview]Conners' Continuous Performance Test (CPT) (Double-blind Portion, Primary Variables)
NCT02178995 (20) [back to overview]Conners CPT Outcomes (Primary Variables) (Open-Label Portion)
NCT02178995 (20) [back to overview]Symbol-digit Matching Test (Open Label Phase)
NCT02178995 (20) [back to overview]Adverse Events Profile (Open-Label)
NCT02178995 (20) [back to overview]Stimulant Side-effects Checklist
NCT02178995 (20) [back to overview]Seizure Frequency (Open-label Portion)
NCT02178995 (20) [back to overview]QOLIE-89 Aggregate Score
NCT02178995 (20) [back to overview]MCG (Open-label Portion)
NCT02178995 (20) [back to overview]Hit Reaction Time (Open-Label)
NCT02178995 (20) [back to overview]Hit Reaction Time (Double Blind)
NCT02178995 (20) [back to overview]Remaining CPT Variables (Open-label)
NCT02178995 (20) [back to overview]Remaining CPT Variables (Double-blind Portion)
NCT02178995 (20) [back to overview]QOLIE-89 Selected Cognitive Subscales (Open-label)
NCT02178995 (20) [back to overview]Seizure Frequency/Severity (Double-blind Portion)
NCT02178995 (20) [back to overview]MCG Paragraph Memory Test (Double-blind Portion)
NCT02178995 (20) [back to overview]QOLIE-89 Additional Subscales (Open-label)
NCT02204410 (2) [back to overview]Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent)
NCT02204410 (2) [back to overview]Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR)
NCT02225106 (1) [back to overview]Perceptual Organization and Processing Speed Index
NCT02255513 (1) [back to overview]SKAMP
NCT02255565 (3) [back to overview]Clinical Global Impressions-ADHD - Severity
NCT02255565 (3) [back to overview]Clinical Global Impression - Improvement (CGI-I)
NCT02255565 (3) [back to overview]ADHD Rating Scale - IV
NCT02293655 (10) [back to overview]Parent Ratings of Emotional Regulation
NCT02293655 (10) [back to overview]Spatial Working Memory
NCT02293655 (10) [back to overview]Written Expression
NCT02293655 (10) [back to overview]% Time on Task
NCT02293655 (10) [back to overview]Barkley Sluggish Cognitive Tempo (SCT) Ratings
NCT02293655 (10) [back to overview]Inhibitory Control Reaction Time Variability (SD of the Reaction Time)
NCT02293655 (10) [back to overview]Parent ADHD Total Symptom Scores
NCT02293655 (10) [back to overview]Math Reasoning
NCT02293655 (10) [back to overview]Math Computation - Number of Problems Completed Correctly
NCT02293655 (10) [back to overview]Reading Comprehension
NCT02327195 (3) [back to overview]Emergence Time
NCT02327195 (3) [back to overview]Number of Participants That Experienced Postoperative Nausea and Vomiting
NCT02327195 (3) [back to overview]Opioid Dose Escalation Prevention
NCT02346201 (2) [back to overview]Neuropsychiatric Inventory (NPI)
NCT02346201 (2) [back to overview]Percentage of Participants With Change in Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (CGIC)
NCT02470234 (10) [back to overview]AUC(0-t)
NCT02470234 (10) [back to overview]Tmax
NCT02470234 (10) [back to overview]V(Dss)/F
NCT02470234 (10) [back to overview]T1/2
NCT02470234 (10) [back to overview]Cmax/Dose
NCT02470234 (10) [back to overview]Cmax
NCT02470234 (10) [back to overview]Kel
NCT02470234 (10) [back to overview]CL/F
NCT02470234 (10) [back to overview]AUC/D
NCT02470234 (10) [back to overview]AUC(0-inf)
NCT02493777 (2) [back to overview]Parent Rating of Evening and Morning Behavior Revised, Morning Subscale (PREMB-R AM).
NCT02493777 (2) [back to overview]Swanson, Kotkin, Agler, M-Flynn and Pelham Combined Score (SKAMP CS) - Model-adjusted Average of All Post-dose Time Points Assessed During a Laboratory Classroom Test Day (Visit 9).
NCT02502799 (4) [back to overview]Mean Youth Self-Report of Functional Impairment
NCT02502799 (4) [back to overview]Mean Youth Self-Report of Disruptive Behaviors
NCT02502799 (4) [back to overview]Mean Youth-Report of Parent-adolescent Conflict
NCT02502799 (4) [back to overview]Mean Youth Self-Report of Likelihood of Future Substance Use
NCT02520388 (2) [back to overview]Before School Functioning Questionnaire (BSFQ) Total Score
NCT02520388 (2) [back to overview]Attention Deficit Hyperactivity Disorder Rating Scale Based on DSM-IV Criteria (ADHD-RS-IV) Total Score.
NCT02536105 (4) [back to overview]Maximum Drug Concentration Observed (Cmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products
NCT02536105 (4) [back to overview]Time to Reach Cmax (Tmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products
NCT02536105 (4) [back to overview]Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products
NCT02536105 (4) [back to overview]Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products
NCT02630017 (1) [back to overview]Number of High-effort Selections in the Effort-based Decision Making Task
NCT02638168 (12) [back to overview]Pittsburgh Side Effects Rating Scale
NCT02638168 (12) [back to overview]Affective Reactivity Index (ARI)
NCT02638168 (12) [back to overview]Length of Wakings
NCT02638168 (12) [back to overview]Parent Rated 10-item IOWA
NCT02638168 (12) [back to overview]Number of Wakings
NCT02638168 (12) [back to overview]Night to Night Variability (Weekends & Weekdays) - in Sleep Onset Latency Measured by Actigraphy
NCT02638168 (12) [back to overview]Wake After Sleep Onset (WASO)
NCT02638168 (12) [back to overview]Total Sleep Time
NCT02638168 (12) [back to overview]Sleep Onset Latency (SOL), Defined as Time in Bed Until Sleep by Actigraphy
NCT02638168 (12) [back to overview]Sleep Onset Latency (SOL) as Reported on the Parent Completed Sleep Log
NCT02638168 (12) [back to overview]Sleep Offset
NCT02638168 (12) [back to overview]Sleep Efficiency
NCT02683265 (5) [back to overview]Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Inattention Subscale Score Change From End of Open Label Phase (Baseline) to End of Double Blind.
NCT02683265 (5) [back to overview]Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Hyperactivity-Impulsivity Subscale Score Change From End of Open Label Phase (Baseline) to End of Double Blind.
NCT02683265 (5) [back to overview]Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Total Score Change From End of Open Label Phase (Baseline) to End of Double Blind.
NCT02683265 (5) [back to overview]Conners Early Childhood Behavior - Parent (Short) (EC BEH-P(S)) Change in T-score From End of Open Label Phase (Baseline) to End of Double Blind
NCT02683265 (5) [back to overview]Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind.
NCT03185065 (4) [back to overview]Acceptability of Treatment as Assessed by a Single Question Questionnaire
NCT03185065 (4) [back to overview]Epworth Sleepiness Scale (ESS) Score
NCT03185065 (4) [back to overview]Modified Fatigue Impact Scale (MFIS) Score
NCT03185065 (4) [back to overview]Quality of Life in Neurological Disorders (Neuro-QoL) Item Bank - Fatigue Score
NCT03811847 (3) [back to overview]Feasibility of a Virtual Multicrossover Randomized Control Trial Design as Measured my Completion Rates and Medication Compliance.
NCT03811847 (3) [back to overview]Cognition as Measured by the Repeatable Battery for the Assessment Neuropsychological Status-Update (RBANS)
NCT03811847 (3) [back to overview]Cognition as Measured by Daily, Home-based Brain Games (Lumosity, Lumos Labs, Inc.)
NCT04178993 (36) [back to overview]Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
NCT04178993 (36) [back to overview]Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
NCT04178993 (36) [back to overview]Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
NCT04178993 (36) [back to overview]Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
NCT04178993 (36) [back to overview]Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
NCT04178993 (36) [back to overview]Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
NCT04178993 (36) [back to overview]Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
NCT04178993 (36) [back to overview]Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
NCT04178993 (36) [back to overview]Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
NCT04178993 (36) [back to overview]Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
NCT04178993 (36) [back to overview]Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
NCT04178993 (36) [back to overview]Snaith-Hamilton-Pleasure Scale to Measure Anhedonia (Inability to Experience Pleasure)
NCT04178993 (36) [back to overview]Temperature After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
NCT04178993 (36) [back to overview]Temperature After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
NCT04178993 (36) [back to overview]Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
NCT04178993 (36) [back to overview]Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
NCT04178993 (36) [back to overview]Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
NCT04178993 (36) [back to overview]Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
NCT04178993 (36) [back to overview]Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
NCT04178993 (36) [back to overview]Reinforcing Effects of Methamphetamine Following Methylphenidate (60 mg) Maintenance.
NCT04178993 (36) [back to overview]Reinforcing Effects of Methamphetamine Following Methylphenidate (40 mg) Maintenance.
NCT04178993 (36) [back to overview]Reinforcing Effects of Methamphetamine Following Methylphenidate (20 mg) Maintenance.
NCT04178993 (36) [back to overview]Reinforcing Effects of Methamphetamine Following Methylphenidate (0 mg; Placebo) Maintenance.
NCT04178993 (36) [back to overview]Heart Rate After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
NCT04178993 (36) [back to overview]Heart Rate After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
NCT04178993 (36) [back to overview]Heart Rate After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
NCT04178993 (36) [back to overview]Heart Rate After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
NCT04178993 (36) [back to overview]Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
NCT04178993 (36) [back to overview]Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
NCT04178993 (36) [back to overview]Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
NCT04178993 (36) [back to overview]Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
NCT04178993 (36) [back to overview]Delay Discounting for Money
NCT04178993 (36) [back to overview]Delay Discounting for Methamphetamine
NCT04178993 (36) [back to overview]Attentional Bias
NCT04178993 (36) [back to overview]Temperature After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
NCT04178993 (36) [back to overview]Temperature After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
NCT04349917 (7) [back to overview]Task-Based Brain Network Organization
NCT04349917 (7) [back to overview]Resting State Brain Network Organization
NCT04349917 (7) [back to overview]Drug-induced Normalization
NCT04349917 (7) [back to overview]Go/No-go (GNG) Commission Rate
NCT04349917 (7) [back to overview]Go/No-go (GNG) Omission Rate
NCT04349917 (7) [back to overview]Go/No-go (GNG) Response Time Variability
NCT04349917 (7) [back to overview]Rest-Task Reconfiguration
NCT04507204 (9) [back to overview]Healthcare Resource Utilization (HCRU)
NCT04507204 (9) [back to overview]Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR
NCT04507204 (9) [back to overview]Assessment of Clinical Global Impression-Severity (CGI-S)
NCT04507204 (9) [back to overview]Assessment of Clinical Global Impression-Improvement (CGI-I)
NCT04507204 (9) [back to overview]Adult ADHD Quality of Life Scale - Revised (AAQoL-R)
NCT04507204 (9) [back to overview]Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority
NCT04507204 (9) [back to overview]Work Productivity and Activity Impairment (WPAI) Questionnaire
NCT04507204 (9) [back to overview]Patient Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)
NCT04507204 (9) [back to overview]Assessment of Treatment Satisfaction

Classroom Behavior

Daily records of percentage of assigned problems completed by children in a 60-minute classroom period. (NCT00050622)
Timeframe: Daily for 45 days

InterventionPercentage of Work Completed (Mean)
No Treatment37
Low Dose Medication Only53
Medium Dose Medication Only57
Higher Dose Medication Only61
Low Intensity BMOD Only53
Low Intensity BMOD + Low Dose Medication67
Low Intensity BMOD + Medium Dose Medication72
Low Intensity BMOD + Higher Dose Medication75
High Intensity BMOD Only58
High Intensity BMOD + Low Dose Medication72
High Intensity BMOD + Medium Dose Medication75
High Intensity BMOD + Higher Dose Medication76

[back to top]

Social Behavior-Negative Verbalizations

Sum of daily frequency of Verbal Abuse toward staff members, Teasing toward peers, and Cursing/Swearing as defined by a behavioral point system that doubles as an objective measure of children's behavior. All instances of these behaviors were reported and noted as they occur throughout daily activities. (NCT00050622)
Timeframe: Daily for 45 days

InterventionNumber of Observed Behaviors (Mean)
No Treatment73.32
Low Dose Medication Only45.41
Medium Dose Medication Only28.41
Higher Dose Medication Only15.08
Low Intensity BMOD Only27.06
Low Intensity BMOD + Low Dose Medication13.70
Low Intensity BMOD + Medium Dose Medication9.27
Low Intensity BMOD + Higher Dose Medication4.28
High Intensity BMOD Only20.23
High Intensity BMOD + Low Dose Medication7.61
High Intensity BMOD + Medium Dose Medication4.08
High Intensity BMOD + Higher Dose Medication2.49

[back to top]

Treatment Satisfaction

Parent rating of treatment satisfaction with medication, behavioral treatment, and their combination,on a scale of 1 (bad) to 7 (good). (NCT00050622)
Timeframe: End of Treatment

InterventionUnits on scale (Mean)
No Treatment1.8
Low Intensity BMOD Only2.7
High Intensity BMOD ONly3.8
Medication Only3.5
Low Intensity BMOD + Med4.6
High Intensity BMOD + Medication5.6

[back to top]

Days to Remission of Depression

Days to a 50% or greater reduction in initial Montgomery-Asberg Depression Rating Scale (MADRS) score. (NCT00129467)
Timeframe: 18 Days

InterventionDays (Mean)
Methylphenidate + SSRI10.3
Placebo + SSRI8.1

[back to top]

Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Scores at 6 Weeks

The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total scoring ranges from 0-100 for each. Increases in scores represent improved well-being in subjects as assessed by their parents. (NCT00151996)
Timeframe: Baseline and 6 weeks

,
InterventionUnits on a scale (Mean)
Physical Summary ScorePsychosocial Summary Score
Amphetamine + SPD5030.2211.56
Methylphenidate + SPD503-0.388.98

[back to top]

Number of Participants With Improvement on Parent Global Assessment (PGA) Scores

Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). The PGA is designed to capture parent's opinions of their child's disease (ADHD) severity and improvement. Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. (NCT00151996)
Timeframe: 6 weeks

InterventionParticipants (Number)
Methylphenidate + SPD50332
Amphetamine + SPD50321

[back to top]

Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores

Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. (NCT00151996)
Timeframe: 6 weeks

InterventionParticipants (Number)
Methylphenidate + SPD50328
Amphetamine + SPD50318

[back to top]

Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks

Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. (NCT00151996)
Timeframe: Baseline and 6 weeks

InterventionUnits on a Scale (Mean)
Methylphenidate + SPD503-17.8
Amphetamine + SPD503-13.8

[back to top]

Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Total Score at 6 Weeks

The Conner's Parent Rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior. (NCT00151996)
Timeframe: Baseline and 6 weeks

InterventionUnits on a Scale (Mean)
Methylphenidate + SPD503-22.18
Amphetamine + SPD503-16.28

[back to top]

Mean Conners' Parent ADHD Index T Score by Week

The ADHD Index of the Conners' Parent Rating Scale-Revised (CPRS-R) assesses symptoms associated with ADHD, including inattentiveness, hyperactivity and impulsivity. Lower T-scores on this subscale are associated with milder ADHD symptoms. T-scores have a mean of 50 and a SD of 10. Thus, T-scores of 70+ (i.e., 2 SD's over the mean) on the ADHD Index are suggestive of very significant ADHD symptomatology. Treatment-related changes of 5+ points are considered to be significant. (NCT00178503)
Timeframe: Measured at each dosing week of the drug trial (placebo, low, medium, high)

InterventionUnits on a scale (T-scores) (Mean)
MPH Trial-Placebo Week70.1
MPH Trial: Low Dose Week64.9
MPH Trial: Med Dose Week62.3
MPH Trial: High Dose Week59.9

[back to top]

Mean Conners' Teacher ADHD Index T Score by Dose

The ADHD Index of the Conners' Teacher Rating Scale-Revised (CTRS-R) assesses symptoms associated with ADHD, including inattentiveness, hyperactivity and impulsivity. Lower T-scores on this subscale are associated with milder ADHD symptoms. T-scores have a mean of 50 and a SD of 10. Thus, T-scores of 70+ (i.e., 2 SD's over the mean) on the ADHD Index are suggestive of very significant ADHD symptomatology. Treatment-related changes of 5+ points are considered to be significant. (NCT00178503)
Timeframe: Measured at each dosing week of the drug trial (placebo, low, medium, high)

InterventionUnits on a scale (T-scores) (Mean)
MPH Trial-Placebo Week72.8
MPH Trial: Low Dose Week63.1
MPH Trial: Med Dose Week63.6
MPH Trial: High Dose Week61.5

[back to top]

Mean Continuous Performance Test (CPT)-Commission Errors by Dose

CPT is a measure of sustained attention using nonverbal stimuli (pictures). Participants are asked to click on the witch (target), which appears for 25% of the trials. Commission errors are measured by number of times they click for the non-target items. (NCT00178503)
Timeframe: Measured at each dosing week of the drug trial (placebo, low, medium, high)

InterventionTotal Errors (Mean)
MPH Trial-Placebo Week2.75
MPH Trial: Low Dose Week1.11
MPH Trial: Med Dose Week1.18
MPH Trial: High Dose Week1.24

[back to top]

Cigarette Smoking

Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ) (NCT00181714)
Timeframe: 24 months

Interventionpercent (Number)
OROS-Methylphenidate7

[back to top]

Assessment of Affective Range (AAR)

Affective problems. This scale consists of 8 items, scored 0-3, with 0 representing no problems and 3 representing extreme problems. This analysis presents sum of scores, higher is worse. Full range from 0 to 24. This score does not have psychometrics available. (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionunits on a scale (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate11.260910.68899.710810.9886
Methylphenidate Then Atomoxetine10.690510.825710.140010.9286

[back to top]

Child Conflict Index (CCI)

Measure of conflict within the home over the past 24 hours. The CCI is a validated measure of family conflicts in the home and is completed by parents. It consists of 42 items (for boys) or 36 items (for girls) reflecting attention-seeking and conflictual behavior, as well as negativity and withdrawal. Items are scored as yes (1 point) or no (0 points). Mean score between 0 and 1 reported, with higher score indicating greater conflict. (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionunits on a scale (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment week 6Block 1 End of Treatment Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate.3224.2386.3526.2118
Methylphenidate Then Atomoxetine.3385.1978.3078.2304

[back to top]

Children's Sleep Questionnaire

Children's Sleep Problems Severity, sum of scores, higher is worse.The scale assessed contains 16 items, each scored 0 to 3, with 0 representing no problems and 3 representing daily problems. total range from 0 to 48. This score does not have psychometrics available. (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionunits on a scale (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate5.143.204.752.94
Methylphenidate Then Atomoxetine5.092.834.553.43

[back to top]

Clinical Global Impressions (CGI)- Severity

The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionunits on a scale (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate5.143.204.752.94
Methylphenidate Then Atomoxetine5.092.834.553.43

[back to top]

Continuous Performance Test (CPT)

CPT Commissions, impulsive responses, higher score is worse. This scale is based on t-scores and does not have psychometrics available. (NCT00183391)
Timeframe: up to 14 weeks

,
InterventionT-scores (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate51.327751.700559.878850.0763
Methylphenidate Then Atomoxetine52.897651.171351.215949.1616

[back to top]

Social Skills Rating Scale (SSRS)- Parent Version

Measure of social skills, higher score is better. This scale is based on t-scores and does not have psychometrics available. (NCT00183391)
Timeframe: up to 14 weeks

,
Interventiont-score (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate82.7191.0778.5891.07
Methylphenidate Then Atomoxetine77.9688.5782.3587.96

[back to top]

Tics: Total Impairment

Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50). (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionunits on a scale (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate5.3041.737.000.500
Methylphenidate Then Atomoxetine.292.132.643.397

[back to top]

Tics: Total Motor

Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50). (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionunits on a scale (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate.196.053.000.160
Methylphenidate Then Atomoxetine.1111.342.214.143

[back to top]

Tics: Total Phonic

Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50). (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionunits on a scale (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate.161.018.039.060
Methylphenidate Then Atomoxetine.0281.329.057.016

[back to top]

Vital Signs - Diastolic Blood Pressure

Diastole blood pressure - blood pressure when the heart muscle is between beats. normal range varies by age, sex, height and weight and can range from 34mm Hg to 90mmHg (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionmm HG (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate61.7864.5862.3362.82
Methylphenidate Then Atomoxetine61.2662.7761.2865.44

[back to top]

Vital Signs - Pulse

Heartbeats per minute. Range varies from 50-205 depending on age and level of activity. (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionbeats per minute (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate78.2084.4682.9684.85
Methylphenidate Then Atomoxetine77.4982.0581.3084.31

[back to top]

Vital Signs - Systolic Blood Pressure

Systolic blood pressure - the amount of pressure in arteries during contraction of the heart muscle Normal range varies by age, sex, height and weight and can range from 80mm Hg to 130mmHg (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionmm HG (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate101.11102.1099.74102.34
Methylphenidate Then Atomoxetine101.60103.29101.29102.51

[back to top]

ADHD - H/I

Attention deficit/hyperactivity disorder - hyperactivity/impulsivity (ADHD- H/I). Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-27. Higher score indicates higher probability of diagnosis. (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionunits on a scale (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate16.567.8213.996.67
Methylphenidate Then Atomoxetine17.317.2414.808.87

[back to top]

ADHD-RS Inattention

Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-27. Higher score indicates higher probability of diagnosis. (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionunits on a scale (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate23.3012.3220.3311.09
Methylphenidate Then Atomoxetine22.4410.3518.7413.26

[back to top]

ADHD-RS Total Score

ADHD-RS Total Score Attention Deficit Hyperactivity Disorder Rating Scale. Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-54. Higher score indicates higher probability of diagnosis. (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionunits on a scale (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate39.5820.0334.3218.08
Methylphenidate Then Atomoxetine39.7517.5933.5422.13

[back to top]

Treatment Preference Survey

(NCT00183391)
Timeframe: Measured at ends of treatments one and two

,
Interventionpercentage of participants (Number)
Treatment Preference of ATXTreatment Preference of MPH
Atomoxetine Then Methylphenidate41.850.5
Methylphenidate Then Atomoxetine27.451.9

[back to top]

Prolonged Abstinence

"The smoking quit date was considered the first day of the O-MPH/P-Stnd Smoking Tx phase, which lasted for 6 weeks or more precisely 42 days (i.e., approximately weeks 5-10). The grace period was the first two weeks (i.e., days 1-14) with the remaining four weeks (days 15-42) comprising the period in which the participant must not meet criteria for treatment failure in order to be scored as obtaining prolonged abstinence. Self-report of cigarette use was assessed using a time-line follow-back (TLFB) assessment using carbon monoxide (CO)levels to correct self-reported smoking days. Smoking days were determined by starting with self-reported smoking and non-smoking days and using CO levels measured at weekly visits to modify the self-reports." (NCT00253747)
Timeframe: Weeks 7-10

Interventionparticipants (Number)
Osmotic-Release Methylphenidate (OROS-MPH)25
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo28

[back to top]

Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale

A Generalized Estimating Equations(GEE)model which included treatment group, week, site, and treatment by week and site by week interaction effects was used to compare the groups on the DSM-IV ADHD total severity score (18 domains score at severity levels of 0[none]-3[severe]; maximum score 54) as measured at screening/baseline and study weeks 1-4 using the the interviewer-administered DSM-IV checklist and by the severity portion of the National Institute of Mental Health Clinical Global Impression (CGI) scale to rate the severity of the participant's ADHD symptoms. A single severity score ranging from 1 to 7 is yielded by the CGI severity scale. (NCT00253747)
Timeframe: Baseline and Study weeks 1,4,7,9,11

InterventionDSM IV ADHD Score (Mean)
Osmotic-Release Methylphenidate (OROS-MPH)-Baseline38.4
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Baseline36.6
Osmotic-Release Methylphenidate (OROS-MPH)-Week 1116.4
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 1124.2
Release Methylphenidate (OROS-MPH)-Week 420.4
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 427.2
Release Methylphenidate (OROS-MPH)-Week 720
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 724
Release Methylphenidate (OROS-MPH)-Week 917.3
Methylphenidate (OROS-MPH) - Placebo-Week 923.9

[back to top]

Point-prevalence Abstinence

A logistic regression including site and treatment group will be used to model rates of achieving point prevalence abstinence as assessed at the final visit of the O-MPH/P-Stnd Smoking Tx phase. Point prevalence abstinence was defined as not smoking in the previous seven days based on self-report using the TLFB method and confirmed with a Carbon Monoxide (CO) level <8 ppm. (NCT00253747)
Timeframe: Week 11

Interventionparticipants (Number)
Osmotic-Release Methylphenidate (OROS-MPH)24
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo26

[back to top]

Swanson, Nolan, and Pelham Questionnaire (SNAP-IV)

"The SNAP-IV Rating Scale is a revision of the Swanson, Nolan and Pelham (SNAP) Questionnaire (Swanson et al, 1983). The SNAP-IV is based on a 0 to 3 rating scale: Not at All = 0, Just A Little = 1, Quite A Bit = 2, and Very Much = 3. Subscale scores on the SNAP-IV are calculated by summing the scores on the items in the subset and dividing by the number of items in the subset. The score for any subset is expressed as the Average Rating-Per-Item, as shown for ratings on the ADHD-Inattentive (ADHD-I) subset.~Sub scale ranges from 0-3. Higher scores mean better outcome. Change score from baseline is reported." (NCT00257725)
Timeframe: week 5

Interventionscore on a scale (Mean)
ADHD Treatment Group-1.09

[back to top]

Children's Global Assessment Scale (C-GAS)

Children's Global Assessment Scale (C-GAS) is designed to assess overall functioning across settings. The scale is rated from 1 to 100, with lower scores reflecting poorer adjustment. Change from baseline is reported. (NCT00257725)
Timeframe: week 5

Interventionscore on a scale (Mean)
ADHD Treatment Group10.55

[back to top]

Clinical Global Impressions-Severity (CGI-S)

"CGI-S is designed to assess severity of illness on a seven-point scale: 1 = normal (not at ll ill) to 7 = among the most extremely ill patients.~Range: 0-7, higher score means worse outcome. Change from baseline is reported." (NCT00257725)
Timeframe: week 5

Interventionscore on a scale (Mean)
ADHD Treatment Group-1.64

[back to top]

ADHD Severity

DSM IV ADHD Rating Scale (ADHD-RS) adolescent informant, ascertained at baseline and weekly throughout the 16 week study. This scale is an 18-item symptom checklist of self-reported adolescent ADHD symptoms. Symptoms are scored as None (0), Mild (1), Moderate (2), and Severe (3), with a summary total of scores for the 18 symptoms. Possible scores range from 0 to 54, with higher scores indicating greater severity. Outcome is measured as the decrease in total severity score over time. (NCT00264797)
Timeframe: baseline and 20 weeks

Interventionunits on a scale (Mean)
Methylphenidate-20.6
Methylphenidate (Placebo)-21.8

[back to top]

OROS-MPH Abuse Liability

Assessed by pill counts in conjunction with weekly review of subjects' medication diaries and self-reported medication compliance. (NCT00264797)
Timeframe: 20 weeks

Interventionpills (Mean)
Methylphenidate15.4
Methylphenidate (Placebo)9.7

[back to top]

Substance Use

The change in number of days of substance use from baseline to end of the trial. The number of days of non-tobacco drug/alcohol ascertained using standard timeline follow back (TLFB) procedures. (NCT00264797)
Timeframe: 20 weeks

Interventiondays (Mean)
Methylphenidate-5.7
Methylphenidate (Placebo)-5.2

[back to top]

Substance Use Outcomes

The mean number of negative urine drug screens (UDS). (NCT00264797)
Timeframe: 20 weeks

Interventionnegative UDS (Mean)
Methylphenidate3.8
Methylphenidate (Placebo)2.8

[back to top]

Peak Plasma Concentration of d-Methylphenidate

Objective measure determined from blood samples, measured 4 hours after the dose (NCT00302458)
Timeframe: 4 hours

Interventionmg/L (Mean)
Placebo- Placebo0.00
IR-MPH + OROS MPH15.06
IR-MPH +IR-MPH25.34
OROS-MPH+OROS-MPH20.34
OROS-MPH+ IR-MPH28.79

[back to top]

Change From OL Baseline in Clinical Global Impression Scale (CGI-S) Score at OL Endpoint

Assessment of the long term effect on overall functioning measured by CGI-S best score: 1 worst score: 7 (NCT00307684)
Timeframe: OL baseline, OL endpoint

Interventionunits on a scale (Mean)
Open Label PR OROS MPH-0.3

[back to top]

Change From OL Baseline in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score at OL Endpoint

Quality of life measured by Q-LES-Q best score: 100 worst score: 0 (NCT00307684)
Timeframe: OL baseline, OL endpoint

Interventionunits on a scale (Mean)
Open Label PR OROS MPH1.4

[back to top]

Change From OL Baseline to OL Endpoint in Conners' Adult ADHD Rating Scale (CAARS) Total and Subscale Scores

"Long term efficacy of PR OROS MPH as assessed by investigator-rated CAARS total score, hyperactivity/impulsivity subscale score and inattention subscale score.~Subscale scores: best value: 0, worst value: 27" (NCT00307684)
Timeframe: OL baseline, OL endpoint

Interventionunits on a scale (Mean)
change from baseline to endpoint in total scorechange from baseline to endpoint in inattentionchange from baseline to endpoint in hyperactivity
Open Label PR OROS MPH-1.9-1.0-0.9

[back to top]

Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)

To evaluate the long term safety and tolerability of PR OROS MPH (18, 36, 54, 72 and 90 mg/day) in adults with Attention Deficit Hyperactivity Disorder (ADHD) (NCT00307684)
Timeframe: Treatment duration for OL extended from 52 wks to 72 wks (International Amendment 2) or 108 wks in Germany. Treatment duration for double-blind (DB) randomized withdrawal: 4 weeks

,,
Interventionparticipants (Number)
at least one AEat least one SAEat least one severe AEat least one AE leading to permanent stopat least one AE leading to temporary stopat least one AE with concomitant therapyat least one AE at least possibly related
Active7000003
Open Label PR OROS MPH126122715239362
Placebo8130245

[back to top]

Change From DB Baseline to DB Endpoint in CGI-S Score

evaluation of treatment effects as rated by the investigator on the CGI-S scale. CGI-S is used to rate the severity of a subject's illness on a 7- point scale ranging from 1 (not ill) to 7 (extremely severe). (NCT00307684)
Timeframe: DB baseline, DB endpoint

Interventionunits on a scale (Mean)
Active0.6
Placebo1.0

[back to top]

Change From DB Baseline to DB Endpoint in CAARS Self Rated Scale (CAARS-S:S) Total Score

Evaluation of treatment effects as rated by the subjects on the CAARS-S:S. best score: 0 worst score: 104 (NCT00307684)
Timeframe: DB baseline, DB endpoint

Interventionunits on a scale (Mean)
Active4.4
Placebo4.0

[back to top]

Change From DB Baseline in Conners' Adult ADHD Rating Scale (CAARS) Total Score at DB Endpoint

"To evaluate maintenance of treatment effects of PR OROS MPH vs. placebo as measured on CAARS.~CAARS assesses ADHD symptoms and behaviors in adults. best value: 0 worst value: 54~Endpoint: last available post-baseline assessment." (NCT00307684)
Timeframe: DB baseline, DB endpoint

Interventionunits on a scale (Mean)
Active4.0
Placebo6.5

[back to top]

AUC of Sleep Quality as Measured by the Pittsburgh Sleep Quality Index at Baseline and at Weeks 1-4

Pittsburgh Sleep Quality Index (PSQI) consists of 19 items and 7 scales. The AUC for the overall PSQI at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better. (NCT00376675)
Timeframe: Baseline to Week 4

Interventionunits on a scale * weeks (Mean)
Methylphenidate144.37
Placebo145.93

[back to top]

AUC of Vitality as Measured by the Short Form-36 Vitality Subscale at Baseline and at Weeks 1-4

The SF-36 is a 36-item short form to measure health status in various populations. The vitality subscale is comprised of 4 items and is a measure of energy level as well as fatigue. The AUC for the vitality subscale at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better. (NCT00376675)
Timeframe: Baseline to Week 4

Interventionunits on a scale * weeks (Mean)
Methylphenidate134.74
Placebo121.59

[back to top]

Prorated AUC of Total Fatigue as Measured by the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4

"The prorated area under the curve (AUC) for the usual fatigue question of the BFI at baseline and at weeks 1-4 after being translated onto a 0 (poor quality of life (QOL) or bad symptoms) to 100 (best QOL or no symptoms) point scale was calculated as the following:~For those completed 4 weeks item: AUC/4;~For those completed up to week 3 item: (AUC * 4) / 3;~For those completed up to week 2 item: AUC * 2;~For those completed up to week 1 item: AUC * 4;~The prorated AUC scores were then transformed onto 0 to 100 point scale with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms) for analysis." (NCT00376675)
Timeframe: Baseline to week 4

Interventionunits on a scale (Mean)
Methylphenidate50.33
Placebo47.15

[back to top]

AUC of Other Fatigue Scores as Measured by Items of the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4

Area under the curve (AUC) for the other fatigue items of the BFI at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better. (NCT00376675)
Timeframe: Baseline to Week 4

,
Interventionunits on a scale * weeks (Mean)
Fatigue right nowWorst fatigue last 24 hoursFatigue interference with general activityFatigue interference with moodFatigue interference with walking abilityFatigue interference with normal workFatigue interference with relations with othersFatigue interference with enjoyment of life
Methylphenidate179.96144.59187.60205.31210.09179.94224.72194.15
Placebo174.94126.36171.06220.29206.46168.84243.87184.12

[back to top]

AUC of Overall Quality of Life (QOL) and QOL Domains as Measured by the Linear Analogue Self Assessment at Baseline and at Weeks 1-4

Linear Analogue Self Assessment (LASA) consists of 6 single-item numeric analogue scales. The AUC for the six-items at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better. (NCT00376675)
Timeframe: Baseline to Week 4

,
Interventionunits on a scale * weeks (Mean)
Overall QOLMental well-beingPhysical well-beingEmotional well-beingSocial activitySpiritual well-being
Methylphenidate204.21227.04188.13203.65189.68231.24
Placebo201.34226.40191.07215.65177.34255.88

[back to top]

Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4

The Symptom Experience Diary (SED) consists of 12 items. All scores were translated onto a 0-100 point scale, with 0 represent poor quality of life (QOL) or bad symptom and 100 is best QOL or no symptoms.The change in severity of adverse events was calculated as subtracting the item scores at baseline from the scores at week 4. (NCT00376675)
Timeframe: Baseline and Week 4

,
Interventionunits on a scale (Mean)
NervousnessAppetite decreaseSex driveAbdominal painDizzinessShakinessHeartbeatVomitingHeadachesTrouble sleepingFatigue distressFatigue control satisfaction
Methylphenidate-2.7-5.2-0.9-3.5-2.2-0.6-2.0-0.8-0.810.622.928.0
Placebo9.56.69.83.62.11.4-1.60.43.911.115.823.2

[back to top]

Anchor-based Minimally Important Difference in SGIC Overall Quality of Life Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue

"Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of a little better via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms)." (NCT00376675)
Timeframe: Baseline and Week 4

Interventionunits on a scale (Mean)
Methylphenidate20.9
Placebo15

[back to top]

Anchor-based Minimally Important Difference in SGIC Physical Condition Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue

"Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of a little better via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms)." (NCT00376675)
Timeframe: Baseline and Week 4

InterventionUnits on scale (Mean)
Methylphenidate20.0
Placebo11.4

[back to top]

Anchor-based Minimally Important Difference in SGIC Emotional State Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue

"Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of a little better via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms)." (NCT00376675)
Timeframe: Baseline and Week 4

InterventionUnits on scale (Mean)
Methylphenidate31.0
Placebo23.8

[back to top]

Number of Sister Chromatoid Exchanges Per Cell

Blood collected at baseline (n=20, n=14) and at the end of treatment, Week 12, (n= 20, n= 14) was cultured for 48 hours using a standard protocol. Giemsa staining and/or fluorescent in situ hybridization (FISH) chromosome painting was done on the cells in metaphase and the number of chromatoid exchanges per cell was recorded by blinded raters. (NCT00409708)
Timeframe: baseline and at end of treatment (Week 12)

,
Interventionnumber of sister chromatoid exchanges (Mean)
BaselineAt the end of treatment i.e. Week12
Behavior Therapy7.5337.303
Ritalin LA Plus Behavior Therapy7.8077.213

[back to top]

The Number of Chromosomal Aberrations Per 100 Cells Excluding Gaps at Baseline and at the End of Treatment i.e Day 84 (Week 12)

The number of chromosomal aberrations per 100 cells excluding gaps at Baseline (n=33, n=32) and at Week 12 (n=33, n=32) was counted in blood samples cultured for 48 hours using a standard protocol. The types of abnormalities included translocations (reciprocal and non-reciprocal), insertions, dicentrics, fragments, inversions, chromatid exchanges (quadriradials and triradials), breaks, and other unusual observations, eg, aneuploidy, tetraploidy or endoreduplication. (NCT00409708)
Timeframe: baseline and at end of treatment (Week 12)

,
Interventionnumber of abnormalities (Mean)
BaselineAt the end of treatment i.e. week12: Mean
Behavior Therapy0.750.41
Ritalin LA Plus Behavior Therapy1.050.53

[back to top]

The Number of Micronuclei Per 1000 Binucleated Cells Endpoints at Baseline and at the End of Treatment i.e Day 84 (Week 12)

The number of micronuclei per 1000 binucleated cells was measured at Baseline ( n=34 , n=29 ) and at the end of treatment, Week 12 (n =34, n= 29), in blood cultured for 48 hours using a standard protocol. (NCT00409708)
Timeframe: baseline and at end of treatment (Week 12)

,
Interventionnumber of micronuclei per 1000 binucleat (Mean)
At BaselineAt the end of treatment i.e. Week 12
Behavior Therapy5.714.19
Ritalin LA Plus Behavior Therapy5.763.63

[back to top]

Change From Baseline to End of Treatment (Week 12) on the Conners' ADHD/DSM-IV Scale for Parents (CADS-P)

"Parents completed the Conners' ADHD/DSM-IV Scale for Parents (CADS-P) consisting of the ADHD Index (12 items) and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)( 18 items). Parents rated their child's behavior of the previous week from a list of common problems. When asked How much of a problem has this been in the last week? parents selected 0 = none, not at all, seldom, or very infrequently; 3 = very much true, or it occurs very often or frequently; or 1 or 2 for ratings in between. A score of 50 is considered normal and more than 70 markedly atypical." (NCT00409708)
Timeframe: Baseline to end of treatment (Week 12)

InterventionUnits on a rating scale (Mean)
Ritalin LA Plus Behavior Therapy-17.0
Behavior Therapy-7.0

[back to top]

Change From Baseline to the End of Treatment (Week 12) on the Global Improvement Rating of the Clinical Global Impression Scale (CGI-I)

The Clinical Global Impression scale (CGI-I) is a clinician-rated instrument designed to assess the overall change of illness relative to baseline. The CGI-I consists of 7 ratings as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. CGI-I assessments are relative to the patient's status at the Baseline visit. (NCT00409708)
Timeframe: From baseline to the end of treatment (Week 12)

InterventionUnits on a rating scale (Mean)
Ritalin LA Plus Behavior Therapy1.9
Behavior Therapy3.0

[back to top]

Change From Baseline to the End of Treatment (Week 12) on the Severity of Illness Rating of the Clinical Global Impression Scale (CGI-S)

The Clinical Global Impression scale (CGI-S) is a clinician-rated instrument designed to assess the severity of illness. The CGI-S rating indicates illness severity at each time-point on a scale as follows: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = extremely ill. CGI-S assessments are relative to the patient's status at the Baseline visit. (NCT00409708)
Timeframe: From baseline to the end of treatment (Week 12)

InterventionUnits on a rating scale (Mean)
Ritalin LA Plus Behavior Therapy-1.9
Behavior Therapy-0.6

[back to top]

Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score

"'Trail Making Test Part A' is a neuropsychological test of visual attention and task switching, administered to measure processing speed, timed as participants follow trail made by consecutive numbers (1,2,3, etc.). The test is finished as quickly as possible, and the time taken to complete the test used as the primary performance metric (in seconds). Maximum time allowed is 300 seconds. A lower change score indicates improvement. Participants tested before starting study medication and 4-5 weeks later while on study medication, reflected in a z score (deviations from population mean)." (NCT00418691)
Timeframe: Baseline to 4-5 weeks on study medication

Interventionz-scores (Mean)
IR Methylphenidate-4.7
SR Methylphenidate0.24
Modafinil-3.7

[back to top]

Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Fatigue Subscale Score

FACIT-F fatigue subscale consists of 13 items. Patients rate the intensity of their fatigue symptoms on a scale of 0 to 4 (0=not at all and 4=very much). Total FACIT-F fatigue subscale score ranges from 0 to 52 with higher scores indicate higher fatigue. We measured the median change in FACIT-F fatigue sub scale score between Baseline and Day 15 using Kruskal-Wallis test. (NCT00424099)
Timeframe: Baseline and Day 15

Interventionscore on a scale (Median)
Methylphenidate (MP) + Nursing Telephone Intervention (NTI)4.00
Methylphenidate (MP) + Control Telephone Intervention (CTI)7.00
Placebo (PL)+ Nursing Telephone Intervention (NTI)8.50
Placebo (PL) + Control Telephone Intervention (CTI)5.00

[back to top]

Change in Edmonton Symptom Assessment System (ESAS) Fatigue Score

The ESAS was used to assess the following 9 symptoms commonly experienced symptoms by cancer patients: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, and well-being. Patients rate the intensity of their fatigue symptoms on a scale of 0 to 10 (0=not at all and 10=very much). Total ESAS fatigue score ranges from 0 to 10 with higher scores indicate higher fatigue. We measured the median change in ESAS fatigue score between Baseline and Day 15 using Kruskal-Wallis test. (NCT00424099)
Timeframe: Baseline and Day 15

Interventionscore on a scale (Median)
Methylphenidate (MP) + Nursing Telephone Intervention (NTI)-3.00
Methylphenidate (MP) + Control Telephone Intervention (CTI)-1.00
Placebo (PL)+ Nursing Telephone Intervention (NTI)-2.00
Placebo (PL) + Control Telephone Intervention (CTI)-2.00

[back to top]

Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating

The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD. (NCT00428792)
Timeframe: Saturday of each of the 2 treatment weeks

InterventionUnits on a scale (Mean)
Very Light Breakfast (VLB) Treatment Group1.15
Standard Breakfast (SB) Treatment Group1.11

[back to top]

Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating

Teacher rating of the hyperactivity subscale (7 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 7) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD. (NCT00428792)
Timeframe: Friday of each of the 2 treatment weeks

InterventionUnits on a scale (Mean)
Very Light Breakfast (VLB) Treatment Group0.72
Standard Breakfast (SB) Treatment Group0.75

[back to top]

Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating

Teacher rating of the hyperactivity subscale (4 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 4) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD. (NCT00428792)
Timeframe: Friday of each of the 2 treatment weeks

InterventionUnits on a scale (Mean)
Very Light Breakfast (VLB) Treatment Group0.93
Standard Breakfast (SB) Treatment Group0.99

[back to top]

Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population

The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD. (NCT00428792)
Timeframe: Friday of each of the 2 treatment weeks

InterventionUnits on a scale (Mean)
Very Light Breakfast (VLB) Treatment Group0.97
Standard Breakfast (SB) Treatment Group1.01

[back to top]

Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Per Protocol (PP) Population

The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD. (NCT00428792)
Timeframe: Friday of each of the 2 treatment weeks

InterventionUnits on a scale (Mean)
Very Light Breakfast (VLB) Treatment Group0.93
Standard Breakfast (SB) Treatment Group1.0

[back to top]

Clinical Global Impression (CGI-I) Scale Score - Physician Rating of Improvement (Change in State)

"The CGI-I is a scale to assess improvement (change in state) of illness. The rating is based on the investigator answering one question: Compared to the patient's condition prior to medication, this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. The investigator compares the patient's overall clinical condition to the 1 week period just prior to the initiation of medication." (NCT00428792)
Timeframe: Saturday of each of the 2 treatment weeks

InterventionUnits on a scale (Mean)
Very Light Breakfast (VLB) Treatment Group3.49
Standard Breakfast (SB) Treatment Group3.56

[back to top]

Clinical Global Impression Severity (CGI-S) Scale Score - Physician Rating of Severity

"The CGI-S is a scale to assess the global severity of illness. The rating is determined by the investigator answering one question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? Ratings are on a 7-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The rating is based upon the average observed and reported symptoms, behavior, and function in the past 7 days." (NCT00428792)
Timeframe: Saturday of each of the 2 treatment weeks

InterventionUnits on a scale (Mean)
Very Light Breakfast (VLB) Treatment Group2.75
Standard Breakfast (SB) Treatment Group2.74

[back to top]

Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating

Teacher rating of the attention deficit subscale (9 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 9) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD. (NCT00428792)
Timeframe: Friday of each of the 2 treatment weeks

InterventionUnits on a scale (Mean)
Very Light Breakfast (VLB) Treatment Group1.19
Standard Breakfast (SB) Treatment Group1.23

[back to top]

10-Minute Math Test - Problems Attempted

"The 10-Minute Math Test is a paper and pencil test consisting of several pages of math problems requiring addition, subtraction, multiplication and division calculations presented in ascending order of difficulty during a 10-minute period. Test difficulty was altered for subjects at different skill levels and ages. The number of problems attempted is an objective measure related to academic productivity. The math test was carried out on the Saturday visit at the end of each of the 2 treatment weeks under supervision of a teacher who had been trained on this test." (NCT00428792)
Timeframe: Saturday of each of the 2 treatment weeks

InterventionProblems attempted (Mean)
Very Light Breakfast (VLB) Treatment Group116.3
Standard Breakfast (SB) Treatment Group118.1

[back to top]

10-Minute Math Test - Problems Solved

"The 10-Minute Math Test is a paper and pencil test consisting of several pages of math problems requiring addition, subtraction, multiplication and division calculations presented in ascending order of difficulty during a 10-minute period. Test difficulty was altered for subjects at different skill levels and ages. The number of problems attempted is an objective measure related to academic productivity. The math test was carried out on the Saturday visit at the end of each of the 2 treatment weeks under supervision of a teacher who had been trained on this test." (NCT00428792)
Timeframe: Saturday of each of the 2 treatment weeks

InterventionProblems solved (Mean)
Very Light Breakfast (VLB) Treatment Group106.7
Standard Breakfast (SB) Treatment Group108.6

[back to top]

ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale)

"The primary clinical efficacy variable for treatment was the ADHD-RS-IV (Attention-Deficit/Hyperactivity Disorder Rating Scale) Total Score and two sub-scales (Inattentive and Hyperactive-Impulsive ).~The rating scale has 18 questions with answer options: None (0), Mild (1), Moderate (2) and Severe (3). Min 0; max 3.~Scores are obtained by summing each item; The higher the score, the worse the outcome.~Total score range: 0-54 Total Inattentive score range: 0-27 Total Hyperactive/Impulsive score range: 0-27" (NCT00429273)
Timeframe: Measured at baseline Week 4 and Week 8

,,
Interventionunits on a scale (Least Squares Mean)
Total ADHD-RS ScoreInattentive SubscaleHyperactive Impulsive Subscale
Estimated Difference Between DMPH and Placebo-7.99-4.10-4.0
Estimated Difference Between Guan and Placebo-7.77-4.14-3.73
Estimated Difference Between Placebo and Combo-10.66-5.89-5.10

[back to top]

Contact Sensitization to Methylphenidate

Contact sensitization to methylphenidate through skin patch testing. (NCT00434213)
Timeframe: 7 weeks

InterventionParticipants (Number)
Daytrana1

[back to top]

Dermal Reactions

Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles. (NCT00434213)
Timeframe: 7 weeks

InterventionParticipants (Number)
0 (no evidence of irritation)1 (minimal erythema)2 (definite eythema)3 (erythema and papules)4 (definite edema)5 (erythema, edema, and papules)6 (vesicular eruption)7 (strong reaction beyond test site)No dermal evaluation
Daytrana4697151630002

[back to top]

Self Report Questionnaire - MASQ

The Multiple Abilities Questionnaire (self rating) is a questionnaire in which participants can identify deficits/complaints in the areas of language, visual perception, verbal memory, visual memory and attention and concentration. A total score is calculated; range is 30-130. Higher scores indicate greater level of complaints (worse outcome). For the purposes of this study, a score one standard deviation above the mean (102.7) indicated significant reported cognitive complaints. (NCT00453921)
Timeframe: post-intervention (at least 7 weeks)

Interventionunits on a scale (Mean)
Placebo Both Conditions116.4
Active Drug/Active Therapy120.5
Active Drug/Placebo Therapy114.1
Placebo Drug/Active Therapy118.1

[back to top]

Neuropsychological Assessment, CVLT-II

Memory measure: California Verbal Learning Test, 2nd edition (CVLT), Total, trials 1-5 (range: 0-80). Higher scores are better outcome. (NCT00453921)
Timeframe: post-intervention (at least 7 weeks)

Interventionunits on a scale (Mean)
Placebo Both Conditions51.3
Active Drug/Active Therapy51.8
Active Drug/Placebo Therapy51.9
Placebo Drug/Active Therapy57.2

[back to top]

Neuropsychological Assessment - CPT, Distractibility Condition (Reaction Time)

Continuous Performance Test, Distractibility Condition (Reaction Time in msecs) (range: 0-800). Higher score is worse performance. (NCT00453921)
Timeframe: post-intervention (at least 7 weeks)

Interventionunits on a scale (Mean)
Placebo Both Conditions426.4
Active Drug/Active Therapy394.7
Active Drug/Placebo Therapy416.6
Placebo Drug/Active Therapy413.0

[back to top]

Functional MRI Task Performance and Brain Activation (Change From Baseline to Post-treatment)

Change in performance (percent correct,adjusted for guessing) from pre-(baseline) to post-treatment (approximately 7 weeks) for in-scanner n-back working memory task (Range: 0-100). Higher scores means better performance. (NCT00453921)
Timeframe: pre- to post-6 week treatment intervention (at least 7 weeks)

Interventionpercentage of correct targets (adjusted) (Mean)
Placebo Both Conditions-4.46
Active Drug/Active Therapy4.69
Active Drug/Placebo Therapy4.86
Placebo Drug/Active Therapy-0.36

[back to top]

Change in Right Inferior Frontal Activation During Working Memory Processing (3-back > 0-back Condition) From Baseline to Post-intervention

Change from pre- to post-treatment in brain activation in the right inferior frontal region of interest in arbitrary units provided by the SPM (statistical parametric mapping) program (range: unknown). Higher scores indicate greater increase in activation from pre- to post-treatment. (NCT00453921)
Timeframe: pre- to post-treatment (at least 7 weeks)

Interventionunits on a scale (Mean)
Placebo Both Conditions-0.18
Active Drug/Active Therapy0.05
Active Drug/Placebo Therapy.15
Placebo Drug/Active Therapy.14

[back to top]

Change in Left Middle/Inferior Frontal Activation During Working Memory Processing (3-back > 0-back Condition) From Baseline to Post-intervention

Change from pre- to post-treatment in brain activation in the left middle/inferior frontal region of interest in arbitrary units provided by the SPM (statistical parametric mapping) program (range: unknown). Higher scores indicate greater increase in activation from pre- to post-treatment. (NCT00453921)
Timeframe: pre- to post-treatment (at least 7 weeks)

Interventionunits on a scale (Mean)
Placebo Both Conditions-0.16
Active Drug/Active Therapy0.04
Active Drug/Placebo Therapy0.07
Placebo Drug/Active Therapy.10

[back to top]

Change in Anterior Cingulate Gyrus Activation During Working Memory Processing (3-back > 0-back Condition) From Baseline to Post-intervention

Change from pre- to post-treatment in brain activation in the anterior cingulate region of interest in arbitrary units provided by the SPM (statistical parametric mapping) program (range: unknown). Higher scores indicate greater increase in activation from pre- to post-treatment. (NCT00453921)
Timeframe: pre- to post-intervention (at least 7 weeks)

Interventionunits on a scale (Mean)
Placebo Both Conditions-0.31
Active Drug/Active Therapy0.09
Active Drug/Placebo Therapy0.20
Placebo Drug/Active Therapy0.05

[back to top]

Baseline AISRS

"Baseline values for all treatment groups are equal because~the constrained longitudinal data analysis (cLDA) model was used~(Liang and Zeger, 2000, Sankhyā: The Indian Journal of Statistics, Series B 62, 134-148)." (NCT00475735)
Timeframe: Baseline

Interventionscore on scale (Least Squares Mean)
MK-024934.6
Concerta34.6
Placebo34.6

[back to top]

Mean Change From Baseline in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) Total Score After 4 Weeks of Treatment

The AISRS total score consists of 18 items from the original Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) which were derived based on Diagnostic and Statistical Manual-4 (DSM-IV) criteria for ADHD. The ADHD-RS include 9 items that address symptoms of inattention and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD. (NCT00475735)
Timeframe: after 4 weeks of treatment

Interventionscore on scale (Least Squares Mean)
MK-0249-9.8
Concerta-15.3
Placebo-7.6

[back to top]

Apathy Evaluation Scale Score at 12 Weeks

The Apathy Evaluation Scale (AES) has been specifically developed to assess apathy and discriminate it from depression. This 18 item scale with score ranging from 18 to 72, assesses apathy in behavioral, cognitive and emotional domains over the previous four weeks. Higher scores indicate worsening apathy. (NCT00495820)
Timeframe: At 12 weeks

Interventionunits on a scale (Mean)
Methylphenidate Group38.2
Placebo Group43.6

[back to top]

Clinical Global Impression

The Clinical Global Impression scale is an observational scale of global evaluation, which assesses the change in degree of illness in relation to the original assessment. The severity sub-scale reported below ranges from 1-7 wherein higher scores indicate worsening severity of illness. (NCT00495820)
Timeframe: At 12 weeks

Interventionunits on a scale (Mean)
Methylphenidate Group3.9
Placebo Group4.8

[back to top]

Mini-mental State Examination (MMSE) at 12 Weeks

Mini-mental State Examination (MMSE) is a commonly used screening measure for cognition with questions pertaining to orientation, registration, recall, visuo-spatial construction, attention span etc. Score on MMSE ranges from 0-30, higher scores indicating improving cognition (NCT00495820)
Timeframe: At 12 weeks

Interventionunits on a scale (Mean)
Methylphenidate Group25.8
Placebo Group23.6

[back to top]

Physiologic Effects Assessed by the Pharmacological Class Questionnaire

"During the peak (assessed at 120 min) of each drug administration, participants were asked to complete the pharmacological class questionnaire. The pharmacological class questionnaire had volunteers indicate which drug class was most similar to the drug condition they received. Ten drug classes were listed with descriptive labels and examples of each: placebo, opiates (or opioid agonist), phenothiazines, barbiturates, antidepressants, opiate antagonists, hallucinogens, benzodiazepines, stimulants, and other. Of these choices, participants chose 3: placebo, opioid agonist, and stimulant.~The outcome measure represents the percentage of participants who chose either placebo, opioid agonist, or stimulant across each drug condition." (NCT00499746)
Timeframe: Measure at 120 min after drug administration

,,,,,,,,
Interventionpercentage of drug identification (Number)
PlaceboOpioid AgonistStimulant
Hydromorphone 4 mg25750
Hydromorphone 8 mg01000
Methylphenidate 30 mg00100
Methylphenidate 60 mg00100
Placebo 0 mg10000
Tramadol 100 mg75250
Tramadol 200 mg37630
Tramadol 400 mg256312
Tramadol 50 mg10000

[back to top]

Discrimination Effects Assessed by Point Distribution

In point distribution, volunteers distributed 50 points among three training drug letters depending on how certain they were of the identity of the administrated drug. Maximum total is 50 points. (NCT00499746)
Timeframe: 1day

,,,,,,,,
InterventionPoints distributed (Mean)
PlaceboHydromorphoneMethylphenidate
Hydromorphone 4 mg11.938.10.0
Hydromorphone 8 mg0.050.00.0
Methylphenidate 30 mg0.00.050.0
Methylphenidate 60 mg0.00.050.0
Placebo 0 mg50.00.00.0
Tramadol 100 mg37.512.50.0
Tramadol 200 mg9.438.30.0
Tramadol 400 mg12.531.36.3
Tramadol 50 mg50.00.00.0

[back to top]

Discrimination Effects Assessed by Operant Responses

Volunteers emitted operant responses on computer keys that corresponded to the training letter, on a fixed interval 1 second schedule for 8.5 minutes. The range is from 0 to 500 operant responses. (NCT00499746)
Timeframe: 1 day

,,,,,,,,
InterventionResponses (Mean)
PlaceboHydromorphoneMethylphenidate
Hydromorphone 4 mg116.6341.30.0
Hydromorphone 8 mg0.0453.40.0
Methylphenidate 30 mg0.00.0465.4
Methylphenidate 60 mg0.00.0465.8
Placebo 0 mg455.50.00.0
Tramadol 100 mg341.3118.10.0
Tramadol 200 mg86.6367.00.0
Tramadol 400 mg115.6282.959.9
Tramadol 50 mg464.10.00.0

[back to top]

Discrimination Effects Assessed by Discrete Choice

"During discrete choice, volunteers were given three choices (placebo, hydromorphone, methylphenidate) and were asked to choose which of the training drugs they thought they received. The outcome measure illustrates the percentage of participants who chose either placebo, hydromorphone, or methylphenidate during each drug condition (i.e., Placebo, Hydromorphone 8 mg, Tramadol 50 mg, etc.), ranging from 0-100.~The outcome measure represents the percentage of participants who chose either placebo, opioid agonist, or stimulant across each drug condition." (NCT00499746)
Timeframe: 1 day

,,,,,,,,
Interventionpercentage of drug identification (Number)
PlaceboHydromorphoneMethylphenidate
Hydromorphone 4 mg25750
Hydromorphone 8 mg01000
Methylphenidate 30 mg00100
Methylphenidate 60 mg00100
Placebo 0 mg10000
Tramadol 100 mg75250
Tramadol 200 mg25750
Tramadol 400 mg256312
Tramadol 50 mg10000

[back to top]

Physiological Effects Assessed by Peak Change From Baseline Pupil Diameter

Change in pupil diameter (mm) at peak (120 min) compared to baseline measure of pupil diameter (NCT00499746)
Timeframe: Measure at 120 min after drug administration

Interventionmm (Mean)
Placebo 0 mg-0.5
Hydromorphone 4 mg-1.2
Hydromorphone 8 mg-1.9
Methylphenidate 30 mg-0.6
Methylphenidate 60 mg-0.3
Tramadol 50 mg-0.5
Tramadol 100 mg-0.2
Tramadol 200 mg-0.8
Tramadol 400 mg-0.8

[back to top]

Peak Change From Baseline Stimulant Effects Assessed by the Visual Analog Scale (VAS)

"The Visual Analog Scale (VAS) measures subjective ratings of stimulant effects. The scale on this measure ranges from 0 being Not at all to 100 being Extremely. On this scale, higher scores indicate a stronger drug effect. The outcome measure illustrates a difference from peak (120 min) to baseline measure." (NCT00499746)
Timeframe: Measure at 120 min after drug administration

Interventionunits on a scale (Mean)
Placebo 0 mg1.4
Hydromorphone 4 mg3.6
Hydromorphone 8 mg3.6
Methylphenidate 30 mg8.0
Methylphenidate 60 mg10.6
Tramadol 50 mg0.6
Tramadol 100 mg0.9
Tramadol 200 mg4.9
Tramadol 400 mg6.9

[back to top]

Peak Change From Baseline Opioid Agonist Effects Assessed by the Visual Analog Scale (VAS)

"The Visual Analog Scale (VAS) measures subjective ratings of opioid agonist effects. The scale on this measure ranges from 0 being Not at all to 100 being Extremely. On this scale, higher scores indicate a stronger drug effect. The outcome measure illustrates a difference from peak (120 min) to baseline measure on VAS." (NCT00499746)
Timeframe: Measure at 120 min after drug administration

Interventionunits on a scale (Mean)
Placebo 0 mg1.4
Hydromorphone 4 mg2.9
Hydromorphone 8 mg4.8
Methylphenidate 30 mg2.1
Methylphenidate 60 mg3.4
Tramadol 50 mg0.4
Tramadol 100 mg1.6
Tramadol 200 mg2.1
Tramadol 400 mg3.8

[back to top]

Acquisition of Discrimination Assessed by Accuracy of the Discrimination Test

The acquisition of discrimination was to test whether volunteers could identify each training drug condition by the correct letter code. Results are the percentage of correct responses with a range of 0% to 100%. (NCT00499746)
Timeframe: 1 day

Interventionpercent of correct response (Mean)
Placebo 0 mg87
Hydromorphone 8 mg87.5
Methylphenidate 60 mg90

[back to top]

Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint

The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true). (NCT00499863)
Timeframe: Baseline and endpoint (up to 7 weeks)

Interventionscores on a scale (Least Squares Mean)
Methylphenidate Transdermal System-20.9
Placebo (PTS)-7.5

[back to top]

Change From Baseline in Weight at Endpoint

(NCT00499863)
Timeframe: Baseline and endpoint (up to 7 weeks)

Interventionlbs (Mean)
Methylphenidate Transdermal System-1.9
Placebo (PTS)1.77

[back to top]

Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint

The Youth Quality of Life Instrument-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). (NCT00499863)
Timeframe: Baseline and endpoint (up to 7 weeks)

Interventionscores on a scale (Least Squares Mean)
Methylphenidate Transdermal System3.3
Placebo (PTS)1.3

[back to top]

Dermal Response Scale (DRS) Scores

Mean dermal reaction scores were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles. (NCT00499863)
Timeframe: up to 7 weeks

Interventionscores on a scale (Mean)
Methylphenidate Transdermal System0.6
Placebo (PTS)0.2

[back to top]

Improvement in Clinical Global Impressions-Improvement (CGI-I) Score

Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale. (NCT00499863)
Timeframe: up to 7 weeks

InterventionParticipants (Number)
Methylphenidate Transdermal System93
Placebo (PTS)22

[back to top]

Improvement in Parent Global Assessment (PGA) Score

Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale. (NCT00499863)
Timeframe: up to 7 weeks

InterventionParticipants (Number)
Methylphenidate Transdermal System76
Placebo (PTS)15

[back to top]

Post Sleep Questionnaire (PSQ) Quality of Sleep

Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses. (NCT00499863)
Timeframe: up to 7 weeks

,
InterventionParticipants (Number)
Very poorPoorAverageGoodVery good
Methylphenidate Transdermal System214274731
Placebo (PTS)27131818

[back to top]

Change From Baseline in Diastolic Blood Pressure at Endpoint

(NCT00499863)
Timeframe: Baseline and endpoint (up to 7 weeks)

InterventionmmHg (Mean)
Methylphenidate Transdermal System1.9
Placebo (PTS)1.1

[back to top]

Change From Baseline in Electrocardiogram Results(QTcF Interval) at Endpoint

QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation. (NCT00499863)
Timeframe: Baseline and endpoint (up to 7 weeks)

Interventionmsec (Mean)
Methylphenidate Transdermal System-1.3
Placebo (PTS)-0.8

[back to top]

Change From Baseline in Pulse Rate at Endpoint

(NCT00499863)
Timeframe: Baseline and endpoint (up to 7 weeks)

Interventionbpm (Mean)
Methylphenidate Transdermal System6.5
Placebo (PTS)-1.4

[back to top]

Change From Baseline in Systolic Blood Pressure at Endpoint

(NCT00499863)
Timeframe: Baseline and endpoint (up to 7 weeks)

InterventionmmHg (Mean)
Methylphenidate Transdermal System2.0
Placebo (PTS)-0.4

[back to top]

Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint

The Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. (NCT00499863)
Timeframe: baseline and endpoint (up to 7 weeks)

Interventionscores on a scale (Least Squares Mean)
Methylphenidate Transdermal System-18.8
Placebo (PTS)-8.8

[back to top]

Electrocardiogram Results (QTcF Interval)

QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation. (NCT00501293)
Timeframe: Baseline and 6 months

,
Interventionmsec (Mean)
Baseline measure6 months
Antecedent Methylphenidate Transdermal System (MTS)391.8395.3
Antecedent Placebo393.2393.5

[back to top]

Diastolic Blood Pressure

(NCT00501293)
Timeframe: Baseline and 6 months

,
InterventionmmHg (Mean)
Baseline measure6 months
Antecedent Methylphenidate Transdermal System (MTS)69.467.9
Antecedent Placebo67.268.9

[back to top]

Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at 6 Months

The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life. (NCT00501293)
Timeframe: Baseline and 6 months

,
InterventionUnits on a scale (Mean)
Baseline measure6 monthsChange from baseline at 6 months
Antecedent Methylphenidate Transdermal System (MTS)82.485.01.9
Antecedent Placebo80.984.62.7

[back to top]

Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores

Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. (NCT00501293)
Timeframe: 6 months

InterventionParticipants (Number)
Antecedent Methylphenidate Transdermal System (MTS)81
Antecedent Placebo39

[back to top]

Number of Participants With Improvement on Parent Global Assessment (PGA) Scores.

Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. (NCT00501293)
Timeframe: 6 months

InterventionParticipants (Number)
Antecedent Methylphenidate Transdermal System (MTS)69
Antecedent Placebo31

[back to top]

Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Scores at 6 Months

The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. (NCT00501293)
Timeframe: Baseline and 6 months

,
InterventionUnits on a scale (Mean)
Baseline measure6 monthsChange from baseline at 6 months
Antecedent Methylphenidate Transdermal System (MTS)16.013.5-2.6
Antecedent Placebo27.414.5-12.9

[back to top]

Dermal Reactions

Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles. (NCT00501293)
Timeframe: 6 months

InterventionParticipants (Number)
0 (No evidence of irritation)1 (Minimal erythema)2 (Definite erythema)3 (Erythema and papules)4 (Definite edema)5 (Erythema, edema, and papules)6 (Vesicular eruption)7 (Strong reaction beyond test site)No dermal evaluation
Antecedent MTS and Antecedent Placebo234282604005

[back to top]

Weight

(NCT00501293)
Timeframe: Baseline and 6 months

,
Interventionlb (Mean)
Baseline measure6 months
Antecedent Methylphenidate Transdermal System (MTS)127.05134.55
Antecedent Placebo131.95124.78

[back to top]

Pulse Rate

(NCT00501293)
Timeframe: Baseline and 6 months

,
Interventionbeats per minute (Mean)
Baseline measure6 months
Antecedent Methylphenidate Transdermal System (MTS)80.481.7
Antecedent Placebo74.378.9

[back to top]

Post Sleep Questionnaire (PSQ) Quality of Sleep

Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses. (NCT00501293)
Timeframe: 6 months

,
InterventionParticipants (Number)
Very poorPoorAverageGoodVery Good
Antecedent Methylphenidate Transdermal System (MTS)16342723
Antecedent Placebo1310159

[back to top]

Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) at 6 Months

The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior. (NCT00501293)
Timeframe: Baseline and 6 months

,
InterventionUnits on a scale (Mean)
Baseline measure6 monthsChange from baseline at 6 months
Antecedent Methylphenidate Transdermal System (MTS)26.522.5-3.9
Antecedent Placebo42.324.6-17.7

[back to top]

Systolic Blood Pressure

(NCT00501293)
Timeframe: Baseline and 6 months

,
InterventionmmHg (Mean)
Baseline measure6 months
Antecedent Methylphenidate Transdermal System (MTS)113.4115.3
Antecedent Placebo113.0115.9

[back to top]

Conners' Adult ADHD Rating Scales (CAARS)

Measures the DSM based ADHD criteria of Inattention and Hyperactivity/Impulsivity. There are 30 items scored 0-3 for a minimum score of 0 (no symptoms) and a maximum score of 90 worst possible symptoms. (NCT00506285)
Timeframe: Double-blind endpoints for MTS and placebo arms

Interventionunits on a scale (Mean)
Scores in MTS Arm30.8
Scores in Placebo Arm49.5

[back to top]

Wender Reimherr Adult Attention Deficit Disorder Scale

This scale measures the 7 domains of the Utah Criteria for Adult ADHD. Total scores run from 0 to 28. Normative samples average below 5. The worst possible score is 28. (NCT00506285)
Timeframe: Double-blind endpoints during MTS and placebo arms

Interventionunits on a scale (Mean)
Scores in MTS Arm11.0
Scores in Placebo Arm17.9

[back to top]

Mean Difference Between Post-Methylphenidate and Post-Placebo Measurement

"The primary endpoint is the fatigue worst score (range: 0 - 10) on the Brief Fatigue Inventory (BFI) at the end of two-week treatment (either Methylphenidate or placebo). Worst fatigue is defined as participants' rating of worst fatigue on a scale of 0 (no fatigue) to 10 (as bad as can imagine). Since each participant is expected to receive both 2-week of Methylphenidate or 2-week placebo at different times, they serve as their own control. The outcome is the difference in fatigue worst score between post-Methylphenidate measurement and post-Placebo measurement." (NCT00516269)
Timeframe: At end of two 2-week treatment cycles (4 weeks total)

Interventionunits on a scale (Mean)
Methylphenidate5.18
Placebo4.76

[back to top]

Duration of Freezing and Shuffling Episodes Between Groups at 12 and 27 Weeks.

Freezing and shuffling are measures of ambulatory impairment. (NCT00526630)
Timeframe: Week 12 and 27

,,
Interventionhours (Mean)
ShufflingFreezing
1. MPD7.673.07
2. Placebo6.153.25
Baseline9.15.4

[back to top]

Montgomery-Åsberg Depression Rating Scale (MADRS) Between Groups at 12 and 27 Weeks.

MADRS is a questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 (NCT00526630)
Timeframe: Week 12 and 27

Interventionunits on a scale (Mean)
1. MPD5.79
2. Placebo6.71
Baseline9.44

[back to top]

The 5-item EuroQoL (EQ-5D) Quality of Life Generic Instrument Between Groups at 12 and 27 Weeks.

The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem; see appendix). A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The range is from 0 to 100, with 100 indicating the best health status. (NCT00526630)
Timeframe: Week 12 and 27

Interventionunits on a scale (Mean)
1. MPD65
2. Placebo63.94
Baseline68.67

[back to top]

The Epworth Sleepiness Scale (ESS) Between Groups at 12 and 27 Weeks

The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire. The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives, though not necessarily every day. The scores for the eight questions are added together to obtain a single number. A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates excessive daytime sleepiness. Higher scores imply worse sleepiness. (NCT00526630)
Timeframe: Week 12 and 27

Interventionunits on a scale (Mean)
1. MPD11.05
2. Placebo10.71
Baseline11.24

[back to top]

The Primary Outcome Measure Was Change in a Gait Stride Length Between Groups at 12 and 27 Weeks.

"Gait stride length is the distance between two consecutive steps in the on state. This will be measured by the GAITRite System, which is an electronic walkway utilized to measure the temporal (timing) and spatial (two dimension geometric position) parameters of its pressure activated sensors." (NCT00526630)
Timeframe: Week 12 and 27

Interventioncentimeters (Mean)
1. MPD107.66
2. Placebo112.29
Baseline103.35

[back to top]

The Primary Outcome Measure Was Change in Gait Velocity Between Groups at 12 and 27 Weeks.

"Gait velocity is a measure of distance over time in the on state. This will be measured by the GAITRite System, which is an electronic walkway utilized to measure the temporal (timing) and spatial (two dimension geometric position) parameters of its pressure activated sensors." (NCT00526630)
Timeframe: Week 12 and 27

Interventioncentimeters/second (Mean)
1. MPD96.96
2. Placebo99.24
Baseline95.76

[back to top]

The Unified Parkinson Disease Rating Scale (UPDRS) Between Groups at 12 and 27 Weeks

Patients will have a mild to severe gait disturbance with score >1 on the motor subscale of the Unified Parkinson's disease rating scale (UPDRS) but without need for a continuous ambulatory aid such as walker or wheelchair (Hoehn & Yahr 2-3). The highest score possible for the UPDRS is 108 which indicates severe motor impairment. The lowest score for the UPDRS is 0 which indicates no motor impairment. (NCT00526630)
Timeframe: At week 12 and 27

Interventionunits on a scale (Mean)
1. MPD21.18
2. Placebo20.33
Baseline18.39

[back to top]

Freezing of Gait Questionnaire (FOGQ) Scores Between Groups at 12 and 27 Weeks.

FOGQ is a questionnaire that quantifies severity of gait and falls. It contains 16 items with a 0-4 severity scale for each, for a range of 0 (normal) to 64 (most severe impairment). (NCT00526630)
Timeframe: Week 12 and 27

Interventionunits on a scale (Mean)
1. MPD12.31
2. Placebo12.56
Baseline12.71

[back to top]

Test of Everyday Attention for Children: Sky Search

The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Sky Search subtest is a measure of selective attention. There is not a finite range of scores on this subtest, but lower scores indicate better performance. (NCT00530257)
Timeframe: 2 weeks

Interventionunits on a scale (Median)
Medication5.8
Placebo4.5

[back to top]

Test of Everyday Attention for Children: Walk, Don't Walk

The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Walk-Don't Walk subtest is a measure of sustained attention and response inhibition. Scores on this subtest can range from 0 to 20 with higher scores representing better performance. (NCT00530257)
Timeframe: 2 weeks

Interventionunits on a scale (Median)
Medication13.5
Placebo11

[back to top]

Wechsler Intelligence Scale for Children-IV, Digit Span Subtest

The verbal assessment of working memory uses the digit span reversed component of the Digit Span subtest of the Wechsler Intelligence Scale for Children-IV edition (WISC-IV).Scores could range from 0 to 16 with higher scores indicating better performance. (NCT00530257)
Timeframe: 2 weeks

Interventionunits on a scale (Median)
Medication5.5
Placebo5.0

[back to top]

ADHD Rating Scale-IV, Parent and Teacher Version

This is the parent and teacher version of the ADHD Rating Scale-IV. The scale has 2 subscales, one for inattention and one for hyperactivity-impulsivity. The scores provided are percentile scores and can range from 1 to 99 percent. Higher scores indicate more problems in inattention or with hyperactivity-impulsivity (NCT00530257)
Timeframe: 2 Weeks

,
InterventionPercentile (Mean)
Parent Inattention RatingParent Hyperactivity-Impulsivity RatingTeacher Inattention RatingTeacher Hyperactivity-Impulsivity Rating
Medication70.664.861.158.1
Placebo92.689.673.375.2

[back to top]

Gordon Diagnostic System Continuous Performance Test

"This is a measure of sustained attention & response inhibition for children 6 yrs and older. During this task a series of numbers flash, one at a time, on a screen. The subject is told to press a button every time a 1 is followed by a 9. There are 45 possible correct responses over the 9-minute task. Omission errors are a measure of sustained attention and can range from 0 to 45. Commission errors are a measure of sustained attention and response inhibition can range from zero to hundreds (each time the button is pushed at the incorrect time). Lower scores indicate better performance." (NCT00530257)
Timeframe: 2 weeks

,
Interventionerrors (Median)
Omission ErrorsCommission Errors
Medication23
Placebo4.510.5

[back to top]

Test of Everyday Attention for Children: Map Mission

The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Map Mission subtest is a measure of selective attention and indicates the number of targets found in one minute. Scores on this subtest can range from 0 to over 70 with higher scores representing improved performance. (NCT00530257)
Timeframe: 2 weeks

Interventionunits on a scale (Median)
Medication27.5
Placebo27

[back to top]

Test of Everyday Attention for Children: Creature Counting

The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Creature Counting subtest is a measure of attentional control. There is not a finite range for this test, but lower scores indicate better performance. (NCT00530257)
Timeframe: 2 weeks

Interventionunits on a scale (Median)
Medication4.9
Placebo4.8

[back to top] [back to top]

Stimulant Side Effect Rating Scale

Parents rate 16 possible stimulant side effects on a 10 point likert scale from 0-9 with 0 indicating no side effects and 9 indicating more severe symptoms. (NCT00530257)
Timeframe: 2 weeks

,
InterventionUnits on a scale (Mean)
InsomniaNightmaresStares/Day DreamsTalks less with othersUninterested in othersDecreased appetiteIrritableStomachachesHeadachesDrowsinessSadProne to CryingAnxietyBites fingernailsEuphoricDizziness
Medication2.80.31.110.83.42.61.50.90.91.62.22.31.30.50.1
Placebo1.20.20.80.40.311.70.50.30.311.41.80.50.30.04

[back to top]

Test of Everyday Attention for Children: Opposite Worlds

The TEA-Ch is a battery of subtests designed to assess multiple attentional capacities in children 6-16y.o. The Opposite Worlds subtest is a measure of attentional control and response inhibition. There is not a finite range of scores on this test. Lower scores indicate better performance.. (NCT00530257)
Timeframe: 2 weeks

Interventionunits on a scale (Median)
Medication38.5
Placebo47.5

[back to top]

Test of Everyday Attention for Children: Score Dual Task (DT)

The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Score DT subtest is a measure of sustained attention. and response inhibition. Scores on this subtest can range from 0 to 20 with higher scores representing better performance. (NCT00530257)
Timeframe: 2 weeks

Interventionunits on a scale (Median)
Medication14
Placebo13

[back to top]

Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit

The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 15 of these items comprise the irritability/agitation/crying factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 45 ( severe behavior problems). (NCT00541346)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Mean)
Baseline: ABC IrritabilityFollow-up: ABC Irritability
Methylphenidate Transdermal System19.89.1

[back to top]

Change in Pediatric Evaluation Disability Inventory (PEDI) Social Function From Baseline to 8-week Follow-up Visit

The PEDI Caregiver Assistance measures rate the child's function in three domains: Self-care, Mobility, and Social Function. Items are scored 0 (total, where the child is completely dependent on assistance) to 5 (independent, where no assistance is given or required). Scale scores represent summed item scores within each domain. The Social-Function scale score ranges from 0 to 25. A higher score indicates a higher degree of independence in the Social-Function area. (NCT00541346)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Mean)
Baseline: PEDI Social FunctionFollow-up: PEDI Social Function
Methylphenidate Transdermal System9.314.9

[back to top]

Change in Pediatric Evaluation Disability Inventory (PEDI) Caregiver Assistance: Self-Care From Baseline to 8-week Follow-up Visit

The PEDI Caregiver Assistance measures rate the child's function in three domains: Self-care, Mobility, and Social Function. Items are scored 0 (total, where the child is completely dependent on assistance) to 5 (independent, where no assistance is given or required). Scale scores represent summed item scores within each domain. The Self-Care scale score ranges from 0 to 40. A higher score indicates a higher degree of independence in the self-care area. (NCT00541346)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Mean)
Baseline: PEDI Self-CareFollow-up: PEDI Self-Care
Methylphenidate Transdermal System28.832.5

[back to top]

Change in Lifetime Participation Scale (LPS) Total Scores From Baseline to 8-week Follow-up Visit

The LPS was developed to capture treatment-related improvements in adaptive functioning including quality of life, social development, and emotion regulation. There are 24 items scored using a 4-point Likert frequency scale (0=Never or Seldom, 1=Sometimes, 2=Often, 3=Very Often). A summed scale score (possible range of 0 to 72) was used in the analyses described below. Higher scores indicate more adaptive functioning. (NCT00541346)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Mean)
Baseline: LPS TotalFollow-up: LPS Total
Methylphenidate Transdermal System26.639.9

[back to top]

Change in Family III General Scale Summed Score From Baseline to 8-week Follow-up Visit

The Family Assessment measure is a self-report instrument that provides quantitative indices of family strengths and weaknesses. Each items is rated 0 (strongly agree) to 3 (strongly disagree). The General scale produces seven subscales: task accomplishment, role performance, communication, affective expression, involvement, control and values and norms. The minimum score for each subscale is 0 while the maximum score is 15. Higher raw scores indicate a higher number of family problems reported. A total summed score of all scale scores was used in the analyses described below. The possible range of this total score was 0 to 105. Like the subscales, higher values for this total summed score indicate a higher number of family problems reported. (NCT00541346)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Mean)
Baseline: FAM-III OverallFollow-up: FAM-III Overall
Methylphenidate Transdermal System55.753.5

[back to top]

Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit

This instrument is a parent rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below. (NCT00541346)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Mean)
Baseline: ADHD-RS-IV Total ScoreFollow-Up: ADHD-RS-IV Total Score
Methylphenidate Transdermal System39.913.8

[back to top]

Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit

The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 7 of these items comprise the stereotypic behavior factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 21 ( severe behavior problems). (NCT00541346)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Mean)
Baseline: ABC StereotypyFollow-up: ABC Stereotypy
Methylphenidate Transdermal System5.61.3

[back to top]

Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit

The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 16 of these items comprise the hyperactivity, noncompliance factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 48 ( severe behavior problems). (NCT00541346)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Mean)
Baseline: ABC HYPERACTIVITYFollow-up: ABC HYPERACTIVITY
Methylphenidate Transdermal System34.111.3

[back to top]

Change in Attention Deficit Hyperactivity Disorder Rating Scale IV: Teacher Assessment Total Scores From Baseline to 8-week Follow-up Visit

This instrument is a teacher rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below. (NCT00541346)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Mean)
Baseline: ADHDRS Teacher TotalFollow-up: ADHDRS Teacher Total
Methylphenidate Transdermal System32.628.0

[back to top]

Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit

The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 16 of these items comprise the lethargy/social withdrawal factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 48 ( severe behavior problems). (NCT00541346)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Mean)
Baseline: ABC LethargyFollow-up: ABC Lethargy
Methylphenidate Transdermal System11.34.5

[back to top]

Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit

The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 4 of these items comprise the lethargy/social withdrawal factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum is 12 ( severe behavior problems). (NCT00541346)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Mean)
Baseline: ABC Inappropriate SpeechFollow-up: ABC Inappropriate Speech
Methylphenidate Transdermal System5.52.1

[back to top]

Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Study

Number of subject who self report no smoking in the last 7 days (7-day point prevalence)at the end of study (week 24) and are biochemically confirmed (expired carbon monoxide <= 8 ppm) (NCT00549640)
Timeframe: 6 months

Interventionparticipants (Number)
Methylphenidate4
Placebo3

[back to top]

Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Treatment.

Number of subject who self report no smoking in the last 7 days (7-day point prevalence)at the end of the medication phase (week 8) and are biochemically confirmed (expired carbon monoxide <= 8 ppm) (NCT00549640)
Timeframe: 8 weeks

Interventionparticipants (Number)
Methylphenidate1
Placebo4

[back to top]

The Change in the Average Nicotine Withdrawal Symptom Score From Baseline to 14 Days Post Target Quit Date.

The average composite nicotine withdrawal score (using Minnesota Nicotine Withdrawal Scale) change from baseline for the first 14 days following target quit date. Scale scores range from 0 (none) to 4 (severe). (NCT00549640)
Timeframe: baseline and 14 days

Interventionunits on a scale (Mean)
Methylphenidate0.28
Placebo0.24

[back to top]

Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent Version)

The Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent:Inv) (Faries, Yalcin, Harder, & Heiligenstein, 2001) is an interviewer-administered semi structured interview with the parent, focusing on the 18 DSM-IV symptoms. Ratings are made on a 0 (never or rarely) to 3 (very often) scale. The range of the ADHDRS-IV is 0-54. A zero (0) scores indicates no ADHD symptoms and 54 indicates most severe ADHD symptoms. The ADHDRS-IV-Parent:Inv provides an overall severity score, symptom count, and ADHD diagnosis for the child. (NCT00550147)
Timeframe: See Arm/Group - repeated measures

Interventionunits on a scale (Mean)
Baseline45.7
Visit 5 - MPH Monotherapy - Week 432.7
Visit 10 - MPH+Quetiapine - Week 1319.4

[back to top]

CGI-S: Clinical Global Improvement Scale

"The CGI-S is a 1-7 investigator rating of overall severity of target behavioral symptoms, which will be completed at each visit as a secondary efficacy measure of global behavioral functioning. A score of 1 indicates normal, not ill at all and a score of 7 indicates among the most extremely ill patients." (NCT00550147)
Timeframe: See Arm/Group - Repeated Measures

Interventionunits on a scale (Mean)
Baseline5.3
Visit 5 - MPH Monotherapy - Week 44.1
Visit 10 - MPH + Quetiapine - Week 132.8

[back to top]

Modified Overt Aggression Scale (MOAS)

"The Modified Overt Aggression Scale (MOAS) is a clinician-rated scale of aggressive outbursts experienced in the past week. Weightings are assigned for severity and frequency of aggression. MOAS total severity score will be completed as a secondary efficacy measure of aggressive behavior. The range for the MOAS is 0-235. A score of 0 indicates no aggression and a score of 235 indicates the most severe and frequent aggressive outbursts." (NCT00550147)
Timeframe: See arm/group - repeated measures

Interventionunits on a scale (Mean)
Baseline229.0
Visit 5 - MPH Monotherapy - Week 473.7
Visit 10 - MPH + Quetiapine - Week 1326.3

[back to top]

RAAPP: Rating of Aggression Against People and/or Property Scale

The RAAPP is a global rating scale of aggression that is completed by a clinician based on interview and observation data. It is scored from 1 (no aggression reported) to 5 (intolerable behavior). (NCT00550147)
Timeframe: See Arm/Group - Repeated Measures

Interventionunits on a scale (Mean)
Baseline4.3
Visit 5 - MPH Monotherapy - Week 43.2
Visit 10 - MPH+Quetiapine - Week 132.0

[back to top]

Swanson, Nolan and Pelham IV (SNAP-IV) Oppositional-Defiant Disorder Subscale

The Swanson, Nolan and Pelham (SNAP-IV) is a 90-item, parent-completed questionnaire consisting of symptoms of ADHD, aggression, depression, and mania. Parents rate each item from 0(not at all) to 3 (very much) based on their child's behavior during the past week. The scores from the Oppositional-Defiant Disorder section of this questionnaire will be used as secondary efficacy measures of parent-reported aggressive behavior. These scores range from 0-24. (NCT00550147)
Timeframe: See arm/group - repeated measures analysis

Interventionunits on a scale (Mean)
Baseline19.0
Visit 5 - MPH Monotherapy - Week 414.5
Visit 10 - MPH+Quetiapine - Week 1310.3

[back to top]

Change From Pre-dose in SKAMP Deportment Score

SKAMP deportment sub-scale is comprised of 6 questions on behavior in the classroom; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 36. (NCT00564954)
Timeframe: 0, 0.5, 1, 2, 4, 6 and 8 hours

,
Interventionscore on a scale (Least Squares Mean)
0.5 hour1 hour2 hours4 hours6 hours8 hours
Dex-methylphenidate Hydrochloride (Focalin XR)0.127-1.863-4.850-4.420-4.614-3.939
Placebo2.2263.1032.8812.5112.3931.969

[back to top]

Change From Pre-dose (0 hr) in SKAMP Combined Score at All Times Excluding the 0.5 Hour Timepoint (Hours 1, 2, 4, 6, 8)

SKAMP rating scale is comprised of 13 questions (7 questions on attention and 6 questions on deportment) evaluating classroom behavior; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78. (NCT00564954)
Timeframe: 0, 1, 2, 4, 6, and 8 hr

,
Interventionscore on a scale (Least Squares Mean)
1 hour2 hours4 hours6 hours8 hours
Dex-methylphenidate Hydrochloride (Focalin XR)-6.358-11.573-11.395-10.622-10.260
Placebo5.6705.4673.9255.3463.621

[back to top]

Change From Pre-dose (0 hr.) in Permanent Product Measure of Performance (PERMP) Math Test-Attempted Scores at All Timepoints (0.5, 1, 2, 4, 6, 8)

Number of math questions attempted within a 10 minute period. (NCT00564954)
Timeframe: 0, 0.5, 1, 2, 4, 6 and 8 hours

,
Interventionquestions attempted (Least Squares Mean)
0.5 hour1 hour2 hours4 hours6 hours8 hours
Dex-methylphenidate Hydrochloride (Focalin XR)6.9333.2645.5245.0137.3344.04
Placebo-4.74-12.18-10.19-7.42-16.70-10.08

[back to top]

Change From Pre-dose (0 hr [Hour]) on the Swanson, Kotkin, Agler, M-Flynn & Pelham (SKAMP) Rating Scale Combined Score at 0.5 Hour During the 8- Hour Laboratory Classroom Day

SKAMP rating scale is comprised of 13 questions (7 questions on attention and 6 questions on deportment) evaluating classroom behavior; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78. (NCT00564954)
Timeframe: 0 hr and 0.5 hr post-dose

Interventionscore on a scale (Least Squares Mean)
Dex-methylphenidate Hydrochloride (Focalin XR)-0.969
Placebo3.336

[back to top]

Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8)

SKAMP attention sub-scale is comprised of 7 questions evaluating concentration in the classroom; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 42. (NCT00564954)
Timeframe: 0, 0.5, 1, 2, 4, 6, and 8 hours

,
Interventionscore on a scale (Least Squares Mean)
0.5 hour1 hour2 hours4 hours6 hours8 hours
Dex-methylphenidate Hydrochloride (Focalin XR)-0.825-4.208-6.591-6.722-5.819-6.061
Placebo0.8622.3042.4651.1832.7151.415

[back to top]

Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test

Number of math questions answered correctly within a 10 minute period. (NCT00564954)
Timeframe: 0, 0.5, 1, 2, 4, 6 and 8 hours

,
Interventionquestions correct (Least Squares Mean)
0.5 hour1 hour2 hours4 hours6 hours8 hours
Dex-methylphenidate Hydrochloride (Focalin XR)7.1031.1044.9243.6437.7843.37
Placebo-5.96-13.21-11.09-7.52-16.90-11.44

[back to top]

The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission.

In the morning of each monitoring day, approximately 60 minutes after medication or placebo pill administration, participants were asked to either abstain from smoking or smoke their first cigarette of the day 5 minutes prior to starting the CPT. (NCT00573859)
Timeframe: 4 days

Interventionerrors (Mean)
ADHD medication + SmokingADHD medication + AbstinencePlacebo + SmokingPlacebo + Abstinence
ADHD Medication Versus Placebo0.401.081.002.8

[back to top]

The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire.

The Shiffman-Jarvik withdrawal questionnaire measures nicotine withdrawal and was completed after each CPT assessment. The questionnaire consists of 25 items using 8-point scales. Total scores range from 0 to 200 and higher scores reflect higher levels of nicotine withdrawal. (NCT00573859)
Timeframe: 4 days

Interventionscores on a scale (Median)
ADHD medication + SmokingADHD medication + AbstinencePlacebo + SmokingPlacebo + Abstinence
ADHD Medication Versus Placebo92.791.397.0102.0

[back to top]

The Effects of ADHD Medication Versus Placebo on Cotinine Levels

Salivary cotinine was measured across two days on ADHD medication versus two days on placebo. (NCT00573859)
Timeframe: 4 days

Interventionng/ml (Mean)
ADHD medicationPlacebo
ADHD Medication Versus Placebo180.7274.0

[back to top]

Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conner's Parent Rating Scale (CPRS: Cognitive Problem T Score)

The Conners' Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-seven questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months (NCT00576472)
Timeframe: From beginning and at completion of home maintenance phase, on average 16.3 months.

InterventionT-score (Mean)
Overall-9.56

[back to top]

Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Parent Rating Scale (CPRS: ADHD T Score)

The Conners' Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-seven questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 and 24.36 months. (NCT00576472)
Timeframe: From beginning and at completion of home maintenance phase, on average 16.3 months.

InterventionT-score (Mean)
Overall-8.74

[back to top]

Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: Cognitive Problem T Score)

The Conners' Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-eight questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months (NCT00576472)
Timeframe: From beginning and at completion of home maintenance phase, on average 16.3 months.

InterventionT-score (Mean)
Overall-3.34

[back to top]

Change From Maintenance Phase Baseline to Completion of Phase as Measured by Social Skill Rating System (SSRS-P)

The Social Skills Rating System- Parent Version (SSRS-P) is a parent rating scale of social behaviors in reference to typically developing children. Thirty eight questions are rated 0 (Never) to 3 (very often). The social skills score is norm-referenced with a mean of 100±15 where a higher score is indicative of better skills. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months (NCT00576472)
Timeframe: From beginning and at completion of home maintenance phase, on average 16.3 months.

InterventionT-score (Mean)
Overall7.99

[back to top]

Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Math: Composite Standard Score

The Wechsler Individual Achievement Test is an examiner administered measure of academic skills. The Math Composite score assesses the child's ability to solve calculation problems (Numerical Operations) and solve applied, word problems (Math Reasoning). Raw scores are converted to standard scores with a mean of 100±15 where higher scores indicate better performance. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months (NCT00576472)
Timeframe: From beginning and after completion of home maintenance phase, on average 16.3 months.

InterventionT-score (Mean)
Overall0.22

[back to top]

Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Reading: Composite Standard Score

The Wechsler Individual Achievement Test is an examiner administered measure of academic skills. The Reading Composite consists of Basic Reading (single word reading) and Reading Comprehension. Raw scores are converted to standard scores with a mean of 100±15 where higher scores indicate better performance. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months (NCT00576472)
Timeframe: From beginning and at completion of home maintenance phase, on average 16.3 months.

InterventionT-score (Mean)
Overall-0.21

[back to top]

Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Spelling: Standard Score

The Wechsler Individual Achievement Test is an examiner administered measure of academic skills. The Spelling score assesses the child's ability to spell words to dictation. Raw scores are converted to standard scores with a mean of 100±15 where higher scores indicate better performance. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months (NCT00576472)
Timeframe: From beginning and after completion of home maintenance phase, on average 16.3 months.

InterventionT-score (Mean)
Overall-2.41

[back to top]

Change From Methylphenidate (MPH) Home Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: ADHD T Score)

The Conners' Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-eight questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Methylphenidate (MPH) Home Maintenance Phase(baseline) and upon completion of the phase. Phase completion ranged between 11.44 and 24.36 months. (NCT00576472)
Timeframe: From beginning and at completion of Methylphenidate (MPH) Home Maintenance Phase, on average 16.3 months.

InterventionT-score (Mean)
Overall-7.17

[back to top]

Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Parent (SSRS-P) - Problem Behavior.

The SSRS assesses social skills for children and adolescents at preschool, elementary and secondary developmental levels. The SSRS is 40 to 57 items, depending on age, completed separately by parents (SSRS-P) and teachers (SSRS-T). Respondents rate the frequency of occurrence for each item ranging from 0 to 2 (0-never, 1-sometimes, 2-very often). The raw scores for the SSRS-P and SSRS-T Social Skills Scales and the SSRS-P and SSRS-T Problem Behaviors Scales have different ranges that are dependent upon age. Raw scores obtained from the SSRS Scales cannot be used to directly interpret social skills or problem behaviors as raw scores vary in meaning based on scale, informant form and developmental level. Raw scores are converted to standard scores with a mean of 100 ± 15. For the Social Skills Scale, a higher score is indicative of better social functioning, and for the Problem Behaviors Scale, a higher score is indicative of greater behavior problems. (NCT00576472)
Timeframe: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.

InterventionEstimated Standard Score (Mean)
Placebo97.4890
Low Dose97.0891
Moderate Dose97.5709

[back to top]

Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Teacher (SSRS-T) - Problem Behavior.

The SSRS assesses social skills for children and adolescents at preschool, elementary and secondary developmental levels. The SSRS is 40 to 57 items, depending on age, completed separately by parents (SSRS-P) and teachers (SSRS-T). Respondents rate the frequency of occurrence for each item ranging from 0 to 2 (0-never, 1-sometimes, 2-very often). The raw scores for the SSRS-P and SSRS-T Social Skills Scales and the SSRS-P and SSRS-T Problem Behaviors Scales have different ranges that are dependent upon age. Raw scores obtained from the SSRS Scales cannot be used to directly interpret social skills or problem behaviors as raw scores vary in meaning based on scale, informant form and developmental level. Raw scores are converted to standard scores with a mean of 100 ± 15. For the Social Skills Scale, a higher score is indicative of better social functioning, and for the Problem Behaviors Scale, a higher score is indicative of greater behavior problems. (NCT00576472)
Timeframe: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.

InterventionEstimated Standard Score (Mean)
Placebo100.6084
Low Dose98.6610
Moderate Dose97.3103

[back to top]

Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Teacher (SSRS-T) - Social Skill.

The SSRS assesses social skills for children and adolescents at preschool, elementary and secondary developmental levels. The SSRS is 40 to 57 items, depending on age, completed separately by parents (SSRS-P) and teachers (SSRS-T). Respondents rate the frequency of occurrence for each item ranging from 0 to 2 (0-never, 1-sometimes, 2-very often). The raw scores for the SSRS-P and SSRS-T Social Skills Scales and the SSRS-P and SSRS-T Problem Behaviors Scales have different ranges that are dependent upon age. Raw scores obtained from the SSRS Scales cannot be used to directly interpret social skills or problem behaviors as raw scores vary in meaning based on scale, informant form and developmental level. Raw scores are converted to standard scores with a mean of 100 ± 15. For the Social Skills Scale, a higher score is indicative of better social functioning, and for the Problem Behaviors Scale, a higher score is indicative of greater behavior problems. (NCT00576472)
Timeframe: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.

InterventionEstimated Standard Score (Mean)
Placebo97.6171
Low Dose100.6957
Moderate Dose102.5281

[back to top]

Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Parent Rating Scale (CPRS) ADHD Index.

The Conners' Parent Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. (NCT00576472)
Timeframe: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.

InterventionEstimated T Score (Mean)
Placebo57.5805
Low Dose54.4226
Moderate Dose53.5317

[back to top]

Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Parent Rating Scale (CPRS) Cognitive Problem/Inattention Scale.

The Conners' Parent Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. (NCT00576472)
Timeframe: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.

InterventionEstimated T Score (Mean)
Placebo57.6595
Low Dose54.6491
Moderate Dose52.9854

[back to top]

Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Parent Rating Scale (CPRS) Hyperactivity Scale.

The Conners' Parent Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. (NCT00576472)
Timeframe: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.

InterventionEstimated T Score (Mean)
Placebo54.2138
Low Dose52.2771
Moderate Dose51.5143

[back to top]

Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Teacher Rating Scale (CTRS) ADHD Index.

The Conners' Teacher Rating Scale-Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. (NCT00576472)
Timeframe: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks

InterventionEstimated T Score (Mean)
Placebo58.7691
Low Dose54.7438
Moderate Dose54.1974

[back to top]

Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Teacher Rating Scale (CTRS) Cognitive Problem/Inattention Scale.

The Conners' Teacher Rating Scale-Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. (NCT00576472)
Timeframe: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.

InterventionEstimated T Score (Mean)
Placebo62.7053
Low Dose59.3272
Moderate Dose59.6638

[back to top]

Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Teacher Rating Scale (CTRS) Hyperactivity Scale.

The Conners' Teacher Rating Scale-Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. (NCT00576472)
Timeframe: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.

InterventionEstimated T Score (Mean)
Placebo55.7638
Low Dose52.1765
Moderate Dose52.6495

[back to top]

Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Color Naming Time.

Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the Stroop Word-Color Association Test (Stroop) to estimate the effectiveness of MPH on laboratory measures of interference, impulsivity, cognitive flexibility, and selective attention. Stroop T scores for Color Naming Time have a mean of 50 and a standard deviation of 10. (NCT00576472)
Timeframe: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.

InterventionEstimated T Score (Mean)
MPH (Methylphenidate)40.7031
Placebo39.8889
MPH Versus Placebo0.8142

[back to top]

Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Ink Color Naming Time.

Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the Stroop Word-Color Association Test (Stroop) to estimate the effectiveness of MPH on laboratory measures of interference, impulsivity, cognitive flexibility, and selective attention. Stroop T scores for Ink Color Naming Time have a mean of 50 and a standard deviation of 10. (NCT00576472)
Timeframe: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.

InterventionEstimated T Score (Mean)
MPH (Methylphenidate)45.1094
Placebo41.7937
MPH Versus Placebo3.3157

[back to top]

Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Interference Score.

Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the Stroop Word-Color Association Test (Stroop) to estimate the effectiveness of MPH on laboratory measures of interference, impulsivity, cognitive flexibility, and selective attention. Stroop T scores for Interference Score have a mean of 50 and a standard deviation of 10. (NCT00576472)
Timeframe: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.

InterventionEstimated T Score (Mean)
MPH (Methylphenidate)52.6875
Placebo50.6349
MPH Versus Placebo2.0526

[back to top]

Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Word Naming Time.

Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the Stroop Word-Color Association Test (Stroop) to estimate the effectiveness of MPH on laboratory measures of interference, impulsivity, cognitive flexibility, and selective attention. Stroop T scores for Word Naming Time have a mean of 50 and a standard deviation of 10. (NCT00576472)
Timeframe: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.

InterventionEstimated T Score (Mean)
MPH (Methylphenidate)39.0156
Placebo37.8571
MPH Versus Placebo1.1585

[back to top]

Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) for Long Delay Free Recall.

Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the California Verbal Learning Test (CVLT) to estimate the effectiveness of MPH on laboratory measures of learning and recall. CVLT Z Score for Long Delay Free Recall has a mean of 0 and a standard deviation of 1. (NCT00576472)
Timeframe: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.

InterventionEstimated Z Score (Mean)
MPH (Methylphenidate)-0.3692
Placebo-0.2090
MPH Versus Placebo-0.1603

[back to top]

Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) for Short Delay Free Recall.

Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the California Verbal Learning Test (CVLT) to estimate the effectiveness of MPH on laboratory measures of learning and recall. CVLT Z Score for Short Delay Free Recall has a mean of 0 and a standard deviation of 1. (NCT00576472)
Timeframe: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.

InterventionEstimated Z Score (Mean)
MPH (Methylphenidate)-0.3636
Placebo-0.3358
MPH Versus Placebo-0.0278

[back to top]

Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) Over Five Learning Trials.

Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the California Verbal Learning Test (CVLT) to estimate the effectiveness of MPH on laboratory measures of learning and recall. CVLT Trials 1-5 have a mean T Score of 50 and Standard Deviation of 10. (NCT00576472)
Timeframe: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.

InterventionEstimated T Score (Mean)
MPH (Methylphenidate)44.6970
Placebo45.9403
MPH Versus Placebo-1.2433

[back to top]

Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Commission Errors.

Change in raw scores for the shortened version of the Conner's CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners' CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners' CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. Commission errors are the raw score for the numbers of nontargets presented where the subject incorrectly responded. Accordingly, the range for this variable is 0-6 with a higher score indicative of worse performance or impulsivity. (NCT00576472)
Timeframe: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.

InterventionEstimated raw score (Mean)
MPH (Methylphenidate)3.6984
Placebo3.5970
MPH Versus Placebo0.1014

[back to top]

Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for d' (Sensitivity).

Change in raw scores for the shortened version of the Conner's CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners' CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners' CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. D' and β are derived variables from signal detection theory. D' is a measure of sensitivity of a person to the signal or target; a higher score is indicative of better performance or better sustained attention. D' was calculated as z(hit) - z(commission). Z-scores were calculated using the NORMSINV function in Microsoft Excel. (NCT00576472)
Timeframe: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.

InterventionEstimated raw score (Mean)
MPH (Methylphenidate)1.6809
Placebo1.7972
MPH Versus Placebo-0.1163

[back to top]

Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Hit Reaction Time.

Change in raw scores for the shortened version of the Conner's CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners' CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners' CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. Hit reaction time is average reaction time in milliseconds for all correct responses when targets were presented. There is no pre-defined range for reaction time; higher score is indicative of slower processing speed. (NCT00576472)
Timeframe: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.

InterventionEstimated raw score (Mean)
MPH (Methylphenidate)350.0590
Placebo354.8515
MPH Versus Placebo-4.7925

[back to top]

Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Omission Errors.

Change in raw scores for the shortened version of the Conner's CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners' CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners' CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. Omission errors are the raw score for the number of targets presented where the subject did not respond. Accordingly, the range for this variable is 0-54 with a higher score indicative of worse performance or problems with sustained attention. (NCT00576472)
Timeframe: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.

InterventionEstimated raw score (Mean)
MPH (Methylphenidate)1.8889
Placebo1.6269
MPH Versus Placebo0.2620

[back to top]

Best Weekly Score Measured by Conners' Parent Rating Scale (CPRS: ADHD T Score) During the 3-week Home Crossover Phase.

The Conners' Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-seven questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were done weekly during the 3-week Home Crossover Period with the best response being used as the measurement for the test. (NCT00576472)
Timeframe: weekly during 3-week home crossover phase

,,
InterventionT score (Mean)
Oppositional T ScoreCognitive Problems/Inattention T ScoreHyperactivity T ScoreAdhd T Score
Low Dose50.8753.1451.1453.08
Moderate Dose50.4451.7250.6352.23
Placebo49.4955.6451.9655.45

[back to top]

Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Beta (Risk Taking).

Change in raw scores for the shortened version of the Conner's CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners' CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners' CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. D' and β are derived variables from signal detection theory. β is a measure of response tendency; higher scores indicate a more conservative response pattern. β was calculated using the formula = -d'*.5*(NORMSINV(hits)-NORMSINV(false alarms)). In the case where the false alarm rate = 0 or the hit rate = 1.0, we used the standard correction of 1/2N and 1- 1/2N, respectively. (NCT00576472)
Timeframe: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.

InterventionEstimated raw score (Mean)
MPH (Methylphenidate)0.2300
Placebo0.2647
MPH Versus Placebo-0.0346

[back to top]

Brain White Matter Volume for Patients Versus Sibling Controls

To compare the white matter volume of patients with those of sibling controls using MRI results captured between -1.8 and 42.36 months from study enrollment. Existing MRIs very close to enrollment were permissable for inclusion in this study. (NCT00576472)
Timeframe: Enrollment to evaluation of MRI, on average 12.8 months.

Interventionpercentage (Mean)
Patients27
Siblings30.3

[back to top]

Brain White Matter Volume for Patients With Acute Lymphoblastic Leukemia Versus Brain Tumors

To compare the white matter volume of Acute Lymphoblastic Leukemia (ALL) patients with those of patients with malignant brain tumors using MRI results captured between -1.8 and 42.36 months from study enrollment. Existing MRIs very close to enrollment were permissable for inclusion in this study. (NCT00576472)
Timeframe: Enrollment to evaluation of MRI, on average 12.8 months.

Interventionpercentage (Mean)
Patients With ALL28.4
Patients With Brain Tumors25.5

[back to top]

Brain White Matter Volume for Treatment Intensity Groups and Sibling Controls

To compare the white matter volume of patients by treatment intensity groups (mild, moderate, and high) and sibling controls using MRI results captured between -1.8 and 42.36 months from study enrollment. Existing MRIs very close to enrollment were permissable for inclusion in this study. (NCT00576472)
Timeframe: Enrollment to evaluation of MRI, on average 12.8 months.

Interventionpercentage (Mean)
Siblings30.3
Mild Treatment Intensity28.8
Moderate Treatment Intensity25.9
High Treatment Intensity25.4

[back to top]

Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Parent (SSRS-P) - Social Skill.

The SSRS assesses social skills for children and adolescents at preschool, elementary and secondary developmental levels. The SSRS is 40 to 57 items, depending on age, completed separately by parents (SSRS-P) and teachers (SSRS-T). Respondents rate the frequency of occurrence for each item ranging from 0 to 2 (0-never, 1-sometimes, 2-very often). The raw scores for the SSRS-P and SSRS-T Social Skills Scales and the SSRS-P and SSRS-T Problem Behaviors Scales have different ranges that are dependent upon age. Raw scores obtained from the SSRS Scales cannot be used to directly interpret social skills or problem behaviors as raw scores vary in meaning based on scale, informant form and developmental level. Raw scores are converted to standard scores with a mean of 100 ± 15. For the Social Skills Scale, a higher score is indicative of better social functioning, and for the Problem Behaviors Scale, a higher score is indicative of greater behavior problems. (NCT00576472)
Timeframe: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.

InterventionEstimated Standard Score (Mean)
Placebo99.4412
Low Dose101.5457
Moderate Dose101.8999

[back to top]

Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)

The primary outcome was the ADHD rating scale. Change scores for the ADHD Rating Scale (RS), from baseline to endpoint (week 7 or last observation carried forward), were analyzed with paired t-tests and nonparametric Wilcoxon sign-rank tests. The best score is a score of 0 (no ADHD symptoms) and the worst score is the highest score possible (54). (NCT00585910)
Timeframe: 7 weeks

InterventionUnits on a Scale (Mean)
Overall Study12.8

[back to top]

Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders

Secondary analyses allowed us to evaluate the effects of treatment on additional measures of functioning (CGIs for ADHD and other psychiatric disorders). The CGI-Severity scale is as follows: 0 = Not assessed, 1 = normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately Ill, 5 = Markedly Ill, 6 = Severely Ill, 7 = Among the most extremely ill patients. (NCT00585910)
Timeframe: 7 weeks

InterventionUnits on a Scale (Mean)
Overall Study2.7

[back to top]

Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires

"The questionnaire includes two a sections, a clinician rated 20-item scale and a 14-item self-report section completed collaboratively by child and parent/guardian.~Units on the clinician rated scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. Units on the self-report section ranged from 0-2 on a scale of severity, with 0 being the least severe item score and 2 being the most severe. The possible range of scores for the questionnaire is 88" (NCT00586157)
Timeframe: Baseline and 4 weeks

InterventionUnits on a scale (Mean)
MTS (Drug A)12.76
Placebo31.37

[back to top]

Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM.

Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe). (NCT00586157)
Timeframe: Baseline and 4 weeks

InterventionUnits on a scale (Mean)
MTS (Drug A)10.03
Placebo23.22

[back to top]

Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day.

Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe). (NCT00586157)
Timeframe: Baseline and 4 weeks

InterventionUnits on a scale (Mean)
MTS (Drug A)14.76
Placebo28.33

[back to top]

H MRS Scan Results - Glutamate & Glutamine (Glx)/Ino

"Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)~This measure is a ratio of Glutamate and it's precursor, Glutamine, to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate." (NCT00593112)
Timeframe: after 6 weeks Concerta treatment

InterventionMRS Ratio (Mean)
OROS Methylphenidate2.58
Control2.59

[back to top]

H MRS Scan Results - Glutamine (Gln)/Ino

"Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)~This measure is a ratio of Glutamine (amino acid precursor to Glu) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate." (NCT00593112)
Timeframe: after 6 weeks Concerta treatment

InterventionMRS Ratios (Mean)
OROS Methylphenidate1.08
Control1.02

[back to top]

Proton Magnetic Resonance Spectroscopy (H MRS) Scan Results - Glutamate(Glu)/Myo-inositol-containing Compounds (Ino)

"Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)~This measure is a ratio of Glutamate (excitatory neurotransmitter) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate." (NCT00593112)
Timeframe: after 6 weeks Concerta treatment

InterventionMRS Ratio (Mean)
OROS Methylphenidate1.50
Control1.56

[back to top]

Hamilton Depression Rating Scale (HDRS) Maintained Scores at Week 16

The Hamilton Depression Rating Scale (HDRS) is a 24-item depression scale and the total score is summed with a minimum score=0 and maximum score=76. There are no subscales and the higher values represent a worse outcome. Outcomes are measured and defined as follows: 1) Response will be defined as HDRS scores of 10 or less; 2) Sustained response will be defined as maintained response at week 16; 4) Remission will be defined as HDRS scores of 6 or less. (NCT00602290)
Timeframe: Maintained response measured at Week 16

Interventionunits on a scale (Mean)
1 - Citalopram + Placebo18.3
2 - Methylphenidate + Placebo18.7
3 - Methylphenidate + Citalopram19.8

[back to top]

Quality of Life Assessment

The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item self-administered questionnaire that captures life satisfaction over the past week. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). The total score is reported for items 1-14. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70 with higher values representing a better outcome. (NCT00602290)
Timeframe: Measured at Baseline and Week 16

,,
Interventionunits on a scale (Mean)
BaselineWeek 16
1 - Citalopram + Placebo45.5054.45
2 - Methylphenidate + Placebo47.0653.54
3 - Methylphenidate + Citalopram47.5257.79

[back to top]

Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS)

The primary endpoint was the change in the ADHD symptoms total score of the investigator-rated CAARS from baseline to the last assessment in the double-blind treatment period. CAARS assesses ADHD symptoms and behaviors in adults using a scale ranging from 0 (best) to 54 (worst). For subjects without a post-baseline efficacy measurement, a change of 0 units was imputed. (NCT00714688)
Timeframe: from baseline to 13 weeks

,,
Interventionunits on a scale (Mean)
BaselineEndpointChange at Endpoint
54 mg PR OROS MPH35.623.0-12.5
72 mg PR OROS MPH37.321.6-15.7
Placebo36.526.1-10.4

[back to top]

Change in Clinical Global Impression-Severity (CGI-S) From Baseline to End of Treatment

The CGI-S rating scale is used to rate the severity of a subject's illness on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe illness). The change in CGI-S was assessed from baseline to end of treatment (week 13 or or last post-baseline assessment) (NCT00714688)
Timeframe: from baseline to13 weeks

Interventionunits on a scale (Median)
Placebo0.0
54 mg PR OROS MPH-1.0
72 mg PR OROS MPH-1.0

[back to top]

Clinical Global Impression-Change (CGI-C)

The CGI-C rating scale is used to rate the change in severity of the subject's illness compared to baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00714688)
Timeframe: 13 weeks

Interventionunits on a scale (Median)
Placebo3.0
54 mg PR OROS MPH2.5
72 mg PR OROS MPH2.0

[back to top]

Change in Conners Adult ADHD Rating Scale Self Report Short Version (CAARS-S:S) Total Score

The CAARS-S:S is a 26-item self-report scale that measures symptoms based on the DSM-IV criteria for ADHD. Respondents were asked to rate items pertaining to their behavior/problems using the following 4-point scale (from 0 = Not at all, never; to 3 = Very much, very frequently). The CAARS-S:S total score range is from 0 (best) to 78 (worse). The change in CAARS-S:S was assessed from baseline to end of treatment (week 13 or or last post-baseline assessment) (NCT00714688)
Timeframe: from baseline to 13 weeks

Interventionunits on a scale (Mean)
Placebo-8.5
54 mg PR OROS MPH-12.8
72 mg PR OROS MPH-12.6

[back to top]

Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)

Motor evoked potential (MEP) amplitudes were measured prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2), and 60 minutes after the treatment (post-training 3).The MEP is elicited by transcranial magnetic stimulation (TMS) at increased intensity. Its amplitude is measured from peak to peak and expressed in millivolts (mV). Measured MEP amplitudes were plotted against the intensity to create a stimulus response curve (SRC). SRCs were modeled by a 3- parameter sigmoid function and MEPmax was extracted. Long-lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning. (NCT00715520)
Timeframe: Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)

InterventionmV (Mean)
Baseline Placebo - MEPmaxPost-Training 1 Placebo - MEPmaxPost-Training 2 Placebo - MEPmaxBaseline - Amphetamine Sulfate - MEPmaxPost-Training 1 Ampletamine Sulfate - MEPmaxPost-Training 2 Amphetamine Sulfate - MEPmaxBaseline Methylphenidate - MEPmaxPost-Training 1 Methylphenidate - MEPmaxPost-Training 2 Methylphenidate - MEPmaxBaseline Carbidopa-Levodopa - MEPmaxPost-Training 1 Carbidopa-Levodopa - MEPmaxPost-Training 2 Carbidopa-Levodopa - MEPmax
Aim 11.011.631.29.731.221.081.041.101.221.811.411.53

[back to top]

Aim 1: Mean Peak Acceleration of Wrist Extension Movements

Mean peak acceleration was measured across study drug conditions prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface. (NCT00715520)
Timeframe: Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)

Interventiong (Mean)
Baseline - PlaceboPost-Training 1 - PlaceboPost-Training 2 - PlaceboBaseline - Amphetamine SulfatePost-Training 1 - Amphetamine SulfatePost-Training 2 - Amphetamine SulfateBaseline - MethylphenidatePost-Training 1 - MethylphenidatePost-Training 2 - MethylphenidateBaseline - Carbidopa-LevodopaPost-Training 1 - Carbidopa-LevodopaPost-Training 2 - Carbidopa-Levodopa
Aim 11.321.331.241.241.281.291.351.271.221.221.231.37

[back to top]

Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency

Mean peak acceleration for the different frequencies of rTMS treatment (placebo, 0.1 Hz, 0.25 Hz, 0.5 Hz) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface. (NCT00715520)
Timeframe: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)

Interventiong (Mean)
Baseline - PlaceboPost-Training 1 - PlaceboPost-Training 2 - PlaceboPost-Training 3 - PlaceboBaseline - .1 HzPost-Training 1 - .1 HzPost-Training 2 - .1 HzPost-Training 3 - .1 HzBaseline - .25 HzPost-Training 1 - .25 HzPost-Training 2 - .25 HzPost-Training 3 - .25 HzBaseline - .5 HzPost-Training 1 - .5 HzPost-Training 2 - .5 HzPost-Training 3 - .5 Hz
Aim 21.441.361.351.331.331.431.501.531.381.351.401.341.321.291.251.29

[back to top]

Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse

Mean peak acceleration of wrist movements for repeated TMS (rTMS) conditions with respect of the TMS pulse (-100, +300, placebo, zero) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface. (NCT00715520)
Timeframe: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)

Interventiong (Mean)
Baseline - Pulse (zero)Post-Training 1 - Pulse (zero)Post-Training 2 - Pulse (zero)Post-Training 3 - Pulse (zero)Baseline - Pulse (placebo)Post-Training 1 - Pulse (placebo)Post-Training 2 - Pulse (placebo)Post-Training 3 - Pulse (placebo)Baseline - Pulse (-100)Post-Training 1 - Pulse (-100)Post-Training 2 - Pulse (-100)Post-Training 3 - Pulse (-100)Baseline - Pulse (+300)Post-Training 1 - Pulse (+300)Post-Training 2 - Pulse (+300)Post-Training 3 - Pulse (+300)
Aim 21.331.431.511.531.441.361.351.331.511.51.461.471.401.321.381.40

[back to top]

Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency

Mean sum of normalized MEP for the different frequencies of rTMS treatment (placebo at 0.1 Hz, 0.1 Hz, 0.25 Hz, 0.5 Hz) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. (NCT00715520)
Timeframe: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)

Interventionmillivolts (Mean)
Baseline - PlaceboPost-Training 1 - PlaceboPost-Training 2 - PlaceboPost-Training 3 - PlaceboBaseline - .1 HzPost-Training 1 - .1 HzPost-Training 2 - .1 HzPost-Training 3 - .1 HzBaseline - .25 HzPost-Training 1 - .25 HzPost-Training 2 - .25 HzPost-Training 3 - .25 HzBaseline - .5 HzPost-Training 1 - .5 HzPost-Training 2 - .5 HzPost-Training 3 - .5 Hz
Aim 2.67.93.941.02.711.061.061.14.67.90.90.98.64.92.90.84

[back to top]

Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse

Mean sum of normalized MEP for repeated TMS (rTMS) conditions with respect to the pulse (-100, +300, placebo, zero) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Its amplitude is measured from peak to peak and expressed in mV. Long- lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning. (NCT00715520)
Timeframe: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)

Interventionmillivolts (Mean)
Baseline - Pulse (zero)Post-Training 1 - Pulse (zero)Post-Training 2 - Pulse (zero)Post-Training 3 - Pulse (zero)Baseline - Pulse (placebo)Post-Training 1 - Pulse (placebo)Post-Training 2 - Pulse (placebo)Post-Training 3 - Pulse (placebo)Baseline - Pulse (-100)Post-Training 1 - Pulse (-100)Post-Training 2 - Pulse (-100)Post-Training 3 - Pulse (-100)Baseline - Pulse (+300)Post-Training 1 - Pulse (+300)Post-Training 2 - Pulse (+300)Post-Training 3 - Pulse (+300)
Aim 2.39.66.63.69.40.54.51.52.39.56.60.61.38.54.48.51

[back to top]

Change in Children's Global Assessment Scale (CGAS) Score

This measures the change in the subject's global assessment of functioning as rated by the clinician. This Children's Global Assessment Scale (CGAS) is rated on a 0-100 scale (refer to baseline information). The change in this score is the difference between the score at baseline to end point. The greater the change score, the more improvement has been observed. (NCT00754208)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
Group 19.9

[back to top]

Change in Clinical Global Impression-Severity

Change in global rating of severity of ADHD symptoms. CGI severity is rated on a scale of 1 to 6 (normal to severely ill; refer to description in baseline information). The change in the severity rating reflects the change in this score from baseline to endpoint. The greater the reduction in score the more improvement has been observed. (NCT00754208)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
Group 1-2.4

[back to top]

Change in Attention Deficit Hyperactivity Disorder Rating Scale-IV Parent Version Investigator-Scored (ADHD-IV-Parent: Inv) Total Score.

Change from baseline to endpoint of investigator-scored, parent version of the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-IV rating scale). The ADHD-IV contains 18 items, and each item is rated 0, 1, 2 or 3. Minimum score is 0. Maximum score is 54. Change in score represents the difference between the total score at end point compared to the total score at baseline. Higher scores indicate greater symptom severity. (NCT00754208)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
Group 1-20.1

[back to top]

Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4

The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants' psychological problems (0-2=normal; 3-4=minor; 5-6=moderate; and 7-12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 4 minus mean CHQ score at Baseline. (NCT00758160)
Timeframe: Baseline and Week 4

InterventionUnits on a scale (Mean)
Baseline: Mother Assessment (n = 275)Baseline: Father Assessment (n = 216)Change at Week 4: Mother Assessment (n = 275)Change at Week 4: Father Assessment (n = 216)
OROS MPH1.91.7-0.10

[back to top]

Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score

Parents of the participants were asked to assess the Family APGAR which is a 5-item questionnaire designed to assess the 5 dimensions of perceived family support: Adaptation, Partnership, Growth, Affection, and Resolve. Each item is rated on a 3-point scale ranging from 0 to 2 where 0=hardly ever, 1=some of the time and 2=almost always. The total score ranges from 0 to 10 with greater scores indicating greater family support. (NCT00758160)
Timeframe: Baseline, Week 4 and 8

InterventionUnits on a scale (Mean)
Baseline: Mother Assessment (n = 275)Baseline: Father Assessment (n = 216)Week 4: Mother Assessment (n = 280)Week 4: Father Assessment (n = 223)Week 8: Mother Assessment (n = 281)Week 8: Father Assessment (n = 226)
OROS MPH6.46.56.66.76.56.6

[back to top]

Clinical Global Impression-Severity (CGI-S) Score

CGI-ADHD-S is a single item assessment of the global severity of ADHD symptoms in relation to the clinician's total experience after reviewing all the returned questionnaires and clinical assessment of participants' behavioral symptoms. Severity is rated on a 7-point scale ranging from 1 to 7 with 1=normal (not at all ill) and 7=most extremely ill. (NCT00758160)
Timeframe: Baseline, Week 2, 4 and 8

InterventionUnits on a scale (Mean)
Baseline (n = 290)Week 2 (n = 291)Week 4 (n = 291)Week 8 (n = 292)
OROS MPH4.33.53.13.0

[back to top]

Global Assessment of Satisfaction by Parents/Caregivers

Parents/caregivers were asked to assess the satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied, and 5=completely satisfied. (NCT00758160)
Timeframe: Baseline, Week 2, 4 and 8

InterventionUnits on a scale (Mean)
Baseline (n = 290)Week 2 (n = 291)Week 4 (n = 291)Week 8 (n = 291)
OROS MPH3.13.43.73.6

[back to top]

Global Assessment of Satisfaction by Participant

Participants were asked to assess their satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied and 5=completely satisfied. (NCT00758160)
Timeframe: Baseline, Week 2, 4 and 8

InterventionUnits on a scale (Mean)
Baseline (n = 290)Week 2 (n = 291)Week 4 (n = 291)Week 8 (n = 291)
OROS MPH3.23.53.73.6

[back to top]

Social Adjustment Scale Score for Children and Adolescents (SAICA)

SAICA is a 77-item semi-structured interview scale designed for administration to school-aged children with age 6-18 years, or to their parents about their children. SAICA provides an evaluation of children's current functioning in the domains of school, spare time, peer relations, and home behaviors. Each item ranged on a 4-point likert scale ranging from 1 to 4 with a higher mean score indicating either poorer social function or a more severe social problem. (NCT00758160)
Timeframe: Baseline, Week 4 and Week 8

InterventionUnits on a scale (Mean)
Baseline (n = 151)Week 4 (n = 160)Week 8 (n = 165)
OROS MPH1.51.81.8

[back to top]

Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8

The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants' psychological problems (0-2=normal; 3-4=minor; 5-6=moderate; and 7-12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 8 minus mean CHQ score at Baseline. (NCT00758160)
Timeframe: Baseline and Week 8

InterventionUnits on a scale (Mean)
Change at Week 8: Mother Assessment (n = 275)Change at Week 8: Father Assessment (n = 216)
OROS MPH-0.10

[back to top]

Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4

Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 4 minus mean SNAP-IV score at Baseline. (NCT00758160)
Timeframe: Baseline and Week 4

InterventionUnits on a scale (Mean)
Change at Week 4: Inattention (n = 293)Change at Week 4: Hyperactivity (n = 293)Change at Week 4: Oppositional (n = 296)
OROS MPH-0.4-0.3-0.3

[back to top]

Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8

Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 8 minus mean SNAP-IV score at Baseline. (NCT00758160)
Timeframe: Baseline and Week 8

InterventionUnits on a scale (Mean)
Change at Week 8: Inattention (n = 293)Change at Week 8: Hyperactivity (n = 293)Change at Week 8: Oppositional (n = 296)
OROS MPH-0.5-0.4-0.4

[back to top]

Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score

CGI-I is a single item assessment of the global improvement of ADHD symptoms in relation to the clinician's total experience after reviewing all the returned questionnaires and clinical assessment of participants' behavioral symptoms. Improvement is rated on a 7-point scale (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse). (NCT00758160)
Timeframe: Baseline, Week 2, 4 and 8

InterventionParticipants (Number)
Week 2: Very much improved (n = 292)Week 2: Much improved (n = 292)Week 2: Minimally improved (n = 292)Week 2: No change (n = 292)Week 2: Minimally worse (n = 292)Week 2: Much worse (n = 292)Week 2: Very much worse (n = 292)Week 4: Very much improved (n = 262)Week 4: Much improved (n = 262)Week 4: Minimally improved (n = 262)Week 4: No change (n = 262)Week 4: Minimally worse (n = 262)Week 4: Much worse (n = 262)Week 4: Very much worse (n = 262)Week 8: Very much improved (n = 282)Week 8: Much improved (n = 282)Week 8: Minimally improved (n = 282)Week 8: No change (n = 282)Week 8: Minimally worse (n = 282)Week 8: Much worse (n = 282)Week 8: Very much worse (n = 282)
OROS MPH49812645162115111962710301612991281341

[back to top]

Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score

Teachers were asked to assess the children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. (NCT00758160)
Timeframe: Baseline, Week 2, 4 and 8

InterventionUnits on a scale (Mean)
Baseline: Inattention (n = 281)Baseline:Hyperactivity (n = 285)Baseline: Oppositional (n = 283)Week 2: Inattention (n = 286)Week 2: Hyperactivity (n = 287)Week 2: Oppositional (n = 286)Week 4: Inattention (n = 287)Week 4: Hyperactivity (n = 288)Week 4: Oppositional (n = 287)Week 8: Inattention (n = 287)Week 8: Hyperactivity (n = 288)Week 8: Oppositional (n = 287)
OROS MPH1.51.10.91.30.90.71.20.90.71.10.80.7

[back to top]

Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2

Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 2 minus mean SNAP-IV score at Baseline. (NCT00758160)
Timeframe: Baseline and Week 2

InterventionUnits on a scale (Mean)
Baseline: Inattention (n = 293)Baseline: Hyperactivity (n = 293)Baseline: Oppositional (n = 296)Change at Week 2: Inattention (n = 293)Change at Week 2: Hyperactivity (n = 293)Change at Week 2: Oppositional (n = 296)
OROS MPH1.71.41.3-0.4-0.3-0.3

[back to top]

Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks

HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status. (NCT00763971)
Timeframe: Baseline and up to 7 weeks

,,
InterventionScores on a scale (Mean)
BaselineUp to 7 weeks
Lisdexamfetamine Dimesylate (LDX)0.8110.878
Methylphenidate Hydrochloride0.8220.887
Placebo0.8060.843

[back to top]

Columbia-Suicide Severity Rating Scale (C-SSRS)

C-SSRS is a 19-item semi-structured interview designed to capture suicide-related thoughts and behaviors. (NCT00763971)
Timeframe: Up to 7 weeks

,,
Interventionparticipants (Number)
Suicidal ideationNon-suicidal self injurious behavior
Lisdexamfetamine Dimesylate (LDX)11
Methylphenidate Hydrochloride00
Placebo00

[back to top]

Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks

The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology. (NCT00763971)
Timeframe: Baseline and up to 7 weeks

InterventionScores on a scale (Least Squares Mean)
Lisdexamfetamine Dimesylate (LDX)-24.3
Methylphenidate Hydrochloride-18.7
Placebo-5.7

[back to top]

Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 Weeks

The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology. (NCT00763971)
Timeframe: Baseline and up to 7 weeks

InterventionScores on a scale (Mean)
Lisdexamfetamine Dimesylate (LDX)-9.15
Methylphenidate Hydrochloride-9.71
Placebo-2.59

[back to top]

Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks

The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior. (NCT00763971)
Timeframe: Baseline and up to 7 weeks

InterventionScores on a scale (Least Squares Mean)
Lisdexamfetamine Dimesylate (LDX)-24.5
Methylphenidate Hydrochloride-18.4
Placebo-3.2

[back to top]

Change From Baseline in the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks

The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health. (NCT00763971)
Timeframe: Baseline and up to 7 weeks

InterventionT-scores (Least Squares Mean)
Lisdexamfetamine Dimesylate (LDX)8.6
Methylphenidate Hydrochloride7.1
Placebo-0.2

[back to top]

Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 Weeks

The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment. (NCT00763971)
Timeframe: Baseline and up to 7 weeks

InterventionScores on a scale (Least Squares Mean)
Lisdexamfetamine Dimesylate (LDX)-0.3
Methylphenidate Hydrochloride-0.3
Placebo0.0

[back to top]

Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores

Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. (NCT00763971)
Timeframe: Up to 7 weeks

Interventionpercentage of participants (Number)
Lisdexamfetamine Dimesylate (LDX)78.0
Methylphenidate Hydrochloride60.6
Placebo14.4

[back to top]

Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Attention Score at 10, 11, and 12 Hour (Averaged) Post-dose

SKAMP is a 13-item rating scale consisting of 2 subscales (7-items for Attention and 6-items for Deportment) that measures classroom manifestations of ADHD. SKAMP was used to generate a score on the Attention subscale at Hours 10, 11, and 12 on Day 7 of Weeks 1, 2, and 3. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 42 for the Attention subscale. The reported measure is the difference from baseline of the subscore averaged over Hours 10, 11, and 12. A negative score indicates improvement. (NCT00776009)
Timeframe: Pre-dose to 10, 11, and 12 hours post-dose

InterventionScores on a scale (Least Squares Mean)
Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg-1.33
Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg-2.62
Placebo0.94

[back to top]

Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Correctly Answered Score at 10, 11, and 12 Hours (Averaged) Post-dose

"Permanent Product Measure of Performance of Measurement (PERMP) is an age-adjusted, paper-and-pencil math test consisting of 5 pages of 80 math problems each presented in ascending order of difficulty (requiring addition, subtraction, multiplication, and division computations, respectively) during a 10-minute time period. At the end of the 10-minute math test, papers are collected and scored; the number of problems attempted and the number of problems correctly answered are generated as objective measures related to academic productivity. A positive score indicates improvement." (NCT00776009)
Timeframe: Pre-dose to 10, 11, and 12 hours post-dose

InterventionNumber correct (Least Squares Mean)
Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg18.45
Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg28.02
Placebo-4.30

[back to top]

Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Attempted Score at 10, 11, and 12 Hours (Averaged) Post-dose

"Permanent Product Measure of Performance of Measurement (PERMP) is an age-adjusted, paper-and-pencil math test consisting of 5 pages of 80 math problems each presented in ascending order of difficulty (requiring addition, subtraction, multiplication, and division computations, respectively) during a 10-minute time period. At the end of the 10-minute math test, papers are collected and scored; the number of problems attempted and the number of problems correctly answered are generated as objective measures related to academic productivity. A positive score indicates improvement." (NCT00776009)
Timeframe: Pre-dose to 10, 11, and 12 hours post-dose

InterventionNumber attempted (Least Squares Mean)
Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg18.76
Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg28.03
Placebo-0.23

[back to top]

Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose

SKAMP is a 13-item rating scale that measures classroom manifestations of ADHD consisting of 2 subscales (7 items for Attention and 6 items for Deportment) used to generate a score at Hours 10, 11 and 12 on Day 7 of Weeks 1, 2 and 3. The ratings were based on both frequency and quality of specific behaviors. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78. The reported measure is the difference from baseline of the 2 combined subscores averaged over Hours 10, 11 and 12. A negative score indicates improvement. (NCT00776009)
Timeframe: Pre-dose to 10, 11, and 12 hours post-dose

InterventionScores on a scale (Least Squares Mean)
Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg-2.02
Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg-4.47
Placebo4.50

[back to top]

Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Deportment Score at 10, 11, and 12 Hour (Averaged) Post-dose

SKAMP is a 13-item rating scale consisting of 2 subscales (7-items for Attention and 6-items for Deportment) that measures classroom manifestations of ADHD. SKAMP was used to generate a score on the Deportment subscale at Hours 10, 11, and 12 on Day 7 of Weeks 1, 2, and 3. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 36 for the Deportment subscale. The reported measure is the difference from baseline of the subscore averaged over Hours 10, 11, and 12. A negative score indicates improvement. (NCT00776009)
Timeframe: Pre-dose to 10, 11, and 12 hours post-dose

InterventionScores on a scale (Least Squares Mean)
Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg-0.39
Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg-1.49
Placebo2.95

[back to top]

Brain Oxygenation Level Dependent Signal in the Fusiform Gyrus and the Amygdala on Concerta vs. Placebo

Each subject viewed shapes and faces on multiple trials. The subject matched faces or shapes on each trial. BOLD activity during shape trials was subtracted from BOLD activity during Face trials and this value was compared on drug vs. placebo trials. (NCT00778310)
Timeframe: Placebo and Drug day, 1-2 weeks apart

,,,
InterventionFace-Shape BOLD signal difference (Mean)
AmygdalaFusiform Gyrus
Adults Drug Condition1.791.46
Adults Placebo Condition0.581.64
Children Drug Condition1.431.99
Children Placebo Condition0.771.06

[back to top]

Number of Participants With Positive Drug Screen

Secondary efficacy endpoints will be substance use during the study, as measured by total number of participants testing positive for substances other than a stimulant on weekly urine drug screens (NCT00780208)
Timeframe: 8 weeks

InterventionParticipants (Count of Participants)
Daytrana (Methylphenidate Patch)4

[back to top]

ADHD Symptom Severity

Primary efficacy endpoint will be ADHD symptom severity, as measured by mean change from baseline in the Wender-Reimherr Adult Attention Deficit Disorder Scale total score (WRAADS).The WRAADS measures symptoms in 7 categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional overreactivity, disorganization, and impulsivity. The scale rates individual items from 0 to 2 (0 = not present, 1 = mild, 2 = clearly present) so there may be a minimum total score of 0 (no symptoms present) through a maximum score of 56 (symptoms clearly present). (NCT00780208)
Timeframe: Baseline, Week 8

Interventionunits on a scale (Mean)
Daytrana (Methylphenidate Patch)-17.93

[back to top]

Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale

The STAI scale consists of total 40 items on separate scales measuring state (20 items) and trait (20 items) anxiety. The participant reports how they feel right now at this moment for state anxiety and how they generally feel for trait anxiety. The state items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very true). The trait items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). The total scores range from 4-80 for each scale. Higher scores indicate more impaired participants. (NCT00783835)
Timeframe: Baseline, Week 4, 8 and 12

InterventionUnit on a scale (Mean)
State Anxiety Score: BaselineTrait Anxiety Score: BaselineState Anxiety Score: Change at Week 4Trait Anxiety Score: Change at Week 4State Anxiety Score: Change at Week 8Trait Anxiety Score: Change at Week 8State Anxiety Score: Change at Week 12Trait Anxiety Score: Change at Week 12
Methylphenidate50.452.7-6.1-8.4-7.8-8.4-9.4-10.7

[back to top]

Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 12

Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms). (NCT00783835)
Timeframe: Baseline and Week 12

InterventionUnit on a scale (Mean)
Methylphenidate-20.6

[back to top]

Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 4

The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported. (NCT00783835)
Timeframe: Baseline and Week 4

InterventionUnit on a scale (Mean)
BaselineChange at Week 4
Methylphenidate39.619.4

[back to top]

Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 8

Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms). (NCT00783835)
Timeframe: Baseline and Week 8

InterventionUnit on a scale (Mean)
Methylphenidate-16.2

[back to top]

Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 12

The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported. (NCT00783835)
Timeframe: Baseline and Week 12

InterventionUnit on a scale (Mean)
Methylphenidate21.9

[back to top]

Clinical Global Impression-Improvement (CGI-I) Score

The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). (NCT00783835)
Timeframe: Week 4, 8 and 12

InterventionUnit on a scale (Mean)
Week 4Week 8Week 12
Methylphenidate2.72.42.2

[back to top]

Change From Screening in the Hamilton Depression Rating (HAM-D) Scale Score at Week 4 and 12

It is a 21-item clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. 11 items are scored on a 3 point scale (0=none/absent to 2=most severe), 2 items are scored on a 4 point scale (0=none/absent to 3=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe). The individual items are summed to yield the HAM-D total score that ranges from 0-60, where higher scores indicate worsening. (NCT00783835)
Timeframe: Screening (Week -2), 4 and 12

InterventionUnit on a scale (Mean)
Screening (Week -2)Change at Week 4Change at Week12
Methylphenidate5.9-2.8-3.3

[back to top]

Change From Screening in Clinical Global Impression-Severity of Illness (CGI-S) Score at Weeks 4, 8 and 12

"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 = Normal, not at all ill and a rating of 7 = Among the most extremely ill participants. Higher scores indicate worsening." (NCT00783835)
Timeframe: Screening (Week -2), 4, 8 and 12

InterventionUnit on a scale (Mean)
Screening (Week -2)Change at Week 4Change at Week 8Change at Week 12
Methylphenidate4.6-1.0-1.3-1.7

[back to top]

Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 4

Adult ASRS assesses 18 core ADHD symptoms corresponding to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms). (NCT00783835)
Timeframe: Baseline and Week 4

InterventionUnit on a scale (Mean)
BaselineChange at Week 4
Methylphenidate52.6-10.9

[back to top]

"Percentage of Participants That Much Improved (Score of 2) in, or Completely Recovered (Score of 1) From Their Irritability Severity, as Measured With the Clinical Global Impression-Improvement (CGI-I)."

"A measure of change of irritability severity taking the baseline before randomization as a reference. Scores range 1 to 8, in which 1=Completely recovered,... 5=Unchanged,... 8=Much worse.~Percentage of participants who responded are based on an estimation and might not match exactly with discrete numbers of participants based on the denominator." (NCT00794040)
Timeframe: Collected weekly during the 8-week trial. The 8th-week outcome is reported.

Interventionestimated percentage of participants (Number)
Add-on Citalopram Following Optimized Methylphenidate35
Add-on Placebo Following Optimized Methylphenidate6

[back to top]

Functional Impairment at 8th Week of Trial

Difference in functional impairment at 8th week of trial as measured with Children's Global Impression Scale (CGAS) with scores ranging from 1=Most impaired to 100=Not impaired at all. (NCT00794040)
Timeframe: Collected weekly during the 8th week trial. The 8th-week outcome is reported.

Interventionunits on a scale (Mean)
Add-on Citalopram Following Optimized Methylphenidate52.6
Add-on Placebo Following Optimized Methylphenidate47.2

[back to top]

Depressive Symptoms at 8th Week of Trial

Difference in depressive symptoms at 8th week of trial as measured with Children's Depression Rating Scale (CDRS) with scores ranging 17-113, where scores >40 are considered over the clinical threshold, and scores <28 are considered within the healthy range. (NCT00794040)
Timeframe: Collected weekly during the 8th week trial. The 8th-week outcome is reported.

Interventionunits on a scale (Mean)
Add-on Citalopram Following Optimized Methylphenidate28.6
Add-on Placebo Following Optimized Methylphenidate30.1

[back to top]

Irritability Severity at 8th Week of Trial.

Clinical Global Impression-Severity (CGI-S): A measure of severity of irritability scale (from 1=Normal, not at all ill to 7=Among the most extremely ill patients). (NCT00794040)
Timeframe: Collected weekly during the 8th week trial. The 8th-week outcome is reported.

Interventionunits on a scale (Mean)
Add-on Citalopram Following Optimized Methylphenidate3.1
Add-on Placebo Following Optimized Methylphenidate3.9

[back to top]

Anxiety Symptoms at 8th Week of Trial

Difference in anxiety symptoms at 8th week of trial as measured with the Pediatric Anxiety Rating Scale (PARS) with scores ranging 0-25. Higher values represent a worse outcome. (NCT00794040)
Timeframe: Collected weekly during the 8th week trial. The 8th-week outcome is reported.

Interventionunits on a scale (Mean)
Add-on Citalopram Following Optimized Methylphenidate12.0
Add-on Placebo Following Optimized Methylphenidate13.4

[back to top]

NCBRF-TIQ D-Total Score

"Parent ratings of aggression and hostility on the Nisonger Child Behavior Rating Form-Typical IQ (NCBRF-TIQ) D-Total Score. The NCBRF provides 1 prosocial subscale (Positive/Social) and 6 problem behavior subscales (Conduct Problem, Oppositional Behavior, Hyperactive, Inattentive, Overly Sensitive, and Withdrawn/Dysphoric). The NCBRF has excellent internal consistency, distinguishes between controls and subjects with DBDs. Conduct Problem and Oppositional Behavior subscales map closely to DSM-IV-TR symptoms of CD and ODD; they were scored together to form a variable called the D-Total.~For the NCBRF D-Total, higher scores reflect worse behavior. Each subscale is scored by taking the rating (0 [did not occur or was not a problem] to 3 [occurred a lot or was a very severe problem]) for all component items. The D-Total score was computed by adding the 6 scores from the Oppositional subscale and the 10 items from the Conduct Problem subscale. Thus D-Total scores could range from 0-69." (NCT00796302)
Timeframe: Measured at baseline and Weeks 3, 4, 5, 6, 7, 8, 9

,
Interventionunits on a scale (Mean)
BaselineWeek 3Week 4Week 5Week 6Week 7Week 8Week 9
Augmented (Stimulant + PMT + Risperidone)42.125.917.112.113.813.011.710.7
Basic (Stimulant + PMT + Placebo)43.524.922.420.120.716.817.817.8

[back to top]

Clinical Global Impressions Scale for Severity of Illness

Using this clinician rating scale the severity of the illness is scored from 1= normal to 7= extremely ill. This scale was used at baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, & 9. Only endpoint (week 9 or subject's last visit) Clinical Global Impressions Scale for Severity of Illness scores are reported below. (NCT00796302)
Timeframe: Measured at endpoint visit

,
Interventionparticipants (Number)
Normal/Borderline/Mildly ill at endpointModerately/Markedly/Severely ill at endpoint
Augmented (Stimulant + PMT + Risperidone)5622
Basic (Stimulant + PMT + Placebo)4934

[back to top]

Antisocial Behavior Scale - Reactive Aggression Subscale

The Antisocial Behavior Scale (ABS) is a 28-item scale that contains 10 Proactive Aggression items and six Reactive Aggression items. Each item is rated on a 3-point scale, ranging from 1 (Never) to 3 (Very often). Thus, scores on the Reactive Aggression subscale can range from 6 through 18; with higher scores indicating more reactive aggression. (NCT00796302)
Timeframe: Measured at baseline and Week 9

,
Interventionunits on a scale (Mean)
BaselineWeek 9
Augmented (Stimulant + PMT + Risperidone)15.511.0
Basic (Stimulant + PMT + Placebo)15.912.3

[back to top]

Clinical Global Impressions Scale for Improvement

"Using this clinician rating scale the patient's improvement is scored on a 7-point scale which ranges from very much improved (1), through no change (4), to very much worse (7). This scale was used at baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, & 9. Only endpoint (week 9 or subject's last visit) Clinical Global Impressions Scale for Improvement scores are reported below." (NCT00796302)
Timeframe: Measured at endpoint visit

,
Interventionparticipants (Number)
Much or very much improved at endpointMinimally improved at endpointUnchanged or worse at endpoint
Augmented (Stimulant + PMT + Risperidone)63116
Basic (Stimulant + PMT + Placebo)58223

[back to top]

Hour 7.5 Test of Handwriting Skills (Revised) (THS-R) Standard Score

The THS-R (range: unbounded) is a standardized, untimed assessment designed to evaluate neurosensory integration manifested in manuscript and cursive writing. The test includes subtests: writing from memory or dictation the letters of the alphabet in order, single digit-numbers out of order, selected words, and copying selected letters, words, and sentences. Each subtest was scored from zero (poorly formed letters) to 3 (perfectly formed letters). 100 is the normal mean; scores lower than 100 indicate performance worse than normal, scores above 100 indicate performance better than normal. (NCT00799409)
Timeframe: Hour 7.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo93.6
Concerta98.3

[back to top]

Hour 8.75 Gray Silent Reading Test (GSRT) Reading Quotient

Gray Silent Reading Test (GSRT)Reading Quotient is a reliable, validated measure of reading comprehension administered in the group setting during the first half hour of the homework session (range: 0,unbounded). A higher score is preferable as it means more questions were answered correctly. (NCT00799409)
Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo85.9
Concerta91.9

[back to top]

Hour 8.75 Packet Activity Alphabetize List of Words

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses). (NCT00799409)
Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo0.676
Concerta0.676

[back to top]

Hour 8.75 Packet Activity Complete Sentences Using Words Provided

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses). (NCT00799409)
Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo0.652
Concerta0.741

[back to top]

Hour 8.75 Packet Activity Decode the Mystery Sentence

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses). (NCT00799409)
Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo0.960
Concerta0.987

[back to top]

Hour 8.75 Packet Activity Identify Multiple Meanings for Words

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses). (NCT00799409)
Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo0.694
Concerta0.795

[back to top]

Hour 8.75 Packet Activity Identify Root Word

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses). (NCT00799409)
Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo0.744
Concerta0.760

[back to top]

Hour 8.75 Packet Activity Short Story With Questions for Comprehension

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses). (NCT00799409)
Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo0.609
Concerta0.629

[back to top]

Hour 8.75 Packet Activity Word Search

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses). (NCT00799409)
Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo0.935
Concerta0.979

[back to top]

Hour 3.0 Grammar Task

"This task, presented once during a laboratory school day, was designed to index attention to detail by determining how many grammatical mistakes each child could identify and circle in a brief paragraph. The errors were not difficult to identify and were designed to show attention to task, not comprehension. A higher number of errors identified, of those possible, was indicative of better attention - identification of grammatical errors(range: 0, 1 represents correct responses divided by the number of possible responses)." (NCT00799409)
Timeframe: Hour 3.0 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo0.241
Concerta0.327

[back to top]

Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS)

The DIBELS (range: 0, 376), used to assess reading fluency, consists of standardized, individually administered measures of early literacy development. These short (1 minute) fluency measures were developed based upon essential early literacy domains to assess development of phonological awareness, alphabetic understanding, and automaticity and fluency. Only the paragraph fluency component of an age/grade-appropriate DIBELS was used. A higher score indicated better performance, as it represented that the subject orally read a greater number of words correctly within the time allowed. (NCT00799409)
Timeframe: Hour 3.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo106.2
Concerta112.0

[back to top]

Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)

PERMP (range: 0, 400) is a measure of academic productivity in children up to 14 years of age. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of attempted problems. A higher number of problems attempted was indicative of greater attention to detail (higher score is preferable) (NCT00799409)
Timeframe: Hour 4 of the of the Lab School Day during Double-Blind Assessment Period

InterventionProblems attempted (Mean)
Placebo74.8
Concerta103.5

[back to top]

Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct)

PERMP (range: 0, 400) is a measure of academic productivity in children up to 14 years of age. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest performed at Visit 2. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of correct problems. A higher number of problems correct, of those attempted, was indicative of greater accuracy. (NCT00799409)
Timeframe: Hour 4 of the Lab School Day During the Double-Blind Assessment Period

InterventionProblems correct (Mean)
Placebo69.0
Concerta97.4

[back to top]

Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention)

The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. The SKAMP-Attention (SKAMP-A) (range: 0, 42) is a sum of the ratings on 7 attention items (getting started, sticking with tasks, attending to an activity, making activity transitions, completing assigned tasks, performing work accurately, and being neat and careful while writing or drawing). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms. (NCT00799409)
Timeframe: Hour 4 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo11.8
Concerta6.7

[back to top]

Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite)

The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. A composite score (range: 0, 78) for the SKAMP variable (13 items total) was obtained by summing the SKAMP-D and SKAMP-A subscale scores. A lower score was preferable, as a higher score represented greater behavioral impairment. (NCT00799409)
Timeframe: Hour 4 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo20.8
Concerta9.9

[back to top]

Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment)

The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. The SKAMP-Deportment (SKAMP-D) (range: 0, 36) is a sum of ratings on 6 deportment items (interacting with other children, interacting with adults, remaining quiet, staying seated, complying with the teacher's directions, and following the classroom rules). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms. (NCT00799409)
Timeframe: Hour 4 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo9.0
Concerta3.1

[back to top]

Hour 5.5 Test of Variables of Attention (TOVA) ADHD Composite Cutoff Score

The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicate better performance, lower scores indicate worse performance. Clinical interpretation: an ADHD scores of -1.80 or lower (<= -1.80) are considered not within normal limits scores above -1.80 (> -1.80) are considered inconclusive (meaning, neither like-ADHD nor like-normal). (NCT00799409)
Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo-4.39
Concerta-1.34

[back to top]

Hour 5.5 Test of Variables of Attention (TOVA) Commissions Standard Score

The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits. (NCT00799409)
Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo86.42
Concerta92.58

[back to top]

Hour 5.5 Test of Variables of Attention (TOVA) Omissions Standard Score

The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits. (NCT00799409)
Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo25.98
Concerta64.07

[back to top]

Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Standard Score

The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits. (NCT00799409)
Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo73.80
Concerta89.72

[back to top]

Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Variability Standard Score

The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits. (NCT00799409)
Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo62.87
Concerta85.14

[back to top]

Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards

Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 14). (NCT00799409)
Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionCorrect Trials (Mean)
Placebo5.1
Concerta5.4

[back to top]

Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards

Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 16). (NCT00799409)
Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionCorrect Trials (Mean)
Placebo9.2
Concerta9.3

[back to top]

Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards

WRAML-2 (range: 0, 28) is designed to evaluate a child's ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly in reverse order. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors. (NCT00799409)
Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionCorrect Sequences (Mean)
Placebo11.2
Concerta12.2

[back to top]

Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards

WRAML-2 (range: 0, 28) is designed to evaluate a child's ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors. (NCT00799409)
Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionCorrect Sequences (Mean)
Placebo12.9
Concerta14.3

[back to top]

Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards

WRAML-2 (range: 0, 28) is designed to evaluate a child's ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors. (NCT00799487)
Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionCorrect Sequences (Mean)
Placebo12.3
Concerta13.2

[back to top]

Hour 8.75 Packet Activity - Decode the Mystery Sentence

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses). (NCT00799487)
Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo0.989
Concerta0.955

[back to top]

Hour 8.75 Packet Activity - Complete Sentences Using Words Provided

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses). (NCT00799487)
Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo0.730
Concerta0.781

[back to top]

Hour 8.75 Packet Activity - Alphabetize List of Words

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses). (NCT00799487)
Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo0.638
Concerta0.660

[back to top]

Hour 8.75 Gray Silent Reading Test (GSRT)

Gray Silent Reading Test (GSRT) is a reliable, validated measure of reading comprehension administered in the group setting during the first half hour of the homework session (observed range: 0, 141). A higher score is preferable as it means more questions were answered correctly. (NCT00799487)
Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo89.1
Concerta92.1

[back to top]

Hour 7.5 Test of Handwriting Skills (Revised) (THS-R)

The THS-R is a standardized, untimed assessment designed to evaluate neurosensory integration manifested in manuscript and cursive writing. The test includes the 10 subtests: writing from memory the upper- and lower-case letters of the alphabet in order, writing from dictation the upper and lower-case letters of the alphabet out of order, single digit-numbers out of order, selected words, and copying selected letters, words, and sentences. Each subtest was scored from zero (poorly formed letters) to 3 (perfectly formed letters). A higher score was preferable (observed range: 0, 118). (NCT00799487)
Timeframe: Hour 7.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo79.1
Concerta82.7

[back to top]

Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)

PERMP (range: 0, 400) is a measure of academic productivity. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of attempted problems. A higher number of problems attempted was indicative of greater attention to detail (higher score is preferable.) (NCT00799487)
Timeframe: Hour 4 of the Double-Blind Assessment Period Lab School Day

InterventionProblems attempted (Mean)
Placebo88.0
Concerta116.1

[back to top]

Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards

WRAML-2 (range: 0, 28) is designed to evaluate a child's ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly in reverse order. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors. (NCT00799487)
Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionCorrect Sequences (Mean)
Placebo9.8
Concerta10.9

[back to top]

Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards

Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 16). (NCT00799487)
Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionCorrect Sequences (Mean)
Placebo8.4
Concerta8.5

[back to top]

Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards

Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 14). (NCT00799487)
Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionCorrect Sequences (Mean)
Placebo4.8
Concerta5.1

[back to top]

Hour 5.5 Test of Variables of Attention(TOVA) Reaction Time Variability (Standard Deviation in Milliseconds (Msecs))

The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. SD of response times (msecs) (observed range: -177.6, 132.9). Higher score indicates less variability. (NCT00799487)
Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

Interventionmilliseconds (Mean)
Placebo56.58
Concerta87.22

[back to top]

Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS)

The DIBELS (observed range: 0, 212), used to assess reading fluency, consists of standardized, individually administered measures of early literacy development. These short (1 minute) fluency measures were developed based upon essential early literacy domains to assess development of phonological awareness, alphabetic understanding, and automaticity and fluency. Only the paragraph fluency component of an age/grade-appropriate DIBELS was used. Children read 3 stories and completed the forms. A higher score was preferable and indicated a greater number of words read correctly in the time allowed (NCT00799487)
Timeframe: Hour 3.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo110.8
Concerta117.8

[back to top]

Hour 5.5 Test of Variables of Attention (TOVA) Omissions

The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. Number of targets missed. Higher score is preferable (observed range: -419.4, 108.9). (NCT00799487)
Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionTargets missed (Mean)
Placebo36.34
Concerta71.49

[back to top]

Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment)

The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of children impairment in classroom behavior. The SKAMP-Deportment (SKAMP-D) (range: 0,36) is a sum of ratings on 6 deportment items (interacting with other children, interacting with adults, remaining quiet, staying seated, complying with the teacher's directions, and following the classroom rules). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms. (NCT00799487)
Timeframe: Hour 4 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo8.0
Concerta3.1

[back to top]

Hour 8.75 Packet Activity - Identify Multiple Meanings for Words

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses). (NCT00799487)
Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo0.814
Concerta0.821

[back to top]

Hour 8.75 Packet Activity - Identiy Root Word

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses). (NCT00799487)
Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo0.580
Concerta0.638

[back to top]

Hour 8.75 Packet Activity - Short Story With Questions for Comprehension

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order)(range: 0, 1 represents correct responses divided by the number of possible responses). (NCT00799487)
Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo0.619
Concerta0.699

[back to top]

Hour 8.75 Packet Activity - Word Search

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses). (NCT00799487)
Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo0.955
Concerta0.984

[back to top]

Hour 5.5 Test of Variables of Attention (TOVA) ADHD Score

The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target (observed range: -15.2, 5.2). An ADHD score of less than -1.80 is suggestive of ADHD. (NCT00799487)
Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo-4.19
Concerta-0.68

[back to top]

Hour 5.5 Test of Variables of Attention (TOVA) Commissions

The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. Responses to non-targets. Higher score is preferable (observed range: -82.4, 128.9). (NCT00799487)
Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionResponses to non-targets (Mean)
Placebo78.35
Concerta90.54

[back to top]

Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time (Msec)

The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. Mean response latency in msecs (observed range: -75.4, 129.5). Higher score indicates faster reaction time. (NCT00799487)
Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

InterventionMilliseconds (msecs) (Mean)
Placebo75.23
Concerta93.21

[back to top]

Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite)

The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of child impairment in classroom behavior. A composite score (range: 0, 78) for the SKAMP variable (13 items total) was obtained by summing the SKAMP-D and SKAMP-A subscale scores. A lower score was preferable, as a higher score represented greater behavioral impairment. (NCT00799487)
Timeframe: Hour 4 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo18.1
Concerta8.7

[back to top]

Hour 3.0 Grammar Task

"This task, presented once during a laboratory school day, was designed to index attention to detail by determining how many grammatical mistakes each child could identify and circle in a brief paragraph. The errors were not difficult to identify and were designed to show attention to task, not comprehension. A higher number of errors identified, of those possible, was indicative of better attention - identification of grammatical errors (range: 0, 1 represents correct responses divided by the number of possible responses)." (NCT00799487)
Timeframe: Hour 3.0 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo0.252
Concerta0.340

[back to top]

Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention)

The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of children impairment in classroom behavior. The SKAMP-Attention (SKAMP-A) (range: 0, 42) is a sum of the ratings on 7 attention items (getting started, sticking with tasks, attending to an activity, making activity transitions, completing assigned tasks, performing work accurately, and being neat and careful while writing or drawing). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms. (NCT00799487)
Timeframe: Hour 4 of the Lab School Day During the Double-Blind Assessment Period

InterventionUnits on a scale (Mean)
Placebo10.1
Concerta5.6

[back to top]

Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct)

PERMP (range: 0, 400) is a measure of academic productivity. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of correct problems. A higher number of problems correct, of those attempted, was indicative of greater accuracy. (NCT00799487)
Timeframe: Hour 4 of the Lab School Day During the Double-Blind Assessment Period

InterventionProblems correct (Mean)
Placebo84.0
Concerta112.8

[back to top]

Change in HbA1c Over Baseline

measure of longer term glycemic control. A1c measured at baseline 6 weeks and 6 months (NCT00844090)
Timeframe: 6 months from baseline

Interventionpercentage of HbA1c (Median)
Methylphenidate-1.0
Placebo-0.1

[back to top]

Clinical Global Improvements-Acceptability (CGI-A) Scale

The CGI-A score at the subject's last study visit at or before Week 6 is one of the 3 secondary endpoints that contribute to the primary endpoint (CGI-E). The CGI-A will be used to assess the acceptability of the study medication with respect to the subject's experience with the formulation of medication. The 7-point rating for the CGI-A will be: 1=very high acceptability, 2=high acceptability, 3=above average acceptability, 4=average acceptability, 5=low acceptability, 6=very low acceptability, 7=extremely low acceptability (NCT00889915)
Timeframe: Measured at each participant's last visit, which can occur at or before Week 6

InterventionUnits on a scale (Median)
Daytrana (Methylphenidate Transdermal System3.0
Vyvanse (Lisdexamfetamine Dimesylate)2.0
Concerta (Osmotic-release Oral System Methylphenidate)2.0
Adderall (Mixed Amphetamine Salts Extended Release)2.0

[back to top]

Clinical Global Impressions-Improvement (CGI-I) Scale

The CGI-I score at the subject's last study visit at or before Week 6, is one of the 3 secondary endpoints that contribute to the primary endpoint (CGI-E). The CGI-I scale will be used to rate improvement in the subject's condition (benefits) since baseline using the following 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse; 7=very much worse. (NCT00889915)
Timeframe: Measured at each participant's last visit, which can occur at or before Week 6

InterventionUnits on a scale (Median)
Daytrana (Methylphenidate Transdermal System2.0
Vyvanse (Lisdexamfetamine Dimesylate)2.0
Concerta (Osmotic-release Oral System Methylphenidate)2.0
Adderall (Mixed Amphetamine Salts Extended Release)2.0

[back to top]

Dichotomized Clinical Global Impression-Effectiveness (CGI-E) Scale

The CGI-E is the value at which the participant's Therapeutic Benefit and Adverse Impact to the study drug intersect. This number is determined by combining each participant's scores for the degree of Therapeutic Benefit versus the degree to which problems with Tolerability and/or Acceptability adversely impact the subject. Participants are then determined to be Responders or Non-responders to the study medication. For example, a subject who is very much improved (CGI-I=1) or much improved (CGI-I=2) therapeutically and whose adverse impact rating is none (score 1,5) or mild (score 2,6) will be categorized as a Responder. All others whose adverse impact rating is moderate (score 3,7,11,15)or outweighs therapeutic effect (score 4,8,12,16) will be categorized as Non-responders to study medication. The CGI scores are totaled for each participant and a mean score is calculated. A median total score was calculated for each treatment group. (NCT00889915)
Timeframe: Measured at each participant's last visit, which can occur at or before Week 6

InterventionUnits on a scale (Median)
Daytrana (Methylphenidate Transdermal System7.0
Vyvanse (Lisdexamfetamine Dimesylate)5.0
Concerta (Osmotic-release Oral System Methylphenidate)6.0
Adderall (Mixed Amphetamine Salts Extended Release)6.0

[back to top]

Time of Plasma Half-Life(T 1/2) of Guanfacine

(NCT00901576)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose

Interventionhours (Mean)
SPD503 Alone20.4
SPD503 + Concerta22.7

[back to top]

Time of Maximum Plasma Concentration (Tmax) of Guanfacine

(NCT00901576)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose

Interventionhours (Mean)
SPD503 Alone8.1
SPD503 + Concerta8.7

[back to top]

T 1/2 of d-Methylphenidate

(NCT00901576)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose

Interventionhours (Mean)
Concerta Alone3.9
SPD503 + Concerta4.1

[back to top]

Maximum Plasma Concentration (Cmax) of Guanfacine

(NCT00901576)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose

Interventionng/ml (Mean)
SPD503 Alone2.6
SPD503 + Concerta2.7

[back to top]

Cmax of d-Methylphenidate

(NCT00901576)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose

Interventionng/ml (Mean)
Concerta Alone9.9
SPD503 + Concerta9.5

[back to top]

AUC of d-Methylphenidate

(NCT00901576)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose

Interventionng*h/ml (Mean)
Concerta Alone102.8
SPD503 + Concerta100.5

[back to top]

Tmax of d-Methylphenidate

(NCT00901576)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose

Interventionhours (Mean)
Concerta Alone6.9
SPD503 + Concerta7.4

[back to top]

Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine

(NCT00901576)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose

Interventionng*h/ml (Mean)
SPD503 Alone96.5
SPD503 + Concerta106.7

[back to top]

Permanent Product Measure of Performance (PERMP) Score Over 12 Hours

The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom. At the end of the 10-minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure a participant's performance. The total score range from 0-160 with higher scores indicating better performance. (NCT00904670)
Timeframe: 0.75, 2, 4, 8, 10, 12 hours post-dose

,
Interventionunits on a scale (Mean)
Hour 0.75Hour 2Hour 4Hour 8Hour 10Hour 12
NWP06111.1118.2119.2105.295.694.0
Placebo85.582.475.572.182.778.1

[back to top]

SKAMP Quality of Work Subscale Score Over 12 Hours

SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP composite score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP composite score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP quality of work subscale is reported which comprises of 3 items, with a total possible score of 0 to 18; higher score indicates worst impairment. (NCT00904670)
Timeframe: 0.75, 2, 4, 8, 10, 12 hours post-dose

,
Interventionunits on a scale (Mean)
Hour 0.75Hour 2Hour 4Hour 8Hour 10Hour 12
NWP064.63.83.65.56.46.5
Placebo6.56.67.37.96.77.6

[back to top]

SKAMP Deportment Subscale Score Over 12 Hours

SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP deportment subscale is reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment. (NCT00904670)
Timeframe: 0.75, 2, 4, 8, 10, 12 hours post-dose

,
Interventionunits on a scale (Mean)
Hour 0.75Hour 2Hour 4Hour 8Hour 10Hour 12
NWP061.71.01.22.12.42.7
Placebo3.33.64.24.53.74.2

[back to top]

Onset and Duration of Clinical Effect Based on SKAMP-Combined Scale

Onset and duration is determined using SKAMP combined rating scale at each post-dose time point. Onset of effect is defined as first assessment time showing statistical significance (i.e. p is less than or equal to [=<] 0.05) between NWP06 and placebo and duration of effect is defined as the as last consecutive time-point at which difference is still statistically significant between NWP06 and placebo. SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. (NCT00904670)
Timeframe: 0.75, 2, 8, 10, 12 hours post-dose

,
Interventionunits on a scale (Mean)
Hour 0.75Hour 2Hour 8Hour 10Hour 12
NWP069.57.210.814.015.1
Placebo15.816.920.017.719.8

[back to top]

SKAMP Compliance Subscale Score Over 12 Hours

SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP composite score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP composite score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP compliance subscale is reported which comprises of 2 items, with a total possible score of 0 to 12; higher score indicates worst impairment. (NCT00904670)
Timeframe: 0.75, 2, 4, 8, 10, 12 hours post-dose

,
Interventionunits on a scale (Mean)
Hour 0.75Hour 2Hour 4Hour 8Hour 10Hour 12
NWP061.91.21.32.12.73.5
Placebo3.54.14.74.84.44.6

[back to top]

SKAMP Attention Subscale Score Over 12 Hours

SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP attention subscale is reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment. (NCT00904670)
Timeframe: 0.75, 2, 4, 8, 10, 12 hours post-dose

,
Interventionunits on a scale (Mean)
Hour 0.75Hour 2Hour 4Hour 8Hour 10Hour 12
NWP061.31.10.91.22.52.4
Placebo2.52.63.12.73.03.4

[back to top]

Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose

The SKAMP scale measures the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment. (NCT00904670)
Timeframe: Hour 4 post-dose

Interventionunits on a scale (Mean)
NWP067.1
Placebo19.3

[back to top]

Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Oppositional Defiant Disorder (ODD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group

Assess ODD symptom severity. Individual subscale items range from 0 (never) to 3 (very often/frequently). Total is expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

InterventionT-Score (Least Squares Mean)
Methylphenidate-13.83

[back to top]

Change From Baseline in the Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Total Score at Week 8

Measures participant's overall ADHD symptom severity. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Higher scores represent greater illness severity. Change scores=Week 8 score-baseline score. The Least Squares (LS) Mean Change was based on the fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, as well as the continuous, fixed effects of baseline CGI-S score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo-1.07
LY2216684 (0.1 mg/kg/Day)-0.96
LY2216684 (0.2 mg/kg/Day)-1.52
LY2216684 (0.3 mg/kg/Day)-1.41

[back to top]

Change From Baseline in the Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Total Score at Week 8 in Stimulant Naive Methylphenidate Group

Measures participant's overall ADHD symptom severity. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Higher scores represent greater illness severity. Change scores=Week 8 score-baseline score. The Least Squares (LS) Mean Change was based on the fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, as well as the continuous, fixed effects of baseline CGI-S score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Methylphenidate-1.69

[back to top]

Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Conduct Disorder Symptom Subscale Score at Week 8

Assess conduct disorder symptom severity. Individual subscale items: 0 (never/seldom) - 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-score=greater conduct disorder. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

InterventionT-Score (Least Squares Mean)
Placebo-4.64
LY2216684 (0.1 mg/kg/Day)-2.24
LY2216684 (0.2 mg/kg/Day)-6.26
LY2216684 (0.3 mg/kg/Day)-7.62

[back to top]

Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Conduct Disorder Symptom Subscale Score at Week 8 in Stimulant Naive Methylphenidate Group

Assess conduct disorder symptom severity. Individual subscale items: 0 (never/seldom) - 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-score=greater conduct disorder. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

InterventionT-Score (Least Squares Mean)
Methylphenidate-7.10

[back to top]

Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Major Depressive Episode Score at Week 8

Assess depressive symptom severity. Individual subscale items range: 0 (never, seldom) to 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater depression. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

InterventionT-Score (Least Squares Mean)
Placebo-10.27
LY2216684 (0.1 mg/kg/Day)-5.41
LY2216684 (0.2 mg/kg/Day)-9.58
LY2216684 (0.3 mg/kg/Day)-13.67

[back to top]

Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Major Depressive Episode Score at Week 8 in Stimulant Naive Methylphenidate Group

Assess depressive symptom severity. Individual subscale items range: 0 (never, seldom) to 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater depression. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

InterventionT-Score (Least Squares Mean)
Methylphenidate-1.09

[back to top]

Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Manic Episode - Total Score at 8 Weeks in Stimulant Naive Methylphenidate Group

Measures manic symptom severity. Individual subscale items range: 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

InterventionT-Score (Least Squares Mean)
Methylphenidate-11.85

[back to top]

Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Manic Episode - Total Score at Week 8

Measures manic symptom severity. Individual subscale items range: 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

InterventionT-Score (Least Squares Mean)
Placebo-9.35
LY2216684 (0.1 mg/kg/Day)-5.00
LY2216684 (0.2 mg/kg/Day)-12.60
LY2216684 (0.3 mg/kg/Day)-12.41

[back to top]

Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Oppositional Defiant Disorder (ODD) Total Score at Week 8

Assess ODD symptom severity. Individual subscale items range from 0 (never) to 3 (very often/frequently). Total is expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

InterventionT-Score (Least Squares Mean)
Placebo-7.17
LY2216684 (0.1 mg/kg/Day)-4.00
LY2216684 (0.2 mg/kg/Day)-10.18
LY2216684 (0.3 mg/kg/Day)-12.29

[back to top]

Change From Baseline in the Swanson, Nolan and Pelham (SNAP-IV) Oppositional Defiant Disorder (ODD) Total Score at Week 8

Measures oppositional defiance disorder symptoms. Total scores range from 0 (not at all) to 3 (very much). Higher total scores represent greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo0.19
LY2216684 (0.1 mg/kg/Day)0.62
LY2216684 (0.2 mg/kg/Day)-0.04
LY2216684 (0.3 mg/kg/Day)-0.30

[back to top]

Change From Baseline in the Swanson, Nolan and Pelham (SNAP-IV) Oppositional Defiant Disorder (ODD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group

Measures oppositional defiance disorder symptoms. Total scores range from 0 (not at all) to 3 (very much). Higher total scores represent greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Methylphenidate-0.72

[back to top]

Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8

Includes Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD criteria for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) symptom subsets. Item score: 0 (not at all) to 3 (very much) rating scale. Total score is average of 18 items. Higher total scores=greater ADHD symptoms. Least Squares Mean change is adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and the continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo0.10
LY2216684 (0.1 mg/kg/Day)0.35
LY2216684 (0.2 mg/kg/Day)-0.21
LY2216684 (0.3 mg/kg/Day)-0.46

[back to top]

Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group

Includes Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD criteria for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) symptom subsets. Item score: 0 (not at all) to 3 (very much) rating scale. Total score is average of 18 items. Higher total scores=greater ADHD symptoms. Least Squares Mean change is adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and the continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
MethylphenidateNA

[back to top]

Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Total Score at Week 8

A working memory subtest of WISC-IV, a measure of attention; concentration; sequencing; number facility; and auditory short-term memory. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, as well as the continuous, fixed effects of baseline Digit Span total score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo0.64
LY2216684 (0.1 mg/kg/Day)1.22
LY2216684 (0.2 mg/kg/Day)0.95
LY2216684 (0.3 mg/kg/Day)1.02

[back to top]

Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Total Score at Week 8 in Stimulant Naive Methylphenidate Group

A working memory subtest of WISC-IV, a measure of attention; concentration; sequencing; number facility; and auditory short-term memory. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, as well as the continuous, fixed effects of baseline Digit Span total score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Methylphenidate0.54

[back to top]

Change From Baseline in the Child Health and Illness Profile - Child Edition (CHIP-CE) at Week 8 in Stimulant Naive Methylphenidate Group

76-item parent-rated assessment of child's health status/functioning level. Most items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) were calculated for all domains by adjusting raw scores based on an established reference group mean and standard deviation (T-scores mean=50, standard deviation=10). Higher scores denote improvement. Least Squares (LS) Mean Change is from an analysis of ANCOVA model that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline domain score. (NCT00922636)
Timeframe: Baseline, 8 weeks

InterventionT-Score (Least Squares Mean)
Achievement Standardized Score (n=17)Comfort Standardized Score (n=18)Resilience Standardized Score (n=18)Risk Avoidance Standardized Score (n=18)Satisfaction Standardized Score(n=18)
Methylphenidate5.214.065.106.971.90

[back to top]

Change From Baseline in the Child Health and Illness Profile-Adolescent Edition (CHIP-AE) Domain Scores at Week 8

Assesses adolescent's health status/functioning level. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. Items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) calculated for all domains by adjusting raw scores based on established reference group mean, standard deviation (T-scores mean=50, standard deviation=10). Higher scores=better health. Least Squares (LS) Mean Change from analysis of covariance model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline score. (NCT00922636)
Timeframe: Baseline, 8 weeks

,,,
InterventionT-Score (Least Squares Mean)
Achievement Section (n=3,3,4,3)Discomfort Section (n=30,31,32,26)Resilience Section (n=30,30,31,26)Risks Section (n=30,30,31,26)Satisfaction Section (n=30,32,32,26)
LY2216684 (0.1 mg/kg/Day)301.790.990.21-0.28-0.05
LY2216684 (0.2 mg/kg/Day)-12.421.101.622.182.95
LY2216684 (0.3 mg/kg/Day)64.552.391.280.740.72
Placebo-339.71-1.291.90-0.08-0.12

[back to top]

Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Content Subscales - Total Score at Week 8

Assess aggressive behaviors, academic difficulties, social problems, violence potential. Individual subscale items range: 0=never to 3=very often. Total expressed as T-score based on gender/age norms (0-100). Change scores=Week 8 score-baseline score. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score, baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

,,,
InterventionT-Score (Least Squares Mean)
Aggressive Behaviors Scale ScoreSocial Problems T-scoreViolence Potential T-score
LY2216684 (0.1 mg/kg/Day)-3.32-3.33-4.22
LY2216684 (0.2 mg/kg/Day)-8.09-5.19-7.95
LY2216684 (0.3 mg/kg/Day)-11.01-12.06-11.88
Placebo-5.52-6.77-6.97

[back to top]

Change From Baseline in the Child Health and Illness Profile-Adolescent Edition (CHIP-AE) Domain Scores at Week 8 in Stimulant Naive Methylphenidate Group

Assesses adolescent's health status/functioning level. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. Items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) calculated for all domains by adjusting raw scores based on established reference group mean, standard deviation (T-scores mean=50, standard deviation=10). Higher scores=better health. Least squares (LS) mean of the change from baseline to endpoint (week 8) is from an ANCOVA model. The model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline CHIP-AE domain score. (NCT00922636)
Timeframe: Baseline, 8 weeks

InterventionT-Score (Least Squares Mean)
Achievement Section (n=1)Discomfort Section (n=6)Resilience Section (n=6)Risks Section (n=6)Satisfaction Section (n=6)
MethylphenidateNA-1.97-4.062.012.19

[back to top]

Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Generalized Anxiety Disorder (GAD) and Separation Anxiety Disorder Symptom Subscales at Week 8

Assess anxiety symptom severity. Individual subscale items: 0 (never, seldom) - 3 (very often/frequently). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater anxiety. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

,,,
InterventionT-Score (Least Squares Mean)
CBRS Generalized Anxiety Disorder T-scoreCBRS Separation Anxiety Disorder Scale T-score
LY2216684 (0.1 mg/kg/Day)-5.34-1.13
LY2216684 (0.2 mg/kg/Day)-11.07-5.88
LY2216684 (0.3 mg/kg/Day)-15.39-8.60
Placebo-9.09-6.71

[back to top]

Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Generalized Anxiety Disorder (GAD) and Separation Anxiety Disorder Symptom Subscales at Week 8 in Stimulant Naive Methylphenidate Group

Assess anxiety symptom severity. Individual subscale items: 0 (never, seldom) - 3 (very often/frequently). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater anxiety. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

InterventionT-Score (Least Squares Mean)
CBRS Generalized Anxiety Disorder T-scoreCBRS Separation Anxiety Disorder Scale T-score
Methylphenidate-8.78-2.91

[back to top]

Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Academic Difficulties Total Score and the Language and Math Subscales at Week 8

The CP-CBRS academic difficulties total/language/math subscale score is a measure of academic performance. Each subscale item score ranges from 0 (never, seldom) to 3 (very often, very frequently). Total score is expressed as T-score based on gender/age norms. Academic difficulties T-score range: 0-100. Higher T-scores denote greater academic difficulties. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

,,,
InterventionT-Score (Least Squares Mean)
Total ScoreLanguage Subscale ScoreMath Subscales Score
LY2216684 (0.1 mg/kg/Day)-6.13-6.75-3.8
LY2216684 (0.2 mg/kg/Day)-5.93-6.07-2.85
LY2216684 (0.3 mg/kg/Day)-12.53-12.5-7.78
Placebo-6.09-5.87-4.63

[back to top]

Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Academic Difficulties Total Score and the Language and Math Subscales at Week 8 in Stimulant Naive Methylphenidate Group

The CP-CBRS academic difficulties total/language/math subscale score is a measure of academic performance. Each subscale item score ranges from 0 (never, seldom) to 3 (very often, very frequently). Total score is expressed as T-score based on gender/age norms. Academic difficulties T-score range: 0-100. Higher T-scores denote greater academic difficulties. Change scores=Week 8 score-baseline score. Least Squares Mean Change is adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

InterventionT-Score (Least Squares Mean)
Total ScoreLanguage Subscale ScoreMath Subscales Score
Methylphenidate-12.14-12.24-7.11

[back to top]

Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Hyperactivity-Impulsivity and Inattention Subtotal Scores at Week 8

Measures ADHD diagnostic symptoms (0=none/never-3=severe/very often). Inattention=sum odd items; hyperactivity-impulsivity=sum even items (subtotal: 0-27). Total scores: 0-54. High score=greater illness severity. Missing data-imputation in manual was applied. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

,,,
Interventionunits on a scale (Least Squares Mean)
Hyperactivity-Impulsivity Score (n=63, 58,60,59)Inattention Score (n=63, 59, 60, 59)
LY2216684 (0.1 mg/kg/Day)-5.94-6.23
LY2216684 (0.2 mg/kg/Day)-7.53-8.58
LY2216684 (0.3 mg/kg/Day)-7.32-9.09
Placebo-4.88-5.55

[back to top]

Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Content Subscales - Total Score at Week 8 in Stimulant Naive Methylphenidate Group

Assess aggressive behaviors, academic difficulties, social problems, violence potential. Individual subscale items range: 0=never to 3=very often. Total expressed as T-score based on gender/age norms (0-100). Change scores=Week 8 score-baseline score. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score, baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

InterventionT-Score (Least Squares Mean)
Aggressive Behaviors Scale ScoreSocial Problems T-scoreViolence Potential T-score
Methylphenidate-10.96-2.12-9.58

[back to top]

Change From Baseline in the Child Health and Illness Profile - Child Edition (CHIP-CE) at Week 8

76-item parent-rated assessment of child's health status/functioning level. Most items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) were calculated for all domains by adjusting raw scores based on an established reference group mean and standard deviation (T-scores mean=50, standard deviation=10). Higher scores denote improvement. Least Squares (LS) Mean Change is from an analysis of covariance model that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline domain score. (NCT00922636)
Timeframe: Baseline, 8 weeks

,,,
InterventionT-Score (Least Squares Mean)
Achievement Standardized Score (n=27,14,19,26)Comfort Standardized Score (n=28,16,19,29)Resilience Standardized Score (n=28,16,19,29)Risk Avoidance Standardized Score (n=28,16,19,29)Satisfaction Standardized Score(n=28,16,19,29)
LY2216684 (0.1 mg/kg/Day)3.452.960.601.81-2.07
LY2216684 (0.2 mg/kg/Day)2.963.500.195.77-1.24
LY2216684 (0.3 mg/kg/Day)3.817.824.754.753.63
Placebo3.828.244.076.061.19

[back to top]

Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR ADHD) Predominantly Hyperactive-Impulsive Type and Predominantly Inattentive Type Total Score and Symptom Scores at Week 8

Measures ADHD symptom severity. Individual items on each subscale are scored from 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms. Subscale total T-scores (0-100); higher T-scores=greater symptom severity. Least Squares Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

,,,
InterventionT-Score (Least Squares Mean)
Predominantly Hyperactive-Impulsive Type TotalPredominantly Inattentive Type Total Scale
LY2216684 (0.1 mg/kg/Day)-6.30-8.32
LY2216684 (0.2 mg/kg/Day)-12.94-10.99
LY2216684 (0.3 mg/kg/Day)-15.69-16.99
Placebo-8.70-10.71

[back to top]

Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Impairment Items Subscales-Total Score at Week 8

Rates schoolwork/grades, friendships/relationships, home life functioning (0=never to 3=very often). Total score expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

,,,
InterventionT-Score (Least Squares Mean)
Schoolwork/Grades ScoreFriendships/Relationships ScoreHome Life Score
LY2216684 (0.1 mg/kg/Day)-0.35-0.00-0.08
LY2216684 (0.2 mg/kg/Day)-0.53-0.22-0.44
LY2216684 (0.3 mg/kg/Day)-0.81-0.65-0.73
Placebo-0.49-0.43-0.40

[back to top]

Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Impairment Items Subscales-Total Score at Week 8 in Stimulant Naive Methylphenidate Group

Rates schoolwork/grades, friendships/relationships, home life functioning (0=never to 3=very often). Total score expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

InterventionT-Score (Least Squares Mean)
Schoolwork/Grades ScoreFriendships/Relationships ScoreHome Life Score
Methylphenidate-0.65-0.28-0.44

[back to top]

Change From Baseline in the CP-CBRS DSM-IV-TR ADHD Predominantly Hyperactive-Impulsive Type and Predominantly Inattentive Type Total Score and Symptom Scores at Week 8 in Stimulant Naive Methylphenidate Group

Measures ADHD symptom severity. Individual items on each subscale are scored from 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms. Subscale total T-scores (0-100); higher T-scores=greater symptom severity. Least Squares Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

InterventionT-Score (Least Squares Mean)
Predominantly Hyperactive-Impulsive Type TotalPredominantly Inattentive Type Total Scale
Methylphenidate-12.41-18.28

[back to top]

Change From Baseline in the Rapid Automatized Naming/Rapid Alternating Stimulus Test (RAN/RAS) Subtotal Scores at Week 8

Assesses ability to accurately and rapidly recognize and name visual symbols. The tests consist of rapid automatized naming tests (that is, Letters, Numbers, Objects, Colors) and 2 rapid alternating stimulus tests (that is, 2-Set Letters and Numbers; 3-Set Letters, Numbers, and Colors). Scores are based on the amount of time required to name all the stimulus items in each test section. Raw scores were converted to standard scores based on participant's age and conversion tables from manual (mean=100, standard deviation=15). Higher scores=better ability. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

,,,
Interventionunits on a scale (Least Squares Mean)
Objects (n=21,18,18,11)Colors (n=25, 21, 26, 16)Numbers (n=28, 26, 30, 23)Letters (n=27,24,27,22)2-set Letters and Numbers (n=27, 23, 28, 19)3-set Letters, Numbers, and Colors (n=26,24,28,21)
LY2216684 (0.1 mg/kg/Day)6.454.862.852.843.213.86
LY2216684 (0.2 mg/kg/Day)11.703.302.993.626.386.47
LY2216684 (0.3 mg/kg/Day)5.642.982.382.224.691.56
Placebo-0.562.853.441.165.237.89

[back to top]

Change From Baseline in the Rapid Automatized Naming/Rapid Alternating Stimulus Test (RAN/RAS) Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group

Assesses ability to accurately and rapidly recognize and name visual symbols. The tests consist of rapid automatized naming tests (that is, Letters, Numbers, Objects, Colors) and 2 rapid alternating stimulus tests (that is, 2-Set Letters and Numbers; 3-Set Letters, Numbers, and Colors). Scores are based on the amount of time required to name all the stimulus items in each test section. Raw scores were converted to standard scores based on participant's age and conversion tables from manual (mean=100, standard deviation=15). Higher scores=better ability. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Objects (n=9)Colors (n=11)Numbers (n=14)Letters (n=11)2-set Letters and Numbers (n=12)3-set Letters, Numbers, and Colors (n=12)
Methylphenidate0.653.376.607.816.654.82

[back to top]

Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Subtotal Scores at Week 8

Measures attention, concentration, sequencing, number facility, and auditory short-term memory. Digit forward and digit backward subscales each comprise 2 trials and 8 items. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

,,,
Interventionunits on a scale (Least Squares Mean)
Digit Span Forward: Scaled Process ScoreDigit Span Backward: Scaled Process Score
LY2216684 (0.1 mg/kg/Day)0.970.98
LY2216684 (0.2 mg/kg/Day)0.561.04
LY2216684 (0.3 mg/kg/Day)0.610.74
Placebo0.430.77

[back to top]

Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group

Measures attention, concentration, sequencing, number facility, and auditory short-term memory. Digit forward and digit backward subscales each comprise 2 trials and 8 items. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Digit Span Forward: Scaled Process ScoreDigit Span Backward: Scaled Process Score
Methylphenidate0.530.36

[back to top]

Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 8

"Captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 3 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and interrupted attempt. Suicidal ideation: yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide, nonfatal suicide attempt, and completed suicide." (NCT00922636)
Timeframe: 8 weeks

,,,
InterventionParticipants (Number)
Suicidal IdeationSuicidal BehaviorSuicidal Acts
LY2216684 (0.1 mg/kg/Day)100
LY2216684 (0.2 mg/kg/Day)500
LY2216684 (0.3 mg/kg/Day)200
Placebo100

[back to top]

Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 8 in Stimulant Naive Methylphenidate Group

"Captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 3 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and interrupted attempt. Suicidal ideation: yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide, nonfatal suicide attempt, and completed suicide." (NCT00922636)
Timeframe: 8 weeks

InterventionParticipants (Number)
Suicidal IdeationSuicidal BehaviorSuicidal Acts
Methylphenidate100

[back to top]

Change From Baseline in the ADHDRS-IV-Parent:Inv Hyperactivity-Impulsivity and Inattention Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group

Measures ADHD diagnostic symptoms (0=none/never-3=severe/very often). Inattention=sum odd items; hyperactivity-impulsivity=sum even items (subtotal: 0-27). Total scores: 0-54. High score=greater illness severity. Missing data-imputation in manual was applied. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Hyperactivity-Impulsivity ScoreInattention Score
Methylphenidate-9.00-10.46

[back to top]

Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8 in Stimulant Naive Methylphenidate Group

Assesses 18 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD diagnosis symptoms/severity in past week. Each item: 0 (none/never, rarely) to 3 (severe/very often). Total score ranges from 0 to 54. Higher total scores indicate greater illness severity. Change scores=Week 8 score-baseline score. LS Mean Change adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Methylphenidate-19.46

[back to top]

Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8

Assesses 18 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD diagnosis symptoms/severity in past week. Each item: 0 (none/never, rarely) to 3 (severe/very often). Total score ranges from 0 to 54. Higher total scores indicate greater illness severity. Change scores=Week 8 score-baseline score. Least Squares (LS) Mean Change adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo-10.35
LY2216684 (0.1 mg/kg/Day)-12.20
LY2216684 (0.2 mg/kg/Day)-16.09
LY2216684 (0.3 mg/kg/Day)-16.39

[back to top]

Number of Participants With a Response (Response Rate) up to Week 8

Response rate analysis compared the frequency of response between LY2216684 treatment groups versus placebo for participants who had a final study period II (weeks 1-8) Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) total score <=60% of their baseline total score. ADHD-RS-IV-PV:IR measures 18 symptoms in Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) ADHD diagnosis. Item scores range: 0 (none/never or rarely) to 3 (severe/very often). Total scores range: 0 to 54. (NCT00922636)
Timeframe: Baseline, up to 8 weeks

InterventionParticipants (Number)
Placebo22
LY2216684 (0.1 mg/kg/Day)19
LY2216684 (0.2 mg/kg/Day)34
LY2216684 (0.3 mg/kg/Day)28

[back to top]

Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Endpoint Score During the Treatment Phase (Weeks 1-8) in Stimulant Naive Methylphenidate Group

Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment. Scores range from 1 (very much improved) to 7 (very much worsened). Lower scores represent greater improvement. Least Squares (LS) Mean Change for weeks 1-8 is from a restricted maximum likelihood-based, mixed model repeated measure analysis. The model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction. (NCT00922636)
Timeframe: Weeks 1 through 8

InterventionTotal Score (Least Squares Mean)
Methylphenidate2.31

[back to top]

Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Endpoint Score During the Treatment Phase (Weeks 1-8)

Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment. Scores range from 1 (very much improved) to 7 (very much worsened). Lower scores represent greater improvement. Least Squares (LS) Mean Change for weeks 1-8 is from a restricted maximum likelihood-based, mixed model repeated measure analysis. The model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction. (NCT00922636)
Timeframe: Weeks 1 through 8

Interventionunits on a scale (Least Squares Mean)
Placebo3.05
LY2216684 (0.1 mg/kg/Day)3.01
LY2216684 (0.2 mg/kg/Day)2.54
LY2216684 (0.3 mg/kg/Day)2.53

[back to top]

Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Total Score at Week 8 in Stimulant Naive Methylphenidate Group

Parent-completed 11-item questionnaire (3 morning items, 8 evening items) on a scale of 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges from 0 to 33; higher score=greater difficulty in evening and morning behavior. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Methylphenidate-6.88

[back to top]

Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Total Score at Week 8

Parent-completed 11-item questionnaire (3 morning items, 8 evening items) on a scale of 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges from 0 to 33; higher score=greater difficulty in evening and morning behavior. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo-4.95
LY2216684 (0.1 mg/kg/Day)-4.72
LY2216684 (0.2 mg/kg/Day)-7.08
LY2216684 (0.3 mg/kg/Day)-8.24

[back to top]

Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Letter-Number Sequencing Score at Week 8

Working memory subtest. Task involves sequencing, mental manipulation, attention, short-term memory, visual spatial imaging, and processing speed; consists of 10 items, 3 trials each. Scaled scores range: 1 to 19. Higher scores denote better performance. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo1.30
LY2216684 (0.1 mg/kg/Day)1.36
LY2216684 (0.2 mg/kg/Day)1.48
LY2216684 (0.3 mg/kg/Day)1.84

[back to top]

Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Morning Summary Score at Week 8 in Stimulant Naive Methylphenidate Group

Measures difficulty level of 3 common morning behaviors (for example, get out of bed) from 0 (no difficulty) to 3 (a lot of difficulty). Total score range is from 0 to 9; a higher score indicates greater difficulty in morning behavior. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline morning score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Methylphenidate-0.80

[back to top]

Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Morning Summary Score at Week 8

Measures difficulty level of 3 common morning behaviors (for example, get out of bed) from 0 (no difficulty) to 3 (a lot of difficulty). Total score range is from 0 to 9; a higher score indicates greater difficulty in morning behavior. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline morning score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo-1.07
LY2216684 (0.1 mg/kg/Day)-0.91
LY2216684 (0.2 mg/kg/Day)-1.53
LY2216684 (0.3 mg/kg/Day)-2.20

[back to top]

Number of Participants With a Response (Response Rate) up to Week 8 in Stimulant Naive Methylphenidate Group

Response rate analysis compared the frequency of response between LY2216684 treatment groups versus placebo for participants who had a final study period II (weeks 1-8) Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) total score <=60% of their baseline total score. ADHD-RS-IV-PV:IR measures 18 symptoms in Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) ADHD diagnosis. Item scores range: 0 (none/never or rarely) to 3 (severe/very often). Total scores range: 0 to 54. (NCT00922636)
Timeframe: Baseline, up to 8 weeks

InterventionParticipants (Number)
Methylphenidate14

[back to top]

Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R ) Evening Summary Score at Week 8 in Stimulant Naive Methylphenidate Group

Measures difficulty level of 8 common evening behaviors (for example, sit through dinner) from 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges: 0 to 24; higher scores indicate greater difficulty in evening behavior. Least Squares (LS) Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis (MMRM) and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline evening score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Methylphenidate-6.17

[back to top]

Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R ) Evening Summary Score at Week 8

Measures difficulty level of 8 common evening behaviors (for example, sit through dinner) from 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges: 0 to 24; higher scores indicate greater difficulty in evening behavior. Least Squares (LS) Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis (MMRM) and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline evening score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo-3.34
LY2216684 (0.1 mg/kg/Day)-3.37
LY2216684 (0.2 mg/kg/Day)-4.77
LY2216684 (0.3 mg/kg/Day)-5.24

[back to top]

Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Letter-Number Sequencing Score at Week 8 in Stimulant Naive Methylphenidate Group

Working memory subtest. Task involves sequencing, mental manipulation, attention, short-term memory, visual spatial imaging, and processing speed; consists of 10 items, 3 trials each. Scaled scores range: 1 to 19. Higher scores denote better performance. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction. (NCT00922636)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Methylphenidate1.58

[back to top]

Sleep Latency

Measure by daily subject sleep diary (NCT00989950)
Timeframe: 9 weeks

Interventionminutes (Mean)
9 hr Wear34
10 hr Wear34
11 hr Wear32
12 hr Wear34

[back to top]

Change From Baseline in Parenting Stress Index (PSI) Total Score at Week 12

"Parenting Stress Index (PSI) was designed to assess parent or guardian child-rearing stress index on a 5-rating scale from never to very truly. Out of 30 items, 20 items are scored, being consisted of 8 child characteristics-related stress items; 9 parent-child interaction-related stress items; and 3 achievement expectation-related stress items. A possible total score ranges from 20 to 100; Increase in score indicates higher stress perceived by the parent." (NCT01012622)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
BaselineChange at Week 12
Osmotic Release Oral System (OROS) Methylphenidate HCL58.20-5.25

[back to top]

Change From Baseline in Korean Version of the Attention-Deficit Hyperactivity Disorder (K-ADHD) Rating Scale (K-ARS) Total Score at Week 12

K-ARS measures the 18 symptoms based on Diagnostic and Statistical Manual of Mental Disorders-forth edition (DSM-IV 1994). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), whereas the rating of 2 points or more was regarded as abnormal. Total scores range from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition. (NCT01012622)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
BaselineChange at Week 12
Osmotic Release Oral System (OROS) Methylphenidate HCL33.37-20.43

[back to top]

Change From Baseline in Interference-Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12

CAT was developed to properly reflect brain function in childhood. It provided measurement of simple interference-selective attention in terms of omission(number of missing response to target stimulus[0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus[0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]). (NCT01012622)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Omission:BaselineOmission:Change at Week 12False alarm:BaselineFalse alarm:Change at Week 12Response mean:BaselineResponse mean:Change at Week 12Response:BaselineResponse:Change at Week 12
Osmotic Release Oral System (OROS) Methylphenidate HCL20.39-10.8326.03-6.14648.48-54.35276.74-72.18

[back to top]

Change From Baseline in Inhibition-Sustained Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12

CAT was developed to properly reflect brain function in childhood. It provided measurement of simple inhibition-sustained attention in terms of omission(number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]). (NCT01012622)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Omission:BaselineOmission:Change at Week 12False alarm:BaselineFalse alarm:Change at Week 12Response mean:BaselineResponse mean:Change at Week 12Response:BaselineResponse:Change at Week 12
Osmotic Release Oral System (OROS) Methylphenidate HCL35.78-20.3927.73-7.54576.55-34.44273.78-66.85

[back to top]

Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 12

The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Improved very much, Improved much and Improved a little are defined as improvement and No change, Aggravated a little, Aggravated much and Aggravated very much were defined as aggravation. (NCT01012622)
Timeframe: Week 12

Interventionparticipants (Number)
ImprovementAggravation
Osmotic Release Oral System (OROS) Methylphenidate HCL1227

[back to top]

Number of Participants With Remission Based on K-ARS Total Score and Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 12

"Remission is defined by all of the following criteria; 1) K-ARS Total score of 18 or less. 2) Very much improved or Much improved in CGI-I. K-ARS total score ranges from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition. CGI-I is a 7-point scale ranging from 1 to 7, where 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse, higher score indicates worsening of condition." (NCT01012622)
Timeframe: Week 12

Interventionparticipants (Number)
Osmotic Release Oral System (OROS) Methylphenidate HCL99

[back to top]

Change From Baseline in Working Memory Forward Subtest of Comprehensive Attention Test (CAT) at Week 12

CAT was developed to properly reflect brain function in childhood. The test battery provided a comprehensive measurement of simple visual auditory attention, interventional visual-auditory selective attention, divided attention, continuous attention, and operational memory. Working memory forward was measured in terms of width of space and number of correct responses ranging from 0 to 10. For width of space boxes were presented on the screen and participants remembered the order of presented box. Participants pressed the box using mouse in the forward order. Maximum number that participants correctly memorized box in the screen in the respective order was reported and overall number of times a participant responded correctly was also reported. (NCT01012622)
Timeframe: Baseline and Week 12

Interventioncorrect responses (Mean)
Baseline:Number of correct responsesChange at Week 12:Number of correct responsesBaseline:Width of spaceChange at Week 12:Width of space
Osmotic Release Oral System (OROS) Methylphenidate HCL5.760.634.460.25

[back to top]

Change From Baseline in Academic Performance Rating Scale (APRS) Score at Week 12

APRS scale measures four factors in elementary school children such as learning ability, academic performance, impulse control, and social withdrawal. In particular, it is excellent in assessing drug effect on the academic performance not measured by other scales. Score ranges from 19 to 95, higher score means better academic performance. (NCT01012622)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
BaselineChange at Week 12
Osmotic Release Oral System (OROS) Methylphenidate HCL55.467.40

[back to top]

Change From Baseline in Auditory Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12

CAT was developed to properly reflect brain function in childhood. It provided measurement of simple auditory selective attention in terms of omission (number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm (number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]). (NCT01012622)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Omission:BaselineOmission:Change at Week 12False alarm:BaselineFalse alarm:Change at Week 12Response mean:BaselineResponse mean:Change at Week 12Response:BaselineResponse:Change at Week 12
Osmotic Release Oral System (OROS) Methylphenidate HCL10.31-6.2712.07-3.61623.95-55.34265.69-63.76

[back to top]

Change From Baseline in Beck Depression Inventory (BDI) Score at Week 12

Beck Depression Inventory (BDI) consisted of 21 items for measuring the subjective severity of depression and emotional, cognitive, motivational, physiological symptoms of depression. Each question has a set of 4 possible answer choices, ranging in intensity, each answer being scored on a scale value of 0 (no symptom) to 3 (the most severe symptom). Accordingly, the total score ranges from 0 (no symptom) to 63 (the most severe symptom) for 21 questions. (NCT01012622)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
BaselineChange at Week 12
Osmotic Release Oral System (OROS) Methylphenidate HCL11.69-1.89

[back to top]

Change From Baseline in Child Health and Illness Profile-Child Edition (CHIP) Total Score and 5 Sub-domains Score at Week 12

CHIP was designed to assess the physical, psychological health conditions and functional well-being of children. The instrument has sub-domains such satisfaction (11 items) ranges from 0 to 44, stability (22 items) ranges from 0 to 88, elasticity (19 items) ranges from 0 to 76, risk aversion (14 items) ranges from 0 to 56, achievement (10 items) ranges from 0 to 40. Good health is in the range from 44 to 56 points for all sub-domains. A score of 43 or below indicates poor health in that domain. A score of 57 or higher indicates excellent health. The total score is an average of the scores for the 5 domains and ranges from 0 to 304. Higher total score indicates better health. (NCT01012622)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Total Score:Baseline (n=126)Total Score:Change at Week 12 (n=126)Satisfaction:Baseline (n=132)Satisfaction:Change at Week 12 (n=132)Stability:Baseline (n=129)Stability:Change at Week 12 (n=129)Elasticity:Baseline (n=132)Elasticity:Change at Week 12 (n=132)Risk aversion:Baseline (n=132)Risk aversion:Change at Week 12 (n=132)Achievement:Baseline (n=133)Achievement:Change at Week 12 (n=133)
Osmotic Release Oral System (OROS) Methylphenidate HCL207.8518.0826.172.2782.134.4738.302.5340.675.7321.002.45

[back to top]

Change From Baseline in Clinical Global Impression-severity (CGI-S) Score at Week 12

"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher change scores indicate worsening." (NCT01012622)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
BaselineChange at Week 12
Osmotic Release Oral System (OROS) Methylphenidate HCL5.14-2.51

[back to top]

Change From Baseline in Divided Attention Subtest of Comprehensive Attention Test (CAT) at Week 12

CAT was developed to properly reflect brain function in childhood. It provided measurement of simple divided attention in terms of omission(number of missing response to target stimulus[0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus[0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]). (NCT01012622)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Omission:BaselineOmission:Change at Week 12False alarm:BaselineFalse alarm:Change at Week 12Response mean:BaselineResponse mean:Change at Week 12Response:BaselineResponse:Change at Week 12
Osmotic Release Oral System (OROS) Methylphenidate HCL16.05-4.0716.03-4.73749.01-27.14349.60-43.90

[back to top]

Change From Baseline in Working Memory Backward Subtest of Comprehensive Attention Test (CAT) at Week 12

CAT was developed to properly reflect brain function in childhood. The test battery provided a comprehensive measurement of simple visual auditory attention, interventional visual-auditory selective attention, divided attention, continuous attention, and operational memory. Working memory forward was measured in terms of width of space and number of correct responses ranging from 0 to 10. For width of space boxes were presented on the screen and participants remembered the order of presented box. Participants pressed the box using mouse in the backward order. Maximum number that participants correctly memorized box in the screen in the respective order was reported and overall number of times a participant responded correctly was also reported. (NCT01012622)
Timeframe: Baseline and Week 12

Interventioncorrect responses (Mean)
Baseline:Number of correct responsesChange at Week 12:Number of correct responsesBaseline:Spatial spanChange at Week 12:Spatial span
Osmotic Release Oral System (OROS) Methylphenidate HCL4.221.863.631.24

[back to top]

Change From Baseline in Visual Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12

CAT was developed to properly reflect brain function in childhood. It provided measurement of simple visual selective attention in terms of omission (number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm (number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]). (NCT01012622)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Omission:BaselineOmission:Change at Week 12False alarm:BaselineFalse alarm:Change at Week 12Response mean:BaselineResponse mean:Change at Week 12Response:BaselineResponse:Change at Week 12
Osmotic Release Oral System (OROS) Methylphenidate HCL8.79-4.5317.42-5.03501.32-37.41201.05-48.36

[back to top]

Number of Participants With Response Based on K-ARS Total Score at Week 12

Response is defined as at least 25 percent (%) decrease in total score of K-ARS compared to baseline. K-ARS measures the 18 symptoms based on DSM-IV (1994). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), whereas the rating of 2 points or more was regarded as abnormal. Total scores range from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition. (NCT01012622)
Timeframe: Week 12

Interventionparticipants (Number)
Osmotic Release Oral System (OROS) Methylphenidate HCL118

[back to top]

Clinical Global Impression - Severity (CGI-S) Score

"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening." (NCT01060150)
Timeframe: Week 12

InterventionUnits on a scale (Mean)
OROS Methylphenidate HCl2.81

[back to top]

Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score

The K-ARS is a rating scale that is used for the ADHD diagnosis and the assessment of treatment efficacy and comprises 18 items in total on the basis of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), each item being rated from 0-3 points. The total score ranges from 0-54 with 0=normal and 54=severe condition. (NCT01060150)
Timeframe: Week 12

InterventionUnits on a scale (Mean)
OROS Methylphenidate HCl11.78

[back to top]

Learning Skill Test (LST) Total Score

The LST measures learning ability of student. This scale is composed of 7 sections: self control, participation, task accomplishment, reading, writing, test taking and information processing. It consists of 70 items for middle school student (age 13-15 years) and 80 items for high school student (age 16-18 years). Each item is rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). The total score range is 70-350 for middle school version and 80-400 for high school version where higher score indicates better ability for learning. In result analysis, each sub-score and total score was converted to T-score for normalization. The score range of T-score is from 1 to 100 with a mean of 50. Higher score indicates better ability for learning. (NCT01060150)
Timeframe: Week 12

InterventionT-score (Mean)
OROS Methylphenidate HCl49.61

[back to top]

Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors

The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/commission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The total value for both, omission errors and commission errors, ranges from 0-100 errors where high value indicates worsening attention. (NCT01060150)
Timeframe: Baseline and Week 12

InterventionErrors (Mean)
Omission errors: BaselineOmission errors: Week 12Commission errors: BaselineCommission errors: Week 12
OROS Methylphenidate HCl58.8857.4062.9851.70

[back to top]

Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability

The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/comission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The score range for both, reaction time and response variability, is 0-100. High score indicates worsening attention. If one or over factor's score is over 65 point, the participant is resulted in having attention deficit. (NCT01060150)
Timeframe: Baseline and Week 12

InterventionUnits on scale (Mean)
Reaction time average: BaselineReaction time average: Week 12Response variability: BaselineResponse variability: Week 12
OROS Methylphenidate HCl54.3249.7385.7759.42

[back to top]

Controlled Oral Words Association Test (COWAT) Score

This test measures the executive function of the frontal lobe and is consisted of examinations of category/meaning fluency and letter/phoneme fluency. It consisted of three 60 second word generation trials in which the participant orally generates as many words as possible that begin with target letters F, A and S. Dependent variables included total number of acceptable words generated for each target letter and total number of words generated across all three letter trials. Total score was calculated as sum of acceptable words generated, with higher scores indicating better verbal fluency. (NCT01060150)
Timeframe: Baseline and Week 12

InterventionWords (Mean)
Category/semantic: BaselineCategory/semantic: Week 12Letter/phenomic: BaselineLetter/phenomic: Week 12
OROS Methylphenidate HCl29.7130.6228.7133.78

[back to top]

Digit Span Test Score

Each participant individually was given a sequence of numbers, with the sequence becoming progressively longer, to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. 1 point was awarded if the participant passed only 1 trial of a sequence length. 0 points were given if the participant failed both trials. Total score range was 0-16 (forwards) and 0-14 (backwards). A higher score was indicative of better recall and attention. (NCT01060150)
Timeframe: Baseline and Week 12

InterventionUnits on a scale (Mean)
Forward: BaselineForward: Week 12Backward: BaselineBackward: Week 12
OROS Methylphenidate HCl11.1911.567.097.32

[back to top]

Finger Window (FW) Test Score

In FW test, a participant shows memory of a demonstrated visual pattern using a 8x11 inch plastic template containing 9 asymmetrically located holes. The examiner models a given sequence of holes and asks the participant to imitate the sequence by placing his/her finger through the same holes in the correct order. The total number of correct sequences constitutes the total score which ranges from 0-24 (forward FW) and 0-28 (backward FW) with higher score indicating a more favorable health state. (NCT01060150)
Timeframe: Baseline and Week 12

InterventionUnits on a scale (Mean)
Forward FW: BaselineForward FW: Week 12Backward FW: BaselineBackward FW: Week 12
OROS Methylphenidate HCl18.4219.0915.5917.36

[back to top]

Stroop Test Result for False Reaction

This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. The total value ranges from 0-24 errors for each execution where high value indicates worsening attention. (NCT01060150)
Timeframe: Baseline and Week 12

InterventionErrors (Mean)
Simple execution false reaction: BaselineSimple execution false reaction: Week 12Middle execution false reaction: BaselineMiddle execution false reaction: Week 12Interfering execution false reaction: BaselineInterfering execution false reaction: Week 12
OROS Methylphenidate HCl0.40.160.30.21.040.84

[back to top]

Stroop Test Result for Reaction Time

This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. This test estimates spending time for execution. High spending time indicates low ability of suppression of automation. (NCT01060150)
Timeframe: Baseline and Week 12

InterventionSeconds (Mean)
Simple execution time: BaselineSimple execution time: Week 12Middle execution time: BaselineMiddle execution time: Week 12Interfering execution time: BaselineInterfering execution time: Week 12
OROS Methylphenidate HCl14.7813.6415.8815.0422.1219.72

[back to top]

Stroop Test Score for Ratio Interference

Ratio interference is calculated by dividing simple execution time by interfering execution time. The score range is 0-1. Higher value indicates better ability of suppression of automation. (NCT01060150)
Timeframe: Baseline and Week 12

InterventionUnits on a scale (Mean)
BaselineWeek 12
OROS Methylphenidate HCl0.700.72

[back to top]

Clinical Global Impression - Improvement (CGI-I) Score

The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. (NCT01060150)
Timeframe: Week 12

InterventionUnits on a scale (Mean)
OROS Methylphenidate HCl2.14

[back to top]

Adult ADHD Investigator Symptom Rating Scale (AISRS)

An 18-item scale rating a subject's level of impairment from 0 (none) to 3 (severe) for each symptom of DSM-IV ADHD, with a maximum possible score of 54. The measure was collected at Baseline and 6 weeks, and a total score was calculated to gauge treatment response of ADHD subjects to open-label Concerta. (NCT01063153)
Timeframe: Baseline and 6 weeks

Interventionunits on a scale (Mean)
Baseline6 weeks
ADHD37.015.0

[back to top]

Percent Errors in Visual Go/NoGo Task

The Go/NoGo visual task was completed by subjects with ADHD as well as healthy controls. The Go/NoGo task is used to assess inhibitory control, and targets response inhibition, executive functions, and sustained attention. The 'Go' stimulus occupies 80% of the trials, and requires the subject to perform a motor response each time it appears on the screen. A rare 'No Go' stimulus (occupies 20% of all trials) requires the subject to refrain from responding. The percentage of errors were measured for each group. (NCT01063153)
Timeframe: Single Point (Baseline)

Interventionpercentage of errors (Number)
ADHD and Visual NoGo Task19.01
Control Group and Visual NoGo Task13.89
ADHD and Visual Go Task2.88
Control Group and Visual Go Task1.27

[back to top]

Number of Patients Who Met and Exceeded Response Criteria of Attention Deficit Hyperactivity Disorder Symptom Scale

Patients given Attention Deficit Hyperactivity Disorder Symptom Scale (ADHDSS), a measure of the features of Attention Deficit Hyperactivity Disorder including inattention, hyperactivity, and impulsivity. This scale has shown excellent reliability in prior studies of individuals with HD. For the ADHDSS the minimum units are 0 and Maximum units on the total scale are 54 (adult). The higher the number on the ADHDSS, the more severe the symptoms. Response was defined as at least a 30% reduction on the ADHDSS. (NCT01100268)
Timeframe: 4 weeks

Interventionparticipants (Number)
Methylphenidate ER4

[back to top]

Number of Patients Who Met Response Criteria for the Saving Inventory-Revised.

Patients given Saving Inventory-Revised (SI-R), an evidence-based measure of three features of hoarding: excessive acquisition, difficulty discarding, and clutter. For the SI-R the minimum units are 0 and Maximum units on the total scale are 92. The higher the number on the SI-R, the more severe the symptoms. Response was defined as at least a 25% reduction on the SI-R. (NCT01100268)
Timeframe: 4 weeks

Interventionparticipants (Number)
Methylphenidate ER2

[back to top]

Change Score for z Weight

difference between baseline and endpoint (month 30 or last assessment point if did not finish study). Measured as a zscore with more negative units reflecting lesser weight gain. Z units used to account for differences between groups in gender and age with both impact weight at a fixed time. (NCT01109849)
Timeframe: baseline to month 30 or to last assessment point

InterventionZ score (Mean)
Behavior Therapy-.01
ER Stimulant-.19

[back to top]

Change Score for Z-height Baseline to Endpoint

"The primary endpoint will be change in z-height at month 30 which is study endpoint.~Measured as a zscore with more negative units reflecting smaller incremental height gain. Z units used to account for differences between groups in gender and age with both impact height at a fixed time." (NCT01109849)
Timeframe: month 30 or last assessment point

InterventionZ score (Mean)
Behavior Therapy-.04
ER Stimulant-.11

[back to top]

Change in Weight z Score During Weight Recovery Phase (Second Randomization) Based on Actual Usage

"difference in height z score from entry into weight recovery phase to exit from that phase (exact duration varied by participant). Randomization could not occur before month 6 (so max of 24 month duration) but could start as late as month 29 (equaling a 1 month duration) based on the pattern of zBMI change. In this post hoc analysis we grouped participants by what they did (caloric supplementation, drug holiday or monitoring) not what they were randomly assigned to. The most common change was from drug holiday to monitoring for participants who were not using medication on weekends before assignment to drug holiday (family stopped weekend med by own accord prior to 2nd randomization) so assignment to drug holiday did not alter actual frequency of use as was designed to.Therefore they were reclassified as monitoring as frequency of med use did not change.~Z score used to account for differences in age and gender between groups. Higher values reflect greater incremental weight gain." (NCT01109849)
Timeframe: between 1 month and 24 months

Interventionzscore (Mean)
Caloric Supplementation0.055
Drug Holiday0.299
Monitoring0.084

[back to top]

Number of Behavior Therapy Sessions

Raw number of behavior therapy sessions attended; participants could cross over to other treatment arm if moderately impaired after 6 months in initial randomly assigned arm (NCT01109849)
Timeframe: months 0 through 30

Interventionsessions attended (Mean)
Behavior Therapy8.1
ER Stimulant8.1

[back to top]

Change in zBody Mass Index (BMI)

BMI will be calculated at endpoint (month 30). Difference between baseline and endpoint (month 30 or last assessment point if did not finish study). Measured as a zscore with more negative units reflecting less BMI gain. Z units used to account for differences between groups in gender and age with both impact BMI at a fixed time. (NCT01109849)
Timeframe: baseline to month 30 or last assessment point

InterventionZ score (Mean)
Behavior Therapy-.06
ER Stimulant-.21

[back to top]

Change in Zscore for BMI During Weight Recovery Phase (Second Randomization)

"difference in BMI z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant.~Z scores used to account for differences in age and gender. Larger values reflecting a greater incremental BMI gain." (NCT01109849)
Timeframe: between 1 month and 24 months

InterventionZ score (Mean)
Caloric Supplementation0.243
Drug Holiday0.443
Monitoring0.247

[back to top]

Change in BMI z Score by Actual Medication Usage

measures change in BMI z score from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44) used med <12.5% of the study duration (with most using not at all). The consistent med group (N=38 used med for at least 87.5% of their time in the study with most using the entire time). The inconsistent med group (N=111, 27.5% used medication 45% of the time in the study. The other 37 participants did not have one year of growth data so were excluded from this analysis. Z scores used to account for differences in age and gender between groups. Higher values represent a larger BMI (NCT01109849)
Timeframe: baseline to month 30 or last assessment point

InterventionZ score (Mean)
Consistent Medication-0.554
Inconsistent Medication Group-0.170
Rare Medication Group0.036

[back to top]

Change Score for Zheight Months 0 to 6

"in addition to the primary outcome of height at month 30, change in z-height from baseline to study month 6 post is also reported. Subjects who were still moderately impaired after 6 months in their initial treatment arm were allowed to cross over and receive the treatments in the other arm so prior to month 6 no participants randomized to behavior arm were prescribed study medication.~This outcome includes all participants with 2+ growth assessments from the behavior therapy and ER stimulant arms. Doesn't include adaptive randomization arms (drug holiday, cal supplement, monitoring) as they didn't exist until 2nd randomization which did not occur until after this assessment period was over.~Height converted to z score to account for differences in age and gender. More negative values reflecting smaller incremental height gain.~If participant dropped out prior to month 6, then the last assessment point was used." (NCT01109849)
Timeframe: baseline to month 6

InterventionZ score (Mean)
Behavior Therapy0.00
ER Stimulant-0.035

[back to top]

Treatment Adherence for Caloric Supplement

percent of days caloric supplement were taken versus prescribed in caloric supplement arm (NCT01109849)
Timeframe: from entry to exit of caloric supplement arm

Interventionpercentage of days (Mean)
Weight Promotion Treatment- Caloric Supplement70

[back to top]

Medication Adherence

% of study days that study ADHD medication was taken when prescribed to be taken; behavior group could be prescribed medication if moderately impaired still after month 6. Once prescribed, all medication was prescribed to be taken 7 days a week except for in the drug holiday weight recovery arm. (NCT01109849)
Timeframe: denominator is number of days in study for which study med was prescribed

Intervention% of days dose taken as prescribed (Number)
Behavior Therapy68.1
ER Stimulant71.1

[back to top]

ADHD Symptoms- Parent Rated

sum of score on 10 item IOWA Conners with range from 0 to 30 and higher values indicating more symptoms. Collected at end point or last assessment point. (NCT01109849)
Timeframe: at month 30 or last collected assessment point

Interventionunits on a scale (Mean)
Behavior Therapy15.6
ER Stimulant15.2

[back to top]

ADHD Symptoms- Teacher Rated

sum of items on 10 item IOWA Conners with range from 0-30 and larger values indicating greater symptoms. Collected at endpoint or last assessment point. (NCT01109849)
Timeframe: month 30 or last assessment point

Interventionunits on a scale (Mean)
Behavior Therapy14.5
ER Stimulant13.8

[back to top]

Change in BMI z Score During Weight Recovery Period (Second Randomization) Based on Actual Usage

"difference in height z score from entry into weight recovery phase to exit from that phase (exact duration varied by participant). Randomization could not occur before month 6 (so max of 24 month duration) but could start as late as month 29 (equaling a 1 month duration) based on the pattern of zBMI change. In this post hoc analysis we grouped participants by what they did (caloric supplementation, drug holiday or monitoring) not what they were randomly assigned to. The most common change was from drug holiday to monitoring for participants who were not using medication on weekends before assignment to drug holiday (family stopped weekend med by own accord prior to 2nd randomization) so assignment to drug holiday did not alter actual frequency of use as was designed to.Therefore they were reclassified as monitoring as frequency of med use did not change.~Z score used to account for differences in age and gender between groups. Higher values reflect greater incremental BMI increase." (NCT01109849)
Timeframe: between 1 month and 24 months

InterventionZ score (Mean)
Caloric Supplementation0.248
Drug Holiday0.496
Monitoring0.260

[back to top]

Change in Height z Score by Actual Medication Usage

measures change in height z score from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44) used med <12.5% of the study duration (with most using not at all). The consistent med group (N=38 used) med for at least 87.5% of their time in the study with most using the entire time. The inconsistent med group (N=111), used medication between 12.5 to 87.5 of the time (mean time on med was 45% of the time in the study) The other 37 participants did not have one year of growth data so were excluded from this analysis. Z scores used to account for differences in age and gender between groups. More negative values reflecting a smaller incremental height gain. (NCT01109849)
Timeframe: baseline to month 30 or last assessment point

InterventionZ score (Mean)
Consistent Medication-0.248
Inconsistent Medication Group-0.113
Rare Medication Group0.042

[back to top]

Change in Height z Score During Weight Recovery Phase (Second Randomization)

"difference in height z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant.~Z scores used to account for differences in age and gender. More negative values reflecting less incremental height gain." (NCT01109849)
Timeframe: between 1 month and 24 months

InterventionZ score (Mean)
Caloric Supplementation-0.185
Drug Holiday-0.030
Monitoring-0.168

[back to top]

Change in Weight z Score by Actual Medication Usage

measures change in weight z score from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44) used med <12.5% of the study duration (with most using not at all). The consistent med group (N=38 used med for at least 87.5% of their time in the study with most using the entire time). The inconsistent med group (N=111, 27.5% used medication 45% of the time in the study. The other 37 participants did not have one year of growth data so were excluded from this analysis. Z scores used to account for differences in age and gender between groups. Higher values represent a greater incremental weight gain. (NCT01109849)
Timeframe: baseline to month 30 or last assessment point

InterventionZ score (Mean)
Consistent Medication-0.507
Inconsistent Medication Group-0.177
Rare Medication Group0.112

[back to top]

Difference in Height z Score During Weight Recovery Phase (Second Randomization) by Actual Usage

"difference in height z score from entry into weight recovery phase to exit from that phase (exact duration varied by participant). Randomization could not occur before month 6 (so max of 24 month duration) but could start as late as month 29 (equaling a 1 month duration) based on the pattern of zBMI change. In this post hoc analysis we grouped participants by what they did (caloric supplementation, drug holiday or monitoring) not what they were randomly assigned to. The most common change was from drug holiday to monitoring for participants who were not using medication on weekends before assignment to drug holiday (family stopped weekend med by own accord prior to 2nd randomization) so assignment to drug holiday did not alter actual frequency of use as was designed to.Therefore they were reclassified as monitoring as frequency of med use did not change.~Z score used to account for differences in age and gender between groups. Larger values reflect greater height change." (NCT01109849)
Timeframe: between 1 month and 24 months

InterventionZ score (Mean)
Caloric Supplementation-0.184
Drug Holiday-0.095
Monitoring-0.105

[back to top]

Change in Weight z Score During Weight Recovery Phase (Second Randomization)

"difference in weight z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant.~Z scores used to account for differences in age and gender. Larger values reflect a greater incremental weight gain." (NCT01109849)
Timeframe: 1 to 24 months duration

InterventionZ score (Mean)
Caloric Supplementation0.050
Drug Holiday0.262
Monitoring0.062

[back to top]

Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change

"Proportion of individuals improving on Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (CGIC) from baseline to 6 weeks; the CGIC is a 7-point Likert scale used to rate each patient with the following scores: marked worsening(7), moderate worsening (6), minimal worsening(5), no change(4), minimal improvement(3), moderate improvement(2), marked improvement(1). Ratings were based on an interview with the caregiver and an examination of the patient. The CGIC requires the clinician to consider a number of aspects of apathy, such as level of initiative, level of interest, and emotional engagement." (NCT01117181)
Timeframe: baseline to 6 weeks

Interventionpercentage of participants who improve (Number)
Methylphenidate21
Placebo3

[back to top]

Apathy Evaluation Scale (AES)

Change in score of Apathy Evaluation Scale from baseline to 6 weeks; the minimum score is 18; the maximum score is 72. Higher scores indicate more severe apathy. (NCT01117181)
Timeframe: baseline to 6 weeks

Interventionunits on a scale (Mean)
Methylphenidate-1.9
Placebo0.6

[back to top]

Digit Span

Change in Digit Span from baseline to 6 weeks. The Wechsler Adult Intelligence Scale - Revised Digit Span is used to assess auditory attention and working memory. Both forward and backward span is assessed. Both tests consist of six number sequences that the psychometrist reads aloud one at a time. After each sequence is read, the participant must repeat the digits back in the same (forward) or reverse (backward) order. Scores range from 0 to 16, with higher numbers indicate better functioning. (NCT01117181)
Timeframe: baseline and 6 weeks

Interventionunits on a scale (Mean)
Methylphenidate0.46
Placebo-0.07

[back to top]

Electrocardiogram (ECG)

Abnormal electrocardiogram results at 6 weeks (NCT01117181)
Timeframe: 6 weeks

Interventionparticipants with abnormal ECG (Number)
Methylphenidate20
Placebo15

[back to top]

Mini-Mental State Exam (MMSE)

Change in Mini-Mental State Exam score from baseline to 6 weeks; this cognitive test estimates of dementia severity. Domains included orientation, memory, working memory, naming, following verbal and written commands, spontaneously writing a sentence, and copying two overlapping pentagons. The minimum MMSE score is 0; the maximum MMSE score is 30. Lower MMSE scores indicate more severe cognitive impairment. (NCT01117181)
Timeframe: baseline and 6 weeks

Interventionunits on a scale (Mean)
Methylphenidate1.3
Placebo-0.3

[back to top]

Neuropsychiatric Inventory (NPI): Apathy Subscale

Change from baseline to 6 weeks in neuropsychiatric symptoms in apathy subscore. Frequency (ranges from 1=occasionally, less than once/week to 4 = very frequently, once or more/day or continuously) and severity (1=mild, 2=moderate, 3=severe) scales are scored based on responses from an informed caregiver involved in the patient's life. To obtain the NPI score, the severity score is multiplied by the frequency score. Range is 0 to 12. Larger numbers indicate more severe behavioral disturbance. (NCT01117181)
Timeframe: baseline to week 6

Interventionunits on a scale (Mean)
Methylphenidate-4.4
Placebo-2.6

[back to top]

Electrolytes

Percent of participants with abnormal electrolyte values at 6 weeks as assessed by local laboratory (NCT01117181)
Timeframe: 6 weeks

,
Interventionpercentage of participants (Number)
SodiumPotassiumChlorideBicarbonate
Methylphenidate3.7014.817.417.41
Placebo010.3410.3410.34

[back to top]

Vital Status

vital status as measured by death (NCT01117181)
Timeframe: vital status at 6 weeks

Interventionparticipants who died (Number)
Methylphenidate0
Placebo0

[back to top]

Change From Baseline in Heart Rate up to 5 Weeks

(NCT01127646)
Timeframe: Baseline, up to 5 weeks

Interventionbeats per minute (bpm) (Mean)
Atomoxetine-1.2
Osmotic-Release Oral System (OROS) Methylphenidate2.5

[back to top]

Change From Baseline in Systolic and Diastolic Blood Pressure up to 5 Weeks

(NCT01127646)
Timeframe: Baseline, up to 5 weeks

,
Interventionmillimeters of mercury (mm Hg) (Mean)
Diastolic Blood PressureSystolic Blood Pressure
Atomoxetine1.9-0.1
Osmotic-Release Oral System (OROS) Methylphenidate-1.5-3.7

[back to top]

Test of Silent Reading Fluency and Comprehension (TOSREC)

The TOSREC measures sentence-level comprehension and silent reading fluency. It is a sentence verification task; children are presented with a list of sentences and must tell whether they are true or false. Items are based on common knowledge (e.g., All apples are blue). The raw score is the number of items answered correctly in 3 minutes. Standardized with a mean of 100 and standard deviation of 15 are reported here. Higher scores represent a better outcome. (NCT01133847)
Timeframe: Week 16, End of Active Treatment Phase

Interventionstandardized scores (Least Squares Mean)
ADHD Treatment17.40
Intensive Reading Instruction17.70
Combined ADHD Treatment and Reading Instruction18.57

[back to top]

Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest

The WIAT-III is an individually-administered test of academic achievement. This subtest involves reading sentences and longer passages and then answering a set of literal and inferential comprehension questions about the text. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15. Higher scores represent a better outcome. (NCT01133847)
Timeframe: Week 16, End of Active Treatment Phase

Interventionstandardized scores (Least Squares Mean)
ADHD Treatment88.27
Intensive Reading Instruction84.70
Combined ADHD Treatment and Reading Instruction86.35

[back to top]

Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)

DIBELS ORF measures oral reading fluency in connected text. Students are presented with a passage on their grade level to read orally, and the score is the number of words of the passage read correctly in a one-minute period. Students in this study read two passages at each test administration, and the mean score for the two passages was the dependent variable analyzed. A research synthesis of studies reporting psychometric properties for DIBELS ORF determined that reliability coefficients in these studies exceeded .80 and that the measure demonstrated moderate to high concurrent and predictive validity across studies (Goffreda & DiPerna, 2010). (NCT01133847)
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-Up

,,
Interventionwords read correctly per minute (Mean)
16-Week OutcomesFollow-Up
ADHD Treatment53.6763.06
Combined ADHD Treatment and Reading Instruction53.8359.05
Intensive Reading Instruction50.7157.40

[back to top]

Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity

Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV (Diagnostic and Statistical Manual) ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008). (NCT01133847)
Timeframe: 16 weeks (end of Active Treatment phase), and follow-up

,,
Interventionunits on a scale (Least Squares Mean)
16-Week OutcomesFollow-up Outcomes
ADHD Treatment0.80.9
Combined ADHD Treatment and Reading Instruction0.60.7
Intensive Reading Instruction1.31.4

[back to top]

Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention

Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV (Diagnostic and Statistical Manual) ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008). (NCT01133847)
Timeframe: 16 weeks (end of Active Treatment phase), and follow-up

,,
InterventionUnits on a scale (Least Squares Mean)
16-Week OutcomesFollow-up Outcomes
ADHD Treatment1.11.3
Combined ADHD Treatment and Reading Instruction1.01.0
Intensive Reading Instruction1.71.6

[back to top]

Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity

Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008). (NCT01133847)
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-Up

,,
InterventionUnits on a scale (Least Squares Mean)
16-Week OutcomesFollow-up
ADHD Treatment0.70.8
Combined ADHD Treatment and Reading Instruction0.80.8
Intensive Reading Instruction1.11.1

[back to top]

Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention

Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008). (NCT01133847)
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-Up

,,
InterventionUnits on a scale (Least Squares Mean)
16-week OutcomesFollow-Up
ADHD Treatment1.21.5
Combined ADHD Treatment and Reading Instruction1.41.5
Intensive Reading Instruction1.71.9

[back to top]

Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency

The TOWRE Phonemic Decoding Efficiency measures the student's fluent decoding of nonsense words that follow the spelling rules of the English language. The raw score is the number of nonwords identified correctly in 45 seconds. Standardized scores with a mean of 100 and standard deviaion of 15 are reported here. Higher scores represent a better outcome. (NCT01133847)
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-Up

,,
Interventionstandardized scores (Least Squares Mean)
16-Week OutcomesFollow-Up
ADHD Treatment80.481.49
Combined ADHD Treatment and Reading Instruction82.984.32
Intensive Reading Instruction83.484.50

[back to top]

Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency

The TOWRE Sight Word Efficiency subtest measures fluency of reading words in lists. The raw score is the number of words or nonwords identified correctly in 45 seconds. Standard scores with a mean of 100 and standard deviaion of 15 are reported here. Higher scores represent a better outcome. (NCT01133847)
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-Up

,,
Interventionstandardized scores (Least Squares Mean)
16-Week OutcomesFollow-Up
ADHD Treatment80.883.57
Combined ADHD Treatment and Reading Instruction83.584.15
Intensive Reading Instruction82.785.04

[back to top]

Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest

The WIAT-III is an individually-administered test of academic achievement. In the Pseudoword Decoding subtest students read a list of increasingly difficult nonsense words as a test of their ability to use phonics to decode unknown words. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15. Higher scores represent a better outcome. (NCT01133847)
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-Up

,,
Interventionstandardized scores (Least Squares Mean)
16-Week OutcomesFollow-Up
ADHD Treatment78.377.1
Combined ADHD Treatment and Reading Instruction83.081.9
Intensive Reading Instruction83.882.6

[back to top]

Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest

The WIAT-III is an individually-administered test of academic achievement. In the Word Reading subtest students read a list of increasingly difficult words. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15. (NCT01133847)
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-Up

,,
Interventionstandardized scores, M=100, SD = 15 (Least Squares Mean)
16-Week OutcomesFollow-Up
ADHD Treatment76.977.1
Combined ADHD Treatment and Reading Instruction79.978.8
Intensive Reading Instruction79.078.1

[back to top]

Rate of Receiving Clinically Definite Answer Regarding the Ability of Experimental Treatment to Reduce Fatigue Using the N-1-T Design

Efficacy of the N-1-T design is defined as patient providing a clinically definite answer regarding the ability of MPH to reduce fatigue.Based on the definition of the outcome being evaluated, aggregation of data for all participants is appropriate. (NCT01164956)
Timeframe: 18 days

Interventionparticipants (Number)
M-P, P-M, M-P0
P-M, P-M, M-P1
P-M, M-P, M-P0

[back to top]

Completion Rate of Two Treatment Pairs Using the N-1-T Design

The feasibility of conducting an N-1-T to evaluate MPH for cancer-related fatigue will be determined by the completion rate of two MPH-placebo pairs. (NCT01164956)
Timeframe: 18 days

Interventionparticipants (Number)
All Participants1

[back to top]

Change Over Treatment Pairs in pedsFACIT-F Score

The pediatric Functional Assessment of Chronic Illness Therapy-Fatigue (pedsFACIT-F) is an 11-item instrument derived from a comprehensive pediatric item bank that assesses fatigue. (Lai et al. Pediatr Hematol Oncol 2007) Measuring fatigue over the past 7 days in a population of pediatric cancer patients, the pedsFACIT-F instrument has a score ranging from 0-44, with a higher score meaning more fatigue. A minimally important difference (MID) was established as 4.7 points. (NCT01164956)
Timeframe: The pedsFACIT-Fwas administered at baseline and at the end of each treatment pair (TP) and related change in score was calculated for each period: baseline to end of TP 1 (day 6); end of TP 1 to end of TP 2 (day 12); end of TP 2 to end of TP 3 (day 18).

Interventionunits on a scale (Number)
Change from Baseline to end of Treatment Pair 1Change from end of Treatment Pair 1 to Pair 2Change from end of Treatment Pair 2 to Pair 3
P-M, P-M, M-P420

[back to top]

Maximum Plasma Concentration (Cmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD)

Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. (NCT01183234)
Timeframe: predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose

Interventionng/ml (Least Squares Mean)
Equasym XL14.9
Metadate CD14.7

[back to top]

Area Under the Steady-state Plasma Concentration-time Curve (AUC 0-t) for Methylphenidate Hydrochloride (MPH) Using Two Different Formulations (Equasym XL and Metadate CD)

AUC 0-t is the area under the plasma concentration versus time curve from time 0 to the time of last quantifiable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. (NCT01183234)
Timeframe: predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose

Interventionng*h/ml (Least Squares Mean)
Equasym XL133
Metadate CD127

[back to top]

Time of Maximum Plasma Concentration (Tmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD)

Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. (NCT01183234)
Timeframe: predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose

Interventionhours (Median)
Equasym XL5.0
Metadate CD5.0

[back to top]

Attention Deficit / Hyperactivity Disorder Total Sum Score of All 18 ADHD Symptom Items

"Parent and teacher Vanderbilt ADHD Rating Scales - Attention Deficit / Hyperactivity Disorder Total sum score of all 18 ADHD symptom items - range equals 0-54~O - No ADHD symptoms 54 - Highest ADHD symptoms" (NCT01238822)
Timeframe: end of first week, end of second week, end of third week, end of fourth week. Total of 4 weeks.

InterventionScore (Mean)
Placebo26.54
Low Dosage25
Medium Dosage18.94
High Dosage18.46

[back to top]

Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3)

"Change in ADHD-RS-IV Total Score from Baseline (Visit 2) to end of Double Blind Phase (Visit 3); [Calculations of baseline values (Visit 2) minus end of Double Blind values (Visit 3), higher differences means better outcomes].~Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV): The home version of the ADHD-RS-IV comprising symptoms of ADHD was used. This 18-item scale incorporates each of the ADHD symptoms regardless of assigned subtype. Trained clinicians administered questionnaire to parents. Scoring was based on symptom severity on a 4-point scale: 0=never or rarely, 1=sometimes, 2=often, and 3=very often. The Total Score is the sum of the scores for all 18 items, and could range from 0 (no impairment) to 54 (maximal impairment)." (NCT01239030)
Timeframe: From baseline (visit 2) to end of of Double-Blind phase (visit 3)

Interventionunits on a scale (Mean)
10 mg9.3
15 mg11.2
20 mg12.3
40 mg13.2
Placebo5.1

[back to top]

Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment

SDS, a 5-self-rated questionnaire to measure the extent a pt's disability due to an illness/health problem interferes with work/school, social life/leisure, family life/home. First 3 items, pts are asked how their symptoms disrupted their reg. activities over the past 7d in ea. using a scale from 0(not at all)-10(extremely) Ea. subscale(work disability, social life disability, family life disability) can be scored independently or combined into a total score(sum of the non-missing responses for items 1-3)from 0-30,higher scores indicate significant functional impairmt. Subscale scores >5 suggest impairment in that subscale area. Final 2 items ask pts about the # of days their symptoms caused them to miss school/work and # of days their symptoms caused them to be underproductive at school/work.(These items were not included in the total score.) Before responding to SDS items 1-3, pts were verbally instructed to recall the past 7d, items 4-5 refer to the last week w/in the item wording. (NCT01259492)
Timeframe: Baseline 1 to End of Period 1 (Week 9)

InterventionUnits on a Scale (Mean)
Ritalin LA 40 mg6.4
Ritalin LA 60 mg4.7
Ritalin LA 80 mg6.1
Placebo2.9

[back to top]

Change From Baseline of Period 1 (Baseline 1) to End of Period 1 on Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score by Treatment

"Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The DSM-IV ADHD RS total score was calculated as the sum of the Inattentive and the Hyperactive-Impulsive subscores. The 18 items are rated from 0 (Never) to 4 (Very often). The total score ranges from 0(least symptomatic) to 72 (most symptomatic). Decrease in the DSM-IV ADHD RS total score indicates improvement, therefore a greater decrease (change at Final Visit compared to baseline) indicates a greater improvement in ADHD symptoms. 30% improvement: 100×(DSM-IV ADHD RS total score during Period 1 - DSM-IV ADHD RS total score at randomization(visit 2))/DSM-IV ADHD RS total score at randomization (visit 2) <= - 30%." (NCT01259492)
Timeframe: Baseline 1 to End of Period 1 (Week 9)

InterventionUnits on a Scale (Mean)
Ritalin LA 40 mg16.0
Ritalin LA 60 mg14.7
Ritalin LA 80 mg16.8
Placebo9.7

[back to top]

Change From Baseline Period 3 (Baseline 2) to End of Period 3 in ASRS Total Score by Treatment

"The ASRS is a self-rating scale designed to assess ADHD symptoms in adults and is now part of the World Health Organization Composite International Diagnostic Interview. It consists of 18 items written to reflect the DSM-IV diagnostic criteria for ADHD and are rated from 0 (Never) to 4 (Very often). The total score ranges from 0 to 72." (NCT01259492)
Timeframe: Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)

InterventionUnits on a scale (Mean)
Ritalin LA 40 mg3.0
Ritalin LA 60 mg3.8
Ritalin LA 80 mg3.0
Placebo8.0

[back to top]

Number of Participants With Clinical Global Impression - Improvement Scale Severity of Illness (CGI-S) Rating at the End of Period 2 (Visit 13/ Week 14)

"CGI-S assesses the patient's current illness state. CGI-S consists of 7 ratings that range from 1 = normal, not at all ill , 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients" (NCT01259492)
Timeframe: Baseline 1 to End of Period 2 (Week 14)

Interventionnumber of participants (Number)
Normal, not ill at allborderline mentally illmildly illmoderately illmarkedly illseverely illamong the most extremely ill patients
ALL Ritalin LA Group9115119350700

[back to top]

Percentage of Participants With Treatment Failures During Period 3

Treatment failure is defined as: 100×(DSM-IV ADHD RS total score during Period 3 - DSM-IV ADHD RS total score at re-randomization (visit 13))/DSM-IV ADHD RS total score at re-randomization (visit 13) >= 30% AND 100×(DSM-IV ADHD RS total score during Period 3 - DSM-IV ADHD RS total score at randomization (visit 2))/DSM-IV ADHD RS total score at randomization (visit 2) > - 30%. The ADHD-RS-IV is an 180item clinician rated scale to assess ADHD by DSM-IV-TR, defined criteria using symptom terminology appropriate for the adult population. Each item pertains to inattention (odd-numbered) or hyperactivity/impulsivity (even-numbered) and is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). A total added score can range from 0-54 (NCT01259492)
Timeframe: Baseline Period 1 (Baseline 1) and Baseline Period 3 (Baseline 2) to End of Week 40

,,,
InterventionPercentage of participants (Number)
Without Imputation - Treatment failureWithout Imputation - Not treatment failureWithout Imputation missing failure statusWith Imputation - Treatment failureWith Imputation - Not treatment failure
Placebo43.531.325.249.650.4
Ritalin LA 40 mg11.854.533.616.483.6
Ritalin LA 60 mg20.350.029.726.673.4
Ritalin LA 80 mg17.556.125.420.279.8

[back to top]

Number of Participants With Clinical Global Impression - Improvement Scale (CGI-I) Rating at the End of Period 2 (Visit 13/ Week 14)

"CGI-I assesses the overall change of illness relative to baseline. CGI-I consists of 7 ratings that range from 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change from baseline, 5 = minimally worse, 6 = much worse 7 = very much worse" (NCT01259492)
Timeframe: Baseline 1 to End of Period 2 (Week 14)

Interventionnumber of participants (Number)
very much improvedmuch improvedminimally improvedno changeminimally worsemuch worsevery much worse
ALL Ritalin LA Group1952304216720

[back to top]

Change From Baseline 1 in DSM-IVADHD RS Total Score, SDS Total Score, The Conners' Adult ADHD Rating Scale Observer Short Version (CAARS-O:S) Total Score and Adult Self-Report Scale (ASRS) Total Score at the End of Period 2 (Visit 13/ Week 14)

"DSM-IV ADHD RS consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The SDS is a five-item, self-rated questionnaire that has been used widely in clinical trials and observational studies. CAARS-O: S consists of 26 items and 6 subscales: Inattention/Memory Problems, Hyperactivity/Restlessness, Impulsivity/Emotional Lability, Problems with Self-Concept, ADHD Index, and Inconsistency Index and is rated by someone close to the patient in their daily life such as a spouse, friend, or coworker. The Adult Self-Report Scale (ASRS) is a self-rating scale designed to assess Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms. The 18 items are written to reflect the DSM-IV diagnostic criteria for ADHD and are rated from 0 (Never) to 4 (Very often)." (NCT01259492)
Timeframe: Baseline 1 to End of Period 2 (Week 14)

InterventionScore on Scale (Mean)
DSM-IV ADHD RS total score n=494SDS total score n=480CAARS-O:S total score n=411ASRS total score n=490
ALL Ritalin LA Group24.810.115.523.2

[back to top]

Percentage of Patients With Improvement on Clinical Global Impression - Improvement Scale (CGI-I) From Baseline Period 1 (Baseline 1) to End of Period 1

"On the CGI-I scale, a lower score reflects greater improvement between 1 and 3, a score of 4 is no change, scores higher than 4 reflect worsening. The CGI-I consists of 7 ratings that range from 1 = Very much improved to 7 =Very much worse. Improvement on the CGI-I scale is defined as a visit rating of 1 very much improved or 2 much improved on the CGI-I scale. Percentage has been calculated from the evaluable patients (N) as Percentage = n/N * 100." (NCT01259492)
Timeframe: Baseline 1 to End of Period 1 (Week 9)

InterventionPercentage of Patients (Number)
Ritalin LA 40 mg56.3
Ritalin LA 60 mg54.8
Ritalin LA 80 mg57.1
Placebo31.7

[back to top]

Number of Patients With Worsening on CGI-S Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment

"CGI-S assesses the patient's current illness state. CGI-S consists of 7 ratings that range from 1 = normal, not at all ill , 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients" (NCT01259492)
Timeframe: Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)

InterventionParticipants (Number)
Ritalin LA 40 mg39
Ritalin LA 60 mg50
Ritalin LA 80 mg35
Placebo72

[back to top]

Number of Patients With Worsening on CGI-I Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment

"On the CGI-I scale, a lower score reflects greater improvement between 1 and 3, a score of 4 is no change, scores higher than 4 reflect worsening. The CGI-I consists of 7 ratings that range from 1 = Very much improved to 7 =Very much worse. Improvement on the CGI-I scale is defined as a visit rating of 1 very much improved or 2 much improved on the CGI-I scale." (NCT01259492)
Timeframe: Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)

Interventionparticipants (Number)
Ritalin LA 40 mg6
Ritalin LA 60 mg13
Ritalin LA 80 mg5
Placebo21

[back to top]

Change From Baseline Period 3 (Baseline 2) to End of Period 3 on SDS Total Score by Treatment

"The Sheehan Disability Scale (SDS) is a self-rating scale designed to assess the extent to which the patient's work social life/leisure activities and home life are impaired by his or her symptoms. The scale generates 4 scores: a work disability score, a social life disability score, a family life disability score and a total score. To get a total score the 3 individual scores (work: social life: family life) are totaled. The maximum possible score is 30 The higher the score, the more impaired a patient's work, social life, family life is." (NCT01259492)
Timeframe: Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)

InterventionUnits on a Scale (Mean)
Ritalin LA 40 mg2.1
Ritalin LA 60 mg2.3
Ritalin LA 80 mg2.0
Placebo5.0

[back to top]

Change From Baseline Period 3 (Baseline 2) to End of Period 3 on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale ADHD RS Total Score by Treatment

The ADHD-RS-IV is an 180 item clinician rated scale to assess ADHD by DSM-IV-TR, defined criteria using symptom terminology appropriate for the adult population. Each item pertains to inattention (odd-numbered) or hyperactivity/impulsivity (even-numbered) and is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). A total added score can range from 0-54. (NCT01259492)
Timeframe: Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)

InterventionUnits on a Scale (Mean)
Ritalin LA 40 mg3.0
Ritalin LA 60 mg5.1
Ritalin LA 80 mg2.6
Placebo9.3

[back to top]

Change From Baseline Period 3 (Baseline 2) to End of Period 3 in Conners Adult ADHD Rating Scales Observer: Short Version (CAARS-O:S:) Total Score by Treatment

"CAARS is an instrument to assess ADHD symptoms and behaviors in adults. This study utilizes the Observer Short Version (CAARS-O: S), consisting of 26 items and 6 subscales: Inattention/Memory Problems, Hyperactivity/Restlessness, Impulsivity/Emotional Lability, Problems with Self-Concept, ADHD Index (to distinguish ADHD adults from non-clinical adults), and Inconsistency Index (to identify random or careless responding) and is rated by someone close to the patient in their daily life such as a spouse, friend, or coworker. The observer is asked to notice the patient carefully and decide how much or how frequently each of the 26 items of the scale describes the patient recently. The response to every question in increasing order of severity is not at all, never = 0; Just a little, once in a while = 1; Pretty much, often = 2; Very much, very frequently = 3. The total score combined from all the 26 items ranges from 0 to 88." (NCT01259492)
Timeframe: Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)

InterventionUnits on a scale (Mean)
Ritalin LA 40 mg-2.7
Ritalin LA 60 mg1.7
Ritalin LA 80 mg-0.2
Placebo2.9

[back to top]

Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task

The task is a rapid-presentation, probablistic gain/loss design. Reversal learning is assessed by means of a simple computerized card game. The paradigm utilizes a visual discrimination task where subjects have to learn to respond to outcome contingencies between two stimuli (high probability gain/low probability loss vs. low probability gain/high probability loss). At an unsignaled time point halfway into testing, the contingencies are reversed; the losing card becomes the winning card and the winning card becomes the losing one. Visual feedback regarding win or loss ($0.20) is provided after each trial and the cumulative total gained/lost is also shown. Using trial-and-error feedback, subjects have to discover which of the two patterns is correct and are instructed to win as much money as possible. The duration of the task is approximately 10 minutes, consisting of 80 trials. (NCT01267292)
Timeframe: Monday of week 4

Interventionnumber of perseverative errors (Mean)
Buspirone Plus Methylphenidate10.88235
Placebo for Buspirone Plus Methylphenidate14.69598

[back to top]

Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task

The task is a rapid-presentation, probablistic gain/loss design. Reversal learning is assessed by means of a simple computerized card game. The paradigm utilizes a visual discrimination task where subjects have to learn to respond to outcome contingencies between two stimuli (high probability gain/low probability loss vs. low probability gain/high probability loss). At an unsignaled time point halfway into testing, the contingencies are reversed; the losing card becomes the winning card and the winning card becomes the losing one. Visual feedback regarding win or loss ($0.20) is provided after each trial and the cumulative total gained/lost is also shown. Using trial-and-error feedback, subjects have to discover which of the two patterns is correct and are instructed to win as much money as possible. The duration of the task is approximately 10 minutes, consisting of 80 trials. (NCT01267292)
Timeframe: baseline

Interventionnumber of perseverative errors (Mean)
Buspirone Plus Methylphenidate14.41176
Placebo for Buspirone Plus Methylphenidate10.625

[back to top]

Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)

"Subjects are required to respond selectively to a series of stimuli (e.g., numbers) presented briefly for 500 ms with a 500 ms intertrial interval (ITI). Increases in false alarm rates are interpreted as failures in response inhibition. Five digit numbers are presented on a computer screen every 500 ms sec. Subjects are instructed to respond when the first number of a set was repeated. A hit response is scored when a subject correctly responds. Distracters consist of five-digit numbers that are completely different from the first, and numbers in which four of the five digits match the original, with the non-matching number occurring randomly across the five digit places. A response to the number with 4 of 5 digits correct is scored as a false alarm. The a-prime value reflects the ability of the participant to discriminate between signal (Go stimulus) and noise (No-Go stimulus) and ranges from 0.5 (chance level) to 1 (perfect discrimination)." (NCT01267292)
Timeframe: Thursday of week 1

Interventiona-prime (Mean)
Buspirone Plus Methylphenidate0.8673529
Placebo for Buspirone Plus Methylphenidate0.8551562

[back to top]

Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)

"Subjects are required to respond selectively to a series of stimuli (e.g., numbers) presented briefly for 500 ms with a 500 ms intertrial interval (ITI). Increases in false alarm rates are interpreted as failures in response inhibition. Five digit numbers are presented on a computer screen every 500 ms sec. Subjects are instructed to respond when the first number of a set was repeated. A hit response is scored when a subject correctly responds. Distracters consist of five-digit numbers that are completely different from the first, and numbers in which four of the five digits match the original, with the non-matching number occurring randomly across the five digit places. A response to the number with 4 of 5 digits correct is scored as a false alarm. The a-prime value reflects the ability of the participant to discriminate between signal (Go stimulus) and noise (No-Go stimulus) and ranges from 0.5 (chance level) to 1 (perfect discrimination)." (NCT01267292)
Timeframe: Monday of week 4

Interventiona-prime (Mean)
Buspirone Plus Methylphenidate0.8569118
Placebo for Buspirone Plus Methylphenidate0.8695347

[back to top]

Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task

The task is a rapid-presentation, probablistic gain/loss design. Reversal learning is assessed by means of a simple computerized card game. The paradigm utilizes a visual discrimination task where subjects have to learn to respond to outcome contingencies between two stimuli (high probability gain/low probability loss vs. low probability gain/high probability loss). At an unsignaled time point halfway into testing, the contingencies are reversed; the losing card becomes the winning card and the winning card becomes the losing one. Visual feedback regarding win or loss ($0.20) is provided after each trial and the cumulative total gained/lost is also shown. Using trial-and-error feedback, subjects have to discover which of the two patterns is correct and are instructed to win as much money as possible. The duration of the task is approximately 10 minutes, consisting of 80 trials. (NCT01267292)
Timeframe: Thursday of week 1

Interventionnumber of perseverative errors (Mean)
Buspirone Plus Methylphenidate11.78154
Placebo for Buspirone Plus Methylphenidate14.13049

[back to top]

Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)

"Subjects are required to respond selectively to a series of stimuli (e.g., numbers) presented briefly for 500 ms with a 500 ms intertrial interval (ITI). Increases in false alarm rates are interpreted as failures in response inhibition. Five digit numbers are presented on a computer screen every 500 ms sec. Subjects are instructed to respond when the first number of a set was repeated. A hit response is scored when a subject correctly responds. Distracters consist of five-digit numbers that are completely different from the first, and numbers in which four of the five digits match the original, with the non-matching number occurring randomly across the five digit places. A response to the number with 4 of 5 digits correct is scored as a false alarm. The a-prime value reflects the ability of the participant to discriminate between signal (Go stimulus) and noise (No-Go stimulus) and ranges from 0.5 (chance level) to 1 (perfect discrimination)." (NCT01267292)
Timeframe: baseline

Interventiona-prime (Mean)
Buspirone Plus Methylphenidate0.8327941
Placebo for Buspirone Plus Methylphenidate0.8498438

[back to top]

Diastolic Blood Pressure

"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.~Diastolic blood pressure is the blood pressure when the heart muscle is between beats." (NCT01267292)
Timeframe: 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3

,
InterventionmmHg (Mean)
15mg Methylphenidate30mg Methylphenidate60mg Methylphenidate0mg Methylphenidate
Buspirone Plus Methylphenidate74.7272774.566847372.92513
Placebo for Buspirone Plus Methylphenidate76.7159178.5340975.562576.88636

[back to top]

Systolic Blood Pressure

"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.~Systolic blood pressure is the amount of pressure in the arteries during contraction of the heart muscle." (NCT01267292)
Timeframe: 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3

,
InterventionmmHg (Mean)
15mg Methylphenidate30mg Methylphenidate60mg Methylphenidate0mg Methylphenidate
Buspirone Plus Methylphenidate118.0856114.8396114.3904114.7914
Placebo for Buspirone Plus Methylphenidate115.9205120.4545113.6932115.6932

[back to top]

Subjective Effects as Assessed by Score on the Vigor Subscale of the Profile of Mood States (POMS)

"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.~The POMS is a self-rating measure of current mood, consisting of six subscales demonstrated to be sensitive to a range of acute drug effects, including amphetamine, cocaine, and caffeine. The six subscales are: depression, vigor, confusion, tension, anxiety, and fatigue. A 37-item short form of the POMS was used, which correlates highly with the full scale. The vigor subscale is reported, and the vigor subscale score ranges from 0 to 28, with 28 representing the highest score for that mood state. The higher the value, the worse the outcome." (NCT01267292)
Timeframe: 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3

,
Interventionunits on a scale (Mean)
15mg Methylphenidate30mg Methylphenidate60mg Methylphenidate0mg Methylphenidate
Buspirone Plus Methylphenidate4.6096269.9243244.7459466.16129
Placebo for Buspirone Plus Methylphenidate3.7701156.2685715.8742865.735632

[back to top]

Risky Decision Making as Assessed by Score on the Risky Decision Making Task

"The mean score over all 4 time points is reported in this outcome measure (i.e., a summary score is reported). Each subject contributed 1 data point for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 20 data points per dose level per arm.~The risky decision making task provides subjects with three choice options on each of 100 repeated trials. Options are low, moderate, and high risk, based on variance and probability in gain/loss amounts. The low risk option is more adaptive over many trials. The outcome measure is a risk index (ranging from 0.33 to 100) that factors in tolerance for variability and amount of gains and losses across the three options. 100 is highest risk. 0.33 is lowest risk." (NCT01267292)
Timeframe: 1 time a day on Wednesday and Friday of week 2; 1 time a day on Monday and Wednesday of week 3

,
Interventionunits on a scale (Mean)
15mg Methylphenidate30mg Methylphenidate60mg Methylphenidate0mg Methylphenidate
Buspirone Plus Methylphenidate9.12666710.771678.94626311.415
Placebo for Buspirone Plus Methylphenidate10.073969.6993337.8898258.715333

[back to top]

Heart Rate

"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.~Heart rate is the measure of heart beats per minute." (NCT01267292)
Timeframe: 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3

,
Interventionbeats per minute (Mean)
15mg Methylphenidate30mg Methylphenidate60mg Methylphenidate0mg Methylphenidate
Buspirone Plus Methylphenidate66.8449266.4331666.3636463.21925
Placebo for Buspirone Plus Methylphenidate67.7556868.2613669.1306869.60795

[back to top]

Attentional Bias as Assessed by Score on the Stroop Task

"The mean score over all 4 time points is reported in this outcome measure (i.e., a summary score is reported). Each subject contributed 1 data point for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 20 data points per dose level per arm.~The Stroop task assesses attentional biases to cocaine-related (drug-related) and rewarding (non-drug related) stimuli vs. neutral stimuli. Participants are instructed to respond to words shown in different colors on the screen, by pressing as quickly and accurately as possible on one of three colored buttons. Attentional bias is measured as the difference in reaction times on cocaine vs. neutral words. The reported score is a difference score in milliseconds (cocaine minus neutral), in which positive means slower to respond to cocaine and thus greater attentional bias, and negative means no attentional bias to cocaine words." (NCT01267292)
Timeframe: 1 time a day on Wednesday and Friday of week 2; 1 time a day on Monday and Wednesday of week 3

,
Interventionmilliseconds (Mean)
15 mg methylphenidate30 mg methylphenidate60 mg methylphenidate0 mg methylphenidate
Buspirone Plus Methylphenidate-13.90333-9.36126915.591674.688844
Placebo for Buspirone Plus Methylphenidate27.11815.3540723.2806341.22625

[back to top]

"Subjective Effects as Assessed by the Elated Subscale of the Visual Analogue Scale (VAS)"

"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.~The VAS presents 100-mm horizontal lines labeled with an adjective: stimulated, high, anxious, elated, hungry, and nauseated. The elated subscale is reported, and this sub scale is anchored by not at all (0) on the left and extremely (100) on the right, with a score range of 0-100. The higher the score, the worse the outcome." (NCT01267292)
Timeframe: 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3

,
Interventionunits on a scale (Mean)
15mg Methylphenidate30mg Methylphenidate60mg Methylphenidate0mg Methylphenidate
Buspirone Plus Methylphenidate11.4812828.7297314.5459521.95676
Placebo for Buspirone Plus Methylphenidate19.5344821.4204521.8114314.89017

[back to top]

"Subjective Effects as Assessed by Score on the Feel High Subscale of the Drug Effects Questionnaire (DEQ)"

"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.~The DEQ is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: Feel Drug, Feel High, Like Drug, and Want More. The Feel High subscale is reported, and this subscale is scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome." (NCT01267292)
Timeframe: 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3

,
Interventionunits on a scale (Mean)
15mg Methylphenidate30mg Methylphenidate60mg Methylphenidate0mg Methylphenidate
Buspirone Plus Methylphenidate9.32258112.713515.88648610.39785
Placebo for Buspirone Plus Methylphenidate9.17816110.788579.8465914.508671

[back to top]

Comparison Following Treatment Between Drug and Placebo Using Evaluation by SKAMP Combined, Attention, and Deportment Scales

"Comparison of Swanson, Kotkin, Alger, M-Flynn and Pelham (SKAMP) Combined, Attention, and Deportment Scales following drug dose versus placebo.~The SKAMP scale is a validated rating scale that assesses behavioral symptoms of ADHD in a classroom setting using a 7-point impairment scale (0 = none through 6 = maximal impairment). The SKAMP total score comprises 13 items, with individual total scores ranging from 0 to 78 (lower scores mean better outcome). The SKAMP-D subscale evaluates deportment, including interacting with other children, interacting with adults, remaining quiet according to classroom rules, and staying seated according to classroom rules. The SKAMP-A subscale is a measure of attention and evaluates getting started on assignments, sticking with tasks, attending to an activity, and making activity transitions. The SKAMP quality of work subscale includes 3 items: completing assigned work, performing work accurately, and being careful and neat while writing or drawing." (NCT01269463)
Timeframe: Average over all post-dose time points (1.0, 2.0, 3.0, 4.5, 6.0, 7.5, 9.0, 10.5, and 12 hours)

Interventionunits on a scale (Mean)
Methylphenidate HCl ER Capsules1.46
Capsule Without Active Drug2.03

[back to top]

Comparison Following Treatment With Drug or Placebo Using PERMP (Permanent Product of Arithmetic) Evaluations

"Comparison of PERMP measurement scores following drug dose versus placebo (math-correct).~The Permanent Product Measure of Performance (PERMP), is a 5-page test consisting of 80 math problems per page (total of 400 problems) and evaluates effortful performance in the classroom as a measure of efficacy. Participants are instructed to work at their seats and to complete as many problems as possible in 10 minutes. The appropriate level of difficulty for each student was determined previously based on results of a math pretest administered at screening. Performance was evaluated using PERMP-A) and PERMP-C scores.~Measures obtained from these tests include the number of problems attempted (Math-Attempted; PERMP-A) and the number of problems answered correctly (Math-Correct; PERMP-C). Higher scores are better. The responses are reviewed by comparing them to an answer template, and they are triple-checked for accuracy" (NCT01269463)
Timeframe: 12 hours post-dose

,
InterventionNumber of Problems (Least Squares Mean)
PERMP-APERMP-C
Capsule Without Active Drug80.3074.80
Methylphenidate HCl ER Capsules92.8586.85

[back to top]

Change From Extension Baseline (Week 40) to End of Study (Week 66) on Sheehan Disability Scale (SDS) Total Score

SDS,5-self-rated questionnaire to measure the extent a pt's disability due to an illness/health problem interferes with work/school,social life/leisure,family life/home. First 3 items, pts are asked how their symptoms disrupted their regular activities over the past 7d in each using a scale from 0(not at all)-10(extremely) Each subscale(work disability, social life disability, family life disability)can be scored independently or combined into a total score(sum of the non-missing responses for items 1-3)from 0-30,higher scores indicate significant functional impairment. Subscale scores>5 suggest impairment in that subscale area. Final 2 items ask pts about the # of days their symptoms caused them to miss school/work and # of days their symptoms caused them to be underproductive at school/work.(These items were not included in the total score.) Before responding to SDS items 1-3, pts were verbally instructed to recall the past 7d, items 4-5 refer to the last week w/in the item wording. (NCT01338818)
Timeframe: week 40 - week 66

InterventionScores on a scale (Mean)
Ritalin LA-4.8

[back to top]

Number of Participants With Adverse Events, Serious Adverse Events and Deaths.

Adverse Events, Serious Adverse Events and Deaths were monitored from week 40 to week 66. (NCT01338818)
Timeframe: Week 40 - Week 66

Interventionparticipants (Number)
Adverse Events (Serious and Non Serious)Serious Adverse EventsDeaths
Ritalin LA20820

[back to top]

Change From Extension Baseline (Week 40) to End of Study (Week 66) in on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score.

"Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The DSM-IV ADHD RS total score was calculated as the sum of the Inattentive and the Hyperactive-Impulsive subscores. The 18 items are rated from 0 (rarely or never) to 3 (Very often). The total score ranges from 0 to 54. Decrease in the DSM-IV ADHD RS total score indicates improvement, therefore a greater decrease (change at Final Visit compared to baseline) indicates a greater improvement in ADHD symptoms. Last Observation Carried Forward (LOCF) applied for each patient with data in extension period. If no post-baseline is available, it is considered as missing." (NCT01338818)
Timeframe: week 40 - week 66

Interventionscores on a scale (Mean)
Ritalin LA-7.2

[back to top]

Average Daytime Napping Minutes in a Week

Outcome measure was the total of daytime napping minutes in a week as assessed by participant sleep diaries (NCT01348607)
Timeframe: 29 days

Interventionminutes (Mean)
Arm I - Methylphenidate Hydrochloride36.7

[back to top]

Adverse Events

Adverse events assessed at all subject visits by interviews with the subject and the subject's parent/ primary caregiver. (NCT01348607)
Timeframe: 29 days

Interventionevents (Number)
Arm I - Methylphenidate Hydrochloride1

[back to top]

Efficacy Measured by Mean Change From Baseline to Endpoint on Clinical Global Impression (CGI) Scale

The Clinical Global Impression (CGI) is a 3-item observer-rated scale that measures illness severity (CGIS), global improvement or change (CGIC) and therapeutic response (CGIE). Scores range from 0 to 7 on each subscale. Total scores range from 0 to 21. T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. A reduction in score indicates improvement. (NCT01399827)
Timeframe: baseline to 12 weeks

InterventionT-Score (Number)
Omega-3 Fatty Acids5
Placebo1

[back to top]

Efficacy Measured by Mean Change From Baseline to Endpoint on the Global Assessment of Functioning (GAF) Scale

The Global Assessment of Functioning (GAF) scale is used to rate how serious a mental illness may be. Lower scores on this scale indicate a lower level of functioning and higher severity of symptoms. Total scores range from 0 to 100. (NCT01399827)
Timeframe: baseline to 12 weeks

Interventionunits on a scale (Number)
Omega-3 Fatty Acids11
Placebo8

[back to top]

Efficacy Measured by Mean Change From Baseline to Endpoint on Adult ADHD Investigator Rating Scale (AISRS) Total Score

"The Adult ADHD Investigator Rating Scale (AISRS) measures ADHD symptoms in adults. This scale is an investigator rated scale. Higher scores on this scale indicate more severe ADHD-like symptoms. Patients symptoms are rated as never, rarely, sometimes, often, or very often by the investigator. Total score ranges from 0 to 54. T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. A reduction in score indicates improvement." (NCT01399827)
Timeframe: baseline to 12 weeks

InterventionT-Score (Number)
Omega-3 Fatty Acids-14
Placebo-23

[back to top]

Mean Change From Baseline to Endpoint on the BRIEF-A Emotional Control Scale

The BRIEF-A is a 75-item questionnaire that assesses and adult's cognitive, emotional, and behavioral functions within the past month. The subject rates each question on a 3-point scale (1=Never, 2=Sometimes, 3=Often). Raw scores are calculated and used to generate T-scores for 8 scales (Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials), 2 summary index scales (Behavioral Regulation Index and Metacognition Index), and one scale reflecting overall functioning (Global Executive Composite). T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. A reduction in score indicates improvement. (NCT01399827)
Timeframe: Baseline to 12 weeks

InterventionT-Score (Number)
Omega-3 Fatty Acids-7
Placebo-33

[back to top]

Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales

The BRIEF-A is a 75-item questionnaire that assesses and adult's cognitive, emotional, and behavioral functions within the past month. The subject rates each question on a 3-point scale (1=Never, 2=Sometimes, 3=Often). Raw scores are calculated and used to generate T-scores for 8 scales (Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials), 2 summary index scales (Behavioral Regulation Index and Metacognition Index), and one scale reflecting overall functioning (Global Executive Composite). T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. A reduction in score indicates improvement. (NCT01399827)
Timeframe: baseline to 12 weeks

,
Interventionunits on a scale (Number)
Change in BRIEF-A Inhibit Scale T-Scores from BaseChange in BRIEF-A Shift Scale T-Scores from BaseliChange in BRIEF-A Self Monitor Scale T-Scores fromChange in BRIEF-A Initiate Scale T-Scores from BasChange in BRIEF-A Working Memory Scale T-Scores frChange in BRIEF-A Plan/Organize Scale T-Scores froChange in BRIEF-A Task Monitor Scale T-Scores fromChange in BRIEF-A Organization of Materials ScaleChange in BRIEF-A BRI Scale T-Scores from BaselineChange in BRIEF-A MI Scale T-Scores from BaselineChange in BRIEF-A GEC Scale T-Scores from Baseline
Omega-3 Fatty Acids-1400-17-11-11-5-6-7-12-11
Placebo-28-13-13-9-30-19-32-22-29-46-29

[back to top]

Percent Change in Global Executive Composite T-Score on the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)

"This is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales: Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Example item: I make careless errors when completing tasks. Items are rated 1 Never, 2 Sometimes, or 3 Often. The Global Executive Composite (GEC) Score is calculated by totaling all items on the scale. GEC T-scores range from 34-108, with higher scores indicating more difficulties with executive function." (NCT01533493)
Timeframe: baseline, 12 weeks

Interventionpercentage change from baseline score (Mean)
Memantine-24
Placebo-21

[back to top]

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events between first dose of double-blind investigational product and up to 3 days after last dose that were absent before treatment or that worsened relative to pretreatment state. (NCT01552902)
Timeframe: Baseline up to 3 days after last dose (last dose at Week 6)

,,
Interventionparticipants (Number)
Participants with TEAEsParticipants with serious TEAEs
Lisdexamfetamine Dimesylate1451
Methylphenidate1291
Placebo491

[back to top]

Change From Baseline in Blood Pressure at Week 6

(NCT01552902)
Timeframe: Baseline, Week 6

,,
Interventionmillimeter of mercury (mmHg) (Mean)
Systolic blood pressureDiastolic blood pressure
Lisdexamfetamine Dimesylate1.53.4
Methylphenidate2.43.5
Placebo-1-0.1

[back to top]

Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6

The ADHD-RS-IV was developed to measure the behaviors of children with ADHD and is commonly used in clinical studies of ADHD. The ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, Higher score = more severe symptoms. (NCT01552902)
Timeframe: Baseline, Week 6

Interventionunits on a scale (Least Squares Mean)
Placebo-17
Lisdexamfetamine Dimesylate-25.4
Methylphenidate-22.1

[back to top]

Change From Baseline in Pulse Rate at Week 6

(NCT01552902)
Timeframe: Baseline, Week 6

InterventionBeats per minute (Mean)
Placebo2.4
Lisdexamfetamine Dimesylate6.7
Methylphenidate8.2

[back to top]

Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6

The Clinical Global Impressions Scale permits a global evaluation of the participant's severity of illness and improvement over time. The scale included a severity of illness item and a global improvement item. The investigator performed the CGI-I to rate the improvement of a participant's ADHD symptoms based on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse.). Percentage of participants with an improved measurement (response of very much improved and much improved) is reported. (NCT01552902)
Timeframe: Week 6

Interventionpercentage of participants (Number)
Placebo50
Lisdexamfetamine Dimesylate81.4
Methylphenidate71.3

[back to top]

Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment

(NCT01552915)
Timeframe: Baseline and up to 8 Weeks

InterventionmmHg (Mean)
Placebo-0.8
SPD4892.4
OROS-MPH0.4

[back to top]

Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment

(NCT01552915)
Timeframe: Baseline and up to 8 weeks

InterventionmmHg (Mean)
Placebo-1.2
SPD4892.8
OROS-MPH2.2

[back to top]

Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF)

Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. (NCT01552915)
Timeframe: Week 8

Interventionpercentage of participants (Number)
Placebo34.8
SPD48983.1
OROS-MPH81.0

[back to top]

Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment

(NCT01552915)
Timeframe: Baseline and up to 8 weeks

Interventionbpm (Mean)
Placebo0.3
SPD4894.7
OROS-MPH6.0

[back to top]

Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8

The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Higher score indicates more severe symptoms. (NCT01552915)
Timeframe: Baseline and week 8

Interventionunits on a scale (Least Squares Mean)
Placebo-13.4
SPD489-25.6
OROS-MPH-23.5

[back to top]

Finger Windows

A neuropsychological measure of motor skill and visual-spatial working memory compared at 6 weeks from baseline. The Finger Windows subtest is a measure of nonverbal, rote sequential recall. scaled scores ranging from 1 to 19, with higher score indicating better attention or concentration. (NCT01678209)
Timeframe: baseline and at 6 weeks

,,
Interventionscore on a scale (Mean)
Baseline6 weeks
Atomoxetine Arm14.5016.25
Control Group fMRI Scans Only17.0417.65
Methylphenidate Arm16.5016.25

[back to top]

Digit Span

A cognitive/neuropsychological measure of auditory/verbal working memory compared at 6 weeks from baseline. Digit Span. Memory span is the longest list of items that a person can repeat back in correct order immediately after presentation on 50% of all trials. Items may include words, numbers, or letters. The task is known as digit span when numbers are used. Memory span is a common measure of short-term memory. A digit-span task is used to measure working memory's number storage capacity.The item score is the sum of the scores on the two trials for that item (range=0-2). The total raw score for backwards digit span is the sum of the item scores; maximum backwards digit span total raw score is 0-16 points. Higher score indicates better health outcomes. (NCT01678209)
Timeframe: baseline and at 6 weeks

,,
Interventionscore on a scale (Mean)
Baseline6 weeks
Atomoxetine Arm9.259.75
Control Group fMRI Scans Only13.309.39
Methylphenidate Arm7.58.5

[back to top]

Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (ADHD-RS)

ADHD-RS is an 18-item list of core ADHD symptoms, each item are scored on a 4-point scale from 0-3, with total 0-54, with higher score indicating more symptoms. (NCT01678209)
Timeframe: 8 weeks

Interventionscore on a scale (Mean)
Control Group fMRI Scans Only1
Atomoxetine Arm15
Methylphenidate Arm18

[back to top]

Clinical Global Impressions-Severity (CGI-S)

a clinician rated measure of symptom severity. CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. (NCT01678209)
Timeframe: up to 6 weeks

Interventionscore on a scale (Mean)
Control Group fMRI Scans Only1
Atomoxetine Arm3.2
Methylphenidate Arm3.4

[back to top]

Continuous Performance Test (CPT)

A neuropsychological assessment of attention compared at 6 weeks from baseline. CPT is a task-oriented computerized assessment of attention-related problems.This score indicates the number of times the client responded but no target was presented. A fast reaction time and high commission error rate points to difficulties with impulsivity. A slow reaction time with high commission and omission errors, indicates inattention in general. Scores are compared with the normative scores for the age, group and gender of the person being tested and represented as a commissioned T-score. The T-score indicates the degree to which performance in CPT task is higher or lower than the performance of a healthy individual matched in age. A T-score of 50 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of more attention-related problems. (NCT01678209)
Timeframe: baseline and at 6 weeks

,,
Interventioncommissioned t-score (Mean)
Baseline6 weeks
Atomoxetine Arm55.2650.70
Control Group fMRI Scans Only46.6544.64
Methylphenidate Arm52.9448.46

[back to top]

Response Time in Attention Networks Test (ANT)

A neuropsychological assessment of attention compared at 6 weeks from baseline by looking at response time. The ANT is a task designed to test three attentional networks in children and adults: alerting, orienting, and executive control. The response time were summed. (NCT01678209)
Timeframe: baseline and at 6 weeks

,,
Interventionmilliseconds (Mean)
Baseline6 weeks
Atomoxetine Arm856.60826.14
Control Group fMRI Scans Only817.50756.87
Methylphenidate Arm885.68783.09

[back to top]

Percentage of Correct Inhibition in Participants Assessed With the Go-No go Task

"Comparison of Go-Nogo at 6 weeks from baseline. Performance on a go-nogo task inside the scanner (fMRI). In the go/no-go task, participants respond to certain stimuli (go stimuli) and make no response for others (no-go stimuli)." (NCT01678209)
Timeframe: Baseline and at 6 weeks

,,
Interventionpercent correct inhibition (Mean)
Baseline6 weeks
Atomoxetine Arm79.4380.72
Control Group fMRI Scans Only79.0878.24
Methylphenidate Arm77.9881.81

[back to top]

Attention Deficit Hyperactivity Disorder Total Symptom Score

"Assessed via parent and teacher Vanderbilt Attention Deficit Hyperactivity Disorder Rating Scales which were completed each the 4 weeks of the titration trial.~Range: min=0, max=54 [sum of 18 symptom items, rated from 0 (none), 1 (occasionally), 2 (often), 3 (very often)], higher scores indicate worse outcomes.~Note to address Review Comment: During the 4 week titration trial, the placebo condition and each of the three active dosages (low, medium, and high) were given for one week each. Because the placebo and active dosages were given in random order to preserve the triple blind, all participants did not receive the same order of dosages and it is not possible to connect the dosages (placebo, low dose MPH, medium dose MPH, high dose MPH) to a specific week number (week 1, week 2, week 3, week 4) which would hold for ALL participants. That is why Timeframe was revised from week 1, week 2, week 3, week 4 to placebo, low dose, medium dose, and high dose week." (NCT01727414)
Timeframe: End of placebo dose week, End of low dose week, End of medium dose week , End of high dose week

,
Interventionunits on a scale (Mean)
ADHD Total Symptom Score on PlaceboADHD Total Symptom Score on Low Dose MPHADHD Total Symptom Score on Medium Dose MPHADHD Total Symptom Score on High Dose MPH
Combined Type30.029.723.922.8
Inattentive Type21.420.217.015.5

[back to top]

mYPAS Measurement in Patients Not Receiving Midazolam

"modified Yale Preoperative Anxiety Scale (mYPAS), which is commonly used for assessing anxiety during the induction of anesthesia, administered to patients who did not receive midazolam prior to anesthesia induction.~Assessment items: Activity (A) 1-4 points (A = score/4), Vocalizations (V) 1-6 points (V = score/6), Emotional expressivity (E) 1-4 points (E = score/4), State of arousal (S) 1-4 points (S = score/4), Use of parent (U) 1-4 points (U = score/4). Final score = [(A + V + E + S +U)/5] x 100. Higher score = more anxiety." (NCT01740206)
Timeframe: Day 1

Interventionscores on a scale (Median)
Patients Taking ADHD Medication28
Patients Not Taking ADHD Medication28

[back to top]

Heart Rate

Heart rate prior to anesthetic induction (NCT01740206)
Timeframe: Day 1

InterventionBPM (Mean)
Patients Taking ADHD Medication96.7
Patients Not Taking ADHD Medication88

[back to top]

Diastolic Blood Pressure

Diastolic blood pressure prior to anesthetic induction (NCT01740206)
Timeframe: Day 1

InterventionmmHg (Mean)
Patients Taking ADHD Medication71.1
Patients Not Taking ADHD Medication67.9

[back to top]

mYPAS Measurement in Patients Receiving Midazolam

"modified Yale Preoperative Anxiety Scale (mYPAS), which is commonly used for assessing anxiety during the induction of anesthesia, administered to patients who received midazolam prior to anesthesia induction.~Assessment items: Activity (A) 1-4 points (A = score/4), Vocalizations (V) 1-6 points (V = score/6), Emotional expressivity (E) 1-4 points (E = score/4), State of arousal (S) 1-4 points (S = score/4), Use of parent (U) 1-4 points (U = score/4). Final score = [(A + V + E + S +U)/5] x 100. Higher score = more anxiety." (NCT01740206)
Timeframe: Day 1

Interventionscores on a scale (Median)
Patients Taking ADHD Medication30
Patients Not Taking ADHD Medication26

[back to top]

Mean Blood Pressure

Mean blood pressure prior to anesthetic induction (NCT01740206)
Timeframe: Day 1

InterventionmmHg (Mean)
Patients Taking ADHD Medication85.3
Patients Not Taking ADHD Medication81.7

[back to top]

Systolic Blood Pressure

Systolic blood pressure prior to anesthetic induction (NCT01740206)
Timeframe: Day 1

InterventionmmHg (Mean)
Patients Taking ADHD Medication113.6
Patients Not Taking ADHD Medication109.2

[back to top]

Timed Get Up and Go Test - Measure of Mobility

Timed Get Up and Go Test (TUG), is used to evaluate the ability to walk by measuring the time it takes to rise from a chair, walk 10 feet, turn around, walk back to the chair, and sit down. The TUG test takes less than 5 minutes to complete. Scored as seconds required to complete the task. (NCT01825577)
Timeframe: Baseline and Post-test at 4 weeks

Interventionseconds (Mean)
BaselinePost-Test
Transdermal Methylphenidate34.344.2

[back to top]

POMA -Performance Oriented Mobility Assessment - Measure of Gait and Balance.

Performance Oriented Mobility Assessment (POMA), used to measure subject's ability to maintain balance. The test takes 10-15 minutes and involves asking subject to stand from a sitting position, standing with eyes closed and sitting down. POMA total score has a range of 0-36 where higher scores represent better performance. POMA total score is an additive combination of the 12 point Gait sub-score and the 16 point balance sub-score. A cut-off score of <21 is generally considered a fall risk among elderly people. (NCT01825577)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
BaselinePost-Test
Transdermal Methylphenidate16.717.8

[back to top]

Accuracy on the Multi-Source Interference Task.

Patients completed 200 trials and the percentage of answers correct was calculated. (NCT01852344)
Timeframe: 20-30 minutes

Interventionpercentage of answers which were correct (Mean)
Placebo Easy94.1
Placebo Hard94.3
Methylphenidate Easy96.1
Methylphenidate Hard96.6

[back to top]

Reaction Time on the Multi-Source Interference Task

Reaction time on the Multi-Source Interference Task is measured in milliseconds. Participants were given 200 trials and their mean reaction time was calculated. (NCT01852344)
Timeframe: 20-30 minutes for task completion

Interventionmilliseconds (Mean)
Placebo Easy300
Placebo Hard330
Methylphenidate Easy310
Methylphenidate Hard280

[back to top]

Reaction Time Variability on the Multi-Source Interference Task.

Reaction time variability on the Multi-Source Interference task is defined as the number of milliseconds between an individual's lowest and highest reaction time. This is averaged across all participants. (NCT01852344)
Timeframe: 20-30 minutes

Interventionmilliseconds (Mean)
Placebo Easy270
Placebo Hard320
Methylphenidate Easy270
Methylphenidate Hard260

[back to top]

Adult ADHD Investigator Symptom Rating Scale (AISRS)

The AISRS is an 18-item questionnaire administered by the clinician assessing each of the individual DSM-IV symptoms of ADHD. Each symptom is rated on a scale of severity from 0 (none) to 3 (severe), and the 18 symptom questions are summed to calculate a total score. The minimum total score is a 0, while the maximum total score is a 54. The AISRS was compared from baseline to completion, over the course of the 12 week study. (NCT01853280)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
L-Methylfolate-22.9
Placebo (for L-Methylfolate)-20.8

[back to top]

Change From Baseline in Timed 25 Foot Walk (T25FW) at 6 Weeks

Mean changes in Timed 25 Foot Walk (T25FW) at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis. (NCT01896700)
Timeframe: 6 weeks

Interventionchange in seconds from baseline (Mean)
Methylphenidate-0.3
Placebo-0.6

[back to top]

Change From Baseline in Pittsburgh Sleep Quality Assessment Questionnaire Score at 6 Weeks

Mean changes in the score attained on the Pittsburgh Sleep Quality Assessment Questionnaire at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis. Scale ranges from 0-21 points, with higher numbers indicating poorer sleep quality. (NCT01896700)
Timeframe: 6 weeks

Interventionchange in score from baseline (Mean)
Methylphenidate0.3
Placebo-0.3

[back to top]

Change From Baseline in Modified Fatigue Index Scale Score at 6 Weeks

Mean changes in the score attached on the Modified Fatigue Index Scale at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis. Scale ranges from 0-84 points, with higher scores indicating greater fatigue. (NCT01896700)
Timeframe: 6 weeks

Interventionchange in score from baseline (Mean)
Methylphenidate-3.8
Placebo-9.8

[back to top]

Change From Baseline in Automatic Postural Response (APR) Latency at 6 Weeks

Mean changes in APR latency at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis. (NCT01896700)
Timeframe: 6 weeks

Interventionchange in milliseconds from baseline (Mean)
Methylphenidate-9.2
Placebo-5.3

[back to top]

Change From Baseline in Vestibular-Ocular Reflex (VOR) Gain at 6 Weeks

The most common rotary chair testing is a battery of subtests, each at a specific rate (Hz) of chair rotation from side to side. The participant is secured in the chair in total darkness while the eyes are monitored by infrared cameras. We completed tests from 0.04 to 0.64 Hz to assess the vestibular system across a range of head movements. The chair and participant's head move together while the cameras track the velocity of the eyes; eye velocity reveals how the vestibular system responds to head velocity. VOR gain is the ratio of average chair (i.e. head) velocity to average eye velocity, and is represented on a unitless scale from 0 to 1. VOR gain close to 1 indicates that eye velocity is nearly equal and opposite to head velocity. While there are normative ranges for VOR gain, we are most interested in is change in mean gain (6-week tests minus baseline tests) for the active and placebo groups. (NCT01896700)
Timeframe: 6 weeks

,
Interventionratio (Mean)
VOR Gain at 0.04 HzVOR Gain at 0.08 HzVOR Gain at 0.16 HzVOR Gain at 0.32 HzVOR Gain at 0.64 Hz
Methylphenidate-0.0107-0.0061-0.0151-0.04220.0221
Placebo-0.0229-0.2830.08710.03220.0151

[back to top]

Change From Baseline in Vestibular Ocular Reflex (VOR) Phase (in Degrees) at 6 Weeks

Mean changes in VOR phase, which is a measure of the timing (in degrees) of the eye movements relative to the chair movement, as measured by rotary chair testing at 6 weeks, will be compared for active and placebo treated subjects using t-tests, or other appropriate statistical analyses. A range of frequencies was tested from 0.04 Hz to 0.64 Hz, as is standard for rotary chair testing. The range of frequencies (i.e. chair speeds) assesses the vestibular system across a range of head movements. This helps to identify abnormality, which may manifest at different frequencies of movement. The measurement outcomes for rotary chair testing are gain, phase and asymmetry of the eye movements. (NCT01896700)
Timeframe: 6 weeks

,
Interventionchange in degrees from baseline (Mean)
VOR Phase at 0.04 HzVOR Phase at 0.08 HzVOR Phase at 0.16 HzVOR Phase at 0.32 HzVOR Phase at 0.64 Hz
Methylphenidate2.27901.89140.9449-1.3564-2.7082
Placebo1.9535-1.4716-0.33420.59810.2833

[back to top]

Change From Baseline in Vestibular Ocular Reflex (VOR) Asymmetry (Percentage Asymmetric) at 6 Weeks

Mean changes in VOR asymmetry, which is a measure of the strength of the eye responses in one direction compared with the other as measured by rotary chair testing at 6 weeks, will be compared for active and placebo treated subjects using t-tests, or other appropriate statistical analyses. A range of frequencies was tested from 0.04 Hz to 0.64 Hz, as is standard for rotary chair testing. The range of frequencies (i.e. chair speeds) assesses the vestibular system across a range of head movements. This helps to identify abnormality, which may manifest at different frequencies of movement. The measurement outcomes for rotary chair testing are gain, phase and asymmetry of the eye movements. (NCT01896700)
Timeframe: 6 weeks

,
Interventionchange in % of asymmetry from baseline (Mean)
VOR Asymmetry at 0.04 HzVOR Asymmetry at 0.08 HzVOR Asymmetry at 0.16 HzVOR Asymmetry at 0.32 HzVOR Asymmetry at 0.64 Hz
Methylphenidate0.9927-0.05722.58331.91570.3104
Placebo-1.7291-6.5209-5.2852-4.1203-1.5111

[back to top]

Change From Baseline in Timed Up and Go (TUG) Test Time at 6 Weeks

The primary outcome of this study will be the difference between mean change in TUG time between methylphenidate and placebo treated subjects at 6 weeks. Mean changes will be compared for active and placebo treated subjects using Bayesian analysis. (NCT01896700)
Timeframe: 6 weeks

Interventionchange in seconds from basline (Mean)
Methylphenidate-0.7
Placebo-1.3

[back to top]

PK Parameters for Rate and Extent of Absorption of MPH in Plasma: Plasma Concentration-time Curve

To determine the rate and extent of absorption of methylphenidate following a single treatment of HLD200 (B formulation; 54 mg) in children and adolescents with ADHD, plasma samples were collected at t=0, 4, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 22, 24, 36 and 48 hours post-HLD200 treatment and methylphenidate concentrations were determined. (NCT01907360)
Timeframe: 48hrs

,
Intervention(ng/mL) (Mean)
t=0 hrst=4 hrst=6 hrst=8 hrst=9 hrst=10 hrst=11 hrst=12 hrst= 13 hrst=14 hrst=15 hrst=16 hrst=18 hrst=20 hrst=22 hrst=24 hrst=36 hrst=48 hrs
HLD200 in Adolescents (13-17 Years)0.000.000.030.150.471.372.333.764.665.706.096.586.135.524.663.671.070.23
HLD200 in Children (6-12 Yrs)0.000.050.130.391.032.154.426.848.109.059.6810.6411.0110.539.227.512.470.48

[back to top]

PK Parameters for Rate and Extent of Absorption of MPH: Lag Time

The absorption lag time for methylphenidate in plasma expressed in hours is the difference in time between the drug administration and the last time point where the drug concentration was below the limit of assay quantitation. (NCT01907360)
Timeframe: 48hrs

Interventionhours (Mean)
HLD200 in Adolescents (13-17 Years)6.3
HLD200 in Children (6-12 Yrs)3.3

[back to top]

PK Parameters for Rate and Extent of Absorption of MPH: Cmax

The maximum drug concentration of methylphenidate in plasma. (NCT01907360)
Timeframe: 48hrs

Interventionng/mL (Mean)
HLD200 in Adolescents (13-17 Years)7.17
HLD200 in Children (6-12 Yrs)11.64

[back to top]

PK Parameters for Rate and Extent of Absorption of MPH: AUC0-tz

Area under the methylphenidate plasma concentration-time curve to time point tz (AUC0-tz), where tz was the last time point over the time interval with a measurable drug concentration (NCT01907360)
Timeframe: 48hrs

Interventionng.hr/mL (Mean)
HLD200 in Adolescents (13-17 Years)105.5
HLD200 in Children (6-12 Yrs)205.6

[back to top]

PK Parameters for Rate and Extent of Absorption of MPH: AUC0-inf

The area under the methylphenidate plasma concentration-time curve to infinite time (NCT01907360)
Timeframe: 48hrs

Interventionng.hr/mL (Mean)
HLD200 in Adolescents (13-17 Years)109.6
HLD200 in Children (6-12 Yrs)210.1

[back to top]

PK Parameters for Rate and Extent of Absorption of MPH: Tmax

The time to reach maximum concentration of methylphenidate in plasma. (NCT01907360)
Timeframe: 48hrs

Interventionhours (Mean)
HLD200 in Adolescents (13-17 Years)17.1
HLD200 in Children (6-12 Yrs)17.7

[back to top]

Change From Baseline ADHD Rating Scale-IV Scores at 8 Weeks

"Attendtion-deficit hyperactivity disorder (ADHD) Rating Scale-IV is the sum of 18 questions, ranging from 0 (no symptoms) to 54 (worst possible symptoms).~Change from baseline ADHD Rating Scale-IV scores at 8 weeks was calculated as baseline minus 8 weeks." (NCT01912352)
Timeframe: baseline and 8 weeks

Interventionunits on a scale (Mean)
Methylphenidate14.9

[back to top]

Clinical Global Impression-Improvement Scale at 8 Weeks

"Clinical Global Impression-Improvement (CGI-I) scale is a one-item measure evaluating the change from the initiation of treatment on a seven-point scale: Compared to the patient's condition at baseline [prior to medication initiation], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.~Clinical Global Impression-Improvement was measured at 8 weeks." (NCT01912352)
Timeframe: baseline and 8 weeks

Interventionunits on a scale (Mean)
Methylphenidate2.3

[back to top]

Parent Outcome-Behavior Rating Inventory of Executive Functioning (BRIEF)

The Behavior Rating Inventory of Executive Functioning (BRIEF)-Parent was used to assess executive functioning behaviors. The global executive composite (GEC), behavior regulatory index (BRI), and metacognitive index (MI) T-scores were used, with higher scores reflecting poorer executive functioning. T-scores were normalized to 50 with a standard deviation of 10. (NCT01933217)
Timeframe: Reported at End of Methylphenidate Arm (Week 4 or 8)

,
Interventionscore on a scale (Mean)
BRIEF GEC-OverallBRIEF BRI-OverallBRIEF MI-Overall
Methylphenidate60.0554.3062.40
Placebo65.2058.0067.75

[back to top]

Neuropsychological Outcome- Wechsler Intelligence Scale for Children, 4th Edition Processing Speed Index (WISC-IV-PSI)

The Wechsler Intelligence Scale for Children, 4th Edition Processing Speed Index (WISC-IV-PSI) has been designed for children 6-16:11 years of age and provides a measure of processing speed. For this index scale, the average score is 100 with a standard deviation of 15. Higher scores reflect better processing speed. One participant was administered the Wechsler Adult Intelligence Scale 4th Edition Processing Speed Index (WAIS-IV-PSI). All scores were included in the combined WISC/WAIS processing speed variable since both measures yield highly correlated standard scores. (NCT01933217)
Timeframe: Reported at End of Methylphenidate Arm (Week 4 or 8)

Interventionscore on a scale (Mean)
Methylphenidate96.05
Placebo91.25

[back to top]

Parent Outcome-Vanderbilt ADHD Parent Rating Scales (VADPRS)

Changes in symptom ratings were assessed on the Vanderbilt ADHD parent rating scales (VADPRS). A measure of ADHD symptom severity (Total Symptom Score [TSS]) is computed by totaling the scores from items 1-18 (Inattentive +Hyperactive-impulse domains), with a rating of none=0, occasionally=1, often=2, very often=3, provided. Scores for inattentive and hyperactive-impulsive domains were generated by totaling the 9 symptoms in these domains, and a TSS was computed by totaling items across domains. (NCT01933217)
Timeframe: Reported at End of Methylphenidate Arm (Week 4 or 8)

,
Interventionunits on a scale (Mean)
Vanderbilt Parent TSSVanderbilt Parent HyperactiveVanderbilt Parent Inattentive
Methylphenidate1.10.841.37
Placebo1.471.141.79

[back to top]

WCST: Percentage of Correct Responses (Rc%)

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of correct responses which meets all the requirements according to the response principles was evaluated. Ranges from 0 to 100 percent (%), the more the better. (NCT01933880)
Timeframe: Baseline and End of Week 12

,
InterventionPercentage of correct responses (Mean)
Baseline (n=128, 40)End of Week 12 (n=111, 40)
Normal Group65.5273.34
OROS-MPH Group58.67870.096

[back to top]

WCST: Percentage of Perseverative Error Responses (Rpe%)

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative (pvt) errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of persistent errors out of total number of responses was evaluated. Ranges from 0 to 100%, the less the better. (NCT01933880)
Timeframe: Baseline and End of Week 12

,
InterventionPercentage of pvt error responses (Mean)
Baseline (n=128, 40)End of Week 12 (n=111, 40)
Normal Group18.4513.59
OROS-MPH Group22.6716.07

[back to top]

WCST: Perseverative Error Responses (Rpe)

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Perseverative error responses are the number of responses which applied continuity principle for matching answers and also had the wrong answer was evaluated. Ranges from 0 to 128, the less the better. (NCT01933880)
Timeframe: Baseline and End of Week 12

,
Interventionnumber of perseverative error responses (Mean)
Baseline (n=128, 40)End of Week 12 (n=111, 40)
Normal Group2316.4
OROS-MPH Group28.719.4

[back to top]

WCST: Perseverative Responses (Rp)

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of perseverative responses were the responses which applied continuity principle for matching answers was evaluated. Ranges from 0 to 100, the less the better. (NCT01933880)
Timeframe: Baseline and End of Week 12

,
Interventionnumber of perseverative responses (Mean)
Baseline (n=128, 40)End of Week 12 (n=111, 40)
Normal Group26.518.6
OROS-MPH Group33.722

[back to top]

Wisconsin Card Sorting Test (WCST): Administered Responses (Ra) of Completed Examination

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. During number of trials administered or administered responses, participants were administered 128 cards and asked to sort the cards until all the 6 sorting categories was completed. Response number used to complete all 6 categories ranges from 50 to 128, lesser the better. (NCT01933880)
Timeframe: Baseline and End of Week 12

,
InterventionResponses (Mean)
Baseline (n=128, 40)End of Week 12 (n=111, 40)
Normal Group120.8117.1
OROS-MPH Group125.1116.4

[back to top]

WCST: Percentage of Conceptual Level Responses (Rf%)

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of the responses completed with 3-10 continuous correct during the entire measuring process was evaluated. Ranges from 0 to 100%, the more the better. (NCT01933880)
Timeframe: Baseline and End of Week 12

,
Interventionpercentage of conceptual level responses (Mean)
Baseline (n=128, 40)End of Week 12 (n=111, 40)
Normal Group54.7365
OROS-MPH Group46.3661.07

[back to top]

Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 2

IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening. (NCT01933880)
Timeframe: Baseline and Week 2

InterventionScores on a scale (Mean)
BaselineChange at Week 2
OROS-MPH Group10-4.1

[back to top]

Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale at Week 12

Remission rate in different dosage groups will be accessed to evaluate the relationship between therapeutic effect and dosage. Remission rate is the percentage of participants with total score of IO sub-scale less than or equal to 5 in IOWA Conners measurement scale. (NCT01933880)
Timeframe: Week 12

InterventionPercentage of participants (Number)
OROS-MPH Group 18 Milligram (mg)85.37
OROS-MPH Group 36 mg74.07
OROS-MPH Group 54 mg100.00

[back to top]

Academic Achievement

Mathematics and language scores will be obtained from their corresponding examinations at school. Scores ranges from 0-100 respectively. Mathematics and language would be summarized separately. (NCT01933880)
Timeframe: Baseline and End of Week 12

,
Interventionscores on a scale (Mean)
Chinese Achievement: Basline (n=128, 40)Chinese Achievement: End of Week 12(n=111, 40)Mathematical Achievement (MA):Baseline (n=128, 40)MA: End of Week 12 (n=111, 40)
Normal Group94.2194.5696.2396.13
OROS-MPH Group77.3583.9478.8686.05

[back to top]

Change From Baseline in Completion Time of Stroop Color-word Test at Week 12

Completion time of stroop color-word test in different dosage groups will be accessed to evaluate the relationship between therapeutic effect and dosage. This is a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A participant will be given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test will be scored on the number of correct answers. There are 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list. Median time of the naming time in the Stroop color word naming test will be accessed. Stroop color word naming test 1 ,2 ,3 and 4 stand for gradually increased difficulty and each test has a corresponding baseline and endpoint. (NCT01933880)
Timeframe: Baseline and End of Week 12

,,
InterventionSeconds (Mean)
Test 1: Baseline (n=86, 30, 1)Test 1: Change at End of Week 12 (n=82, 27, 1)Test 2: Baseline (n=86, 30, 1)Test 2: Change at End of Week 12 (n=82, 27, 1)Test 3: Baseline (n=86, 30, 1)Test 3: Change at End of Week 12 (n=82, 27, 1)Test 4: Baseline (n=86, 30, 1)Test 4: Change at End of Week 12 (n=82, 27, 1)
OROS-MPH Group 18 Milligram (mg)22.229-3.31820.538-2.16419.515-2.33623.61-4.374
OROS-MPH Group 36 mg17.7-117.29-1.23317.473-2.99622.154-3.974
OROS-MPH Group 54 mg509073151

[back to top]

Change From Baseline in Digit Span Test Total Score at Week 12

The digit span test is mainly used to measure the ability of short-term memory and attention. The participant will be given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward. The score is the number of correct responses, where the digits were repeated correctly. One point will be given for each correctly repeated string of digits. The maximum subscore in the Digits Forward is 16, and the maximum subscore in the Digits Backward is 14, summed for a total score of 30. A higher score is indicative of better recall and attention. (NCT01933880)
Timeframe: Baseline and Week 12

,
InterventionScores on a scale (Mean)
BaselineChange at Week 12
Normal Group13.70.5
OROS-MPH Group11.71

[back to top]

Change From Baseline in I/O Score of IOWA Conners Behavior Rating Scale at Week 12

IOWA conners behavior rating scale score in different dosage groups will be accessed to evaluate relationship between therapeutic effect and dosage. IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening. (NCT01933880)
Timeframe: Baseline and End of Week 12

,,
InterventionScores on a scale (Mean)
BaselineChange at End of Week 12
OROS-MPH Group 18 Milligram (mg)10-6.8
OROS-MPH Group 36 mg10.3-5.8
OROS-MPH Group 54 mg7-4

[back to top]

Change From Baseline in Inattention/Overactivity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 1

IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening. (NCT01933880)
Timeframe: Baseline and Week 1

InterventionScores on a scale (Mean)
BaselineChange at Week 1
OROS-MPH Group10-2.7

[back to top]

Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 12

IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening. (NCT01933880)
Timeframe: Baseline and Week 12

InterventionScores on a scale (Mean)
BaselineChange at Week 12
OROS-MPH Group10-6.2

[back to top]

Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 3

IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening. (NCT01933880)
Timeframe: Baseline and Week 3

InterventionScores on a scale (Mean)
BaselineChange at Week 3
OROS-MPH Group10-5

[back to top]

Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 7

IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening. (NCT01933880)
Timeframe: Baseline and Week 7

InterventionScores on a scale (Mean)
BaselineChange at Week 7
OROS-MPH Group10-5.8

[back to top]

Change From Baseline in Total Scores of Digit Span Test at Week 12

The digit span test total score will be accessed in different dosage groups to evaluate the relationship between therapeutic effect and dosage. The digit span test is mainly used to measure the ability of short-term memory and attention. The participant will be given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward. The score is the number of correct responses, where the digits were repeated correctly. One point will be given for each correctly repeated string of digits. The maximum subscore in the Digits Forward is16, and the maximum subscore in the Digits Backward is 14, for a total score of 30. A higher score was indicative of better recall and attention. (NCT01933880)
Timeframe: Baseline and End of Week 12

,,
InterventionScores on a scale (Mean)
BaselineChange at End of Week 12
OROS-MPH Group 18 Milligram (mg)11.71.2
OROS-MPH Group 36 mg11.30.8
OROS-MPH Group 54 mg150

[back to top]

Coding Test

The coding Test is a common test indicator for perceptual speed. The test presents a series of corresponding relationship between graphics and symbols to the participant, and then participants will be required to fill out the appropriate symbol following single symbol in the test part. The test is limited within 150 seconds and evaluated the number of symbols been replaced correctly by the participants. (NCT01933880)
Timeframe: Baseline and End of Week 12

,
InterventionNumber of symbols correctly replaced (Mean)
Baseline (n=128, 40)End of Week 12 (n=111, 40)
Normal Group77.483.1
OROS-MPH Group63.473.2

[back to top]

Number of Participants Compliant With Treatment

Number of Participants who are Compliant with Treatment will be accessed. Less than 80 percent and more than 120 percent compliance signifies bad compliance, 80 to 120 percent compliance signifies good compliance . The compliance was calculated by the percentage of dose (actual dose multiplied by 100/theoretical dose).The theoretical dose means the dose prescribed by the Investigator. (NCT01933880)
Timeframe: End of Week 12

Interventionparticipants (Number)
Less than 80 percentBetween 80 to 120 percentMore than 120 percent
OROS-MPH Group171100

[back to top]

Number of Participants With Clinical Global Impression - CGI Scale Score

CGI is an overall rating scale. Clinical Global Impression (Improvement of Diseases) is divided into seven grades: 1=very significant improvement, 24=significant improvement or advanced, 3=improvement or slightly advanced, 4=no change, 5=slight aggravation, 6=significant aggravation, and 7=very significant aggravation or seriously aggravated. Number of participants in each category of grade were assessed. (NCT01933880)
Timeframe: End of Week 1, 2, 3, 7 and 12

InterventionParticipants (Number)
Significantly Advanced: End of Week 1Significantly Advanced: End of Week 2Significantly Advanced: End of Week 3Significantly Advanced: End of Week 7Significantly Advanced: End of Week 12Advanced: End of Week 1Advanced: End of Week 2Advanced: End of Week 3Advanced: End of Week 7Advanced: End of Week 12Slightly Advanced: End of Week 1Slightly Advanced: End of Week 2Slightly Advanced: End of Week 3Slightly Advanced: End of Week 7Slightly Advanced: End of Week 12No Change: End of Week 1No Change: End of Week 2No Change: End of Week 3No Change: End of Week 7No Change: End of Week 12Slightly Aggravated: End of Week 1Slightly Aggravated: End of Week 2Slightly Aggravated: End of Week 3Slightly Aggravated: End of Week 7Slightly Aggravated: End of Week 12Aggravated: End of Week 1Aggravated: End of Week 2Aggravated: End of Week 3Aggravated: End of Week 7Aggravated: End of Week 12Seriously Aggravated: End of Week 1Seriously Aggravated: End of Week 2Seriously Aggravated: End of Week 3Seriously Aggravated: End of Week 7Seriously Aggravated: End of Week 12
OROS-MPH Group20282935365953444146332833282515101173020310000000000

[back to top]

Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale.

Remission rate is the percentage of participants with total score of IO sub-scale less than or equal to 5 in IOWA Conners measurement scale (NCT01933880)
Timeframe: End of Week 1, 2, 3, 7 and 12

InterventionPercentage of Participants (Number)
End of Week 1End of Week 2End of Week 3End of Week 7End of Week 12
OROS-MPH Group25.9851.9766.9378.7481.10

[back to top]

Stroop Color Word Naming Test

This is a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A participant will be given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test is scored on the number of correct answers. There are 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list. Median naming time in the Stroop color word naming test will be assessed. Stroop color word naming test 1 ,2 ,3 and 4 stand for gradually increased difficulty and each test has a corresponding baseline and endpoint. (NCT01933880)
Timeframe: Baseline and End of Week 12

,
InterventionSeconds (Mean)
Test 1: Baseline (n=128, 40)Test 1: End of Week 12 (n=111, 40)Test 2: Baseline (n=128, 40)Test 2: End of Week 12 (n=111, 40)Test 3: Baseline (n=128, 40)Test 3: End of Week 12 (n=111, 40)Test 4: Baseline (n=128, 40)Test 4: End of Week 12 (n=111, 40)
Normal Group6.2135.77.156.6756.8756.51311.76310.488
OROS-MPH Group20.56118.96119.3218.28118.65216.94622.86819.388

[back to top]

WCST: Completed Categories (Cc)

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. In completed categoriies, number of categories completed out of 6 sorting categories after the test was evaluated. Ranges from 0 to 6. The more the number of categories completed the better is the response. (NCT01933880)
Timeframe: Baseline and End of Week 12

,
InterventionNunber of Categories Completed (Mean)
Baseline (n=128, 40)End of Week 12 (n=111, 40)
Normal Group3.34
OROS-MPH Group3.24.1

[back to top]

WCST: Correct Responses (Rc)

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. The number of correct responses which meets all the requirements according to the response principles was evaluated. Ranges from 0-116, the more the better. (NCT01933880)
Timeframe: Baseline and End of Week 12

,
Interventionnumber of correct responses (Mean)
Baseline (n=128, 40)End of Week 12 (n=111, 40)
Normal Group77.984.7
OROS-MPH Group72.980.3

[back to top]

WCST: Error Responses (Re)

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of error responses which did not comply with the response principles was evaluated. Ranges from 0 to 128, the less the better. (NCT01933880)
Timeframe: Baseline and End of Week 12

,
Interventionnumber of error responses (Mean)
Baseline (n=128, 40)End of Week 12 (n= 111, 40)
Normal Group42.932.3
OROS-MPH Group52.336.1

[back to top]

WCST: Failure to Maintain Set (Fm)

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. The frequency (number of times) of responses completed with 5 to 9 continuous correct was evaluated. Ranges from 0 to 26 and was not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case). (NCT01933880)
Timeframe: Baseline and End of Week 12

,
Interventionnumber of times (Mean)
Baseline (n=128, 40)End of Week 12 (n=111, 40)
Normal Group2.32.5
OROS-MPH Group1.72

[back to top]

WCST: First Response (Rf)

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of responses needed to complete the first color classification was evaluated. Ranges from 9 to 128, the lesser the better. (NCT01933880)
Timeframe: Baseline and End of Week 12

,
Interventionnumber of first responses (Mean)
Baseline (n=128,40)End of Week 12 (n=111, 40)
Normal Group25.226.5
OROS-MPH Group22.623.4

[back to top]

WCST: Learning to Learn (L-C)

"WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. Learning to learn indicator was a measure of decrement in the number of responses needed to achieve each successive category. The raw score ranged from 0 to 100. The high, negative value suggests the participants could not effectively learn the task presented by the WCST. Only calculated in those completed 3 or more categories and not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case)." (NCT01933880)
Timeframe: Baseline and End of Week 12

,
Interventionnumber of responses (Mean)
Baseline (n=128, 40)End of Week 12 (n=111, 40)
Normal Group-2.37-1.34
OROS-MPH Group-2.49-1.87

[back to top]

WCST: Non-Persistent Error Responses (nRpe)

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Non perseverative error responses are the errors remaining after subtracting persistent errors from total errors. Ranges from 0 to 128 and was not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case). (NCT01933880)
Timeframe: Baseline and End of Week 12

,
Interventionnumber of non-persistent error responses (Mean)
Baseline (n=128, 40)End of Week 12 (n=111, 40)
Normal Group19.9815.8
OROS-MPH Group23.5416.75

[back to top]

Reaction Time on the Multi-Source Interference Task

Reaction time of the Multi-Source Interference Task is measured in seconds. (NCT01993108)
Timeframe: Two hours

Interventionseconds (Mean)
Methlyphenidate in Healthy Controls.78
Naltrexone in Healthy Controls.83
Placebo in Healthy Controls.85
Methlyphenidate in ADHD.71
Naltrexone in ADHD.73
Placebo in ADHD.77

[back to top]

Characterize the Effects of Methylphenidate and Naltrexone on Neural Circuits in Prefrontal Cortex Associated With Top-down Control.

The effects of methylphenidate, naltrexone, and placebo on the change in BOLD (Blood Oxygen Level Dependent) signal will be characterized in the incongruent condition (cognitive regulation condition) of the MSIT (multi-source interference task) relative to the congruent condition (no regulation condition). Specifically, the summed BOLD signal in three regions--dorsal lateral prefrontal cortex, anterior insula, anterior cingulate--are measured. (NCT01993108)
Timeframe: Two hours

InterventionMean percentage of BOLD signal change (Mean)
Methlyphenidate in Healthy Controls.21
Naltrexone in Healthy Controls.51
Placebo in Healthy Controls.20
Methlyphenidate in ADHD.43
Naltrexone in ADHD.58
Placebo in ADHD.47

[back to top]

Accuracy on the Multi-Source Interference Task

Accuracy is the calculated percentage of correct responses over total trials in the Multi-Source Interference Task. (NCT01993108)
Timeframe: Two hours

Interventionpercent of total trials (Mean)
Methlyphenidate in Healthy Controls96
Naltrexone in Healthy Controls93
Placebo in Healthy Controls91
Methlyphenidate in ADHD93
Naltrexone in ADHD93
Placebo in ADHD92

[back to top]

Reaction Time Variability on the Multi-Source Interference Task

Multi-Source Interference Task is a psychological task that measures the psychological construct of cognitive control, the ability to suppress automatic response tendencies. Reaction time variability is the standard deviation of the trial to trial reaction time measured in seconds. (NCT01993108)
Timeframe: 2 hours

Interventionseconds (Mean)
Methlyphenidate in Healthy Controls.22
Naltrexone in Healthy Controls.23
Placebo in Healthy Controls.26
Methlyphenidate in ADHD.20
Naltrexone in ADHD.20
Placebo in ADHD.21

[back to top]

Endpoint Medication Dose

Dose of medication reported in mg/kg/day (NCT02039908)
Timeframe: End of Phase 2 School Year

InterventionMg/kg/day (Mean)
Methylphenidate 7-day Dosing1.30
Methylphenidate 5-day Dosing1.24

[back to top]

Time to First Dose Increase

The amount of time elapsed before a child requires a dose increase during the school year will be measured in months. (NCT02039908)
Timeframe: 10 months

InterventionMonths (Mean)
Methylphenidate 7-day Dosing3.8
Methylphenidate 5-day Dosing4.1

[back to top]

Number of Dose Changes Required Per Protocol

Monthly evaluations of medication efficacy will be used to determine whether dose adjustments are needed due to anticipated tolerance effects. (NCT02039908)
Timeframe: 10 months

InterventionNumber of Increases (Mean)
Methylphenidate 7-day Dosing1.79
Methylphenidate 5-day Dosing1.61

[back to top]

Number of Participants With Adverse Events

Recorded as a measure of safety and tolerability (NCT02051452)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Methylphenidate0
Placebo0

[back to top]

Time to Emergence From General Anesthesia

Measured as the time from drug (MPH or saline placebo) administration to extubation (NCT02051452)
Timeframe: 1-4 hours

Interventionminutes (Mean)
Methylphenidate7.5
Placebo8.73

[back to top]

Change in Adult ADHD Investigator Symptom Report Scale (AISRS) Score

"The Adult ADHD Investigator Symptom Report Scale (AISRS) assesses each of the 18 individual symptoms of ADHD in DSM-IV on a Likert scale from 0 (not present) to 3 (severe), with a total possible score of 54.~The change in AISRS score from baseline to endpoint (6 weeks) was calculated as the later time point score minus the earlier time point score." (NCT02096952)
Timeframe: Baseline to 6 weeks

Interventionunits on a scale (Mean)
Methylphenidate Extended-release Liquid-22.8

[back to top]

Measure of Heart Rate

The heart rate was monitored with two disposable electrodes on the ribcage midway between the waist and the armpit. (NCT02153944)
Timeframe: 20 minutes after arrival for study; 10 minutes & 145 minutes post drug administration

,
Interventionbeats/minute (Mean)
20 minutes after arrival for study10 minutes post drug administration145 minutes post drug administration
fMRI: Drug Challenge With Methylphenidate79.029411872.181818274.3030303
fMRI: Drug Challenge With Placebo77.294117672.647058869.7647059

[back to top]

Reaction Time to Stimuli: Threat Condition - 3BACK - Run 1

Reaction time (RT) is the time it takes to respond to stimuli. Participants RTs were measured while undergoing alternating periods of safety and shock threat conditions i.e. while anticipating unpleasant electric shocks (threat) or no shock (safe) during the n-back paradigm task. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. Two levels of difficulties were tested: 1Back and 3Back (n-back). Participants were instructed to indicate whether the letter currently displayed was the same as the letter presented 1 or 3 letters back. The task was organized in 2 runs, 8 blocks per run (4 safe and 4 threat presented alternatively), 18 sequential letters per block. Each block (threat or safe) corresponded to 2 tasks, 1- and 3-back tasks. RT was analyzed using condition (threat, safe) x Load (1Back, 3Back) repeated-measures ANOVA. (NCT02153944)
Timeframe: 90 minutes plus 135 seconds within a 6-hour study visit

Interventionmilliseconds (ms) (Mean)
fMRI: Drug Challenge With Methylphenidate971.676875
fMRI: Drug Challenge With Placebo995.619697

[back to top]

Reaction Time to Stimuli: Threat Condition - 3BACK - Run 2

Reaction time (RT) is the time it takes to respond to stimuli. Participants RTs were measured while undergoing alternating periods of safety and shock threat conditions i.e. while anticipating unpleasant electric shocks (threat) or no shock (safe) during the n-back paradigm task. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. Two levels of difficulties were tested: 1Back and 3Back (n-back). Participants were instructed to indicate whether the letter currently displayed was the same as the letter presented 1 or 3 letters back. The task was organized in 2 runs, 8 blocks per run (4 safe and 4 threat presented alternatively), 18 sequential letters per block. Each block (threat or safe) corresponded to 2 tasks, 1- and 3-back tasks. RT was analyzed using condition (threat, safe) x Load (1Back, 3Back) repeated-measures ANOVA. (NCT02153944)
Timeframe: 90 minutes plus 305 seconds within a 6-hour study visit

Interventionmilliseconds (ms) (Mean)
fMRI: Drug Challenge With Methylphenidate925.3409677
fMRI: Drug Challenge With Placebo929.6796875

[back to top]

Magnitude of Startle Reflex During Safe Condition

"The magnitude of the startle reflex during working memory tasks (n-back) while undergoing alternating periods of safety and threat of shock. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. The participant holds each stimulus in short-term memory while new stimuli are presented. For each new item presented, the participant's task is to decide if it is the same as the stimulus presented one time before (1Back), two times before (2Back) or three times before (3Back) by responding yes if the stimulus currently presented matches the stimulus presented earlier. Participants responded with a button press. The startle reflex was elicited with a 102 decibel (dB) white noise (40-ms duration) delivered via headphone. The eyeblink component of the startle reflex was recorded binaurally with two silver chloride (AgCl) electrodes placed under one eye." (NCT02153944)
Timeframe: 20-120 milliseconds following the onset of the startle stimulus

,,
Interventionmillivolts (mV) (Mean)
1Back2Back3Back
Behavioral: Drug Challenge With Methylphenidate42.288089344.188640845.7608354
Behavioral: Drug Challenge With Placebo42.3980145.3298946.63108
Behavioral: Drug Challenge With Propranolol43.6124344.9669247.15858

[back to top]

Magnitude of Startle Reflex During Threat Condition

"The magnitude of the startle reflex during working memory tasks (n-back) while undergoing alternating periods of safety and threat of shock. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. The participant holds each stimulus in short-term memory while new stimuli are presented. For each new item presented, the participant's task is to decide if it is the same as the stimulus presented one time before (1Back), two times before (2Back) or three times before (3Back) by responding yes if the stimulus currently presented matches the stimulus presented earlier. Participants responded with a button press. The startle reflex was elicited with a 102 decibel (dB) white noise (40-ms duration) delivered via headphone. The eyeblink component of the startle reflex was recorded binaurally with two silver chloride (AgCl) electrodes placed under one eye." (NCT02153944)
Timeframe: 20-120 milliseconds following the onset of the startle stimulus

,,
Interventionmillivolts (mV) (Mean)
1Back2Back3Back
Behavioral: Drug Challenge With Methylphenidate51.681383351.095372552.1700802
Behavioral: Drug Challenge With Placebo51.7988251.6149251.40215
Behavioral: Drug Challenge With Propranolol52.2078350.1392950.53474

[back to top]

Measure of BOLD Response in Brain Cluster - Threat Condition - 1BACK

The blood-oxygen-level dependent (BOLD) responses were measured using an fMRI scanner. The cerebral fMRI BOLD uses magnetic fields to measure localized changes in brain blood flow and blood oxygenation in activated regions-of-interest (ROI). Participants BOLD responses were measured while undergoing alternating periods of safety and shock threat conditions i.e. while anticipating unpleasant electric shocks or no shock (safe) during the n-back task. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. Two levels of difficulties were tested: 1Back and 3Back (n-back). Participants were instructed to indicate whether the letter currently displayed was the same as the letter presented 1 or 3 letters back. (NCT02153944)
Timeframe: started 90 minutes post drug administration plus up to 360 seconds within a 6-hour study visit

,
Interventionarbitrary units (A.U) (Mean)
Brain Cluster-001 - Posterior Cingulate Cortex (PCC)Brain Cluster-002 - Right Prefrontal Cortex (PFC)Brain Cluster-003 - Left Prefrontal Cortex (PFC)Brain Cluster-004 - Anterior Cingulate Cortex (ACC)Brain Cluster-009 - Right PutamenBrain Cluster-11 - Frontal PoleBrain Cluster-12 - Right InsulaBrain Cluster-13 - Frontal PoleBrain Cluster-14-Right Insula
fMRI: Drug Challenge With Methylphenidate-0.1725431-0.0806112-0.1557721-0.1201138-0.06733-0.0929706-0.0543121-0.1420901-0.0580487
fMRI: Drug Challenge With Placebo-0.1488312-0.0609964-0.1297947-0.0940195-0.0435053-0.0173495-0.0434811-0.0822257-0.0542862

[back to top]

Measure of BOLD Response in Brain Cluster - Threat Condition - 3BACK

The blood-oxygen-level dependent (BOLD) responses were measured using an fMRI scanner. The cerebral fMRI BOLD uses magnetic fields to measure localized changes in brain blood flow and blood oxygenation in activated regions-of-interest (ROI). Participants BOLD responses were measured while undergoing alternating periods of safety and shock threat conditions i.e. while anticipating unpleasant electric shocks or no shock (safe) during the n-back task. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. Two levels of difficulties were tested: 1Back and 3Back (n-back). Participants were instructed to indicate whether the letter currently displayed was the same as the letter presented 1 or 3 letters back. (NCT02153944)
Timeframe: started 90 minutes post drug administration plus up to 450 seconds within a 6-hour study visit

,
Interventionarbitrary units (A.U) (Mean)
Brain Cluster-001 - Posterior Cingulate Cortex (PCC)Brain Cluster-002 - Right Prefrontal Cortex (PFC)Brain Cluster-003 - Left Prefrontal Cortex (PFC)Brain Cluster-004 - Anterior Cingulate Cortex (ACC)Brain Cluster-009 - Right PutamenBrain Cluster-11 - Frontal PoleBrain Cluster-12 - Right InsulaBrain Cluster-13 - Frontal PoleBrain Cluster-14-Right Insula
fMRI: Drug Challenge With Methylphenidate-0.0884053-0.0248587-0.0465762-0.089146-0.0470163-0.037367-0.0549414-0.1711822-0.0592526
fMRI: Drug Challenge With Placebo-0.1575204-0.0701165-0.0900214-0.1278046-0.0758935-0.022933-0.0925233-0.1896215-0.0882445

[back to top]

Measure of BOLD Response in Brain Clusters - Safe Condition - 1BACK

The blood-oxygen-level dependent (BOLD) responses were measured using an fMRI scanner. The cerebral fMRI BOLD uses magnetic fields to measure localized changes in brain blood flow and blood oxygenation in activated regions-of-interest (ROI). Participants BOLD responses were measured while undergoing alternating periods of safety and shock threat conditions i.e. while anticipating unpleasant electric shocks or no shock (safe) during the n-back task. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. Two levels of difficulties were tested: 1Back and 3Back (n-back). Participants were instructed to indicate whether the letter currently displayed was the same as the letter presented 1 or 3 letters back. (NCT02153944)
Timeframe: started 90 minutes post drug administration plus 90 seconds within a 6-hour study visit

,
Interventionarbitrary units (A.U) (Mean)
Brain Cluster-001 - Posterior Cingulate Cortex (PCC)Brain Cluster-002 - Right Prefrontal Cortex (PFC)Brain Cluster-003 - Left Prefrontal Cortex (PFC)Brain Cluster-004 - Anterior Cingulate Cortex (ACC)Brain Cluster-009 - Right PutamenBrain Cluster-11 - Frontal PoleBrain Cluster-12 - Right InsulaBrain Cluster-13 - Frontal PoleBrain Cluster-14 - Right Insula
fMRI: Drug Challenge With Methylphenidate-0.151002-0.0712797-0.1331336-0.1140823-0.0501889-0.0928793-0.0349776-0.1301602-0.0431302
fMRI: Drug Challenge With Placebo-0.2039758-0.1167484-0.1876725-0.151052-0.0848515-0.0743447-0.0830865-0.1309601-0.0856204

[back to top]

Measure of BOLD Response in Brain Clusters - Safe Condition - 3BACK

The blood-oxygen-level dependent (BOLD) responses were measured using an fMRI scanner. The cerebral fMRI BOLD uses magnetic fields to measure localized changes in brain The blood-oxygen-level dependent (BOLD) responses were measured using an fMRI scanner. The cerebral fMRI BOLD uses magnetic fields to measure localized changes in brain blood flow and blood oxygenation in activated regions-of-interest (ROI). Participants BOLD responses were measured while undergoing alternating periods of safety and shock threat conditions i.e. while anticipating unpleasant electric shocks or no shock (safe) during the n-back task. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. Two levels of difficulties were tested: 1Back and 3Back (n-back). Participants were instructed to indicate whether the letter currently displayed was the same as the letter presented 1 or 3 letters back. (NCT02153944)
Timeframe: started 90 minutes post drug administration plus up to 270 seconds within a 6-hour study visit

,
Interventionarbitrary units (A.U) (Mean)
Brain Cluster-001 - Posterior Cingulate Cortex (PCC)Brain Cluster-002 - Right Prefrontal Cortex (PFC)Brain Cluster-003 - Left Prefrontal Cortex (PFC)Brain Cluster-004 - Anterior Cingulate Cortex (ACC)Brain Cluster-009 - Right PutamenBrain Cluster-11 - Frontal PoleBrain Cluster-12 - Right InsulaBrain Cluster-13 - Frontal PoleBrain Cluster-14 - Right Insula
fMRI: Drug Challenge With Methylphenidate-0.1255616-0.0557781-0.0797764-0.1212111-0.0716675-0.0695188-0.0868275-0.2002039-0.0783793
fMRI: Drug Challenge With Placebo-0.1256943-0.0542905-0.0719455-0.1206337-0.05603060.001909-0.0971834-0.1695771-0.0832567

[back to top]

Reaction Time to Stimuli: Safe Condition - 3BACK - Run 1

Reaction time (RT) is the time it takes to respond to stimuli. Participants RTs were measured while undergoing alternating periods of safety and shock threat conditions i.e. while anticipating unpleasant electric shocks (threat) or no shock (safe) during the n-back paradigm task. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. Two levels of difficulties were tested: 1Back and 3Back (n-back). Participants were instructed to indicate whether the letter currently displayed was the same as the letter presented 1 or 3 letters back. The task was organized in 2 runs, 8 blocks per run (4 safe and 4 threat presented alternatively), 18 sequential letters per block. Each block (threat or safe) corresponded to 2 tasks, 1- and 3-back tasks. RT was analyzed using condition (threat, safe) x Load (1Back, 3Back) repeated-measures ANOVA. (NCT02153944)
Timeframe: 90 minutes post drug admin plus 45 seconds within a 6-hour study visit

Interventionmilliseconds (ms) (Mean)
fMRI: Drug Challenge With Methylphenidate976.1853125
fMRI: Drug Challenge With Placebo1007.74

[back to top]

Reaction Time to Stimuli: Safe Condition - 1BACK - Run 2

Reaction time (RT) is the time it takes to respond to stimuli. Participants RTs were measured while undergoing alternating periods of safety and shock threat conditions i.e. while anticipating unpleasant electric shocks (threat) or no shock (safe) during the n-back paradigm task. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. Two levels of difficulties were tested: 1Back and 3Back (n-back). Participants were instructed to indicate whether the letter currently displayed was the same as the letter presented 1 or 3 letters back. The task was organized in 2 runs, 8 blocks per run (4 safe and 4 threat presented alternatively), 18 sequential letters per block. Each block (threat or safe) corresponded to 2 tasks, 1- and 3-back tasks. RT was analyzed using condition (threat, safe) x Load (1Back, 3Back) repeated-measures ANOVA. (NCT02153944)
Timeframe: 90 minutes plus 180 seconds within a 6-hour study visit

Interventionmilliseconds (ms) (Mean)
fMRI: Drug Challenge With Methylphenidate707.7925806
fMRI: Drug Challenge With Placebo741.5425

[back to top]

Proportion of Correct Responses in the Working Memory Task (N-back): Safe Condition - 1BACK - Run 2

Stimuli were presented one at a time on a screen. Participants were instructed to remember (working memory) one or three stimuli back (N-back) from the current stimulus on the screen while undergoing alternating periods of safety and threat of shock i.e. while anticipating unpleasant electric shocks or no shock (safe). Two levels of difficulties were tested: 1- and 3-back. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. Participants indicated whether the letter currently displayed was the same as the letter presented 1 or 3 letters back. The task included 3 runs, 8 blocks per run (4 safe and 4 threat presented alternatively), 18 sequential letters per block. Each block represented a given level of difficulty, i.e., 1- and 3-back. Performance on working memory task (n-back) accuracy was measured across condition (threat and safe) x Load (1-back, 3-back) using repeated measures ANOVA. (NCT02153944)
Timeframe: 90 minutes plus 180 seconds within a 6-hour study visit

InterventionProportion of correct responses (Mean)
fMRI: Drug Challenge With Methylphenidate0.9529032
fMRI: Drug Challenge With Placebo0.953125

[back to top]

Measure of Heart Rate

The heart rate was monitored with two disposable electrodes on the ribcage midway between the waist and the armpit. (NCT02153944)
Timeframe: 20 minutes after arrival for study; 80 minutes & 125 minutes post drug administration

,,
Interventionbeats/minute (Mean)
20 minutes after arrival for study80 minutes post drug administration125 minutes post drug administration
Behavioral: Drug Challenge With Methylphenidate72.873.675.75
Behavioral: Drug Challenge With Placebo74.3575.172.45
Behavioral: Drug Challenge With Propranolol66.3564.660.05

[back to top]

Measure of Level of Anxiety

"The level of anxiety was assessed using the State Anxiety Inventory questionnaire. The State Anxiety Scale (S-Anxiety) evaluates the current state of anxiety. The State Anxiety Scale has 20 items. All items are rated on a 4-point scale ranging from 1 = not at all to 4 = very much so. The scale has a minimum score of 20 and a maximum score of 80. Higher score indicates greater anxiety. State Anxiety score was measured at different time points during the study." (NCT02153944)
Timeframe: 20 minutes after arrival for study; 10 minutes & 145 minutes post drug administration

,
InterventionUnits on a scale (Mean)
20 minutes after arrival for study10 minutes post drug administration145 minutes post drug administration
fMRI: Drug Challenge With Methylphenidate24.636363627.235294132.4705882
fMRI: Drug Challenge With Placebo23.181818224.235294129.6969697

[back to top]

Measure of Level of Anxiety

"The level of anxiety was assessed using the State Anxiety Inventory questionnaire. The State Anxiety Scale (S-Anxiety) evaluates the current state of anxiety. The State Anxiety Scale has 20 items. All items are rated on a 4-point scale ranging from 1 = not at all to 4 = very much so. The scale has a minimum score of 20 and a maximum score of 80. Higher score indicates greater anxiety. State Anxiety score was measured at different time points during the study." (NCT02153944)
Timeframe: 20 minutes after arrival for study; 80, 100, & 125 minutes post drug administration

,,
InterventionUnits on a scale (Mean)
20 minutes after arrival for study80 minutes post drug administration100 minutes post drug administration125 minutes post drug administration
Behavioral: Drug Challenge With Methylphenidate26.3525.7536.434.15
Behavioral: Drug Challenge With Placebo25.725.536.233.25
Behavioral: Drug Challenge With Propranolol27.6528.337.934.31579

[back to top]

Proportion of Correct Responses in the Working Memory Task (N-back) - Safe Condition

"Stimuli were presented one at a time on a screen. Participants were instructed to remember (working memory) one, two, or three stimuli back (N-back) from the current stimulus on the screen while undergoing alternating periods of safety and threat of shock i.e. while anticipating unpleasant electric shocks or no shock (safe). The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. The participant holds each stimulus in short-term memory while new stimuli are presented. For each new item presented, the participant's task is to decide if it is the same as the stimulus presented one time before (1Back), two times before (2Back) or three times before (3Back) by responding yes if the stimulus currently presented matches the stimulus presented earlier. Performance on working memory task (n-back) accuracy was measured across condition (threat and safe) x Load (1Back, 2Back, 3Back) using repeated measures ANOVA." (NCT02153944)
Timeframe: Task started 90 minutes post drug admin up to max of 125 mins post drug admin (max total is 35 mins) during a 6-hour single day visit

,,
InterventionProportion of correct responses (Mean)
1Back2Back3Back
Behavioral: Drug Challenge With Methylphenidate0.962350.925850.82115
Behavioral: Drug Challenge With Placebo0.92850.87340.792
Behavioral: Drug Challenge With Propranolol0.945350.90390.8528

[back to top]

Proportion of Correct Responses in the Working Memory Task (N-back) - Threat Condition

"Stimuli were presented one at a time on a screen. Participants were instructed to remember (working memory) one, two, or three stimuli back (N-back) from the current stimulus on the screen while undergoing alternating periods of safety and threat of shock i.e. while anticipating unpleasant electric shocks or no shock (safe). The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. The participant holds each stimulus in short-term memory while new stimuli are presented. For each new item presented, the participant's task is to decide if it is the same as the stimulus presented one time before (1Back), two times before (2Back) or three times before (3Back) by responding yes if the stimulus currently presented matches the stimulus presented earlier. Performance on working memory task (n-back) accuracy was measured across condition (threat and safe) x Load (1Back, 2Back, 3Back) using repeated measures ANOVA." (NCT02153944)
Timeframe: task started 90 minutes post drug admin up to max of 125 mins post drug admin (max total is 35 mins) during a 6-hour single day visit

,,
InterventionProportion of correct responses (Mean)
1Back2Back3Back
Behavioral: Drug Challenge With Methylphenidate0.95860.885050.8358
Behavioral: Drug Challenge With Placebo0.927550.832550.74575
Behavioral: Drug Challenge With Propranolol0.944450.882750.8152

[back to top]

Proportion of Correct Responses in the Working Memory Task (N-Back): Safe Condition - 1BACK - Run 1

Stimuli were presented one at a time on a screen. Participants were instructed to remember (working memory) one or three stimuli back (N-back) from the current stimulus on the screen while undergoing alternating periods of safety and threat of shock i.e. while anticipating unpleasant electric shocks or no shock (safe).Two levels of difficulties were tested: 1- and 3-back. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. Participants indicated whether the letter currently displayed was the same as the letter presented 1 or 3 letters back. The task included 3 runs, 8 blocks per run (4 safe and 4 threat presented alternatively), 18 sequential letters per block. Each block represented a given level of difficulty, i.e., 1- and 3-back. Performance on working memory task (n-back) accuracy was measured across condition (threat and safe) x Load (1-back, 3-back) using repeated measures ANOVA. (NCT02153944)
Timeframe: 90 minutes post drug admin plus zero seconds within a 6-hour study visit

InterventionProportion of correct responses (Mean)
fMRI: Drug Challenge With Methylphenidate0.9565625
fMRI: Drug Challenge With Placebo0.919697

[back to top]

Proportion of Correct Responses in the Working Memory Task (N-back): Threat Condition - 3BACK - Run 2

Stimuli were presented one at a time on a screen. Participants were instructed to remember (working memory) one or three stimuli back (N-back) from the current stimulus on the screen while undergoing alternating periods of safety and threat of shock i.e. while anticipating unpleasant electric shocks or no shock (safe). Two levels of difficulties were tested: 1- and 3-back. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. Participants indicated whether the letter currently displayed was the same as the letter presented 1 or 3 letters back. The task included 3 runs, 8 blocks per run (4 safe and 4 threat presented alternatively), 18 sequential letters per block. Each block represented a given level of difficulty, i.e., 1- and 3-back. Performance on working memory task (n-back) accuracy was measured across condition (threat and safe) x Load (1-back, 3-back) using repeated measures ANOVA. (NCT02153944)
Timeframe: 90 minutes plus 305 seconds within a 6-hour study visit

InterventionProportion of correct responses (Mean)
fMRI: Drug Challenge With Methylphenidate0.7816129
fMRI: Drug Challenge With Placebo0.7671875

[back to top]

Proportion of Correct Responses in the Working Memory Task (N-back): Threat Condition - 3BACK - Run 1

Stimuli were presented one at a time on a screen. Participants were instructed to remember (working memory) one or three stimuli back (N-back) from the current stimulus on the screen while undergoing alternating periods of safety and threat of shock i.e. while anticipating unpleasant electric shocks or no shock (safe). Two levels of difficulties were tested: 1- and 3-back. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. Participants indicated whether the letter currently displayed was the same as the letter presented 1 or 3 letters back. The task included 3 runs, 8 blocks per run (4 safe and 4 threat presented alternatively), 18 sequential letters per block. Each block represented a given level of difficulty, i.e., 1- and 3-back. Performance on working memory task (n-back) accuracy was measured across condition (threat and safe) x Load (1-back, 3-back) using repeated measures ANOVA. (NCT02153944)
Timeframe: 90 minutes plus 135 seconds within a 6-hour study visit

InterventionProportion of correct responses (Mean)
fMRI: Drug Challenge With Methylphenidate0.73
fMRI: Drug Challenge With Placebo0.7275758

[back to top]

Proportion of Correct Responses in the Working Memory Task (N-back): Threat Condition - 1BACK - Run 2

Stimuli were presented one at a time on a screen. Participants were instructed to remember (working memory) one or three stimuli back (N-back) from the current stimulus on the screen while undergoing alternating periods of safety and threat of shock i.e. while anticipating unpleasant electric shocks or no shock (safe). Two levels of difficulties were tested: 1- and 3-back. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. Participants indicated whether the letter currently displayed was the same as the letter presented 1 or 3 letters back. The task included 3 runs, 8 blocks per run (4 safe and 4 threat presented alternatively), 18 sequential letters per block. Each block represented a given level of difficulty, i.e., 1- and 3-back. Performance on working memory task (n-back) accuracy was measured across condition (threat and safe) x Load (1-back, 3-back) using repeated measures ANOVA. (NCT02153944)
Timeframe: 90 minutes plus 260 seconds within a 6-hour study visit

InterventionProportion of correct responses (Mean)
fMRI: Drug Challenge With Methylphenidate0.9435484
fMRI: Drug Challenge With Placebo0.9425

[back to top]

Reaction Time to Stimuli: Threat Condition - 1BACK - Run 2

Reaction time (RT) is the time it takes to respond to stimuli. Participants RTs were measured while undergoing alternating periods of safety and shock threat conditions i.e. while anticipating unpleasant electric shocks (threat) or no shock (safe) during the n-back paradigm task. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. Two levels of difficulties were tested: 1Back and 3Back (n-back). Participants were instructed to indicate whether the letter currently displayed was the same as the letter presented 1 or 3 letters back. The task was organized in 2 runs, 8 blocks per run (4 safe and 4 threat presented alternatively), 18 sequential letters per block. Each block (threat or safe) corresponded to 2 tasks, 1- and 3-back tasks. RT was analyzed using condition (threat, safe) x Load (1Back, 3Back) repeated-measures ANOVA. (NCT02153944)
Timeframe: 90 minutes plus 260 seconds within a 6-hour study visit

Interventionmilliseconds (ms) (Mean)
fMRI: Drug Challenge With Methylphenidate729.0251613
fMRI: Drug Challenge With Placebo735.5509375

[back to top]

Proportion of Correct Responses in the Working Memory Task (N-back): Threat Condition - 1BACK - Run 1

Stimuli were presented one at a time on a screen. Participants were instructed to remember (working memory) one or three stimuli back (N-back) from the current stimulus on the screen while undergoing alternating periods of safety and threat of shock i.e. while anticipating unpleasant electric shocks or no shock (safe). Two levels of difficulties were tested: 1- and 3-back. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. Participants indicated whether the letter currently displayed was the same as the letter presented 1 or 3 letters back. The task included 3 runs, 8 blocks per run (4 safe and 4 threat presented alternatively), 18 sequential letters per block. Each block represented a given level of difficulty, i.e., 1- and 3-back. Performance on working memory task (n-back) accuracy was measured across condition (threat and safe) x Load (1-back, 3-back) using repeated measures ANOVA. (NCT02153944)
Timeframe: 90 minutes plus 90 seconds within a 6-hour study visit

InterventionProportion of correct responses (Mean)
fMRI: Drug Challenge With Methylphenidate0.9228125
fMRI: Drug Challenge With Placebo0.9378788

[back to top]

Reaction Time to Stimuli: Threat Condition - 1BACK - Run 1

Reaction time (RT) is the time it takes to respond to stimuli. Participants RTs were measured while undergoing alternating periods of safety and shock threat conditions i.e. while anticipating unpleasant electric shocks (threat) or no shock (safe) during the n-back paradigm task. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. Two levels of difficulties were tested: 1Back and 3Back (n-back). Participants were instructed to indicate whether the letter currently displayed was the same as the letter presented 1 or 3 letters back. The task was organized in 2 runs, 8 blocks per run (4 safe and 4 threat presented alternatively), 18 sequential letters per block. Each block (threat or safe) corresponded to 2 tasks, 1- and 3-back tasks. RT was analyzed using condition (threat, safe) x Load (1Back, 3Back) repeated-measures ANOVA. (NCT02153944)
Timeframe: 90 minutes plus 90 seconds within a 6-hour study visit

Interventionmilliseconds (ms) (Mean)
fMRI: Drug Challenge With Methylphenidate771.2671875
fMRI: Drug Challenge With Placebo779.1712121

[back to top]

Reaction Time to Stimuli: Safe Condition - 3BACK - Run 2

Reaction time (RT) is the time it takes to respond to stimuli. Participants RTs were measured while undergoing alternating periods of safety and shock threat conditions i.e. while anticipating unpleasant electric shocks (threat) or no shock (safe) during the n-back paradigm task. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. Two levels of difficulties were tested: 1Back and 3Back (n-back). Participants were instructed to indicate whether the letter currently displayed was the same as the letter presented 1 or 3 letters back. The task was organized in 2 runs, 8 blocks per run (4 safe and 4 threat presented alternatively), 18 sequential letters per block. Each block (threat or safe) corresponded to 2 tasks, 1- and 3-back tasks. RT was analyzed using condition (threat, safe) x Load (1Back, 3Back) repeated-measures ANOVA. (NCT02153944)
Timeframe: 90 minutes plus 215 seconds within a 6-hour study visit

Interventionmilliseconds (ms) (Mean)
fMRI: Drug Challenge With Methylphenidate912.6574194
fMRI: Drug Challenge With Placebo915.005625

[back to top]

Proportion of Correct Responses in the Working Memory Task (N-back): Safe Condition - 3BACK - Run 1

Stimuli were presented one at a time on a screen. Participants were instructed to remember (working memory) one or three stimuli back (N-back) from the current stimulus on the screen while undergoing alternating periods of safety and threat of shock i.e. while anticipating unpleasant electric shocks or no shock (safe). Two levels of difficulties were tested: 1- and 3-back. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. Participants indicated whether the letter currently displayed was the same as the letter presented 1 or 3 letters back. The task included 3 runs, 8 blocks per run (4 safe and 4 threat presented alternatively), 18 sequential letters per block. Each block represented a given level of difficulty, i.e., 1- and 3-back. Performance on working memory task (n-back) accuracy was measured across condition (threat and safe) x Load (1-back, 3-back) using repeated measures ANOVA. (NCT02153944)
Timeframe: 90 minutes post drug admin plus 45 seconds within a 6-hour study visit

InterventionProportion of correct responses (Mean)
fMRI: Drug Challenge With Methylphenidate0.725625
fMRI: Drug Challenge With Placebo0.739697

[back to top]

Proportion of Correct Responses in the Working Memory Task (N-back): Safe Condition - 3BACK - Run 2

Stimuli were presented one at a time on a screen. Participants were instructed to remember (working memory) one or three stimuli back (N-back) from the current stimulus on the screen while undergoing alternating periods of safety and threat of shock i.e. while anticipating unpleasant electric shocks or no shock (safe). Two levels of difficulties were tested: 1- and 3-back. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. Participants indicated whether the letter currently displayed was the same as the letter presented 1 or 3 letters back. The task included 3 runs, 8 blocks per run (4 safe and 4 threat presented alternatively), 18 sequential letters per block. Each block represented a given level of difficulty, i.e., 1- and 3-back. Performance on working memory task (n-back) accuracy was measured across condition (threat and safe) x Load (1-back, 3-back) using repeated measures ANOVA. (NCT02153944)
Timeframe: 90 minutes plus 215 seconds within a 6-hour study visit

InterventionProportion of correct responses (Mean)
fMRI: Drug Challenge With Methylphenidate0.7570968
fMRI: Drug Challenge With Placebo0.7428125

[back to top]

Reaction Time to Stimuli: Safe Condition - 1BACK - Run 1

Reaction time (RT) is the time it takes to respond to stimuli. Participants RTs were measured while undergoing alternating periods of safety and shock threat conditions i.e. while anticipating unpleasant electric shocks (threat) or no shock (safe) during the n-back paradigm task. The n-back is a paradigm used to assess working memory function by presenting sequential stimuli individually. Two levels of difficulties were tested: 1Back and 3Back (n-back). Participants were instructed to indicate whether the letter currently displayed was the same as the letter presented 1 or 3 letters back. The task was organized in 2 runs, 8 blocks per run (4 safe and 4 threat presented alternatively), 18 sequential letters per block. Each block (threat or safe) corresponded to 2 tasks, 1- and 3-back tasks. RT was analyzed using condition( threat, safe) x Load (1Back, 3Back) repeated-measures ANOVA. (NCT02153944)
Timeframe: 90 minutes post drug admin plus zero seconds within a 6-hour study visit

Interventionmilliseconds (ms) (Mean)
fMRI: Drug Challenge With Methylphenidate743.283125
fMRI: Drug Challenge With Placebo794.7833333

[back to top]

Symbol-digit Matching Test (Double-blind Portion)

Symbol-digit matching test is a measure processing speed and working memory. The task involves matching nonsense symbols with numbers based on a key as quickly as possible within 90s. Score represents the number of correct responses within the time frame. Minimum score is 0. There is not a meaningful 'maximum' score, as there are too many symbols for a participant to successfully complete within the allotted time. A higher score is better. (NCT02178995)
Timeframe: Difference in scores between MPH 20mg, 10mg, or placebo during double-blind portion during which medication was randomized to weeks 2, 3, or 4.

Interventionpoints (Mean)
Participants With Epilepsy: Placebo49.8
Participants With Epilepsy: Methylphenidate 10 mg Dose52.2
Participants With Epilepsy: Methylphenidate 20 mg50.6

[back to top]

Neuropsychiatric Questionnaires

"Beck Depression Inventory, Beck Anxiety Inventory, Apathy Evaluation Scale. These were not primary or secondary variables of interest given methylphenidate's primary expected action being on cognition. Included given one author's interest, as other studies suggesting psychiatric improvements (particularly apathy and depression) with methylphenidate.~BDI is a common clinical and research measure of depression. It has 21 questions and is scored 0 (no depression) to 63 (most severe depression). A higher score is worse.~BAI is a measure of anxiety, which also has 21 questions and is scored 0 (no anxiety) to 63 (most severe anxiety). A higher score is worse.~AES is a measure of clinical apathy, and is an 18-item scale. It rates symptoms as not at all, slightly, somewhat, or a lot, which are then converted to numerical values 1 (least apathy) to 4 (most apathy). Scores range from 18 (no apathy) to 72 (most apathy)." (NCT02178995)
Timeframe: Baseline (Visit 1) vs end of Open-label (week 8)

,,,
InterventionPoints (Mean)
BDIBAIAES
Healthy Controls: Visit 1 (Baseline)2.02.423.3
Healthy Controls: Visit 51.11.722.9
Participants With Epilepsy: Visit 1 (Baseline)9.610.931.2
Participants With Epilepsy: Visit 5 (Open Label)6.49.628.7

[back to top]

CPT Scores (Double-blind Portion) (Secondary Variables)

"Secondary variables in CPT: hits, omissions, commissions~Hits represents the raw number of accurate responses to target stimuli, out of a maximum of 288. A higher number is better.~Omissions are errors committed when a target stimuli is not appropriately responded to. A higher number is worse. Theoretically, the maximum number of omissions would be 288. A lower number is BETTER.~Commissions are errors committed when a participant responds to a non-target stimuli. Because a participant may make multiple such errors for a given stimuli, there is no raw maximum. A lower number is BETTER." (NCT02178995)
Timeframe: Difference between scores on MPH 20mg, 10mg, or placebo during randomized visits weeks 2, 3, or 4

,,
InterventionUnits (Mean)
HitsOmissionsCommissions
Participants With Epilepsy: Methylphenidate 10 mg Dose286.90.321.5
Participants With Epilepsy: Methylphenidate 20 mg2870.321.2
Participants With Epilepsy: Placebo285.30.924

[back to top]

CPT Outcomes (Secondary Variables) (Open-label Portion)

"Omissions, commissions, and hits~Hits represents the raw number of accurate responses to target stimuli, out of a maximum of 288. A higher number is better.~Omissions are errors committed when a target stimuli is not appropriately responded to. A higher number is worse. Theoretically, the maximum number of omissions would be 288. A lower number is BETTER.~Commissions are errors committed when a participant responds to a non-target stimuli. Because a participant may make multiple such errors for a given stimuli, there is no raw maximum. A lower number is BETTER." (NCT02178995)
Timeframe: Baseline (Visit 1) vs end of Open-label (week 8)

,,,
InterventionPoints (Mean)
HitsOmissionsCommissions
Healthy Controls: Visit 1 (Baseline)2870.316.7
Healthy Controls: Visit 5287.60.113.2
Participants With Epilepsy: Visit 1 (Baseline)284.61.034.8
Participants With Epilepsy: Visit 5 (Open Label)287.60.118.5

[back to top]

Conners' Continuous Performance Test (CPT) (Double-blind Portion, Primary Variables)

"Scores on this test measure attentiveness/vigilance and response time. Primary measures are: D', HRTSD D' represents 'detectability,' and is a derived statistic which measures a participant's ability to distinguish target stimuli from non-target stimuli, and incorporates response time and accuracy factors. The equation for deriving it is proprietary to the test which markets the CPT. A higher, or less negative, score is considered WORSE.~HRTSD represents the standard deviation of participant hit reaction time data, as measured for a variety of different stimuli types across the trial. It is a measure of the participant's ability to maintain attention across the trial. A higher score represents more variability and is considered WORSE." (NCT02178995)
Timeframe: difference in scores on specific variables between MPH 20mg, 10mg, and placebo (randomized to administration at weeks 2, 3, or 4)

,,
InterventionUnits (Mean)
D'HRTSD
Participants With Epilepsy: Methylphenidate 10 mg Dose-3.580.17
Participants With Epilepsy: Methylphenidate 20 mg-3.660.17
Participants With Epilepsy: Placebo-3.30.19

[back to top]

Conners CPT Outcomes (Primary Variables) (Open-Label Portion)

"Within-groups comparison (between visit 1 and visit 5 within patients with epilepsy, comparing scores at baseline to scores on methylphenidate) as well as a comparison against healthy controls who repeated the cognitive measures an equal number of times (to assess and control for test/retest and placebo improvements).~D' represents 'detectability,' and is a derived statistic which measures a participant's ability to distinguish target stimuli from non-target stimuli, and incorporates response time and accuracy factors. The equation for deriving it is proprietary to the test which markets the CPT. A higher, or less negative, score is considered WORSE.~HRTSD represents the standard deviation of participant hit reaction time data, as measured for a variety of different stimuli types across the trial. It is a measure of the participant's ability to maintain attention across the trial. A higher score represents more variability and is considered WORSE." (NCT02178995)
Timeframe: Difference between scores at baseline (visit 1) and on methylphenidate open-label (visit 5), compared to untreated healthy controls

,,,
InterventionUnits (Mean)
HRTSDD'
Healthy Controls: Visit 1 (Baseline)0.20-3.7
Healthy Controls: Visit 50.15-4.2
Participants With Epilepsy: Visit 1 (Baseline)0.22-2.9
Participants With Epilepsy: Visit 5 (Open Label)0.16-3.8

[back to top]

Symbol-digit Matching Test (Open Label Phase)

Symbol-digit matching test is a measure processing speed and working memory. The task involves matching nonsense symbols with numbers based on a key as quickly as possible within 90s. Score represents the number of correct responses within the time frame. Minimum score is 0. There is not a meaningful 'maximum' score, as there are too many symbols for a participant to successfully complete within the allotted time. A higher score is better. (NCT02178995)
Timeframe: The single-dose double blind phase was followed by an open-label 4-week treatment phase.

Interventionpoints (Mean)
Participants With Epilepsy: Visit 1 (Baseline)48.1
Participants With Epilepsy: Visit 5 (Open Label)53.8
Healthy Controls: Visit 1 (Baseline)55.9
Healthy Controls: Visit 560.1

[back to top]

Adverse Events Profile (Open-Label)

"This is a side-effects reporting scale for anti-epileptic medications. Because it encompasses cognitive and non-cognitive side effects, it was not considered one of our main cognitive/quality of life outcomes of interest. It is used in other studies of AED side effects, however, so was included.~The scale consists of 19 symptoms rated 1 (Never a problem) to 4 (Always or often a problem). Minimum score is 19, maximum score is 76. A higher score is WORSE." (NCT02178995)
Timeframe: Baseline (Visit 1) vs end of Open-label (week 8)

InterventionPoints (Mean)
Participants With Epilepsy (Baseline)41.9
Participants With Epilepsy (Open-label Portion)34.4

[back to top]

Stimulant Side-effects Checklist

"This is a questionnaire covering common stimulant side-effects, intended to help monitor for any significant or common adverse effects.~The scale lists 16 common stimulant side effects rated 0 (absent) to 9 (serious). Minimum score is 0, maximum is 144. A higher score is WORSE." (NCT02178995)
Timeframe: Baseline (Visit 1) vs end of Open-label (week 8)

InterventionPoints (Mean)
Participants With Epilepsy (Baseline)37.2
Participants With Epilepsy (Open-label Portion)27.3

[back to top]

Seizure Frequency (Open-label Portion)

Seizures per 28 'at-risk' days. This is a comparison of 28 days prior to baseline visit as compared to seizure rate while taking methylphenidate, adjusted to provide a 'number of seizures per 28 days' measurement. (NCT02178995)
Timeframe: Randomized portion is followed by 1-month open-label portion.

InterventionSeizures per 28 at-risk days (Mean)
Participants With Epilepsy (Baseline)2.8
Participants With Epilepsy (Open-label Portion)2.4

[back to top]

QOLIE-89 Aggregate Score

"QOLIE-89 is a questionnaire to assess quality of life and subjective cognitive effects. The aggregate score is the overall calculated score. Note: most of its questions are specific to patients with epilepsy, and therefore the questionnaire cannot be validly completed by healthy controls. Therefore, only participants with epilepsy completed the questionnaire.~QOLIE aggregate scores and subscale scores are calculated based on individual patient responses throughout the survey, and according to scoring rules as determined by the creator of the questionnaire. Scores are rated 0 (worst) to 100 (best)." (NCT02178995)
Timeframe: Change from baseline to end of methylphenidate open label treatment (end month 2)

InterventionPoints (Mean)
Participants With Epilepsy (Baseline)60.2
Participants With Epilepsy (Open-label Portion)72.0

[back to top]

MCG (Open-label Portion)

MCG paragraph memory test is a measure verbal memory. Participants are read aloud a long, detailed story, and are then asked to immediately repeat all information they can remember from the story. Each pertinent story element (as pre-defined on a key) is considered 1 correct response. Minimum score is 0, maximum is 100. A higher score is better. (NCT02178995)
Timeframe: The single-dose double blind phase was followed by an open-label 4-week treatment phase.

InterventionPoints (Mean)
Participants With Epilepsy: Visit 1 (Baseline)18.6
Participants With Epilepsy: Visit 5 (Open Label)30.5
Healthy Controls: Visit 1 (Baseline)32.7
Healthy Controls: Visit 544.9

[back to top]

Hit Reaction Time (Open-Label)

"Hit reaction time represents the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.~This was not a pre-specified variable or an intentional post-hoc analysis, but it is calculated automatically and included here only for completeness of data submission." (NCT02178995)
Timeframe: Visits 2 vs 3 vs 4 on randomized medication doses.

InterventionMilliseconds (Mean)
Participants With Epilepsy: Visit 1 (Baseline)431.2
Participants With Epilepsy: Visit 5 (Open Label)425.7
Healthy Controls: Visit 1 (Baseline)447.7
Healthy Controls: Visit 5423.4

[back to top]

Hit Reaction Time (Double Blind)

"Hit reaction time represents the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.~This was not a pre-specified variable or an intentional post-hoc analysis, but it is calculated automatically and included here only for completeness of data submission." (NCT02178995)
Timeframe: Visits 2 vs 3 vs 4 on randomized medication doses.

Interventionms (Mean)
Participants With Epilepsy: Placebo437.4
Participants With Epilepsy: Methylphenidate 10 mg Dose433.9
Participants With Epilepsy: Methylphenidate 20 mg435.6

[back to top]

Remaining CPT Variables (Open-label)

"These are automatically-calculated CPT variables which were not pre-specified variables of interest or intentional post-hoc analyses. They are included ONLY for completeness of data. They include hit reaction time (HRT), variability (VAR), and perseverations (PRS).~Hit reaction time represents to the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.~Variability refers to variations in response time across individual blocks of time within the trial. It differs from HRTSD in that HRTSD measures variability across the entire trial. Minimum is 0. There are no absolute maximums. A higher score is WORSE.~Perseverations are errors made either faster than physiologically possible (<100ms). Minimum is 0, there is no maximum. Higher scores are WORSE." (NCT02178995)
Timeframe: Baseline vs end of open-label (week 8)

,,,
InterventionUnits (Mean)
Variability (units)Perseverations (units)
Healthy Controls: Visit 1 (Baseline)0.0420.08
Healthy Controls: Visit 50.0350.0
Participants With Epilepsy: Visit 1 (Baseline)0.050.2
Participants With Epilepsy: Visit 5 (Open Label)0.040.01

[back to top]

Remaining CPT Variables (Double-blind Portion)

"Remaining CPT variables are automatically calculated by the program. They were not pre-specified variables of interest nor intentional post-hoc analyses. They are included ONLY for completeness of data submission.~Hit reaction time represents to the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.~Variability refers to variations in response time across individual blocks of time within the trial. It differs from HRTSD in that HRTSD measures variability across the entire trial. Minimum is 0. There are no absolute maximums. A higher score is WORSE.~Perseverations are errors made either faster than physiologically possible (<100ms). Minimum is 0, there is no maximum. Higher scores are WORSE." (NCT02178995)
Timeframe: Placebo vs 10mg vs 20mg (visits 2, 3, 4)

,,
InterventionUnits (Mean)
Variability (units)Perseverations (units)
Participants With Epilepsy: Methylphenidate 10 mg Dose0.040.05
Participants With Epilepsy: Methylphenidate 20 mg0.040.04
Participants With Epilepsy: Placebo0.040.06

[back to top]

QOLIE-89 Selected Cognitive Subscales (Open-label)

"Pre-selected secondary variables were cognitive subscales on the QOLIE-89 felt likely to be affected by MPH: attention/concentration; memory; language; energy/fatigue.~QOLIE aggregate scores and subscale scores are calculated based on individual patient responses throughout the survey, and according to scoring rules as determined by the creator of the questionnaire. Scores are rated 0 (worst) to 100 (best)." (NCT02178995)
Timeframe: Comparing baseline (visit 1) to end of open-label (end of week 8)

,
InterventionPoints (Mean)
Attention/ConcentrationMemoryLanguageEnergy/Fatigue
Participants With Epilepsy (Baseline)50.436.858.145.9
Participants With Epilepsy (Open-label Portion)74.859.772.361.6

[back to top]

Seizure Frequency/Severity (Double-blind Portion)

Seizures per 28 'at-risk' days. This is a comparison of 28 days prior to baseline visit as compared to seizure rate while taking methylphenidate, adjusted to provide a 'number of seizures per 28 days' measurement. (NCT02178995)
Timeframe: Seizure rate during 28 days prior to study compared to during randomized, single-dose portion, rate adjusted to seizures per 28 patient days.

InterventionSeizures per 28 at-risk days (Mean)
Participants With Epilepsy (Baseline)2.5
Participants With Epilepsy (Double-blind Portion)2.0

[back to top]

MCG Paragraph Memory Test (Double-blind Portion)

MCG paragraph memory test is a measure of verbal memory. Participants are read aloud a long, detailed story, and are then asked to immediately repeat all information they can remember from the story. Each pertinent story element (as pre-defined on a key) is considered 1 correct response. Minimum score is 0, maximum is 100. A higher score is better. (NCT02178995)
Timeframe: Difference in scores between MPH 20mg, 10mg, or placebo, randomized to be given at weeks 2, 3, or 4

InterventionPoints (Mean)
Participants With Epilepsy: Placebo25.2
Participants With Epilepsy: Methylphenidate 10 mg Dose27.4
Participants With Epilepsy: Methylphenidate 20 mg28

[back to top]

QOLIE-89 Additional Subscales (Open-label)

"These are the remaining subscales of the QOLIE-89. These were not pre-specified variables of interest or intentional post-hoc analyses, but are automatically calculated in scoring the QOLIE-89 and are included ONLY for completeness of data submission.~QOLIE aggregate scores and subscale scores are calculated based on individual patient responses throughout the survey, and according to scoring rules as determined by the creator of the questionnaire. Scores are rated 0 (worst) to 100 (best)." (NCT02178995)
Timeframe: Visit 1 (baseline) vs end of open-label (week 8)

,
InterventionPoints (Mean)
Health PerceptionsOverall QOL (pt rating)Physical FunctionRole Limitations (Emotional)Role Limitations (Physical)PainWork/Driving/SocialEmotional WellbeingHealth DiscouragementSeizure WorryMedication EffectsSocial SupportSocial Isolation
Participants With Epilepsy (Baseline)55.265.578.067.862.870.461.170.366.455.548.171.274.6
Participants With Epilepsy (Open-label Portion)63.473.083.279.382.878.169.575.181.861.950.973.081.4

[back to top]

Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent)

"The Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales. The Emotional Control subscale measures the impact of executive function problems on emotional expression and assesses a child's ability to modulate or control his or her emotional responses. It is a 10-item subscale, and each item is scored Never, Sometimes, or Often. Raw scores for all scales are computed with Software Portfolio (BRIEF-SP), which provides a raw score and T score (based on child's age) for each scale. Higher scores represent more greater emotional dysregulation." (NCT02204410)
Timeframe: Baseline and 12 Weeks

Interventionunits on a scale (Mean)
Emotional Control Subscale T Score BaselineEmotional Control Subscale T Score Endpoint
Omega-3 Fatty Acids and Stimulant Treatment65.358.4

[back to top]

Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR)

"The Clinical Global Impression (CGI) is a clinician rated measure of illness severity, improvement, and efficacy of treatment (collected at all study visits). We examined the CGI Improvement specifically. The CGI Improvement for Deficient Emotional Self-Regulation (DESR) was reported at baseline and completion. The CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is rated as:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse" (NCT02204410)
Timeframe: Baseline and 12 Weeks

Interventionunits on a scale (Mean)
CGI Improvement for DESR BaselineCGI Improvement for DESR Endpoint
Omega-3 Fatty Acids and Stimulant Treatment4.63.0

[back to top]

Perceptual Organization and Processing Speed Index

"Relationship between tonic DA release (assessed by displacement of [11C] raclopride by oral methylphenidate) and improvement in processing speed after 4 weeks of treatment with oral methylphenidate.~The Perceptual organization and processing speed index is measured from the Digit Symbol and Symbol Searches from the Weschler Adult Intelligence Scale (WAIS-IV). The tasks that comprise the PSI, (Coding, Symbol Search), are timed and require attending to visual material, visual perception and organization, visual scanning, and hand-eye coordination. It is a standardized scale were 100 is the mean of a normal population, and each 10 points represents 1 standard deviation above or below the mean. Thus, an index of 110 is 1 SD above the mean, 90 is 1 SD below the mean." (NCT02225106)
Timeframe: 4 weeks

Interventionscore on a scale (Mean)
Open Label Methylphenidate Treatment89

[back to top]

SKAMP

"Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) Combined Scores - Average of 8:00 am to 4:00 pm assessments from the laboratory school day.~The SKAMP is a validated, 13-item, observer-rated scale designed to assess the level of impairment of classroom-observed behaviors (Wigal and Wigal, 2006). Items 1 through 4 assess subject attention; items 5 through 8 assess deportment; items 9 through 11 assess quality of work; while items 12 and 13 assess subject compliance with teacher/classroom rules. Each individual item is rated on a 7-point scale from 0 (normal, no impairment) to 6 (maximal impairment). When all individual item scores are summed together, they produce a 13-item combined score that ranges from 0 to 78, with higher scores signifying greater impairment. In the present study, the SKAMP rating scale was utilized across 6 sessions occurring at 8:00 am, 9:00 am, 10:00 am, 12:00 pm, 2:00 pm, 4:00 pm of the laboratory school day." (NCT02255513)
Timeframe: 8-hours from 8:00 am to 4:00 pm

InterventionSKAMP Combined Score (Least Squares Mean)
HLD20011.8
Placebo18.9

[back to top]

Clinical Global Impressions-ADHD - Severity

The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill. (NCT02255565)
Timeframe: once a week for 6 weeks

Interventionunits on a scale (Mean)
Very Low Dose Quillivant XR - Week 14.78
Very Low Dose Quillivant XR - Week 24.33
Very Low Dose Quillivant XR - Week 34.44
Very Low Dose Quillivant XR - Week 44.33
Very Low Dose Quillivant XR - Week 54.11
Very Low Dose Quillivant XR - Week 64.00
Low Dose Quillivant XR - Week 14.33
Low Dose Quillivant XR - Week 24.00
Low Dose Quillivant XR - Week 33.67
Low Dose Quillivant XR - Week 42.75
Low Dose Quillivant XR - Week 52.88
Low Dose Quillivant XR - Week 62.78
Moderate Dose Quillivant XR - Week 14.89
Moderate Dose Quillivant XR - Week 24.56
Moderate Dose Quillivant XR - Week 34.11
Moderate Dose Quillivant XR - Week 44.00
Moderate Dose Quillivant XR - Week 53.56
Moderate Dose Quillivant XR - Week 63.44

[back to top]

Clinical Global Impression - Improvement (CGI-I)

The CGI-I scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse. (NCT02255565)
Timeframe: once a week for 6 weeks

Interventionunits on a scale (Mean)
Very Low Dose Quillivant XR - Week 13.89
Very Low Dose Quillivant XR - Week 23.56
Very Low Dose Quillivant XR - Week 33.44
Very Low Dose Quillivant XR - Week 43.22
Very Low Dose Quillivant XR - Week 53.00
Very Low Dose Quillivant XR - Week 62.89
Low Dose Quillivant XR - Week 13.78
Low Dose Quillivant XR - Week 23.00
Low Dose Quillivant XR - Week 32.22
Low Dose Quillivant XR - Week 41.63
Low Dose Quillivant XR - Week 52.13
Low Dose Quillivant XR - Week 62.00
Moderate Dose Quillivant XR - Week 13.33
Moderate Dose Quillivant XR - Week 23.11
Moderate Dose Quillivant XR - Week 32.67
Moderate Dose Quillivant XR - Week 42.89
Moderate Dose Quillivant XR - Week 52.56
Moderate Dose Quillivant XR - Week 62.22

[back to top]

ADHD Rating Scale - IV

Measures the severity of Total ADHD symptoms, Inattention and Hyperactivity/Impulsive symptoms. The Inattention and Hyperactivity/Impulsive symptoms can range from 0 to 27 each, with a higher score reflecting more severe ADHD symptoms. The total score is calculated by summing the inattention and Hyperactivity/Impulsive subscales. The total score can range from 0 to 54 with a higher score reflecting more severe ADHD symptoms. (NCT02255565)
Timeframe: once a week for 6 weeks

,,,,,,,,,,,,,,,,,
Interventionunits on a scale (Mean)
Inattention Subscale ScoreHyperactivity Subscale ScoreTotal Score
Low Dose Quillivant XR - Week 116.3315.3331.67
Low Dose Quillivant XR - Week 214.0014.3328.33
Low Dose Quillivant XR - Week 312.0010.2222.22
Low Dose Quillivant XR - Week 48.386.8815.25
Low Dose Quillivant XR - Week 59.509.3818.88
Low Dose Quillivant XR - Week 69.566.5616.11
Moderate Dose Quillivant XR - Week 118.1112.7830.89
Moderate Dose Quillivant XR - Week 214.6711.3326.00
Moderate Dose Quillivant XR - Week 313.6711.7825.44
Moderate Dose Quillivant XR - Week 413.569.6723.22
Moderate Dose Quillivant XR - Week 513.009.2222.22
Moderate Dose Quillivant XR - Week 611.787.3319.11
Very Low Dose Quillivant XR - Week 117.8912.4430.33
Very Low Dose Quillivant XR - Week 216.7810.5627.33
Very Low Dose Quillivant XR - Week 316.6711.5628.22
Very Low Dose Quillivant XR - Week 414.3312.3326.67
Very Low Dose Quillivant XR - Week 514.569.2223.78
Very Low Dose Quillivant XR - Week 612.898.7821.67

[back to top]

Parent Ratings of Emotional Regulation

assessed via parent-completed Emotion Regulation Checklist (ERC). Outcome assessed is ERC total mean score: minimum value=1, max value=4, higher scores indicate worse outcome (NCT02293655)
Timeframe: baseline, study weeks 8, 9, 10 &12

,
Interventionscore on a scale (Mean)
BaselineMaintenance (wk 8)Randomization 1 (wk 9)Randomization 2 (wk 10)Randomization 3 (wk 12)
MPH Discontinuation2.11.81.81.91.9
Sustained MPH2.11.81.71.81.8

[back to top]

Spatial Working Memory

Spatial working memory was assessed via the Corsi Computerized Spatial Span Task, which requires the participant to reproduce a sequence of movements by tapping a series of blocks on a computer screen in the same order demonstrated by the examiner. Outcome of interest is total trials correct. Minimum score=0, max score=10. Higher scores indicate better performance. (NCT02293655)
Timeframe: baseline, study weeks 8, 9, 10 &12

,
Interventiontotal number of correct trials (Mean)
BaselineWeek 8 (med maintenance)week 9week 10week 12
MPH Discontinuation6.436.466.676.546.48
Sustained MPH6.836.637.427.617.24

[back to top]

Written Expression

"Assessed by child completion of the AIMSWEB curriculum based measure (CBM) test of Written Expression, with the measure assessing number of words written by the child after receiving a prompt. At baseline (week 1), child's performance was assigned a value of 1.0. The child's performance at weeks 8, 9, 10, and 12 was derived by dividing actual score (# of words written) on the test by the score predicted at that time point after applying the measure's normed rate of improvement (ROI) metric to the baseline score. For example, a score of 1.5 at week 8 would indicate that the child's actual score at week 8 was 50% higher than the predicted score at week 8 (which was derived by applying the normed ROI metric to the baseline score). Scores at weeks 8, 9, 10, 12 that are >1.0 indicate greater improvement than expected (so better outcome), while scores at weeks 8, 9, 10, 12 that are <1.0 indicate less improvement than expected (so worse outcome)." (NCT02293655)
Timeframe: baseline, study weeks 1, 8, 9, 10 &12

,
Interventionpercentage of expected improvement (Mean)
baselineweek 8week 9week 10week 12
MPH Discontinuation1.001.161.021.040.91
Sustained MPH1.000.941.060.931.05

[back to top]

% Time on Task

Participants were videotaped while completing the 20-minute Analogue Math task. Their behavior was coded in 20-second intervals by trained coders who determined if the children were on-task or off-task during each interval. The amount of time coded as on-task was divided by the total amount of time and then multiplied by 100 to generate the % of time on task variable. (NCT02293655)
Timeframe: baseline, study weeks 8, 9, 10, 12

,
Interventionpercentage of time spent on task (Mean)
BaselineWeek 8 (MPH Maintenance dose)Week 9Week 10Week 12
MPH Discontinuation Group74.483.973.169.566.6
Sustained MPH Group85.292.791.589.282.6

[back to top]

Barkley Sluggish Cognitive Tempo (SCT) Ratings

assessed via parent-completed Barkley Sluggish Cognitive Tempo Scale. Minimum=12, Max=48, higher scores indicate worse outcome. (NCT02293655)
Timeframe: baseline, study weeks 8, 9, 10 &12

,
Interventionscore on a scale (Mean)
Baseline (week 1)Maintenance (week 8)Randomization 1 (week 9)Randomization 2 (week 10)Randomization 3 (week 12)
MPH Discontinuation24.4118.518.418.718.8
Sustained MPH24.1918.217.518.017.6

[back to top]

Inhibitory Control Reaction Time Variability (SD of the Reaction Time)

Assessed via the Go/No-Go computerized measure of inhibitory control reaction time variability (with standard deviation of the reaction time being the indicator variability variability). Unit of measure is msec. Minimum is 0, Maximum is 500. Higher scores indicate more variability (higher standard deviation) in reaction time, indicating worse outcome (more characteristic of individuals with ADHD and less characteristic of typically developing individuals). (NCT02293655)
Timeframe: baseline, study weeks 8, 9, 10 & 12

,
Interventionmsec (Mean)
BaselineMaintenance Visit (week 8)Randomization 1 (week 9)Randomization 2 (week 10)Randomization 3 (week 12)
MPH Discontinuation219.6195.9250.8288.2285.2
Sustained MPH196.0199.6183.8228.5199.8

[back to top]

Parent ADHD Total Symptom Scores

Parent Vanderbilt ADHD Rating Scale Total Symptom Score, minimum=0, maximum=54, higher scores indicate more/worse ADHD symptoms (NCT02293655)
Timeframe: baseline, study weeks 8, 9, 10, 12

,
Interventionscore on a scale (Mean)
BaselineMaintenance Visit (week 8)Randomization 1 (week 9)Randomization 2 (week 10)Randomization 3 (week 12)
MPH Discontinuation36.217.616.523.825.2
Sustained MPH34.615.312.314.317.3

[back to top]

Math Reasoning

"Math reasoning was assessed by child completion of the AIMSWEB curriculum based measure (CBM) test of Math Concepts and Applications. At baseline (week 1), child's performance was assigned a value of 1.0. The child's performance at weeks 8, 9, 10, and 12 was derived by dividing actual score on the test by the score predicted at that time point after applying the measure's normed rate of improvement (ROI) metric to the baseline score. For example, a score of 1.5 at week 8 would indicate that the child's actual score at week 8 was 50% higher than the predicted score at week 8 (which was derived by applying the normed ROI metric to the baseline score). Scores at weeks 8, 9, 10, 12 that are >1.0 indicate greater improvement than expected (so better outcome), while scores at weeks 8, 9, 10, 12 that are <1.0 indicate less improvement than expected (so worse outcome)." (NCT02293655)
Timeframe: baseline, study weeks 1, 8, 9, 10 &12

,
Interventionpercentage of expected improvement (Mean)
BaselineWeek 8week 9week 10week 12
MPH Discontinuation1.01.091.111.151.10
Sustained MPH1.01.271.501.501.65

[back to top]

Math Computation - Number of Problems Completed Correctly

Math Computation Curriculum-Based Measure - Number of Problems Completed Correctly. Minimum=0, Maximum=600. Higher scores indicate improved/better performance (NCT02293655)
Timeframe: baseline, study weeks 8, 9, 10 & 12

,
InterventionNumber of problems completed correctly (Mean)
BaselineMaintenance Visit (week 8)Randomization 1 (week 9)Randomization 2 (week 10)Randomization 3 (week 12)
MPH Discontinuation200.84264.71221.19201.69201.10
Sustained MPH230.93320.12333.50323.25277.51

[back to top]

Reading Comprehension

"Reading Comprehension was assessed by child completion of the AIMSWEB curriculum based measure (CBM) test of Reading Comprehension. At baseline (week 1), child's performance was assigned a value of 1.0. The child's performance at weeks 8, 9, 10, and 12 was derived by dividing actual score on the test by the score predicted at that time point after applying the measure's normed rate of improvement (ROI) metric to the baseline score. For example, a score of 1.5 at week 8 would indicate that the child's actual score at week 8 was 50% higher than the predicted score at week 8 (which was derived by applying the normed ROI metric to the baseline score). Scores at weeks 8, 9, 10, 12 that are >1.0 indicate greater improvement than expected (so better outcome), while scores at weeks 8, 9, 10, 12 that are <1.0 indicate less improvement than expected (so worse outcome)." (NCT02293655)
Timeframe: baseline, study weeks 8, 9, 10 &12

,
Interventionpercentage of expected improvement (Mean)
baselineweek 8week 9week 10week 12
MPH Discontinuation1.001.001.021.121.01
Sustained MPH1.000.991.251.271.29

[back to top]

Emergence Time

After stopping isoflurane infusion, when the patient breathes spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated and the time will be recorded. (NCT02327195)
Timeframe: From the moment when isoflurane infusion is stopped until time of extubation

Interventionminutes (Median)
Methylphenidate9
Placebo9

[back to top]

Number of Participants That Experienced Postoperative Nausea and Vomiting

Efficacy of methylphenidate in preventing post operative nausea and vomiting (PONV) by limited opioids consumption: PONV verbal response scale on a 0 to 10 verbally elicited scale: 0 (no nausea) to 10 (nausea as bad as it could be) (NCT02327195)
Timeframe: First 24 Hours Postoperatively

InterventionParticipants (Count of Participants)
Methylphenidate5
Placebo3

[back to top]

Opioid Dose Escalation Prevention

Assess the efficacy of methylphenidate in preventing opioids dose escalation (fast cognitive improvement with efficient pain control -Postoperative Pain Numeric Rating Scale: O=None; (1-3)=Mild; (4-6)= Moderate; (7-10)=Severe). (NCT02327195)
Timeframe: During the length of hospital stay post surgery (on average 24 hours), and up to 3 days after surgery

InterventionMorphine Milligram Equivalents (MME) (Mean)
Methylphenidate1.9
Placebo2.8

[back to top]

Neuropsychiatric Inventory (NPI)

"Mean difference in change from baseline to 6 months in the NPI apathy subscale scores as administered by certified personnel to the study caregiver.~SEVERITY is graded 1 to 3 and FREQUENCY is graded 1 to 4. The overall score for the domain is the product of the severity and frequency which ranges from 1 to 12 with higher scores indicating more apathy." (NCT02346201)
Timeframe: baseline to 6 months

Interventionscore on a scale (Mean)
Methylphenidate-4.5
Placebo-3.1

[back to top]

Percentage of Participants With Change in Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (CGIC)

"Percentage of individuals improving on Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (CGIC) from baseline to 6 months; the CGIC is a 7-point Likert scale used to rate each patient with the following scores: marked worsening(7), moderate worsening (6), minimal worsening(5), no change(4), minimal improvement(3), moderate improvement(2), marked improvement(1). Ratings were based on an interview with the caregiver and an examination of the patient. The CGIC requires the clinician to consider a number of aspects of apathy, such as level of initiative, level of interest, and emotional engagement. Reported data is the percentage of participants with minimal/moderate/marked improvement." (NCT02346201)
Timeframe: Baseline to month 6

Interventionpercentage of participants (Number)
Methylphenidate39
Placebo32

[back to top]

AUC(0-t)

"Area under the plasma concentration versus time curve (calculated to the last measurable observation).~AUC: Area Under the Curve" (NCT02470234)
Timeframe: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Interventionng*hr/mL (Mean)
Methylphenidate HCl ER 10 mg89.18
Methylphenidate HCl ER 15 mg118.49
Methylphenidate HCl ER 20 mg155.95

[back to top]

Tmax

Time to peak plasma concentration (NCT02470234)
Timeframe: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Interventionh (Median)
Methylphenidate HCl ER 10 mg2.0
Methylphenidate HCl ER 15 mg3.0
Methylphenidate HCl ER 20 mg2.0

[back to top]

V(Dss)/F

Volume of distribution (NCT02470234)
Timeframe: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

InterventionL (Mean)
Methylphenidate HCl ER 10 mg682.49
Methylphenidate HCl ER 15 mg1952.17
Methylphenidate HCl ER 20 mg1396.96

[back to top]

T1/2

Elimination half-life (NCT02470234)
Timeframe: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Interventionh (Mean)
Methylphenidate HCl ER 10 mg4.80
Methylphenidate HCl ER 15 mg12.69
Methylphenidate HCl ER 20 mg6.98

[back to top]

Cmax/Dose

Dose-normalized Cmax (NCT02470234)
Timeframe: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Interventionng/mL/mg (Mean)
Methylphenidate HCl ER 10 mg0.81
Methylphenidate HCl ER 15 mg0.67
Methylphenidate HCl ER 20 mg0.77

[back to top]

Cmax

Maximum plasma concentration (NCT02470234)
Timeframe: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Interventionng/mL (Mean)
Methylphenidate HCl ER 10 mg8.07
Methylphenidate HCl ER 15 mg10.09
Methylphenidate HCl ER 20 mg15.45

[back to top]

Kel

Terminal elimination constant (NCT02470234)
Timeframe: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Interventionh-1 (Mean)
Methylphenidate HCl ER 10 mg0.15
Methylphenidate HCl ER 15 mg0.05
Methylphenidate HCl ER 20 mg0.10

[back to top]

CL/F

Apparent clearance. CL: Clearance (NCT02470234)
Timeframe: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

InterventionL/h (Mean)
Methylphenidate HCl ER 10 mg97.51
Methylphenidate HCl ER 15 mg106.63
Methylphenidate HCl ER 20 mg Capsule138.64

[back to top]

AUC/D

Dose-normalized AUC0-t. AUC: Area Under the Curve (NCT02470234)
Timeframe: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Interventionng*hr/mL/mg (Mean)
Methylphenidate HCl ER 10 mg8.92
Methylphenidate HCl ER 15 mg7.90
Methylphenidate HCl ER 20 mg7.80

[back to top]

AUC(0-inf)

"Area under the plasma concentration versus time curve, extrapolated to infinity.~AUC: Area Under the Curve" (NCT02470234)
Timeframe: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Interventionng*hr/mL (Mean)
Methylphenidate HCl ER 10 mg105.26
Methylphenidate HCl ER 15 mg140.68
Methylphenidate HCl ER 20 mg144.26

[back to top]

Parent Rating of Evening and Morning Behavior Revised, Morning Subscale (PREMB-R AM).

The PREMB-R is an 11-item rating scale designed to assess at-home functional impairments in children with ADHD during both early morning (AM) and late afternoon/evening (PM) time periods. With demonstrated validity and reliablility (Faraone et al., 2015), the AM subscale total score (sum of items 1 to 3) was designated in this study as a key secondary endpoint. Items are scored from 0 (none) to 3 (a lot), with higher scores signifying greater impairment of function. The PREMB-R rating scale was completed by parents during the 2-days prior to study visits at the beginning and end of the open-label period (Visits 2 and 8, respectively), as well as at the end of the randomized, double-blind period (Visit 9). At each visit, these ratings were used only for review by the clinician (MD, PhD, DO, licensed social worker, or any trained mental health professional approved by the sponsor) as part of a structured interview to enable collection of a clinician-rated PREMB-R AM subscale score. (NCT02493777)
Timeframe: PREMB-R AM mean subscale score for the 2-days prior to Visit 9.

InterventionPREMB-R AM subscale total score (Least Squares Mean)
HLD200 (Methylphenidate)0.9
Placebo2.7

[back to top]

Swanson, Kotkin, Agler, M-Flynn and Pelham Combined Score (SKAMP CS) - Model-adjusted Average of All Post-dose Time Points Assessed During a Laboratory Classroom Test Day (Visit 9).

The SKAMP is a validated, 13-item, observer-rated scale designed to assess the level of impairment of classroom-observed behaviors (Wigal and Wigal, 2006). Items 1 through 4 assess subject attention; items 5 through 8 assess deportment; items 9 through 11 assess quality of work; while items 12 and 13 assess subject compliance with teacher/classroom rules. Each individual item is rated on a 7-point scale from 0 (normal, no impairment) to 6 (maximal impairment). When all individual item scores are summed together, they produce a 13-item combined score that ranges from 0 to 78, with higher scores signifying greater impairment. In the present study, the SKAMP rating scale was utilized across 9 sessions occuring at 8:00 am, 9:00 am, 10:00 am, 12:00 pm, 2:00 pm, 4:00 pm, 6:00 pm, 7:00 pm, and 8:00 pm of the laboratory classroom day. Successful training of qualified individuals on the SKAMP scale was required before raters were allowed to perform study assessments. (NCT02493777)
Timeframe: 12-hours from 8:00 am to 8:00 pm

InterventionSKAMP CS (12-hour average) (Least Squares Mean)
HLD200 (Methylphenidate)14.8
Placebo20.7

[back to top]

Mean Youth Self-Report of Functional Impairment

Level of impairment experienced across multiple domains of functioning (e.g., at school, at home, with peers) as measured by adolescent self-report on the Impairment Rating Scale. Total score is the mean item rating on a scale from 0 (No problem) to 6 (Extreme problem). Higher scores are indicative of greater impairment. (NCT02502799)
Timeframe: Assessed at 6 months after randomization to treatment

Interventionscore on a scale (Mean)
Continued Monitoring and Assessment1.43
PT With ACBT1.6
PT With ACBT and Methylphenidate1.91

[back to top]

Mean Youth Self-Report of Disruptive Behaviors

Adolescent disruptive behaviors as measured by adolescent self-report and parent report on the Deviant Behavior Scale. Total scores on this measure reflect the average item rating across all items. Scores range from zero to 20 with higher scores reflecting self-report of engaging in more frequent deviant behaviors. (NCT02502799)
Timeframe: Assessed at 6 months after randomization to treatment

Interventionscore on a scale (Mean)
Continued Monitoring and Assessment.090
PT With ACBT.025
PT With ACBT and Methylphenidate.100

[back to top]

Mean Youth-Report of Parent-adolescent Conflict

Youth report of conflict with parents on the Conflict Behavior Questionnaire. Higher scores reflect higher parent teen conflict. Total score equals the average across item scores (ranging 1 to 5). (NCT02502799)
Timeframe: Assessed at 6 months after randomization to treatment

Interventionscore on a scale (Mean)
Continued Monitoring and Assessment3.14
PT With ACBT3.15
PT With ACBT and Methylphenidate3.00

[back to top]

Mean Youth Self-Report of Likelihood of Future Substance Use

Youth self-report of likelihood of future substance use during the next year. Score reflects participant report of likelihood of using substances over the next year on a scale from 0 (Definitely will not use) to 10 (Definitely will use). (NCT02502799)
Timeframe: Assessed at 6 months after randomization to treatment

Interventionscore on a scale (Mean)
Continued Monitoring and Assessment5.14
PT With ACBT4.33
PT With ACBT and Methylphenidate6.00

[back to top]

Before School Functioning Questionnaire (BSFQ) Total Score

The BSFQ was developed as a hybrid measure completed by a clinician or parent/legal guardian to assess commonly reported areas of morning dysfunction - both behaviors and functions associated with the post-waking, early morning period (from approximately 6:00 am to 9:00 am) - in children and adolescents with ADHD (Wilens et al., 2010; Wilens et al., 2013). Symptom severity and functional impairment were rated from 0 (none) to 3 (severe - different from peers all days, all settings) with total scores ranging from 0 to 60. Ratings were completed by a site clinician (MD, PhD, DO, licensed social worker, or trained mental health professional approved by the sponsor) at Visits 2 through 5 using a structured interview format. (NCT02520388)
Timeframe: Last week of 3-week treatment period assessed at Visit 5.

InterventionBSFQ total score (Least Squares Mean)
HLD200 (Methylphenidate)18.7
Placebo28.4

[back to top]

Attention Deficit Hyperactivity Disorder Rating Scale Based on DSM-IV Criteria (ADHD-RS-IV) Total Score.

The ADHD-RS-IV was developed to measure the behaviors of children with ADHD (DuPaul et al., 1998). The scale consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored in a range from 0 (reflecting no symptoms or a frequency of never or rarely) to 3 (reflecting severe symptoms or a frequency of almost always), with a range of total scores ranging from 0 to 54. In this study, a site clinican (required to be an MD, PhD, DO, licensed social worker, or any trained mental health professional approved by the sponsor) completed ADHD-RS-IV assessments at each visit using a structured interview format. (NCT02520388)
Timeframe: Last week of 3-week treatment period assessed at Visit 5.

InterventionADHD-RS-IV total score (Least Squares Mean)
HLD200 (Methylphenidate)24.1
Placebo31.2

[back to top]

Maximum Drug Concentration Observed (Cmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products

PK samples will be taken eight times on each classroom day at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose, and Cmax will be measured. The objectives of this measure is to estimate PK metrics, including Cmax, appropriate for characterizing rate and extent of absorption in each phase of the drug release and the evaluate the disposition and eliminating processes for each medication studied. The minimum value is pg/mL and there is was no maximum defined prior to the interventions. (NCT02536105)
Timeframe: 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose on each classroom day

Interventionpg/mL (Mean)
Methylphenidate HCl ER Tablets 176339
Placebo4327
Methylphenidate HCl ER Tablets 281611
Methylphenidate HCl ER for Suspension81498

[back to top]

Time to Reach Cmax (Tmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products

PK samples will be taken eight times on each classroom day at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose, and Tmax will be measured (NCT02536105)
Timeframe: 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose on each classroom day

InterventionHours (Mean)
Methylphenidate HCl ER Tablets 17.35
Placebo4.7
Methylphenidate HCl ER Tablets 26.35
Methylphenidate HCl ER for Suspension3.97

[back to top]

Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products

The Permanent Product Measure of Performance (PERMP) involves objective individualized mathematics tests. Scores will be obtained ten times on each classroom day at pre-dose, and at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose. PERMP Attempted is reported here. Scale ranges 0 math questions answered to 400 math questions answered. The more number of questions answered (better score), the higher the PERMP Attempted score is. (NCT02536105)
Timeframe: 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day

,,,
Interventionscore on a scale (Mean)
HOUR 0HOUR .5HOUR 1.5HOUR 2.5HOUR 4HOUR 5HOUR 6HOUR 8HOUR 10HOUR 12
Methylphenidate HCl ER for Suspension92.176114.294131.191139.132129.735122.91124.86297.35899.88182.642
Methylphenidate HCl ER Tablets 166.92578.463112.493124.313120.985103.985107.303117.403113.03112.09
Methylphenidate HCl ER Tablets 280.62188.333112.364127.848130.591117.879112.985123.803103.864109.909
Placebo95.36190.19489.36686.23685.98671.71873.4282.40880.76182.718

[back to top]

Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products

The Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) scale is a validated, 13-item rating of subjective impairment of classroom behaviors (0 = normal/no impairment; 1 = slight impairment; 2 = mild impairment; 3 = moderate impairment; 4 = severe impairment; 5 = very severe impairment; 6 = maximal impairment). The SKAMP consists of four subscales: SKAMP-Attention, SKAMP-Deportment, SKAMP-Quality of Work, and SKAMP-Compliance, in addition to SKAMP-Total (reported here). SKAMP-Total is a sum of the four sub-scales and has a range of 0-78. The higher the score, the higher the impairment. Scores will be obtained during each classroom cycle during each full laboratory classroom day at pre-dose, and at 0.5, 1.5, 2.5, 4, 5, 6, 8, 10, and 12 hours post-dose. The scores will be based on the child's behavior during 20 minutes of each cycle. (NCT02536105)
Timeframe: 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day

,,,
Interventionunits on a scale (Mean)
HOUR 0HOUR .5HOUR 1.5HOUR 2.5HOUR 4HOUR 5HOUR 6HOUR 8HOUR 10HOUR 12
Methylphenidate HCl ER for Suspension33.470627.058817.867615.808817.441220.676522.838228.338231.941234.7353
Methylphenidate HCl ER Tablets 136.432835.283623.432820.074619.164222.388122.164221.044820.716423.0746
Methylphenidate HCl ER Tablets 234.287932.106125.409120.393915.757617.106115.863619.378824.439427.3485
Placebo27.791730.736133.972233.486133.402836.291735.0035.097234.222232.2778

[back to top]

Number of High-effort Selections in the Effort-based Decision Making Task

Number of high-effort selections in the effort-based decision making task from the placebo to the methylphenidate condition. This is a decision-making task where participants make high- or low-effort choices to earn a small financial reward. High-effort selections require 100 button presses with non-dominant hand pinky finger and low-effort selections require 30 button presses with dominant hand index finger (within 15 seconds). The number of high effort selections are summed across 50 trials of the task. This task measures the willingness to perform effort in relation to changing reward magnitude and probability. This is a basic science experiment, the clinical and/or physiological relevance of these results are not established. (NCT02630017)
Timeframe: 1 hour post drug (or placebo) administration for each study session

InterventionNumber of high-effort selections (Mean)
ADHD Subjects, Placebo Condition16.4
ADHD Subjects, Methylphenidate Condition21.35
Non-ADHD Subjects, Placebo Condition20.45
Non-ADHD Subjects, Methylphenidate Condition19.8

[back to top]

Pittsburgh Side Effects Rating Scale

Pittsburgh Side Effects Rating Scale to evaluate adverse reactions to Methylphenidate Higher scores mean a worse outcome (more side effects with medication) This scales has 13 items, which are reported as None (0), Mild (1), Moderate (2) and Severe (3) Total score is calculated by summiting all items. Total Score Ranges (0-39) (NCT02638168)
Timeframe: 3 weeks

Interventionscore on a scale (Mean)
With-in Subjects Trial3.66

[back to top]

Affective Reactivity Index (ARI)

Higher scores mean a worse symptoms This scales has 7 items, which are reported as Not true (0), somewhat true (1) certainly true (2) Total score is calculated by summiting all items. Total Score Ranges (0-14) (NCT02638168)
Timeframe: 3 weeks

Interventionscore on a scale (Mean)
With-in Subjects Trial5

[back to top]

Length of Wakings

(NCT02638168)
Timeframe: 3 weeks

Interventionminutes (Mean)
With-in Subjects Trial3.28

[back to top]

Parent Rated 10-item IOWA

Higher scores mean severe symptoms This scales has 10 items, which are reported as Not at all (0), just a little (1), pretty much (2) and very much (3) Total score is calculated by summiting all items. Total Score Ranges (0-30) (NCT02638168)
Timeframe: 3 weeks

Interventionscore on a scale (Mean)
With-in Subjects Trial13.3

[back to top]

Number of Wakings

(NCT02638168)
Timeframe: 3 weeks

InterventionWakings (Mean)
With-in Subjects Trial22.81

[back to top]

Night to Night Variability (Weekends & Weekdays) - in Sleep Onset Latency Measured by Actigraphy

We calculated Night to night variability by the difference between the mean sleep onset latency during the weekend days and the mean sleep onset latency during the weekdays. (NCT02638168)
Timeframe: 3 weeks

Interventionminutes (Mean)
With-in Subjects Trial35.96

[back to top]

Wake After Sleep Onset (WASO)

(NCT02638168)
Timeframe: 3 weeks

Interventionminutes (Median)
With-in Subjects Trial73.81

[back to top]

Total Sleep Time

(NCT02638168)
Timeframe: 3 weeks

Interventionminutes (Mean)
With-in Subjects Trial492.45

[back to top]

Sleep Onset Latency (SOL), Defined as Time in Bed Until Sleep by Actigraphy

Sleep onset latency is defines as duration of time in bed until sleep actigraphy (NCT02638168)
Timeframe: 3 weeks

Interventionminutes (Mean)
With-in Subjects Trial37.81

[back to top]

Sleep Onset Latency (SOL) as Reported on the Parent Completed Sleep Log

Sleep onset latency is defines as duration of time in bed until sleep, as reported on the parent completed sleep log (NCT02638168)
Timeframe: 3 weeks

Interventionminutes (Mean)
With-in Subjects Trial61.04

[back to top]

Sleep Offset

(NCT02638168)
Timeframe: 3 weeks

Interventionminutes (Mean)
With-in Subjects Trial604

[back to top]

Sleep Efficiency

(NCT02638168)
Timeframe: 3 weeks

Interventionpercentage of time spent asleep in bed (Mean)
With-in Subjects Trial81.45

[back to top]

Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Inattention Subscale Score Change From End of Open Label Phase (Baseline) to End of Double Blind.

"This 18-item scale incorporates each of the ADHD symptoms listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) regardless of assigned subtype. Scoring was based on the universally accepted symptom severity as recommended in the DSM-IV-TR manual on a 4-point scale: 0=never or rarely, 1=sometimes, 2=often, and 3=very often. The Inattention subscales were based upon the sum of the odd items. The Inattention subscale score was the sum of the scores for the 9 odd items and could range from 0 (no impairment) to 27 (maximal impairment) for each administration per subject. Higher score means higher frequency and severity of symptoms.~Trained clinicians administered the questionnaire to parents." (NCT02683265)
Timeframe: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.

Interventionscore on a scale (Mean)
Aptensio XR2.9
Placebo Comparator7.9

[back to top]

Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Hyperactivity-Impulsivity Subscale Score Change From End of Open Label Phase (Baseline) to End of Double Blind.

"This 18-item scale incorporates each of the ADHD symptoms listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) regardless of assigned subtype. Scoring was based on the universally accepted symptom severity as recommended in the DSM-IV-TR manual on a 4-point scale: 0=never or rarely, 1=sometimes, 2=often, and 3=very often. The Hyperactivity-Impulsivity even items. The Hyperactivity-Impulsivity subscale score was the sum of the scores for the 9 even items and could range from 0 (no impairment) to 27 (maximal impairment) for each administration per subject. Higher score means higher frequency and severity of symptoms.~Trained clinicians administered the questionnaire to parents." (NCT02683265)
Timeframe: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.

Interventionscore on a scale (Mean)
Aptensio XR3.36
Placebo Comparator9.37

[back to top]

Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Total Score Change From End of Open Label Phase (Baseline) to End of Double Blind.

"ADHD-RS-IV is 18-item scale incorporates each of the ADHD symptoms listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) regardless of assigned subtype. Scoring was based on the universally accepted symptom severity as recommended in the DSM-IV-TR manual on a 4-point scale: 0 = never or rarely, 1 = sometimes, 2 = often, and 3 = very often. The total score is the sum of the scores for all 18 items and could range from 0 (no impairment) to 54 (maximal impairment) for each administration per subject. Higher score means higher frequency and severity of symptoms.~Trained clinicians administered the questionnaire to parents. The ADHD-RS-IV Preschool Version was used to determine eligibility, optimal dosing and the efficacy of double blind treatment." (NCT02683265)
Timeframe: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.

Interventionscore on a scale (Mean)
Aptensio XR6.3
Placebo Comparator17.3

[back to top]

Conners Early Childhood Behavior - Parent (Short) (EC BEH-P(S)) Change in T-score From End of Open Label Phase (Baseline) to End of Double Blind

"Conners EC BEH-P(S) is an assessment tool used to obtain a parent's observations about his/her child's behavior. This tool is designed to assess a range of behavioral, emotional, & social issues in young children. The tool consists of 47 items, responses to which are summarized in 6 behavioral scales & 2 validity scales.~Items on Conners assessment are rated on a Likert scale ranging from 0-3. The ratings were converted to raw item scores. Raw item scores were grouped, standardized, and/or compared to lookup tables for interpretation. Assessments were presented as T-scores: item raw scores for a given scale are added together; this raw sum is compared to age- and gender-matched normative data and converted to a T-score. Higher scores indicate higher concerns. T-score is a standard score with a mean of 50 and standard deviation of 10. Note that Conners assessments do not use T-scores greater than 90; raw scores that produce extremely high T-scores are reported as ''T-score >= 90." (NCT02683265)
Timeframe: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.

,
InterventionT-score (Mean)
Inattention/HyperactivityDefiant/Aggressive BehaviorsSocial Functioning / Atypical BehaviorsAnxietyMood and AffectPhysical Symptoms
Aptensio XR1.921.003.791.892.631.92
Placebo Comparator7.733.673.83-0.025.13-0.15

[back to top]

Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind.

The scale provides a global rating of illness severity during the trial. The subject is rated relative to the clinician's past experience with other subjects who have the same diagnosis. The CGI-S scale is 1 question and rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill subjects). A lower value a better the outcome. (NCT02683265)
Timeframe: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.

InterventionParticipants (Count of Participants)
Baseline72161948Baseline72161947End of Double-blind Treatment72161947End of Double-blind Treatment72161948
1 = Normal, not at all ill2 = Borderline mentally ill3 = Mildly ill6 = Severely ill4 = Moderately ill5 = Markedly ill7 = Among the most extremely ill subjects
Placebo Comparator13
Aptensio XR15
Placebo Comparator14
Aptensio XR8
Aptensio XR7
Placebo Comparator11
Placebo Comparator1
Aptensio XR1
Placebo Comparator0
Aptensio XR4
Placebo Comparator3
Aptensio XR12
Placebo Comparator5
Aptensio XR5
Placebo Comparator4
Aptensio XR6
Placebo Comparator10
Aptensio XR10
Placebo Comparator19
Aptensio XR2
Placebo Comparator7
Aptensio XR0
Placebo Comparator2

[back to top]

Acceptability of Treatment as Assessed by a Single Question Questionnaire

"Participants will answer yes or no to this question: Taken into consideration the possible benefits and/or disadvantages of this medication, would you choose it, going forward to treat your MS fatigue?. The number of participants who answered Yes to this question is reported here." (NCT03185065)
Timeframe: Week 5 of each treatment period

InterventionParticipants (Count of Participants)
Placebo39
Amantadine41
Modafinil55
Methylphenidate55

[back to top]

Epworth Sleepiness Scale (ESS) Score

ESS score during the fifth week of treatment period. The ESS score can range from 0 to 24. The higher the score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'. (NCT03185065)
Timeframe: Week 5 of each treatment period

Interventionscore on a scale (Least Squares Mean)
Placebo9.4
Amantadine9.3
Modafinil8.3
Methylphenidate8.8

[back to top]

Modified Fatigue Impact Scale (MFIS) Score

MFIS score during the fifth week of treatment period. The total score of the MFIS ranges from 0 to 84. Higher scores denote more severe fatigue. (NCT03185065)
Timeframe: Week 5 of each treatment period

Interventionscore on a scale (Least Squares Mean)
Placebo40.6
Amantadine41.3
Modafinil39.0
Methylphenidate38.6

[back to top]

Quality of Life in Neurological Disorders (Neuro-QoL) Item Bank - Fatigue Score

Neuro-QoL Item Bank - Fatigue T score during the fifth week of treatment period. T-score distributions rescale raw scores into standardized scores with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores denote more severe fatigue. (NCT03185065)
Timeframe: Week 5 of each treatment period

Interventionscore on a scale (Least Squares Mean)
Placebo53.1
Amantadine53.0
Modafinil52.5
Methylphenidate52.0

[back to top]

Feasibility of a Virtual Multicrossover Randomized Control Trial Design as Measured my Completion Rates and Medication Compliance.

To assess feasibility of this study design, completion rates of all study tasks and medication dosing will be evaluated. Benchmark goals for feasibility measures are set as follows: retain >80% of participants enrolled, observe >80% medication adherence, and >80% outcome assessment completion rates. (NCT03811847)
Timeframe: 4 months

InterventionParticipants (Count of Participants)
Participant retentionMedication ComplianceAssessment completion
All Study Participants777

[back to top]

Cognition as Measured by the Repeatable Battery for the Assessment Neuropsychological Status-Update (RBANS)

This study is investigating the effects of methylphenidate to see if it will help improve cognition in adults with Alzheimer's Disease. RBANS scores range from 40 to 160 with higher scores indicating higher cognitive functioning. (NCT03811847)
Timeframe: 4 months

Interventionscores on scale (Mean)
Study Participants on MPH Treatment68.8
Study Participants on PBO Block70.7

[back to top]

Cognition as Measured by Daily, Home-based Brain Games (Lumosity, Lumos Labs, Inc.)

This study is investigating the effects of methylphenidate to see if it will help improve cognition in adults with Alzheimer's Disease using daily Lumosity brain games. The range of possible Lumosity scores varies, but higher scores indicate better game performance. LPI (Lumosity Performance Index) is a standardized performance metric that shows how well you are performing on Lumosity games and lets you compare performance across games and Cognitive Areas. Cognitive LPI is calculated using a weighted average of the Game LPIs from all Cognitive Areas. LPI: The low score is 0, the high score is 2000. Average is 1000. (NCT03811847)
Timeframe: 4 months

Interventionscores on a scale (Mean)
Study Participants on MPH Blocks465.8
Study Participants on Placebo451.6

[back to top]

Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.

Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionMillimeters (Mean)
Sluggish/Fatigued/LazyRestlessNervous/AnxiousNauseated/Queasy/Sick to StomachTalkative/FriendlyIrregular/Racing HeartbeatEuphoricShaky/JitteryActive/Alert/EnergeticWill Pay ForWill Take AgainPerformance ImprovedPerformance ImpairedStimulatedLike DrugRushHighGood EffectsBad EffectsAny Effect
Active Comparator: Duloxetine0.001.000.000.0012.502.2518.250.0025.5022.2523.5011.500.0014.2515.008.2512.0013.750.0016.00
Placebo Comparator: Placebo22.331.000.673.004.330.3315.671.0015.3323.0046.337.0011.3321.3333.6710.679.3312.672.6712.67

[back to top]

Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.

Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionMillimeter of Mercury (Mean)
Methamphetamine (0 mg)Methamphetamine (10 mg)Methamphetamine (20 mg)
Active Comparator: Duloxetine127.00129.75135.25
Placebo Comparator: Placebo139.00138.67139.67

[back to top]

Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.

Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionMillimeter of Mercury (Mean)
Methamphetamine (0 mg)Methamphetamine (10 mg)Methamphetamine (20 mg)
Active Comparator: Duloxetine129.75132.25139.25
Placebo Comparator: Placebo133.33129.00130.00

[back to top]

Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.

Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionMillimeter of Mercury (Mean)
Methamphetamine (0 mg)Methamphetamine (10 mg)Methamphetamine (20 mg)
Active Comparator: Duloxetine124.25128.00132.75
Placebo Comparator: Placebo129.67131.67130.33

[back to top]

Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.

Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionMillimeter of Mercury (Mean)
Methamphetamine (0 mg)Methamphetamine (10 mg)Methamphetamine (20 mg)
Active Comparator: Duloxetine128.75131.00144.25
Placebo Comparator: Placebo132.67133.00132.67

[back to top]

Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.

Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionMillimeters (Mean)
Sluggish/Fatigued/LazyRestlessNervous/AnxiousNauseated/Queasy/Sick to StomachTalkative/FriendlyIrregular/Racing HeartbeatEuphoricShaky/JitteryActive/Alert/EnergeticWill Pay ForWill Take AgainPerformance ImprovedPerformance ImpairedStimulatedLike DrugRushHighGood EffectsBad EffectsAny Effect
Active Comparator: Duloxetine0.001.250.000.0018.251.0018.000.2521.5018.7521.5018.7513.5020.2521.502.5020.2520.250.0019.25
Placebo Comparator: Placebo6.670.000.330.0029.3330.6732.332.0037.3334.0037.6722.0010.3336.0036.3335.6737.0039.009.6738.00

[back to top]

Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.

Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionMillimeters (Mean)
Sluggish/Fatigued/LazyRestlessNervous/AnxiousNauseated/Queasy/Sick to StomachTalkative/FriendlyIrregular/Racing HeartbeatEuphoricShaky/JitteryActive/Alert/EnergeticWill Pay ForWill Take AgainPerformance ImprovedPerformance ImpairedStimulatedLike DrugRushHighGood EffectsBad EffectsAny Effect
Active Comparator: Duloxetine0.001.250.000.0015.500.7514.751.2524.7521.2523.7515.000.0023.2524.756.7520.5022.750.0019.50
Placebo Comparator: Placebo1.330.330.000.0025.332.3333.007.0028.0038.0041.6712.335.3331.6734.3329.0028.0035.0012.0033.67

[back to top]

Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.

Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionMillimeters (Mean)
Sluggish/Fatigued/LazyRestlessNervous/AnxiousNauseated/Queasy/Sick to StomachTalkative/FriendlyIrregular/Racing HeartbeatEuphoricShaky/JitteryActive/Alert/EnergeticWill Pay ForWill Take AgainPerformance ImprovedPerformance ImpairedStimulatedLike DrugRushHighGood EffectsBad EffectsAny Effect
Active Comparator: Duloxetine0.001.000.000.5014.503.5014.250.0024.5017.2524.7514.500.2519.7518.7512.7516.5014.250.0013.75
Placebo Comparator: Placebo4.339.333.331.6722.673.0033.331.3330.0045.6748.0016.6711.3336.6747.3333.3333.3335.676.3336.33

[back to top]

Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.

Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionMillimeters (Mean)
Sluggish/Fatigued/LazyRestlessNervous/AnxiousNauseated/Queasy/Sick to StomachTalkative/FriendlyIrregular/Racing HeartbeatEuphoricShaky/JitteryActive/Alert/EnergeticWill Pay ForWill Take AgainPerformance ImprovedPerformance ImpairedStimulatedLike DrugRushHighGood EffectsBad EffectsAny Effect
Active Comparator: Duloxetine0.000.500.000.0013.754.2516.000.0027.9920.5025.2512.000.2523.5026.2516.0020.5023.000.2524.50
Placebo Comparator: Placebo10.330.670.670.3320.001.0021.670.6735.6736.6750.0026.3332.6738.3337.6731.3336.6730.3323.6738.33

[back to top]

Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.

Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionMillimeters (Mean)
Sluggish/Fatigued/LazyRestlessNervous/AnxiousNauseated/Queasy/Sick to StomachTalkative/FriendlyIrregular/Racing HeartbeatEuphoricShaky/JitteryActive/Alert/EnergeticWill Pay ForWill Take AgainPerformance ImprovedPerformance ImpairedStimulatedLike DrugRushHighGood EffectsBad EffectsAny Effect
Active Comparator: Duloxetine0.001.000.000.0011.003.7511.752.0023.0018.0023.759.500.0017.2523.7510.7515.7520.250.0020.75
Placebo Comparator: Placebo0.005.000.004.6729.000.0028.333.6725.0036.0033.3314.675.3333.0032.6727.3327.0025.334.6724.67

[back to top]

Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.

Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionMillimeters (Mean)
Sluggish/Fatigued/LazyRestlessNervous/AnxiousNauseated/Queasy/Sick to StomachTalkative/FriendlyIrregular/Racing HeartbeatEuphoricShaky/JitteryActive/Alert/EnergeticWill Pay ForWill Take AgainPerformance ImprovedPerformance ImpairedStimulatedLike DrugRushHighGood EffectsBad EffectsAny Effect
Active Comparator: Duloxetine5.501.000.000.2513.751.259.750.0020.2517.0017.2511.252.259.5015.004.5010.259.252.5011.50
Placebo Comparator: Placebo8.675.333.002.0018.672.0030.006.3322.3333.0039.3320.006.0031.3333.6730.0030.3331.333.6730.33

[back to top]

Snaith-Hamilton-Pleasure Scale to Measure Anhedonia (Inability to Experience Pleasure)

A 14-item Snaith-Hamilton-Pleasure Scale covers four domains of pleasure response (interest/pastimes, social interaction, sensory experience and food/drink) with higher scores representing less anhedonia. Scores range from 0 to 56 units: lower scores representing greater anhedonia. (NCT04178993)
Timeframe: 4 times over approximately 4.5 weeks

,
InterventionUnits on a Scale (Mean)
Methylphenidate (0 mg)Methylphenidate (20 mg)Methylphenidate (40 mg)Methylphenidate (60 mg)
Active Comparator: Duloxetine (60 mg)51.2552.7554.0053.00
Placebo Comparator: Placebo44.3344.0044.3344.67

[back to top]

Temperature After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.

Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionDegrees Fahrenheit (Mean)
Methamphetamine (0 mg)Methamphetamine (10 mg)Methamphetamine (20 mg)
Active Comparator: Duloxetine98.6598.6598.58
Placebo Comparator: Placebo98.3798.4398.47

[back to top]

Temperature After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.

Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionDegrees Fahrenheit (Mean)
Methamphetamine (0 mg)Methamphetamine (10 mg)Methamphetamine (20 mg)
Active Comparator: Duloxetine98.6098.6598.55
Placebo Comparator: Placebo98.1798.1398.43

[back to top]

Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.

Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionMillimeters (Mean)
Sluggish/Fatigued/LazyRestlessNervous/AnxiousNauseated/Queasy/Sick to StomachTalkative/FriendlyIrregular/Racing HeartbeatEuphoricShaky/JitteryActive/Alert/EnergeticWill Pay ForWill Take AgainPerformance ImprovedPerformance ImpairedStimulatedLike DrugRushHighGood EffectsBad EffectsAny Effect
Active Comparator: Duloxetine0.500.500.000.0013.750.0013.000.0016.2518.5021.7513.000.0011.7514.003.0014.259.750.2514.75
Placebo Comparator: Placebo10.672.002.000.3314.670.0022.000.6717.3333.3340.0015.005.6720.3335.3319.0021.6721.006.3316.00

[back to top]

Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.

Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionMillimeters (Mean)
Sluggish/Fatigued/LazyRestlessNervous/AnxiousNauseated/Queasy/Sick to StomachTalkative/FriendlyIrregular/Racing HeartbeatEuphoricShaky/JitteryActive/Alert/EnergeticWill Pay ForWill Take AgainPerformance ImprovedPerformance ImpairedStimulatedLike DrugRushHighGood EffectsBad EffectsAny Effect
Active Comparator: Duloxetine0.000.000.000.000.000.500.000.000.250.003.000.000.000.000.500.002.000.750.003.50
Placebo Comparator: Placebo0.000.000.000.0012.330.0015.330.0014.0032.3331.009.0014.3324.0029.6713.3312.0013.673.0015.33

[back to top]

Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.

Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionMillimeters (Mean)
Sluggish/Fatigued/LazyRestlessNervous/AnxiousNauseated/Queasy/Sick to StomachTalkative/FriendlyIrregular/Racing HeartbeatEuphoricShaky/JitteryActive/Alert/EnergeticWill Pay ForWill Take AgainPerformance ImprovedPerformance ImpairedStimulatedLike DrugRushHighGood EffectsBad EffectsAny Effect
Active Comparator: Duloxetine0.000.500.000.000.500.000.000.000.500.751.000.000.000.501.250.001.251.250.004.25
Placebo Comparator: Placebo0.000.000.000.008.000.677.000.6710.3317.3323.006.677.6717.3316.338.0010.678.336.337.00

[back to top]

Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.

Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionMillimeters (Mean)
Sluggish/Fatigued/LazyRestlessNervous/AnxiousNauseated/Queasy/Sick to StomachTalkative/FriendlyIrregular/Racing HeartbeatEuphoricShaky/JitteryActive/Alert/EnergeticWill Pay ForWill Take AgainPerformance ImprovedPerformance ImpairedStimulatedLike DrugRushHighGood EffectsBad EffectsAny Effect
Active Comparator: Duloxetine0.001.000.000.000.750.250.000.000.751.001.500.750.250.251.500.001.501.500.001.50
Placebo Comparator: Placebo3.001.331.671.674.001.674.003.003.338.0011.672.672.334.677.674.674.334.002.673.67

[back to top]

Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.

Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine. (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionMillimeters (Mean)
Sluggish/Fatigued/LazyRestlessNervous/AnxiousNauseated/Queasy/Sick to StomachTalkative/FriendlyIrregular/Racing HeartbeatEuphoricShaky/JitteryActive/Alert/EnergeticWill Pay ForWill Take AgainPerformance ImprovedPerformance ImpairedStimulatedLike DrugRushHighGood EffectsBad EffectsAny Effect
Active Comparator: Duloxetine0.000.000.000.000.000.000.000.001.500.251.500.000.002.250.000.250.000.250.001.25
Placebo Comparator: Placebo1.331.001.001.001.001.330.671.331.331.331.671.331.001.001.001.000.671.331.001.00

[back to top]

Reinforcing Effects of Methamphetamine Following Methylphenidate (60 mg) Maintenance.

"Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to work for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose)." (NCT04178993)
Timeframe: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week

,
InterventionTrials Completed (Mean)
Methamphetamine (0mg)Methamphetamine (10mg)Methamphetamine (20mg)
Active Comparator: Duloxetine (60 mg)07.509.75
Placebo Comparator: Placebo2.333.3310

[back to top]

Reinforcing Effects of Methamphetamine Following Methylphenidate (40 mg) Maintenance.

"Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to work for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose)." (NCT04178993)
Timeframe: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week

,
InterventionTrials Completed (Mean)
Methamphetamine (0mg)Methamphetamine (10mg)Methamphetamine (20mg)
Active Comparator: Duloxetine05.0010
Placebo Comparator: Placebo1.671010

[back to top]

Reinforcing Effects of Methamphetamine Following Methylphenidate (20 mg) Maintenance.

"Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to work for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose)." (NCT04178993)
Timeframe: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week

,
InterventionTrials Completed (Mean)
Methamphetamine (0mg)Methamphetamine (10mg)Methamphetamine (20mg)
Active Comparator: Duloxetine (60 mg)2.507.009.75
Placebo Comparator: Placebo06.678.00

[back to top]

Reinforcing Effects of Methamphetamine Following Methylphenidate (0 mg; Placebo) Maintenance.

"Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have ten opportunities (e.g., trials) to work for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose)." (NCT04178993)
Timeframe: Following at least 4 days of maintenance on placebo during inpatient admission, up to 1 week

,
InterventionTrials Completed (Mean)
Methamphetamine (0mg)Methamphetamine (10mg)Methamphetamine (20mg)
Active Comparator: Duloxetine (60 mg)07.259.75
Placebo Comparator: Placebo03.3310

[back to top]

Heart Rate After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.

Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionBeats Per Minute (Mean)
Methamphetamine (0 mg)Methamphetamine (10 mg)Methamphetamine (20 mg)
Active Comparator: Duloxetine88.0087.5088.00
Placebo Comparator: Placebo87.3383.6799.67

[back to top]

Heart Rate After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.

Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionBeats Per Minute (Mean)
Methamphetamine (0 mg)Methamphetamine (10 mg)Methamphetamine (20 mg)
Active Comparator: Duloxetine91.2587.7587.00
Placebo Comparator: Placebo85.0089.6787.67

[back to top]

Heart Rate After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.

Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionBeats Per Minute (Mean)
Methamphetamine (0 mg)Methamphetamine (10 mg)Methamphetamine (20 mg)
Active Comparator: Duloxetine76.0078.5089.50
Placebo Comparator: Placebo83.6784.3385.67

[back to top]

Heart Rate After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.

Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionBeats Per Minute (Mean)
Methamphetamine (0 mg)Methamphetamine (10 mg)Methamphetamine (20 mg)
Active Comparator: Duloxetine78.0077.2583.75
Placebo Comparator: Placebo77.6787.3381.33

[back to top]

Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.

Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionMillimeter of Mercury (Mean)
Methamphetamine (0 mg)Methamphetamine (10 mg)Methamphetamine (20 mg)
Active Comparator: Duloxetine82.2582.2584.25
Placebo Comparator: Placebo82.6781.6788.33

[back to top]

Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.

Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionMillimeter of Mercury (Mean)
Methamphetamine (0 mg)Methamphetamine (10 mg)Methamphetamine (20 mg)
Active Comparator: Duloxetine81.0082.2585.00
Placebo Comparator: Placebo78.0084.6784.67

[back to top]

Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.

Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionMillimeter of Mercury (Mean)
Methamphetamine (0 mg)Methamphetamine (10 mg)Methamphetamine (20 mg)
Active Comparator: Duloxetine74.5083.2585.00
Placebo Comparator: Placebo81.6785.3383.00

[back to top]

Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.

Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionMillimeter of Mercury (Mean)
Methamphetamine (0 mg)Methamphetamine (10 mg)Methamphetamine (20 mg)
Active Comparator: Duloxetine78.5083.7586.25
Placebo Comparator: Placebo80.0082.3387.33

[back to top]

Delay Discounting for Money

"Subjects will complete a delay discounting task in 4 sessions following 4 days of medication maintenance. Subjects are presented a series of hypothetical choices between a smaller sum of money offered now or a larger sum of money offered a later times in the future (e.g., 4 hours, a day, 3 weeks). The discounting rate, 'k', is calculated and log10-transformed. Greater values of log-transformed 'k' correspond with greater rates of discounting (i.e., preference for smaller reinforcer provided now rather than larger, delayed reinforcers [e.g., smaller sum of money given now as opposed to a larger sum given later]). The units for discounting rates are theoretical and not linked to a physical dimension (e.g., number of button presses) and the range is theoretically not bound (i.e., negative infinity to positive infinity)." (NCT04178993)
Timeframe: 4 sessions over approximately 4.5 weeks

,
Interventionlog(k) (Mean)
Methylphenidate (0mg)Methylphenidate (20mg)Methylphenidate (40mg)Methylphenidate (60mg)
Active Comparator: Duloxetine (60 mg)-1.29-1.37-1.15-1.04
Placebo Comparator: Placebo-1.40-1.40-1.45-1.48

[back to top]

Delay Discounting for Methamphetamine

"Subjects will complete a delay discounting task in 4 sessions following 4 days of medication maintenance. Subjects are presented a series of hypothetical choices between a smaller amount of methamphetamine offered now or a larger amount of methamphetamine offered a later times in the future (e.g., 4 hours, a day, 3 weeks). The discounting rate, 'k', is calculated and log10-transformed. Greater values of log-transformed 'k' correspond with greater rates of discounting (i.e., preference for smaller reinforcer provided now rather than larger, delayed reinforcers [e.g., smaller amount of methamphetamine given now as opposed to a larger amount given later]). The units for discounting rates are theoretical and not linked to a physical dimension (e.g., number of button presses) and the range is theoretically not bound (i.e., negative infinity to positive infinity)." (NCT04178993)
Timeframe: 4 sessions over approximately 4.5 weeks

,
Interventionlog(k) (Mean)
Methylphenidate (0mg)Methylphenidate (20mg)Methylphenidate (40mg)Methylphenidate (60mg)
Active Comparator: Duloxetine (60 mg)-1.31-1.27-1.15-1.04
Placebo Comparator: Placebo-1.40-1.04-1.45-1.17

[back to top]

Attentional Bias

"Subjects will complete an attentional bias task. The number of inhibitory failures (i.e., commission errors) to no-go targets following methamphetamine-related stimuli will be used to evaluate attentional bias (range 0 - 1: greater values represent greater number of errors committed). Commission errors are when you response (i.e., press the corresponding key on a computer) when you were instructed not to respond." (NCT04178993)
Timeframe: 12 sessions over approximately 4.5 weeks

,
InterventionProportion of Responses (Mean)
Methylphenidate (0mg)Methylphenidate (20mg)Methylphenidate (40mg)Methylphenidate (60mg)
Active Comparator: Duloxetine (60 mg)0.080.130.110.12
Placebo Comparator: Placebo0.070.040.080.12

[back to top]

Temperature After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.

Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionDegrees Fahrenheit (Mean)
Methamphetamine (0 mg)Methamphetamine (10 mg)Methamphetamine (20 mg)
Active Comparator: Duloxetine98.5098.7598.35
Placebo Comparator: Placebo98.3798.1098.27

[back to top]

Temperature After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.

Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg) (NCT04178993)
Timeframe: Daily over approximately 1 week of inpatient stay.

,
InterventionDegrees Fahrenheit (Mean)
Methamphetamine (0 mg)Methamphetamine (10 mg)Methamphetamine (20 mg)
Active Comparator: Duloxetine98.4598.4898.48
Placebo Comparator: Placebo98.1098.2398.40

[back to top]

Task-Based Brain Network Organization

Assessment of network topology during the Go/No-go (GNG) regular and GNG reward tasks. Subjects see a series of sports balls and are told to respond to most balls (go trials), but not to some specific balls (no-go trials). GNG tasks are identical, except in the rewarded task, correct fast go responses and correct withholding on no-go trials are rewarded with 1 cent and 5 cents respectively. Graph theoretical methods are applied to functional connectivity estimates from fMRI scans to determine modularity during each task. Modularity (-1 to 1 scale) measures the degree to which the whole-brain system separates into distinct communities, such that greater modularity reflects stronger community structure, or stronger tendency of brain regions to separate into distinct, highly interconnected networks with few connections across networks. Optimal modularity value depends on context. During complex tasks lower modularity is better, while higher modularity is better for basic tasks. (NCT04349917)
Timeframe: 1 to 3 hours after administration of intervention

,
Interventionunits on a scale (Mean)
GNG regularGNG reward
Methylphenidate0.2130.235
Placebo0.2180.213

[back to top]

Resting State Brain Network Organization

Assessment of network topology during a resting state using functional connectivity estimates. Modularity will be determined by applying graph theoretical methods to functional connectivity estimates acquired during functional magnetic resonance imaging (fMRI) scans. Modularity is measured on a -1 to 1 scale, with higher scores indicating stronger community structure, or a stronger tendency of clusters of brain regions to separate into distinct, highly interconnected networks with sparse connections across networks. The optimal modularity value depends on the context. For example, during complex tasks lower modularity is better, while during basic, automatic tasks higher modularity is better. (NCT04349917)
Timeframe: 1 to 3 hours after administration of intervention

Interventionunits on a scale (Mean)
Methylphenidate0.223
Placebo0.228

[back to top]

Drug-induced Normalization

Assessment of how changes in brain network topology relate to improvements in behavioral performance on the GNG regular and reward tasks, in which subjects respond to go stimuli and withhold responses to no-go stimuli. GNG tasks are identical, except subjects are rewarded for good performance on the reward task. Brain measures include change in modularity during rest, GNG regular, and GNG reward (Outcome Measures 1, 2); behavioral measures include change in commission rate, omission rate, and coefficient of variation of response time during GNG tasks (Outcome Measures 5-7). Pearson correlations are used to relate change in brain measures with change in behavioral measures from the placebo to the methylphenidate scans. Positive correlations indicate that subjects with greater change in the brain measure had greater change in the behavioral measure. Negative correlations indicate that subjects with less change in the brain measure had greater change in the behavioral measure. (NCT04349917)
Timeframe: 1 to 3 hours after administration of intervention

Interventioncorrelation coefficient (Number)
Delta rest mod vs delta GNG reg commission rateDelta rest mod vs delta GNG reg omission rateDelta rest mod vs delta GNG reg RT variabilityDelta rest mod vs delta GNG rew commission rateDelta rest mod vs delta GNG rew omission rateDelta rest mod vs delta GNG rew RT variabilityDelta GNG reg mod vs delta GNG reg commission rateDelta GNG reg mod vs delta GNG reg omission rateDelta GNG reg mod vs delta GNG reg RT variabilityDelta GNG rew mod vs delta GNG rew commission rateDelta GNG rew mod vs delta GNG rew omission rateDelta GNG rew mod vs delta GNG rew RT variability
Methylphenidate and Placebo-0.3610.5080.2870.162-0.2240.003-0.033-0.170-0.1950.220-0.276-0.027

[back to top]

Go/No-go (GNG) Commission Rate

"Evaluation of commission errors assessed during the GNG regular and GNG reward tasks. In the GNG tasks, subjects see a series of sports balls and are told to respond to most of the balls (go trials), but not to some specific balls (no-go trials). GNG tasks are identical, except in the rewarded task, correct fast go responses and correct withholding on no-go trials are rewarded with 1 cent and 5 cents respectively. In both tasks, commission errors occur on trials on which participants respond to a stimulus (go response) when they are supposed to withhold a response (no-go trial). Commission errors are scored from 0 (no commission errors) to 1 (100% commission errors), with lower values indicating better performance." (NCT04349917)
Timeframe: 1 to 3 hours after administration of intervention

,
Interventionunits on a scale (Mean)
GNG regularGNG reward
Methylphenidate0.3960.292
Placebo0.4030.348

[back to top]

Go/No-go (GNG) Omission Rate

"Evaluation of omission errors assessed during the GNG regular and GNG reward tasks. In the GNG tasks, subjects see a series of sports balls and are told to respond to most of the balls (go trials), but not to some specific balls (no-go trials). GNG tasks are identical, except in the rewarded task, correct fast go responses and correct withholding on no-go trials are rewarded with 1 cent and 5 cents respectively. In both tasks, omission errors occur on trials on which participants do not respond to a go stimulus to which they are supposed to respond. Omission errors are scored from 0 (no omission errors) to 1 (100% omission errors), with lower values indicating better performance." (NCT04349917)
Timeframe: 1 to 3 hours after administration of intervention

,
Interventionunits on a scale (Mean)
GNG regularGNG reward
Methylphenidate0.0710.040
Placebo0.1040.101

[back to top]

Go/No-go (GNG) Response Time Variability

Evaluation of response time variability assessed during the GNG regular and GNG reward tasks. In the GNG tasks, subjects see a series of sports balls and are told to respond to most of the balls (go trials), but not to some specific balls (no-go trials). GNG tasks are identical, except in the rewarded task, correct fast go responses and correct withholding on no-go trials are rewarded with 1 cent and 5 cents respectively. Coefficient of variation (standard deviation / mean) will be calculated for response time in GNG regular and GNG reward tasks separately to account for group differences in mean response time. (NCT04349917)
Timeframe: 1 to 3 hours after administration of intervention

,
Interventioncoefficient of variation (Mean)
GNG regularGNG reward
Methylphenidate0.2980.253
Placebo0.3440.342

[back to top]

Rest-Task Reconfiguration

Assessment of reconfiguration of network topology between the GNG regular task and the resting state and GNG reward task and resting state. In the GNG tasks, subjects see a series of sports balls and are told to respond to most of the balls (go trials), but not to some specific balls (no-go trials). GNG tasks are identical, except in the rewarded task, correct fast go responses and correct withholding on no-go trials are rewarded with 1 cent and 5 cents respectively. Normalized mutual information will be determined by applying the same graph theoretical methods to functional connectivity estimates acquired during fMRI scans for each rest-task pair. Normalized mutual information is measured on a 0 to 1 scale, with higher scores indicating more similarity in network structure across task and rest conditions. (NCT04349917)
Timeframe: 1 to 3 hours after administration of intervention

,
Interventionunits on a scale (Mean)
GNG regularGNG reward
Methylphenidate0.1040.122
Placebo0.1190.150

[back to top]

Healthcare Resource Utilization (HCRU)

A comparison of the frequency of health care encounters between the 2 treatment groups. Healthcare resource utilization were evaluated monthly by comparing the frequency of clinic visits (outpatient), inpatient/hospitalizations (and length of stay), and emergency department visits between the 2 treatment groups. (NCT04507204)
Timeframe: Baseline (past 6 months) Months -2, -4, and -6

,
InterventionVisits or Inpatient Admissions (Least Squares Mean)
Baseline (past 6 months) Overall Total Visits or Inpatient AdmissionsMonth 2 - Overall Total Visits or Inpatient AdmissionsMonth 4 - Overall Total Visits or Inpatient AdmissionsMonth 6 - Overall Total Visits or Inpatient Admissions
Adhansia XR2.142.261.671.34
Concerta2.932.431.731.85

[back to top]

Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR

The ADHD-RS-5 assesses the frequency and severity of each of the 18 ADHD symptoms among adults based on DSM-5 criteria. Each of the 18 DSM-5 symptoms are rated on a 4 point scale from 0 (never or rarely) to 3 (very often), yielding a total score of 0 to 54. A higher score corresponds to worse ADHD severity. (NCT04507204)
Timeframe: Baseline to Month-2

Interventionscore on a scale (Mean)
Total Score at baselineTotal Score at Month 2
Adhansia XR34.618.7

[back to top]

Assessment of Clinical Global Impression-Severity (CGI-S)

The CGI-S rates symptoms from 1 (not ill) to 7 (extremely ill). A higher score corresponds to higher ADHD severity. (NCT04507204)
Timeframe: Baseline, Month-2, Month-4, and Month-6

,
Interventionscore on a scale (Least Squares Mean)
BaselineMonth 2Month 4Month 6
Adhansia XR4.63.12.72.7
Concerta4.63.23.03.1

[back to top]

Assessment of Clinical Global Impression-Improvement (CGI-I)

The CGI-I measures global improvement prior to and after initiating the study medication. The CGI-I scale is 1 question, and rates improvement compared with the baseline visit using a 7-point scale. The range of responses are from 1 (very much improved) through 7 (very much worse). A higher score corresponds to higher ADHD severity. (NCT04507204)
Timeframe: Month-2, Month-4, and Month-6

,
Interventionscore on a scale (Least Squares Mean)
Month 2Month 4Month 6
Adhansia XR2.32.02.0
Concerta2.32.22.3

[back to top]

Adult ADHD Quality of Life Scale - Revised (AAQoL-R)

Used to assess health-related quality of life for adult patients. The AAQoL yields a total score based on 29 items. The raw scores are transformed to a 0 to 100 scale with higher scores indicating a better quality of life. (NCT04507204)
Timeframe: Baseline, Months -1, -2, -3, -4, -5 and -6

,
Interventionscore on a scale (Least Squares Mean)
Total Score at BaselineTotal Score at Month 1Total Score at Month 2Total Score at Month 3Total Score at Month 4Total Score at Month 5Total Score at Month 6
Adhansia XR41.155.563.063.464.766.367.4
Concerta41.155.059.160.961.860.263.6

[back to top]

Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority

TASS was completed at the end of waking hours (14 - 16 hours post-dosing) at Month-2 after baseline visit. TASS was developed to capture the change in ADHD symptoms over the course of a day and consists of 18 items that directly correspond to the 18 ADHD symptom domains listed in the DSM-5. Each item is scored on a 4-point scale as follows: 0 (none), 1 (mild), 2 (moderate), and 3 (severe); the maximum total score is 54. A higher total score corresponds to worse ADHD severity. (NCT04507204)
Timeframe: Month-2

Interventionscore on a scale (Least Squares Mean)
Adhansia XR20.2
Concerta22.1

[back to top]

Work Productivity and Activity Impairment (WPAI) Questionnaire

The WPAI questionnaire is designed to measure the effect of general health and symptom severity on work productivity and regular activities during the past 7 days. It consists of 4 domains [absenteeism (missing work), presenteeism (impaired productivity at work), overall work performance (combined absenteeism and presenteeism), and non-work activities (activity impairment)]. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. (NCT04507204)
Timeframe: Baseline, Months -2, -3, -4, -5, and -6

,
Interventionpercentage of impairment (Least Squares Mean)
Percent work time missed due to health (Absenteeism) - BaselinePercent work time missed due to health (Absenteeism) - Month 2Percent work time missed due to health (Absenteeism) - Month 3Percent work time missed due to health (Absenteeism) - Month 4Percent work time missed due to health (Absenteeism) - Month 5Percent work time missed due to health (Absenteeism) - Month 6Percent impairment while working due to health (Presenteeism) - BaselinePercent impairment while working due to health (Presenteeism) - Month 2Percent impairment while working due to health (Presenteeism) - Month 3Percent impairment while working due to health (Presenteeism) - Month 4Percent impairment while working due to health (Presenteeism) - Month 5Percent impairment while working due to health (Presenteeism) - Month 6Percent overall work impairment due to health - BaselinePercent overall work impairment due to health - Month 2Percent overall work impairment due to health - Month 3Percent overall work impairment due to health - Month 4Percent overall work impairment due to health - Month 5Percent overall work impairment due to health - Month 6Percent activity impairment due to health - BaselinePercent activity impairment due to health - Month 2Percent activity impairment due to health - Month 3Percent activity impairment due to health - Month 4Percent activity impairment due to health - Month 5Percent activity impairment due to health - Month 6
Adhansia XR5.44.23.02.44.82.932.019.720.113.517.815.934.122.421.815.819.718.439.726.126.119.523.621.9
Concerta5.63.73.24.74.94.133.324.225.024.618.317.635.527.226.425.319.518.940.930.127.128.626.323.5

[back to top]

Patient Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)

"The PSQI is an instrument used to measure the quality and patterns of sleep; It differentiates poor from good sleep. It is filled out by the caregiver or the patient and the global sum score ranges from 0 to 21, with higher scores indicating worse sleep quality." (NCT04507204)
Timeframe: Baseline and Months -2, -4, and -6

,
Interventionscore on a scale (Least Squares Mean)
Global PSQI - BaselineGlobal PSQI - Month 2Global PSQI - Month 4Global PSQI - Month 6
Adhansia XR9.687.928.117.92
Concerta9.599.597.767.80

[back to top]

Assessment of Treatment Satisfaction

"The Treatment Satisfaction Questionnaire for Medications (TSQM) measures a patient's level of satisfaction or dissatisfaction with the study medication. It assesses perceptions of effectiveness, side effects and convenience of the medication and consists of 14 items that evaluate these three domains and one global scale item (ie, global satisfaction). Scores for each domain are computed by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100.~A lower score indicates a lower satisfaction with treatment." (NCT04507204)
Timeframe: Month-1, Month-2, and Month-6

,
Interventionscore on a scale (Least Squares Mean)
Global Satisfaction at Month 1Global Satisfaction at Month 2Global Satisfaction at Month 6Effectiveness at Month 1Effectiveness at Month 2Effectiveness at Month 6Side Effects at Month 1Side Effects at Month 2Side Effects at Month 6Convenience at Month 1Convenience at Month 2Convenience at Month 6
Adhansia XR84.885.286.251.361.163.974.072.070.758.957.059.7
Concerta84.382.884.352.458.861.969.667.674.159.258.757.0

[back to top]