Compounds > dexmethylphenidate hydrochloride
Page last updated: 2024-11-07

dexmethylphenidate hydrochloride

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Description

Dexmethylphenidate Hydrochloride: A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID154100
CHEMBL ID904
MeSH IDM0514652

Synonyms (75)

Synonym
equasym ir
equasym xl
(+/-)-threo-methylphenidate hydrochloride
nwp-06
ritalin sr
metadate mr
metadate cd
metadate er
biphentin
methypatch
ritalin qd
focalin (tn)
19262-68-1
dexmethylphenidate hydrochloride (usan)
D03721
dexmethylphenidate hydrochloride
focalin xr
2-piperidineacetic acid, alpha-phenyl-, methyl ester, hydrochloride, (r-(r*,r*))-
dexmethylphenidate hydrochloride [usan]
2-piperidineacetic acid, alpha-phenyl-, methyl ester, hydrochloride, (alphar,2r)-
d-threo-methylphenidate hydrochloride
methyl (2r)-phenyl((2r)-piperidin-2-yl)acetate hydrochloride
focalin
ritalin
equasym
(r)-methyl 2-phenyl-2-((r)-piperidin-2-yl)acetate hydrochloride
methylphenidate d-threo-form hydrochloride
dexmethylphenidate hcl
dex-methylphenidate hydrochloride
CHEMBL904 ,
unii-1678ok0e08
1678ok0e08 ,
4b3sc438hi ,
dl-threo-methylphenidate hydrochloride
2-piperidineacetic acid, alpha-phenyl-, methyl ester, hydrochloride, (r*,r*)- (+-)-
23655-65-4
dl-threo-methylphenidate hcl
unii-4b3sc438hi
rac-threo-methylphenidate hydrochloride
methyl (2r)-phenyl[(2r)-piperidin-2-yl]acetate hydrochloride
dexmethylphenidate hydrochloride [orange book]
azstarys component dexmethylphenidate hydrochloride
2-piperidineacetic acid, .alpha.-phenyl-, methyl ester, hydrochloride,(.alpha.r,2r)-
dexmethylphenidate hydrochloride [vandf]
methylphenidate d-threo-form hydrochloride [mi]
dexmethylphenidate hydrochloride [mart.]
dexmethylphenidate hydrochloride component of azstarys
dexmethylphenidate hydrochloride [who-dd]
methylphenidate hydrochloride [ep monograph]
methylphenidate hydrochloride [jan]
methylphenidate hydrochloride [orange book]
methylphenidate hydrochloride [usp monograph]
methylphenidate hydrochloride [mi]
methylphenidate hydrochloride cii [usp-rs]
methylphenidate hydrochloride [who-dd]
methylphenidate hydrochloride [mart.]
2-piperidineacetic acid, .alpha.-phenyl-, methyl ester, hydrochloride, (r*,r*)-(+/-)-
jornay pm
methylphenidate hydrochloride [vandf]
adhansia xr
methyl (2r)-2-phenyl-2-[(2r)-piperidin-2-yl]acetate;hydrochloride
AKOS027321667
methylphenidate hydrochloride 1.0 mg/ml in methanol (as free base)
Q47487562
DTXSID50940927
methyl phenyl(piperidin-2-yl)acetate--hydrogen chloride (1/1)
d-threo methylphenidate hydrochloride
JUMYIBMBTDDLNG-OJERSXHUSA-N
19262-68-1 (hcl)
methyl (2r)-2-phenyl-2-[(2r)-piperidin-1-ium-2-yl]acetate;chloride
dexmethylphenidate hydrochloride (mart.)
hydrochloride, dexmethylphenidate
focalinxr
dexmethylphenidate hydrochlorideextended-release
2-piperidineacetic acid, alpha-phenyl-, methyl ester, hydrochloride,(alphar,2r)-

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" 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
"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)		0.33
"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)		0.34
" 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)		0.35
" 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)		0.35
"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)		0.35
" 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)		0.35

Pharmacokinetics

ExcerptReferenceRelevance
" 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)		0.35
"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)		0.38

Bioavailability

ExcerptReferenceRelevance
" 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)		0.32
"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)		0.39
" 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)		0.43
" 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)		0.51

Dosage Studied

ExcerptRelevanceReference
"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)		0.32
" 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)		0.32
"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)		0.32
" 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)		0.65
" 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)		0.33
" 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)		0.34
" 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
"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)		0.35
"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
" 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)		0.36
"This study seeks to determine if variation in the dopamine transporter gene (SLC6A3/DAT1) moderates the dose-response effects of long-acting dexmethylphenidate (D-MPH) and mixed amphetamine salts (MAS) in children with attention-deficit/hyperactivity disorder (ADHD)."( Dopamine transporter genotype and stimulant dose-response in youth with attention-deficit/hyperactivity disorder.
Bishop, J; Cook, EH; Kittles, R; Newcorn, J; Stein, MA; Waldman, I, 2014)		0.4
"2) participated in a double-blind, two period crossover, dose-response study with a randomized placebo week in each 4 week drug period."( Dopamine transporter genotype and stimulant dose-response in youth with attention-deficit/hyperactivity disorder.
Bishop, J; Cook, EH; Kittles, R; Newcorn, J; Stein, MA; Waldman, I, 2014)		0.4
"Doses of 10-20 mg of either D-MPH or MAS had little to no effect on hyperactivity-impulsivity and total ADHD symptom scores in subjects with the 9/9 genotype; this was in contrast to the dose-response curves of subjects with either the 10/10 or 10/9 genotype."( Dopamine transporter genotype and stimulant dose-response in youth with attention-deficit/hyperactivity disorder.
Bishop, J; Cook, EH; Kittles, R; Newcorn, J; Stein, MA; Waldman, I, 2014)		0.4
"We sought to determine the dose-response effects of extended-release (ER) dexmethylphenidate (d-MPH) and ER mixed amphetamine salts (MAS) on objective measures of sleep."( Effect of extended-release dexmethylphenidate and mixed amphetamine salts on sleep: a double-blind, randomized, crossover study in youth with attention-deficit hyperactivity disorder.
Bergmame, L; Gruber, R; Santisteban, JA; Stein, MA, 2014)		0.4
" 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)		0.43
"Two hundred seven participants aged 7-14 years enrolled in an 8-week double-blind randomized trial of GUAN-IR (1-3 milligrams (mg)/day), DMPH (5-20 mg/day), or COMB with fixed-flexible dosing and titrated to optimal behavioral response."( Acute and Long-Term Cardiovascular Effects of Stimulant, Guanfacine, and Combination Therapy for Attention-Deficit/Hyperactivity Disorder.
Castelo, E; Cowen, J; Levitt, J; McCracken, JT; McGough, JJ; Sayer, GR; Sturm, A, 2016)		0.43
"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)		0.46
" 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)		0.51
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Protein Targets (8)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
DRattus norvegicus (Norway rat)IC50 (µMol)0.12350.00030.50267.7625AID62873; AID62874
D(3) dopamine receptorRattus norvegicus (Norway rat)IC50 (µMol)0.12350.00030.39075.4000AID62873; AID62874
Sodium-dependent dopamine transporterRattus norvegicus (Norway rat)Ki0.07460.00030.37088.1600AID288615
D(1B) dopamine receptorRattus norvegicus (Norway rat)IC50 (µMol)0.12350.00030.35635.4000AID62873; AID62874
D(4) dopamine receptorRattus norvegicus (Norway rat)IC50 (µMol)0.12350.00030.38715.4000AID62873; AID62874
Mu-type opioid receptorRattus norvegicus (Norway rat)Ki0.27000.00000.38458.6000AID288616
D(2) dopamine receptorRattus norvegicus (Norway rat)IC50 (µMol)0.12350.00010.54948.4000AID62873; AID62874
TransporterRattus norvegicus (Norway rat)Ki0.27000.00010.866710.0000AID288616
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (10)

Assay IDTitleYearJournalArticle
AID288615Displacement of [3H]WIN-35428 from DAT in Sprague-Dawley rat striatum2007Journal of medicinal chemistry, May-31, Volume: 50, Issue:11
Synthesis and pharmacology of site-specific cocaine abuse treatment agents: restricted rotation analogues of methylphenidate.
AID288623Selectivity for rat DAT over rat NET2007Journal of medicinal chemistry, May-31, Volume: 50, Issue:11
Synthesis and pharmacology of site-specific cocaine abuse treatment agents: restricted rotation analogues of methylphenidate.
AID6423Ability to displace 0.4 nM [3H]paroxetine binding to 5-hydroxytryptamine receptor in rat frontal cortex2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Synthesis of methylphenidate analogues and their binding affinities at dopamine and serotonin transport sites.
AID288616Displacement of [3H]nisoxetine from NET in Sprague-Dawley rat cortical tissue2007Journal of medicinal chemistry, May-31, Volume: 50, Issue:11
Synthesis and pharmacology of site-specific cocaine abuse treatment agents: restricted rotation analogues of methylphenidate.
AID288622Selectivity for rat DAT over rat 5HTT2007Journal of medicinal chemistry, May-31, Volume: 50, Issue:11
Synthesis and pharmacology of site-specific cocaine abuse treatment agents: restricted rotation analogues of methylphenidate.
AID288621Inhibition of [3H]DA uptake at DAT in Sprague-Dawley rat striatum2007Journal of medicinal chemistry, May-31, Volume: 50, Issue:11
Synthesis and pharmacology of site-specific cocaine abuse treatment agents: restricted rotation analogues of methylphenidate.
AID288624Selectivity for rat NET over rat 5HTT2007Journal of medicinal chemistry, May-31, Volume: 50, Issue:11
Synthesis and pharmacology of site-specific cocaine abuse treatment agents: restricted rotation analogues of methylphenidate.
AID62873Potency of inhibiting 10 pM [125I]-RTI-55 binding to dopamine receptor in rat striatal membranes2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Synthesis of methylphenidate analogues and their binding affinities at dopamine and serotonin transport sites.
AID62874Potency of inhibiting [3H]WIN-35428 binding to dopamine receptor in rat striatal membranes2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Synthesis of methylphenidate analogues and their binding affinities at dopamine and serotonin transport sites.
AID288620Displacement of [3H]citalopram from 5HTT in Sprague-Dawley rat cerebrum at 10 uM2007Journal of medicinal chemistry, May-31, Volume: 50, Issue:11
Synthesis and pharmacology of site-specific cocaine abuse treatment agents: restricted rotation analogues of methylphenidate.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (61)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's37 (60.66)29.6817
2010's21 (34.43)24.3611
2020's3 (4.92)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 55.84

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 Index55.84 (24.57)
Research Supply Index4.53 (2.92)
Research Growth Index4.43 (4.65)
Search Engine Demand Index89.43 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (55.84)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials27 (41.54%)5.53%
Reviews14 (21.54%)6.00%
Case Studies2 (3.08%)4.05%
Observational0 (0.00%)0.25%
Other22 (33.85%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (21)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
An Open-Label Treatment, Investigator-Initiated Study, on the Duration and Efficacy of Azstarys (Serdexmethylphenidate and Dexmethylphenidate) on Adult ADHD Symptoms and Executive Function in Early Evening [NCT06000501]Phase 430 participants (Anticipated)Interventional2023-09-14Recruiting
A Randomized, Two-Way, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Dexmethylphenidate Hydrochloride, (10 mg), Compared to and Equivalent Dose of a Commercially Available Reference Drug Product (Focalin®, No [NCT00829712]Phase 124 participants (Actual)Interventional2004-06-30Completed
A Multicenter, Dose-Optimized, Open-Label, Safety/Tolerability and Pharmacokinetic Study With Azstarys® in Children 4 and 5 Years of Age With Attention-Deficit/Hyperactivity Disorder [NCT05721235]Phase 4100 participants (Anticipated)Interventional2023-05-24Recruiting
A Phase 3, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled, Parallel Efficacy and Safety Laboratory Classroom Study in Children (6-12) With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate) [NCT05924594]Phase 382 participants (Anticipated)Interventional2023-07-31Recruiting
A Phase 3, Double-blind, Randomized, Placebo-controlled, Multi-center, Fixed-dose, Parallel Group Efficacy and Safety in Pediatrics (6-17) With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate) [NCT05286762]Phase 3385 participants (Anticipated)Interventional2023-07-25Recruiting
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
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
Sleep and Tolerability of Extended Release Dexmethylphenidate vs. Mixed Amphetamine Salts: A Double Blind, Placebo Controlled Study (SAT STUDY) [NCT00393042]Phase 377 participants (Actual)Interventional2006-01-31Completed
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
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD [NCT00141063]Phase 390 participants Interventional2005-06-30Completed
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD [NCT00141050]Phase 390 participants Interventional2005-05-31Completed
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
Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of d-MPH in the Treatment of Fatigue and Neurobehavioral Impairment Related to Chemotherapy in Adult Cancer Patients [NCT00047476]Phase 2160 participants Interventional2002-06-30Completed
A Multicenter, Dose-Optimized, Randomized, Double Blind, Efficacy and Safety Study With Azstarys® in Children 4 to 12 Years of Age With Attention Deficit/Hyperactivity Disorder [NCT05685732]Phase 4230 participants (Anticipated)Interventional2023-03-22Recruiting
A 5-Week Treatment, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Fixed-Dose Study of the Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules Administered Once Daily in Pediatric Children Wit [NCT00301236]Phase 3252 participants Interventional2006-02-28Completed
A Randomized, Single-dose, Four-sequence, Four-period, Crossover Study in Adult ADHD Subjects to Establish Safety, Tolerability, and Comparative Bioavailability of CTx-1301 (Dexmethylphenidate) to Focalin XR™ Under Fasted Conditions [NCT04138498]Phase 1/Phase 245 participants (Actual)Interventional2019-12-06Completed
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
A Phase 3, Dose-Optimized, Randomized, Double-Blind, Placebo-Controlled, Single-Center, Parallel Efficacy and Safety Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate) [NCT05631626]Phase 321 participants (Actual)Interventional2022-12-29Completed
A Randomized, Two-Way, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Dexmethylphenidate Hydrochloride, (10 mg), Compared to an Equivalent Dose of a Commercially Available Reference Product (Focalin®, Novartis [NCT00829673]Phase 124 participants (Actual)Interventional2004-06-30Completed
An Open-label, Randomized, Single-dose, Two-period, Two-treatment (Fed vs Fasted), Two-sequence, Crossover Study in Healthy Adult Subjects to Assess the Effect of Food on the Absorption and Bioavailability of CTx-1301 (Dexmethylphenidate) [NCT04449250]Phase 127 participants (Actual)Interventional2022-09-14Completed
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
NCT00393042 (6) [back to overview]Clinical Global Impression - Severity
NCT00393042 (6) [back to overview]Sleep Duration
NCT00393042 (6) [back to overview]ADHD Parent Rating Scale-IV
NCT00393042 (6) [back to overview]Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms
NCT00393042 (6) [back to overview]Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks.
NCT00393042 (6) [back to overview]Weiss Functional Impairment Rating Scale (WFIRS)
NCT00429273 (1) [back to overview]ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale)
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
NCT00564954 (6) [back to overview]Change From Pre-dose in SKAMP Deportment Score
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 (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) in SKAMP Combined Score at All Times Excluding the 0.5 Hour Timepoint (Hours 1, 2, 4, 6, 8)
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 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 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 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
NCT00829673 (3) [back to overview]AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
NCT00829673 (3) [back to overview]Cmax (Maximum Observed Concentration)
NCT00829673 (3) [back to overview]AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
NCT00829712 (3) [back to overview]AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
NCT00829712 (3) [back to overview]Cmax (Maximum Observed Concentration)
NCT00829712 (3) [back to overview]AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
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]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]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
NCT04138498 (9) [back to overview]AUC(Last)
NCT04138498 (9) [back to overview]Cmax
NCT04138498 (9) [back to overview]Half-life
NCT04138498 (9) [back to overview]Incidence of Treatment-Emergent Adverse Events
NCT04138498 (9) [back to overview]K
NCT04138498 (9) [back to overview]Tlag
NCT04138498 (9) [back to overview]Tmax
NCT04138498 (9) [back to overview]Partial AUCs
NCT04138498 (9) [back to overview]AUC(0-infinity)

Clinical Global Impression - 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. (NCT00393042)
Timeframe: 8-10 weeks

Interventionunits on a scale (Mean)
Adderall XR - Placebo4.26
Adderall XR - 10 mg4.09
Adderall XR - 20 mg3.48
Adderall XR - 25/30 mg3.56
Focalin XR - Placebo4.24
Focalin - 10 mg4.24
Focalin XR - 20 mg3.63
Focalin XR - 25/30 mg3.55

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Sleep Duration

Actigraphs (AW64 series) were worn each night and were used to assess participant's sleep patterns in their natural home environment. These computerized wristwatch-like devices collect data generated by movements. They are minimally invasive and allow sleep to be recorded reliably without interfering with the family's routine. One-minute epochs were used to analyze actigraphic sleep sata. Bedtimes and wake times were reported for each participant using sleep logs, and these times were used as the start and end times for the analyses. For each 1-min epoch, the total sum of activity counts were computed. If they exceeded a threshold (threshold sensitivity value = mean score in active period/45), then the epoch was considered waking. If it fell below that threshold, then it was considered sleep.The data for Adderall XR and Focalin XR was combined to look at the cumulative effects that medication has on sleep. (NCT00393042)
Timeframe: 8-10 weeks

Interventionminutes (Mean)
Placebo459.6
10mg of Either Focalin XR or Adderall XR446.7
20 mg of Either Focalin XR or Adderall XR432.17
25/30mg of Either Focalin XR or Adderall XR425.5
Adderall XR All Dose Levels438.82
Focalin XR All Dose Levels443.2

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ADHD Parent 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. (NCT00393042)
Timeframe: completed weekly over 8-10 weeks

,,,,,,,
Interventionunits on a scale (Mean)
Inattention Symptom Subscale ScoresHyperactivity/Impulsivity Symptom subscale scoresTotal Symptoms scores
Adderall XR - 10 mg6.4010.7827.15
Adderall XR - 20 mg12.27.9220.12
Adderall XR - 25/30mg12.747.6720.40
Adderall XR - Placebo16.6111.4128.02
Focalin XR - 10 mg17.5110.8428.35
Focalin XR - 20 mg13.338.4921.82
Focalin XR - 25/30mg12.118.4920.41
Focalin XR - Placebo17.3113.2430.58

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Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms

Three variations of the DAT 1 gene were observed, the 9/9 allele, the 9/10 allele and the 10/10 allele. The ADHD Rating Scale (ADHD-RS) and Clinical Global Impressions - Severity (CGI-S) measures were used to evaluate how the DAT 1 gene allele type altered the efficacy of the medication. The DAT 1 genotype did not predict differential response to Focalin XR or Adderall XR so the dose levels of each drug was combined to examine how the genotype interacted with the dose level. The ADHD-RS evaluates the severity of the participant's ADHD symptoms and includes two subscales: Inattention and Hyperactivity/Impulsivity. Both subscale scores range from 0 to 27 with a higher score representing more severe symptoms. The subscales are summed to calculate the total score which can range from 0 to 54. 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. (NCT00393042)
Timeframe: 8-10 weeks

,,,,,,,,,,,,,,,,,,,,,,,
Interventionunits on a scale (Mean)
ADHD-RS Inattention subscale scoreADHD-RS Hyperactivity/Impulsivity subscale scoreADHD-RS total scoreCGI-S score
10/10 Allele: 10 mg of Adderall XR16.139.6325.774.07
10/10 Allele: 10 mg of Focalin XR16.5610.6327.194.19
10/10 Allele: 20 mg of Adderall XR9.367.0716.433.21
10/10 Allele: 20 mg of Focalin XR12.568.4120.963.52
10/10 Allele: 25/30 mg of Adderall XR11.967.5019.463.54
10/10 Allele: 25/30mg of Focaling XR11.158.6519.813.31
10/10 Allele: Placebo of Adderall XR15.0711.8726.934.17
10/10 Allele: Placebo of Focalin XR16.4413.7430.194.15
9/10 Allele: 10 mg of Adderall XR16.2710.6726.804.07
9/10 Allele: 10 mg of Focalin XR16.938.2725.204.27
9/10 Allele: 20 mg of Adderall XR15.868.3624.213.71
9/10 Allele: 20 mg of Focalin XR13.366.7320.093.58
9/10 Allele: 25/30 mg of Adderall XR13.436.4319.863.50
9/10 Allele: 25/30 mg of Focalin XR13.707.0020.703.90
9/10 Allele: Placebo of Adderall XR18.649.3628.004.36
9/10 Allele: Placebo of Focalin XR18.088.9227.084.31
9/9 Allele: 10 mg of Adderall XR18.8318.3337.174.33
9/9 Allele: 10 mg of Focalin XR22.2017.4039.604.60
9/9 Allele: 20 mg Adderall XR19.0014.8033.804.80
9/9 Allele: 20 mg of Focalin XR16.7514.0030.754.50
9/9 Allele: 25/30 mg of Focalin XR12.509.0024.004.00
9/9 Allele: 25/30mg of Adderall XR15.4010.4025.804.00
9/9 Allele: Placebo of Adderall XR18.6012.8031.404.40
9/9 Allele: Placebo of Focalin XR19.3317.3336.674.67

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Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks.

Actigraphs (AW64 series) were worn each night and were used to assess participant's sleep patterns in their natural home environment. These computerized wristwatch-like devices collect data generated by movements. They are minimally invasive and allow sleep to be recorded reliably without interfering with the family's routine. One-minute epochs were used to analyze actigraphic sleep sata. Bedtimes and wake times were reported for each participant using sleep logs, and these times were used as the start and end times for the analyses. For each 1-min epoch, the total sum of activity counts were computed. If they exceeded a threshold (threshold sensitivity value = mean score in active period/45), then the epoch was considered waking. If it fell below that threshold, then it was considered sleep. The data for Adderall XR and Focalin XR was combined to look at the cumulative effects that medication has on sleep. (NCT00393042)
Timeframe: 8-10 weeks

,,,,,
InterventionHHMM.SS (Mean)
Sleep start timeSleep End time
10mg of Either Focalin XR or Adderall XR23040728
20mg of Either Focalin XR or Adderall XR23190735
25/30mg of Either Focalin XR or Adderall XR23250732
Adderall XR All Dose Levels23090735
Focalin XR All Dose Levels23090734
Placebo22490742

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Weiss Functional Impairment Rating Scale (WFIRS)

The WFIRS consists of 50 questions where respondents are asked to rate their child's functional impairment. The items of the WFIRS are scored on a four point Likert-type rating scale: 0 (never or not at all), 1 (sometimes or somewhat), 2 (often or much) or 3 (very often or very much) and aggregated to produce six domain scores: Family (ranges between 0-24), Learning or School (ranges between 0-33), Self-Concept (ranges between 0-15), Social Activities (ranges between 0-27), Life Skills (ranges between 0-36), and Risky Activities (ranges between 0-42). The subscales are scored by summing the responses in the subsection. The Total score is the sum of all the responses and it ranges between 0-150. The higher the score in each of the subscales the more impairment is recorded, this is also true for the total score. (NCT00393042)
Timeframe: 8-10 weeks

,,,,,,,
Interventionunits on a scale (Mean)
Family subscale scoreLearning subscale scoreLife skills subscale scoreSelf-concept subscale scoreSocial activities subscale scoreRisky activities subscale scoreTotal score
Adderall XR - 10 mg7.028.757.911.593.911.9431.06
Adderall XR - 20 mg6.356.867.441.422.982.2427.32
Adderall XR - 25/30mg6.706.217.341.063.061.6826.23
Adderall XR - Placebo6.726.747.431.113.512.1927.70
Focalin XR - 10 mg7.359.257.651.193.851.9631.13
Focalin XR - 20 mg6.507.548.301.333.541.7829.20
Focalin XR - 25/30mg6.507.397.601.313.171.6727.45
Focalin XR - Placebo7.399.308.301.253.731.9120.91

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Bioequivalence based on AUC0-t. (NCT00829673)
Timeframe: Blood samples collected over a 16 hour period.

Interventionpg*h/mL (Mean)
Dexmethylphenidate HCl81531.55
Focalin®79972.63

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Cmax (Maximum Observed Concentration)

Bioequivalence based on Cmax. (NCT00829673)
Timeframe: Blood samples collected over a 16 hour period.

Interventionpg/mL (Mean)
Dexmethylphenidate HCl15668.17
Focalin®14526.09

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AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)

Bioequivalence based on AUC0-inf. (NCT00829673)
Timeframe: Blood samples collected over a 16 hour period.

Interventionpg*h/mL (Mean)
Dexmethylphenidate HCl86046.67
Focalin®84376.75

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AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Bioequivalence based on AUC0-t. (NCT00829712)
Timeframe: Blood samples collected over a 16 hour period.

Interventionpg*h/mL (Mean)
Dexmethylphenidate HCl67045.82
Focalin®67210.48

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Cmax (Maximum Observed Concentration)

Bioequivalence based on Cmax. (NCT00829712)
Timeframe: Blood samples collected over a 16 hour period.

Interventionpg/mL (Mean)
Dexmethylphenidate HCl14802.55
Focalin®14808.74

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AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)

Bioequivalence based on AUC0-inf. (NCT00829712)
Timeframe: Blood samples collected over a 16 hour period.

Interventionpg*h/mL (Mean)
Dexmethylphenidate HCl69379.08
Focalin®68973.94

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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

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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

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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

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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

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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

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AUC(Last)

AUC from time 0 to the last measurable concentration (NCT04138498)
Timeframe: Hours 0 to 28

Interventionpg/mL (Geometric Mean)
Treatment A22793.45
Treatment B25540.99
Treatment B/A1.12
Treatment C190456.27
Treatment D221949.48
Treatment D/C1.17

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Cmax

d-MPH Plasma concentration (NCT04138498)
Timeframe: Hours 0 to 28

Interventionpg/mL (Geometric Mean)
Treatment A3138.41
Treatment B2874.52
Treatment B/A0.92
Treatment C23884.13
Treatment D24685.37
Treatment D/C1.03

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Half-life

Time (Hours) it takes for the concentration of the drug in plasma to be reduced by 50% (NCT04138498)
Timeframe: Hours 0 to 28

Interventionhr*pg/mL (Geometric Mean)
Treatment A3.77
Treatment B4.32
Treatment C4.05
Treatment D4.21

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Incidence of Treatment-Emergent Adverse Events

TEAEs will be measured from Day 0 to Day 10 (End of Study) (NCT04138498)
Timeframe: Day 0 to Day 10

Interventionparticipants (Number)
Treatment A7
Treatment B4
Treatment C22
Treatment D14

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K

Rate at which a drug is removed from the system (NCT04138498)
Timeframe: Hours 0 to 28

Intervention(1/hr) (Geometric Mean)
Treatment A0.18
Treatment B0.16
Treatment C0.17
Treatment D0.16

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Tlag

Delay (hours) between the time of dosing and time of appearance of concentration in the sampling (NCT04138498)
Timeframe: Hours 0 to 28

Interventionhr (Median)
Treatment A0.00
Treatment B0.00
Treatment C0.00
Treatment D0.00

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Tmax

Time (Hours) after administration of a drug when the maximum plasma concentration is reached (NCT04138498)
Timeframe: Hours 0 to 28

Interventionhr*pg/mL (Median)
Treatment A5.00
Treatment B5.00
Treatment C6.00
Treatment D5.00

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Partial AUCs

AUC from Hours 0-3, 3-6, 6-9, 9-12, and 12 to 16 (NCT04138498)
Timeframe: Hours 0 to 28

,,,,,
Interventionhr*pg/mL (Geometric Mean)
AUC0-3AUC3-6AUC6-9AUC9-12AUC12-16
Treatment A4928.246939.765644.672769.681643.22
Treatment B3943.216317.475624.503638.053092.55
Treatment B/A.800.911.001.311.88
Treatment C37963.3751204.3449159.0125193.8715739.33
Treatment D32744.3551368.6053313.0234316.2626183.15
Treatment D/C.861.001.081.361.66

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AUC(0-infinity)

Area under the curve from time 0 extrapolated to infinite time (NCT04138498)
Timeframe: Hours 0 to 28

Interventionng/mL (Geometric Mean)
Treatment A24384.31
Treatment B27661.46
Treatment B/A1.13
Treatment C203127.64
Treatment D239317.53
Treatment D/C1.18

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SubstanceRelationship StrengthStudiesTrialsClassesRoles
chlorine
chloride : A halide anion formed when chlorine picks up an electron to form an an anion.		2.4110halide anion;
monoatomic chlorine		cofactor;
Escherichia coli metabolite;
human metabolite
bupropion
Bupropion: A propiophenone-derived antidepressant and antismoking agent that inhibits the uptake of DOPAMINE.. bupropion : An aromatic ketone that is propiophenone carrying a tert-butylamino group at position 2 and a chloro substituent at position 3 on the phenyl ring.		2.3110aromatic ketone;
monochlorobenzenes;
secondary amino compound		antidepressant;
environmental contaminant;
xenobiotic
iodine
Iodine: A nonmetallic element of the halogen group that is represented by the atomic symbol I, atomic number 53, and atomic weight of 126.90. It is a nutritionally essential element, especially important in thyroid hormone synthesis. In solution, it has anti-infective properties and is used topically.. diiodine : Molecule comprising two covalently bonded iodine atoms with overall zero charge..		2.4110diatomic iodinenutrient
cetirizine
Cetirizine: A potent second-generation histamine H1 antagonist that is effective in the treatment of allergic rhinitis, chronic urticaria, and pollen-induced asthma. Unlike many traditional antihistamines, it does not cause drowsiness or anticholinergic side effects.. cetirizine : A member of the class of piperazines that is piperazine in which the hydrogens attached to nitrogen are replaced by a (4-chlorophenyl)(phenyl)methyl and a 2-(carboxymethoxy)ethyl group respectively.		2.110ether;
monocarboxylic acid;
monochlorobenzenes;
piperazines		anti-allergic agent;
environmental contaminant;
H1-receptor antagonist;
xenobiotic
clonidine
Clonidine: An imidazoline sympatholytic agent that stimulates ALPHA-2 ADRENERGIC RECEPTORS and central IMIDAZOLINE RECEPTORS. It is commonly used in the management of HYPERTENSION.. clonidine (amino form) : A clonidine that is 4,5-dihydro-1H-imidazol-2-amine in which one of the amino hydrogens is replaced by a 2,6-dichlorophenyl group.		2.0510clonidine;
imidazoline
guanfacine
Guanfacine: A centrally acting antihypertensive agent with specificity towards ADRENERGIC ALPHA-2 RECEPTORS.		4.9221acetamides
methylphenidate
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.. 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.. 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.		15.945525beta-amino acid ester;
methyl ester;
piperidines
modafinil
Modafinil: A benzhydryl acetamide compound, central nervous system stimulant, and CYP3A4 inducing agent that is used in the treatment of NARCOLEPSY and SLEEP WAKE DISORDERS.. modafinil : A racemate comprising equimolar amounts of armodafinil and (S)-modafinil. A central nervous system stimulant, it is used for the treatment of sleeping disorders such as narcolepsy, obstructive sleep apnoea, and shift-work sleep disorder. The optical enantiomers of modafinil have similar pharmacological actions in animals.. 2-[(diphenylmethyl)sulfinyl]acetamide : A sulfoxide that is dimethylsulfoxide in which two hydrogens attached to one of the methyl groups are replaced by phenyl groups, while one hydrogen attached to the other methyl group is replaced by a carbamoyl (aminocarbonyl) group.		5.8230monocarboxylic acid amide;
sulfoxide
dextroamphetamine
Dextroamphetamine: The d-form of AMPHETAMINE. It is a central nervous system stimulant and a sympathomimetic. It has also been used in the treatment of narcolepsy and of attention deficit disorders and hyperactivity in children. Dextroamphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulating release of monamines, and inhibiting monoamine oxidase. It is also a drug of abuse and a psychotomimetic.. (S)-amphetamine : A 1-phenylpropan-2-amine that has S configuration.		6.04401-phenylpropan-2-amineadrenergic agent;
adrenergic uptake inhibitor;
dopamine uptake inhibitor;
dopaminergic agent;
neurotoxin;
sympathomimetic agent
methylprednisolone
Methylprednisolone: A PREDNISOLONE derivative with similar anti-inflammatory action.. 6alpha-methylprednisolone : The 6alpha-stereoisomer of 6-methylprednisolone.		5.55206-methylprednisolone;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		adrenergic agent;
anti-inflammatory drug;
antiemetic;
environmental contaminant;
neuroprotective agent;
xenobiotic
paroxetine
Paroxetine: A serotonin uptake inhibitor that is effective in the treatment of depression.. paroxetine : A benzodioxole that consists of piperidine bearing 1,3-benzodioxol-5-yloxy)methyl and 4-fluorophenyl substituents at positions 3 and 4 respectively; the (3S,4R)-diastereomer. Highly potent and selective 5-HT uptake inhibitor that binds with high affinity to the serotonin transporter (Ki = 0.05 nM). Ki values are 1.1, 350 and 1100 nM for inhibition of [3H]-5-HT, [3H]-l-NA and [3H]-DA uptake respectively. Displays minimal affinity for alpha1-, alpha2- or beta-adrenoceptors, 5-HT2A, 5-HT1A, D2 or H1 receptors at concentrations below 1000 nM, however displays weak affinity for muscarinic ACh receptors (Ki = 42 nM). Antidepressant and anxiolytic in vivo.		5.5520aromatic ether;
benzodioxoles;
organofluorine compound;
piperidines		antidepressant;
anxiolytic drug;
hepatotoxic agent;
P450 inhibitor;
serotonin uptake inhibitor
atomoxetine hydrochloride
Atomoxetine Hydrochloride: A propylamine derivative and selective ADRENERGIC UPTAKE INHIBITOR that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.. atomoxetine hydrochloride : The hydrochloride salt of atomoxetine.		4.1140hydrochlorideadrenergic uptake inhibitor;
antidepressant
ritalinic acid
[no description available]		3.411monocarboxylic acid;
piperidines		drug metabolite;
marine xenobiotic metabolite
dexmethylphenidate
dexmethylphenidate : A methyl phenyl(piperidin-2-yl)acetate in which both stereocentres have R configuration. It is the active enantiomer in the racemic drug methylphenidate.		2.0310methyl phenyl(piperidin-2-yl)acetateadrenergic agent
cocaine
Cocaine: An alkaloid ester extracted from the leaves of plants including coca. It is a local anesthetic and vasoconstrictor and is clinically used for that purpose, particularly in the eye, ear, nose, and throat. It also has powerful central nervous system effects similar to the amphetamines and is a drug of abuse. Cocaine, like amphetamines, acts by multiple mechanisms on brain catecholaminergic neurons; the mechanism of its reinforcing effects is thought to involve inhibition of dopamine uptake.. cocaine : A tropane alkaloid obtained from leaves of the South American shrub Erythroxylon coca.		4.3711benzoate ester;
methyl ester;
tertiary amino compound;
tropane alkaloid		adrenergic uptake inhibitor;
central nervous system stimulant;
dopamine uptake inhibitor;
environmental contaminant;
local anaesthetic;
mouse metabolite;
plant metabolite;
serotonin uptake inhibitor;
sodium channel blocker;
sympathomimetic agent;
vasoconstrictor agent;
xenobiotic
cocaine hydrochloride
cocaine hydrochloride : The hydrochloride salt of cocaine. It is a local anesthetic and vasoconstrictor and is clinically used for that purpose, particularly in the eye, ear, nose, and throat. It also has powerful central nervous system effects similar to the amphetamines and is a drug of abuse.		2.0310hydrochloridecentral nervous system stimulant;
local anaesthetic
eszopiclone
Eszopiclone: A pyridine, pyrazine, and piperazine derivative that is used as a HYPNOTIC AND SEDATIVE in the treatment of INSOMNIA.. eszopiclone : The (5S)- (active) enantiomer of zopiclone. Unlike almost all other hypnotic sedatives, which are approved only for the relief of short-term (6-8 weeks) insomnia, eszopiclone is approved by the U.S. Food and Drug Administration for long-term use.		2.110zopiclonecentral nervous system depressant;
sedative
levocetirizine
[no description available]		2.110diarylmethane
n-iodoallyl-2-carbomethoxy-3-(4-fluorophenyl)tropane
N-iodoallyl-2-carbomethoxy-3-(4-fluorophenyl)tropane: a SPECT imaging agent for viewing dopamine transporter sites; structure in first source		4.3711azabicycloalkane
s 1743
Esomeprazole: The S-isomer of omeprazole.. esomeprazole : A 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole that has S configuration at the sulfur atom. An inhibitor of gastric acid secretion, it is used (generally as its sodium or magnesium salt) for the treatment of gastro-oesophageal reflux disease, dyspepsia, peptic ulcer disease, and Zollinger-Ellison syndrome.		2.110magnesium saltanti-ulcer drug;
EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor
dexlansoprazole
Dexlansoprazole: The R-isomer of lansoprazole that is used to treat severe GASTROESOPHAGEAL REFLUX DISEASE.		2.110benzimidazoles;
sulfoxide
lisdexamfetamine dimesylate
Lisdexamfetamine Dimesylate: A dextroamphetamine drug precursor that also functions as a CENTRAL NERVOUS SYSTEM STIMULANT and DOPAMINE UPTAKE INHIBITOR and is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.		2.5220
levoleucovorin
Levoleucovorin: A folate analog consisting of the pharmacologically active isomer of LEUCOVORIN.. (6S)-5-formyltetrahydrofolic acid : The pharmacologically active (6S)-stereoisomer of 5-formyltetrahydrofolic acid.		2.1105-formyltetrahydrofolic acidantineoplastic agent;
metabolite
ConditionIndicatedRelationship StrengthStudiesTrials
Cocaine Abuse
[description not available]		02.0310
Cocaine-Related Disorders
Disorders related or resulting from use of cocaine.		02.0310
Cardiometabolic Syndrome
A cluster of symptoms that are risk factors for CARDIOVASCULAR DISEASES and TYPE 2 DIABETES MELLITUS. The major components not only include metabolic dysfunctions of METABOLIC SYNDROME but also HYPERTENSION, and ABDOMINAL OBESITY.		02.4110
Metabolic Syndrome
A cluster of symptoms that are risk factors for CARDIOVASCULAR DISEASES and TYPE 2 DIABETES MELLITUS. The major components of metabolic syndrome include ABDOMINAL OBESITY; atherogenic DYSLIPIDEMIA; HYPERTENSION; HYPERGLYCEMIA; INSULIN RESISTANCE; a proinflammatory state; and a prothrombotic (THROMBOSIS) state.		02.4110
ADDH
[description not available]		014.244018
Attention Deficit Disorder with Hyperactivity
A behavior disorder originating in childhood in which the essential features are signs of developmentally inappropriate inattention, impulsivity, and hyperactivity. Although most individuals have symptoms of both inattention and hyperactivity-impulsivity, one or the other pattern may be predominant. The disorder is more frequent in males than females. Onset is in childhood. Symptoms often attenuate during late adolescence although a minority experience the full complement of symptoms into mid-adulthood. (From DSM-V)		116.244018
Autism Spectrum Disorder
Wide continuum of associated cognitive and neurobehavioral disorders, including, but not limited to, three core-defining features: impairments in socialization, impairments in verbal and nonverbal communication, and restricted and repetitive patterns of behaviors. (from DSM-V)		02.3110
Depression, Involutional
Form of depression in those MIDDLE AGE with feelings of ANXIETY.		02.3110
Depressive Disorder, Major
Disorder in which five (or more) of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at least one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure. Symptoms include: depressed mood most of the day, nearly every daily; markedly diminished interest or pleasure in activities most of the day, nearly every day; significant weight loss when not dieting or weight gain; Insomnia or hypersomnia nearly every day; psychomotor agitation or retardation nearly every day; fatigue or loss of energy nearly every day; feelings of worthlessness or excessive or inappropriate guilt; diminished ability to think or concentrate, or indecisiveness, nearly every day; or recurrent thoughts of death, recurrent suicidal ideation without a specific plan, or a suicide attempt. (DSM-5)		02.3110
Chemical Dependence
[description not available]		03.0610
Substance-Related Disorders
Disorders related to substance use or abuse.		03.0610
Breast Cancer
[description not available]		02.0810
Age-Related Memory Disorders
[description not available]		02.0810
Benign Neoplasms
[description not available]		010.7794
Breast Neoplasms
Tumors or cancer of the human BREAST.		02.0810
Memory Disorders
Disturbances in registering an impression, in the retention of an acquired impression, or in the recall of an impression. Memory impairments are associated with DEMENTIA; CRANIOCEREBRAL TRAUMA; ENCEPHALITIS; ALCOHOLISM (see also ALCOHOL AMNESTIC DISORDER); SCHIZOPHRENIA; and other conditions.		02.0810
Neoplasms
New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.		010.7794
Lassitude
[description not available]		012.05128
Fatigue
The state of weariness following a period of exertion, mental or physical, characterized by a decreased capacity for work and reduced efficiency to respond to stimuli.		012.05128
Bilateral Headache
[description not available]		03.4311
Headache
The symptom of PAIN in the cranial region. It may be an isolated benign occurrence or manifestation of a wide variety of HEADACHE DISORDERS.		03.4311
Nervous System Disorders
[description not available]		03.4311
Dermatoses
[description not available]		03.4311
Nervous System Diseases
Diseases of the central and peripheral nervous system. This includes disorders of the brain, spinal cord, cranial nerves, peripheral nerves, nerve roots, autonomic nervous system, neuromuscular junction, and muscle.		03.4311
Skin Diseases
Diseases involving the DERMIS or EPIDERMIS.		03.4311
Habit Chorea
[description not available]		03.4411
Chronic Motor and Vocal Tic Disorder
[description not available]		03.4411
Tourette Syndrome
A neuropsychological disorder related to alterations in DOPAMINE metabolism and neurotransmission involving frontal-subcortical neuronal circuits. Both multiple motor and one or more vocal tics need to be present with TICS occurring many times a day, nearly daily, over a period of more than one year. The onset is before age 18 and the disturbance is not due to direct physiological effects of a substance or another medical condition. The disturbance causes marked distress or significant impairment in social, occupational, or other important areas of functioning. (From DSM-IV, 1994; Neurol Clin 1997 May;15(2):357-79)		03.4411
Tics
Habitual, repeated, rapid contraction of certain muscles, resulting in stereotyped individualized actions that can be voluntarily suppressed for only brief periods. They often involve the face, vocal cords, neck, and less often the extremities. Examples include repetitive throat clearing, vocalizations, sniffing, pursing the lips, and excessive blinking. Tics tend to be aggravated by emotional stress. When frequent they may interfere with speech and INTERPERSONAL RELATIONS. Conditions which feature frequent and prominent tics as a primary manifestation of disease are referred to as TIC DISORDERS. (From Adams et al., Principles of Neurology, 6th ed, pp109-10)		03.4411
Chronic Insomnia
[description not available]		04.3711
Sleep Initiation and Maintenance Disorders
Disorders characterized by impairment of the ability to initiate or maintain sleep. This may occur as a primary disorder or in association with another medical or psychiatric condition.		04.3711
Germinoblastoma
[description not available]		02.0110
Lymphoma
A general term for various neoplastic diseases of the lymphoid tissue.		02.0110
Pulmonary Sarcoidosis
[description not available]		07.4744
Sarcoidosis, Pulmonary
Sarcoidosis affecting predominantly the lungs, the site most frequently involved and most commonly causing morbidity and mortality in sarcoidosis. Pulmonary sarcoidosis is characterized by sharply circumscribed granulomas in the alveolar, bronchial, and vascular walls, composed of tightly packed cells derived from the mononuclear phagocyte system. The clinical symptoms when present are dyspnea upon exertion, nonproductive cough, and wheezing. (Cecil Textbook of Medicine, 19th ed, p431)		07.4744