dextroamphetamine and ADDH studies

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.

Research Excerpts

Excerpt	Relevance	Reference
" Lisdexamfetamine dimesylate offered beneficial effects on body weight, body mass index and several metabolic parameters."	9.17	The effect of lisdexamfetamine dimesylate on body weight, metabolic parameters, and attention deficit hyperactivity disorder symptomatology in adults with bipolar I/II disorder. ( Almagor, D; Alsuwaidan, M; Bilkey, TS; Cha, DS; Gallaugher, LA; Kennedy, SH; McIntyre, RS; Powell, AM; Soczynska, JK; Szpindel, I; Woldeyohannes, HO, 2013)
"Lisdexamfetamine dimesylate (LDX) is the only drug currently approved by the FDA for the treatment of Binge-Eating Disorder (BED), but little is known about the behavioural mechanisms that underpin the efficacy of LDX in treating BED."	5.51	The effects of lisdexamfetamine dimesylate on eating behaviour and homeostatic, reward and cognitive processes in women with binge-eating symptoms: an experimental medicine study. ( Chamberlain, SR; Dourish, CT; Higgs, S; Martin, E; Qureshi, KL; Rotshtein, P; Schneider, E; Spetter, MS, 2022)
" Lisdexamfetamine dimesylate offered beneficial effects on body weight, body mass index and several metabolic parameters."	5.17	The effect of lisdexamfetamine dimesylate on body weight, metabolic parameters, and attention deficit hyperactivity disorder symptomatology in adults with bipolar I/II disorder. ( Almagor, D; Alsuwaidan, M; Bilkey, TS; Cha, DS; Gallaugher, LA; Kennedy, SH; McIntyre, RS; Powell, AM; Soczynska, JK; Szpindel, I; Woldeyohannes, HO, 2013)
"We provided n-of-1 trials for osteoarthritis (OA), comparing paracetamol and ibuprofen; and attention deficit hyperactivity disorder (ADHD), comparing dexamphetamine or methylphenidate and placebo."	5.11	Using n-of-1 trials as a clinical tool to improve prescribing. ( Clavarino, AM; Del Mar, CB; Nikles, CJ, 2005)
" Levels of CSF 5-hydroxyindoleacetic acid (5-HIAA), homovanillic acid (HVA), and 3-methoxy-4-hydroxyphenylglycol (MHPG), the metabolites of serotonin, dopamine, and norepinephrine, respectively, correlated significantly with behavioral measures of aggression and impulsivity/hyperactivity."	5.07	Cerebrospinal fluid monoamine metabolites in boys with attention-deficit hyperactivity disorder. ( Castellanos, FX; Elia, J; Gulotta, CS; Kruesi, MJ; Mefford, IN; Potter, WZ; Rapoport, JL; Ritchie, GF, 1994)
"Twenty boys (mean age, 9 +/- 2 years) with attention deficit disorder with hyperactivity received three weeks each of dextroamphetamine sulfate (0."	5.06	Fenfluramine and dextroamphetamine treatment of childhood hyperactivity. Clinical and biochemical findings. ( Donnelly, M; Keysor, CS; Murphy, DL; Oliver, J; Potter, WZ; Rapoport, JL, 1989)
"2 years) with Attention Deficit Disorder With Hyperactivity during an initial placebo period, after four weeks of treatment with either dextroamphetamine sulfate (N=5) or a monoamine oxidase inhibitor (N=9) and at the end of a subsequent two-week placebo "washout" period."	5.05	Treatment of hyperactive children with monoamine oxidase inhibitors. II. Plasma and urinary monoamine findings after treatment. ( Ismond, D; Karoum, F; Linnoila, M; Murphy, DL; Potter, WZ; Rapoport, JL; Zametkin, A, 1985)
"An 18-year-old man with attention-deficit-hyperactivity disorder (ADHD) was prescribed varenicline for smoking cessation."	3.74	Interference with smoking-cessation effects of varenicline after administration of immediate-release amphetamine-dextroamphetamine. ( Moorman, KL; Whitley, HP, 2007)
" Methylphenidate hydrochloride ('Ritalin') was the prescribers' most popular agent and 'narcolepsy' was the most frequently cited clinical indication for psychostimulants."	3.70	Psychostimulants and psychiatrists: the Trent Adult Psychiatry Psychostimulant Survey. ( Bramble, D, 2000)
" These cases were selected from a prior quantitative study in which three antihistamines (meclizine, cyclizine, dimenhydrinate) and three stimulants (pemoline, methylphenidate, dextroamphetamine) were tested in variable combinations (using a specific clinical method) for favorable responses by 100 children characterized by diagnostic evidence of learning disabilities and cerebellar-vestibular dysfunctioning."	3.68	Dramatic favorable responses of children with learning disabilities or dyslexia and attention deficit disorder to antimotion sickness medications: four case reports. ( Levinson, HN, 1991)
"Children with attention deficit disorder with hyperactivity were given either methylphenidate hydrochloride or dextroamphetamine sulfate to compare the effects on urinary excretion of catecholamines, indoleamines, and phenylethylamine (PEA)."	3.67	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)
"To test the hypothesis that any change in urinary noradrenergic excretion accompanies drug-induced improvement in attention deficit disorder with hyperactivity, the authors gave pemoline (mean dose, 2."	3.67	Pemoline and urinary excretion of catecholamines and indoleamines in children with attention deficit disorder. ( Karoum, F; Linnoila, M; Sallee, R; Zametkin, AJ, 1986)
"Nicotine has been less widely studied with alternative ADHD pharmacotherapy bupropion, but we also discuss this research."	3.01	The co-use of nicotine and prescription psychostimulants: A review of their behavioral and neuropharmacological interactions. ( Bevins, RA; McNealy, KR; Weyrich, L, 2023)
" Clinical effects of LDX in attention-deficit/hyperactivity disorder (ADHD) have been shown to persist up to 14 hours; however, pharmacokinetic (PK) data of LDX and amphetamine in ADHD adults are not currently available."	2.84	Pharmacokinetic and Pharmacodynamic Properties of Lisdexamfetamine in Adults with Attention-Deficit/Hyperactivity Disorder. ( Adler, LA; Alperin, S; Faraone, SV; Leon, T, 2017)
" Safety assessments included physical examination, chemistry, hematology, vital signs, and treatment-emergent adverse events (TEAEs)."	2.80	The Efficacy and Safety of Evekeo, Racemic Amphetamine Sulfate, for Treatment of Attention-Deficit/Hyperactivity Disorder Symptoms: A Multicenter, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled Crossover Laboratory Classroom Study. ( Brams, M; Childress, AC; Cutler, AJ; Kollins, SH; Northcutt, J; Padilla, A; Turnbow, JM, 2015)
"Lisdexamfetamine dimesylate (LDX) is a long-acting, prodrug stimulant therapy for patients with attention-deficit/hyperactivity disorder (ADHD)."	2.79	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)
"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."	2.79	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)
" Safety assessments included treatment-emergent adverse events (TEAEs), vital signs, laboratory findings, and electrocardiograms."	2.78	A long-term open-label safety and effectiveness trial of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. ( Childress, AC; Cutler, AJ; Ferreira-Cornwell, MC; Findling, RL; Gasior, M; Hamdani, M; Saylor, K, 2013)
"Lisdexamfetamine dimesylate (LDX) is a long-acting prodrug stimulant for the treatment of attention-deficit/hyperactivity disorder (ADHD)."	2.78	Efficacy and safety of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder and recent methylphenidate use. ( Adeyi, B; Babcock, T; Burtea, T; Dirks, B; Duncan, D; Jain, R; Lasser, R; Renna, J; Scheckner, B, 2013)
" Tolerability and safety were assessed by monitoring treatment-emergent adverse events (TEAEs), height and weight, vital signs and electrocardiogram parameters."	2.78	Efficacy and safety of lisdexamfetamine dimesylate and atomoxetine in the treatment of attention-deficit/hyperactivity disorder: a head-to-head, randomized, double-blind, phase IIIb study. ( Anderson, CS; Bloomfield, R; Caballero, B; Cardo, E; Civil, R; Coghill, D; Dittmann, RW; Higgins, N; Hodgkins, P; Lyne, A; Nagy, P, 2013)
"To explore dose-response effects of lisdexamfetamine dimesylate (LDX) treatment for ADHD."	2.77	Dose response effects of lisdexamfetamine dimesylate treatment in adults with ADHD: an exploratory study. ( Faraone, SV; Glatt, SJ; Goodman, D; Kollins, SH; Spencer, TJ, 2012)
"To evaluate the type, frequency, duration, and severity of treatment emergent adverse events (TEAEs) of the prodrug lisdexamfetamine dimesylate (LDX) in children with and without previous exposure to stimulant medication in the treatment of attention-deficit/hyperactivity disorder (ADHD)."	2.77	Adverse events in medication treatment-naïve children with attention-deficit/hyperactivity disorder: results from a small, controlled trial of lisdexamfetamine dimesylate. ( Jun, A; Lerner, MA; Stehli, A; Steinberg-Epstein, R; Wigal, SB; Wong, AA, 2012)
" Self-report rating scales of functioning and direct assessment of ADHD symptoms, verbal learning/memory, and adverse side effects were collected (baseline only for control students)."	2.77	Double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in college students with ADHD. ( Carson, KM; Dupaul, GJ; O'Dell, SM; Rossi, JS; Swentosky, A; Verdi, G; Vilardo, BA; Weyandt, LL, 2012)
"Rating forms could quantify substance use interest in subjects with some drug culture exposure but encountered a floor effect in those without."	2.76	The "younger-sibling-at-risk design": a pilot study of adolescents with ADHD and an older sibling with substance use disorder. ( Donovan, SJ; Levin, FR, 2011)
"Zinc glycinate was chosen as having less gastrointestinal discomfort than sulfate."	2.76	Zinc for attention-deficit/hyperactivity disorder: placebo-controlled double-blind pilot trial alone and combined with amphetamine. ( Abdel-Rasoul, M; Arnold, LE; Bozzolo, D; Bozzolo, H; Crowl, L; Disilvestro, RA; Fernandez, S; Joseph, E; Mo, X; Ramadan, Y; Thompson, S, 2011)
" Safety assessments included treatment-emergent adverse events (TEAEs), vital signs, laboratory findings, physical examinations, and ECG."	2.76	Efficacy and safety of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. ( Childress, AC; Cutler, AJ; Ferreira-Cornwell, MC; Findling, RL; Gasior, M; Hamdani, M; Squires, L, 2011)
"Lisdexamfetamine dimesylate (LDX) is a long-acting oral prodrug stimulant indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6 to 12 years old and in adults."	2.75	Pharmacokinetics of lisdexamfetamine dimesylate and its active metabolite, d-amphetamine, with increasing oral doses of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: a single-dose, randomized, open-label, crossover ( Boellner, SW; Krishnan, S; Stark, JG; Zhang, Y, 2010)
" Safety assessments included treatment-emergent adverse events (TEAEs), vital signs, and electrocardiograms."	2.75	Randomized, double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: novel findings using a simulated adult workplace environment design. ( Brams, M; Gao, J; Gasior, M; Giblin, J; Squires, L; Wigal, T, 2010)
" Safety assessments included adverse events."	2.75	Lisdexamfetamine dimesylate: linear dose-proportionality, low intersubject and intrasubject variability, and safety in an open-label single-dose pharmacokinetic study in healthy adult volunteers. ( Buckwalter, M; Ermer, J; Homolka, R; Martin, P; Purkayastha, J; Roesch, B, 2010)
" 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."	2.74	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)
" Safety assessments included treatment-emergent adverse events (TEAEs), vital signs, and electrocardiograms."	2.74	Effectiveness, safety, and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: an open-label, dose-optimization study. ( Findling, RL; Gao, J; Ginsberg, LD; Jain, R, 2009)
" Safety assessments included adverse events inquiries, vital signs, and electrocardiograms while the primary effectiveness assessment was the ADHD Rating Scale (ADHD-RS) total score."	2.74	Long-term safety and effectiveness of lisdexamfetamine dimesylate in adults with attention-deficit/ hyperactivity disorder. ( Adler, L; Gao, J; Mattingly, G; Squires, L; Weisler, R; Young, J, 2009)
"Lisdexamfetamine dimesylate is a therapeutically inactive prodrug in which d-amphetamine is covalently bound to l-lysine, a naturally occurring amino acid."	2.73	Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study. ( Biederman, J; Boellner, SW; Childress, A; Krishnan, S; Lopez, FA; Zhang, Y, 2007)
" Most adverse events were mild to moderate and occurred during the first 4 weeks."	2.73	Long-term effectiveness and safety of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder. ( Childress, AC; Findling, RL; Krishnan, S; McGough, JJ, 2008)
" Adverse events were generally mild and included dry mouth, decreased appetite, and insomnia."	2.73	Double-blind, placebo-controlled study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. ( Adler, LA; Biederman, J; Goodman, DW; Kollins, SH; Krishnan, S; Weisler, RH; Zhang, Y, 2008)
"Risperidone-treated patients had clinically and statistically significant reductions in both disruptive behavior and hyperactivity subscale scores, compared to placebo, regardless of concomitant stimulant use."	2.71	Risperidone effects in the presence/absence of psychostimulant medicine in children with ADHD, other disruptive behavior disorders, and subaverage IQ. ( Aman, MG; Binder, C; Turgay, A, 2004)
"Assess the bioavailability of mixed amphetamine salts extended-release (MAS XR) 30-mg capsules and the dose proportionality of pharmacokinetic measures for MAS XR 20, 40, and 60 mg."	2.71	Single- and multiple-dose pharmacokinetics of an oral mixed amphetamine salts extended-release formulation in adults. ( Clausen, SB; Read, SC; Tulloch, SJ, 2005)
" Although parent behavior ratings and locomotor activity showed improvements up to 12 hours after single doses of all three drugs, the number of math problems attempted and completed correctly 4 hours after dosing were only robustly increased by Spansules."	2.70	Double-blind, placebo-controlled study of single-dose amphetamine formulations in ADHD. ( Bastain, TM; Castellanos, FX; Czarnolewski, M; James, RS; Lee, PP; Sharp, WS; Walter, JM, 2001)
" 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."	2.69	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)
"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."	2.68	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)
" Transient sedation lasting 2 to 3 days occurred after initial administration or dosage increase; otherwise, clonidine was well tolerated."	2.67	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)
" No dose-response relationship was found for either stimulant."	2.67	Classroom academic performance: improvement with both methylphenidate and dextroamphetamine in ADHD boys. ( Elia, J; Gullotta, CS; Rapoport, JL; Welsh, PA, 1993)
"Dextroamphetamine tended to produce more compulsive behaviors, which were also more likely to resemble clinical obsessive-compulsive disorder (OCD), than did methylphenidate."	2.67	Motor/vocal tics and compulsive behaviors on stimulant drugs: is there a common vulnerability? ( Amass, J; Borcherding, BG; Elia, J; Keysor, CS; Rapoport, JL, 1990)
" Dosage may be crucial; 8 Efamol capsules per day were used in this study."	2.66	Gamma-linolenic acid for attention-deficit hyperactivity disorder: placebo-controlled comparison to D-amphetamine. ( Arnold, LE; Kleykamp, D; Kontras, SB; Taylor, WA; Tobin, K; Votolato, NA, 1989)
" In one study, tics limited further dosage increases of methylphenidate."	2.58	Pharmacological treatment for attention deficit hyperactivity disorder (ADHD) in children with comorbid tic disorders. ( Osland, ST; Pringsheim, T; Steeves, TD, 2018)
" Withdrawals due to all-cause, adverse effects and lack of efficacy were defined as primary outcomes evaluating the safety of such medications."	2.55	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)
"Amphetamine dependence is relatively common in Sweden and it is the most frequently used substance among patients with intravenous drug abuse."	2.53	[Substitution therapy tested against amphetamine dependence]. ( Bloniecki Kallio, V; Franck, J; Guterstam, J, 2016)
"In short-term, parallel-group, placebo-controlled, phase III trials, treatment-emergent adverse events (TEAEs) in children, adolescents, and adults receiving LDX were typical for those reported for stimulants in general."	2.50	A systematic review of the safety of lisdexamfetamine dimesylate. ( Caballero, B; Civil, R; Coghill, DR; Sorooshian, S, 2014)
"Lisdexamfetamine dimesylate (LDX) is a long-acting oral prodrug stimulant."	2.50	The use of lisdexamfetamine dimesylate for the treatment of ADHD and other psychiatric disorders. ( Álvarez, FJ; Roncero, C, 2014)
" The dosage of lisdexamfetamine was 30 to 70 mg/day."	2.50	Exploratory meta-analysis on lisdexamfetamine versus placebo in adult ADHD. ( Maneeton, B; Maneeton, N; Martin, SD; Reungyos, J; Srisurapanont, M; Suttajit, S, 2014)
"Amphetamine was discovered over 100 years ago."	2.49	Amphetamine, past and present--a pharmacological and clinical perspective. ( Gosden, J; Heal, DJ; Nutt, DJ; Smith, SL, 2013)
" 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."	2.49	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)
"Methylphenidate displays a high degree of effectiveness and safety in the treatment of adults at doses of around 1 mg/kg/day."	2.48	[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)
"Lisdexamfetamine dimesylate (LDX) is a long-acting amphetamine prodrug indicated for the treatment of ADHD and has been shown to be effective in children, adolescents and adults."	2.48	The use of lisdexamfetamine dimesylate for the treatment of ADHD. ( Childress, AC; Sallee, FR, 2012)
"Lisdexamfetamine dimesylate (LDX) is an inactive, water-soluble prodrug in which d-amphetamine is bonded to l-lysine, a naturally occurring amino acid."	2.46	Lisdexamfetamine dimesylate: a prodrug stimulant for the treatment of ADHD in children and adults. ( Mattingly, G, 2010)
"Lisdexamfetamine dimesylate (LDX) is a once-daily medication approved by the US Food and Drug Administration for the management of attention-deficit/hyperactivity disorder (ADHD) in children (aged 6-12 years) and adults."	2.45	The efficacy and safety profile of lisdexamfetamine dimesylate, a prodrug of d-amphetamine, for the treatment of attention-deficit/hyperactivity disorder in children and adults. ( Najib, J, 2009)
" The unique pharmacokinetic profile owing to lisdexamfetamine's prodrug design and rate-limited enzymatic biotransformation allows for once-daily dosing with a duration of activity of approximately 12 hours."	2.45	Lisdexamfetamine for treatment of attention-deficit/hyperactivity disorder. ( Cowles, BJ, 2009)
" The recommended starting dosage of lisdexamfetamine is 30 mg orally daily, which can be adjusted to a maximum dosage of 70 mg daily."	2.45	Lisdexamfetamine: a prodrug for the treatment of attention-deficit/hyperactivity disorder. ( Bhattacharya, P; Popovic, B; Sivaswamy, L, 2009)
"Amphetamines evaluated were D- and D,L-amphetamine and methamphetamine."	2.43	NTP-CERHR monograph on the potential human reproductive and developmental effects of amphetamines. ( , 2005)
" AMPH exerted a paradoxical effect on CORT secretion only in maternally deprived subjects while affecting behaviour mainly in deprived female subjects, which showed a generalised shift to the left in the dose-response curve to this drug."	2.41	Paradoxical effects of D-amphetamine in infant and adolescent mice: role of gender and environmental risk factors. ( Cirulli, F; Laviola, G, 2000)
"Clonidine has not been adequately examined but seems to have small or uncertain effects."	2.40	Antidepressants in the treatment of attention-deficit/hyperactivity disorder. ( Popper, CW, 1997)
" 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."	2.40	Psychopharmacology of ADHD: children and adolescents. ( Dogin, JW; Findling, RL, 1998)
"However, current substance abuse precludes use of the drug and former abuse liability and social adjustment problems are relative contraindications."	2.40	[Central nervous system stimulants and their potential risk of abuse in hyperkinetic disorders]. ( Aanonsen, NO, 1999)
" 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."	2.40	Treatment of attention-deficit/hyperactivity disorder. ( Boyle, M; Cunningham, C; Jadad, AR; Kim, M; Schachar, R, 1999)
"Although there is no pharmacological treatment for autism spectrum disorder (ASD) itself, behavioral and pharmacological therapies have been used to address its symptoms and common comorbidities."	1.62	Medication Use in the Management of Comorbidities Among Individuals With Autism Spectrum Disorder From a Large Nationwide Insurance Database. ( Avillach, P; Feroe, AG; Greenspun, P; Gutiérrez-Sacristán, A; Kohane, IS; Mousavi, S; Surati, R; Uppal, N, 2021)
"Methylphenidate was also found to produce activation of the cortical EEG in anaesthetised rats."	1.46	Effect of methylphenidate on visual responses in the superior colliculus in the anaesthetised rat: Role of cortical activation. ( Dommett, EJ; Haensel, JX; Hetherington, L; Overton, PG; Riley, TB; Turner, AC, 2017)
"Methylphenidate was used by 88 % of drug users."	1.43	Use of drugs for ADHD among adults-a multinational study among 15.8 million adults in the Nordic countries. ( Bahmanyar, S; Furu, K; Karlstad, Ø; Kieler, H; Martikainen, JE; Pottegård, A; Zoëga, H, 2016)
"Adolescents with autism spectrum disorders (ASD) are increasingly attending college."	1.43	College students with autism spectrum disorders: A growing role for adult psychiatrists. ( Beyer, C; Martin, A; van Schalkwyk, GI; Volkmar, FR, 2016)
" In the present study, we have examined the effect of lisdexamfetamine dimesylate (LDX), an amphetamine pro-drug that is approved for the treatment of ADHD on acetylcholine and histamine efflux in pre-frontal cortex and hippocampus alone and in combination with the anti-depressant s-citalopram."	1.42	Effects of lisdexamfetamine alone and in combination with s-citalopram on acetylcholine and histamine efflux in the rat pre-frontal cortex and ventral hippocampus. ( Folgering, JH; Heins, MS; Hutson, PH, 2015)
"Diagnoses of SUD and alcohol abuse were obtained from The Danish Psychiatric Central Register."	1.40	ADHD, stimulant treatment in childhood and subsequent substance abuse in adulthood - a naturalistic long-term follow-up study. ( Dalsgaard, S; Frydenberg, M; Mortensen, PB; Thomsen, PH, 2014)
"To compare therapy augmentation and deviation rates from the recommended once-daily dosing regimen in Attention Deficit Hyperactivity Disorder (ADHD) patients initiated on lisdexamfetamine (LDX) vs other once-daily Food and Drug Administration (FDA) approved stimulants."	1.39	Comparison of therapy augmentation and deviation rates from the recommended once-daily dosing regimen between LDX and commonly prescribed long-acting stimulants for the treatment of ADHD in youth and adults. ( Cloutier, M; Erder, MH; Gauthier, G; Guérin, A; Hodgkins, P; Setyawan, J; Wu, E, 2013)
" However, later timing of stimulant dosing was correlated with later sleep times, p < ."	1.39	Adults with ADHD-without insomnia history have subclinical sleep disturbance but not circadian delay: an ADHD phenotype? ( Fargason, RE; Gamble, KL; Hollar, AF; White, S, 2013)
"These cases suggest that ADHD and chronic fatigue syndrome (and possibly fibromyalgia) share a common underlying mechanism."	1.39	Chronic fatigue syndrome: 3 cases and a discussion of the natural history of attention-deficit/hyperactivity disorder. ( Young, JL, 2013)
"An example application is based on two treatments for attention deficit hyperactivity disorder (ADHD): osmotic-release oral system methylphenidate (OROS-MPH) and lisdexamfetamine dimesylate (LDX)."	1.38	Identifying patient subgroups who benefit most from a treatment: using administrative claims data to uncover treatment heterogeneity. ( Betts, KA; Erder, MH; Hodgkins, P; Parikh, K; Setyawan, J; Signorovitch, JE; Wu, EQ; Xie, J; Yang, H, 2012)
"Lisdexamfetamine dimesylate (LDX) is a prodrug stimulant approved for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and children 6-12 years of age."	1.36	Assessing effects of treatment with lisdexamfetamine dimesylate for pediatric ADHD using a parental survey. ( Antonucci, D; Kerney, DL; Kunins, C; López, FA; Manos, M, 2010)
"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."	1.36	Attention-deficit hyperactivity disorder: recent advances in paediatric pharmacotherapy. ( Kratochvil, CJ; May, DE, 2010)
"Following reports of sudden death in patients taking medication to treat attention-deficit hyperactivity disorder (ADHD), this study aimed to identify cases of death in patients prescribed stimulants and atomoxetine and to determine any association between these and sudden death."	1.35	Mortality associated with attention-deficit hyperactivity disorder (ADHD) drug treatment: a retrospective cohort study of children, adolescents and young adults using the general practice research database. ( Cranswick, N; McCarthy, S; Potts, L; Taylor, E; Wong, IC, 2009)
"Lisdexamfetamine dimesylate is a therapeutically inactive molecule."	1.35	Lisdexamfetamine dimesylate: the first long-acting prodrug stimulant treatment for attention deficit/hyperactivity disorder. ( Faraone, SV, 2008)
"Lisdexamfetamine dimesylate is a long-acting amfetamine prodrug that requires in vivo hydrolysis to gradually release active d-amfetamine."	1.35	Lisdexamfetamine dimesylate: in attention-deficit hyperactivity disorder in adults. ( Siddiqui, MA; Weber, J, 2009)
"Drug treatment for attention deficit disorder (ADD) was rare in the United Kingdom (UK) until in the mid-1990s."	1.32	Incidence and prevalence of drug-treated attention deficit disorder among boys in the UK. ( Black, C; Jick, H; Kaye, JA, 2004)
" Personal or family tic history, medication selection, or dosage was not related to onset of T/D."	1.29	Tics and dyskinesias associated with stimulant treatment in attention-deficit hyperactivity disorder. ( Adesman, AR; Goldstein, IJ; Lipkin, PH, 1994)
"Early signs of Tourette's syndrome may be difficult to distinguish from hyperactive and attention disordered symptoms, leading the clinician to consider treatment with stimulants."	1.26	Stimulant medications precipitate Tourette's syndrome. ( Cohen, DJ; Detlor, J; Kremenitzer, MW; Lowe, TL; Shaywitz, BA, 1982)
"Three main symptoms of minimal brain dysfunction (MBD), a common disorder in children, are hyperactivity, learning disabilities, and attention deficits."	1.26	An evaluation of the young dopamine-lesioned rat as an animal model for minimal brain dysfunction (MBD). ( Dijkstra, H; Stoof, JC; Thieme, RE, 1980)
"Early signs of Tourette's syndrome may be difficult to distinguish from hyperactive and attention disordered symptoms, leading the clinician to consider, treatment with stimulants."	1.26	Stimulant medications precipitate Tourette's syndrome. ( Cohen, DJ; Detlor, J; Kremenitzer, MW; Lowe, TL; Shaywitz, BA, 1982)
" No correlations were found between dosage level and changes in weight and height percentiles."	1.26	Growth of hyperkinetic children taking methylphenidate, dextroamphetamine, or imipramine/desipramine. ( Gross, MD, 1976)
"Minimal brain dysfunction is a neurodevelopmental disorder which can be found in nearly 20% of school children."	1.26	Minimal brain dysfunction/specific learning disability: a clinical approach for the primary physician. ( Levy, HB, 1976)

Research

Studies (528)

Authors

Clinical Trials (39)

Trial Overview

Trial Outcomes

Inattentive/Overactive Rating

Timeframe	Studies, this research(%)	All Research%
pre-1990	127 (24.05)	18.7374
1990's	77 (14.58)	18.2507
2000's	149 (28.22)	29.6817
2010's	158 (29.92)	24.3611
2020's	17 (3.22)	2.80

Authors	Studies
Schneider, E	1
Martin, E	1
Rotshtein, P	1
Qureshi, KL	1
Chamberlain, SR	1
Spetter, MS	1
Dourish, CT	1
Higgs, S	1
Bruno, C	1
Zoega, H	2
Gillies, MB	1
Havard, A	1
Coghill, D	9
Pearson, SA	1
Brett, J	1
van Stralen, J	1
Parhar, G	1
Parhar, A	1
Tourjman, V	1
Khattak, S	1
Ahmed, T	1
Donnelly, GAE	1
Ratz, J	1
McNealy, KR	1
Weyrich, L	1
Bevins, RA	1
Rose, SJ	1
Hathcock, MA	1
White, WM	1
Borowski, K	1
Rivera-Chiauzzi, EY	1
Efron, D	6
Mulraney, M	1
Sciberras, E	1
Hiscock, H	1
Hearps, S	1
Gordon, CT	1
Fabiano, GA	1
Hulme, KF	1
Sodano, SM	1
Adragna, M	1
Lim, R	1
Stanford, S	1
Janikowski, L	1
Bufalo, B	1
Rodriguez, Z	1
Swiatek, D	1
Ross, L	1
Sapre, V	1
Stanislaus, C	1
Poulton, AS	3
Mac Avin, M	1
Teeling, M	1
Bennett, KE	1
Miller, J	1
Perera, B	1
Shankar, R	1
Grimmsmann, T	1
Himmel, W	1
Kooij, JJS	1
Elliott, J	1
Johnston, A	1
Husereau, D	1
Kelly, SE	1
Eagles, C	1
Charach, A	1
Hsieh, SC	1
Bai, Z	1
Hossain, A	1
Skidmore, B	1
Tsakonas, E	1
Chojecki, D	1
Mamdani, M	1
Wells, GA	1
Sakai, C	1
Feroe, AG	1
Uppal, N	1
Gutiérrez-Sacristán, A	1
Mousavi, S	1
Greenspun, P	1
Surati, R	1
Kohane, IS	1
Avillach, P	1
Cortese, S	2
Newcorn, JH	3
Hetherington, L	1
Dommett, EJ	2
Turner, AC	1
Riley, TB	1
Haensel, JX	1
Overton, PG	3
Scrandis, DA	1
Armstrong, B	1
Nanan, RK	1
Rojas-Leguizamón, M	1
Baroja, JL	1
Sanabria, F	1
Orduña, V	1
Suhaiban, H	1
Javanbakht, A	1
Frampton, JE	1
Osland, ST	1
Steeves, TD	1
Pringsheim, T	1
Castells, X	1
Blanco-Silvente, L	1
Cunill, R	1
Fowler, E	1
Maderal, A	1
Yosipovitch, G	1
López, FA	7
Childress, A	3
Adeyi, B	16
Dirks, B	14
Babcock, T	13
Scheckner, B	12
Lasser, RA	2
Shepski, J	1
Arnold, V	3
Findling, RL	14
Cutler, AJ	4
Saylor, K	3
Gasior, M	11
Hamdani, M	5
Ferreira-Cornwell, MC	4
Childress, AC	7
Lasser, R	7
DeLeon, A	1
Ginsberg, LD	3
Lensing, MB	1
Zeiner, P	1
Sandvik, L	1
Opjordsmoen, S	1
Rostain, A	1
Jensen, PS	5
Connor, DF	1
Miesle, LM	1
Faraone, SV	12
McCarthy, S	6
Wilton, L	3
Murray, M	3
Hodgkins, P	13
Asherson, P	6
Wong, IC	6
Heal, DJ	1
Smith, SL	1
Gosden, J	1
Nutt, DJ	1
Leroux, JR	1
Setyawan, J	5
Guérin, A	3
Gauthier, G	3
Cloutier, M	3
Wu, EQ	2
Erder, MH	5
Ramtvedt, BE	3
Røinås, E	1
Aabech, HS	2
Sundet, KS	1
Jain, R	4
Burtea, T	1
Renna, J	1
Duncan, D	1
Coghill, DR	6
Banaschewski, T	9
Lecendreux, M	6
Zuddas, A	6
Dittmann, RW	4
Otero, IH	1
Civil, R	7
Bloomfield, R	3
Squires, LA	5
Senior, HE	2
McKinlay, L	2
Nikles, J	1
Schluter, PJ	2
Carmont, SA	2
Waugh, MC	2
Epps, A	2
Lloyd, O	1
Mitchell, GK	4
Soutullo, C	3
Johnson, M	6
Anderson, C	2
Higgins, N	4
Ogrim, G	2
Hestad, KA	1
Wu, E	2
Adler, LA	7
Deas, PF	1
Raychaudhuri, A	2
Dauphin, MR	1
Weisler, RH	5
Katic, A	4
Richards, C	3
Cardo, E	2
Nagy, P	2
Anderson, CS	3
Caballero, B	3
Lyne, A	3
McIntyre, RS	1
Alsuwaidan, M	1
Soczynska, JK	1
Szpindel, I	1
Bilkey, TS	1
Almagor, D	1
Woldeyohannes, HO	1
Powell, AM	1
Cha, DS	1
Gallaugher, LA	1
Kennedy, SH	1
Dalsgaard, S	3
Nielsen, HS	2
Simonsen, M	2
Mortensen, PB	2
Frydenberg, M	1
Thomsen, PH	2
Deas, P	1
Dauphin, M	2
Weisler, R	3
Cook, A	1
Bradley-Johnson, S	1
Johnson, CM	1
Martin, PT	1
Corcoran, M	1
Zhang, P	1
Cherkasova, MV	1
Faridi, N	1
Casey, KF	1
O'Driscoll, GA	1
Hechtman, L	5
Joober, R	1
Baker, GB	2
Palmer, J	1
Dagher, A	1
Leyton, M	1
Benkelfat, C	1
Nikles, CJ	5
Lloyd, OT	1
Dahl, E	1
Roskell, NS	1
Zimovetz, EA	1
Sundet, K	2
Hart, AB	1
Gamazon, ER	1
Engelhardt, BE	1
Sklar, P	1
Kähler, AK	1
Hultman, CM	1
Sullivan, PF	1
Neale, BM	1
de Wit, H	2
Cox, NJ	1
Palmer, AA	2
Sorooshian, S	1
Waxmonsky, JG	3
Waschbusch, DA	3
Babinski, DE	2
Humphrey, HH	1
Alfonso, A	2
Crum, KI	2
Bernstein, M	2
Slavec, J	2
Augustus, JN	2
Pelham, WE	5
Clements, KM	1
Devonshire, IM	1
Reynolds, JN	1
Bink, M	1
van Nieuwenhuizen, C	1
Popma, A	1
Bongers, IL	1
van Boxtel, GJ	1
Roncero, C	1
Álvarez, FJ	1
Tramontana, MG	1
Cowan, RL	1
Zald, D	1
Prokop, JW	1
Guillamondegui, O	1
Norum, J	1
Olsen, AI	1
Nohr, FI	1
Heyd, A	1
Totth, A	1
Rothermel, B	1
Poustka, L	1
Barbaresi, WJ	2
Katusic, SK	2
Colligan, RC	2
Weaver, AL	2
Leibson, CL	2
Jacobsen, SJ	2
Alperin, S	2
Leon, T	2
Faraone, S	1
Brams, M	9
Maneeton, N	1
Maneeton, B	1
Suttajit, S	1
Reungyos, J	1
Srisurapanont, M	1
Martin, SD	1
Humphrey, H	1
Duda, TA	1
Casey, JE	1
McNevin, N	1
Fridman, M	1
Kollins, SH	8
Northcutt, J	1
Padilla, A	1
Turnbow, JM	1
Stuhec, M	1
Munda, B	1
Svab, V	1
Locatelli, I	1
Hutson, PH	1
Heins, MS	1
Folgering, JH	1
Young, S	1
Khondoker, M	1
Emilsson, B	1
Sigurdsson, JF	1
Philipp-Wiegmann, F	1
Baldursson, G	1
Olafsdottir, H	1
Gudjonsson, G	1
Schrantee, A	1
Ferguson, B	1
Stoffers, D	1
Booij, J	1
Rombouts, S	1
Reneman, L	1
Leckman, JF	1
Barkla, XM	1
McArdle, PA	1
Newbury-Birch, D	1
Bui, Q	1
Melzer, E	1
Evans, R	1
Ghosh, M	1
Holman, CD	2
Preen, DB	2
Bloniecki Kallio, V	1
Guterstam, J	1
Franck, J	1
van Schalkwyk, GI	1
Beyer, C	1
Martin, A	1
Volkmar, FR	1
Clarke, AR	6
Barry, RJ	6
Baker, IE	1
McCarthy, R	5
Selikowitz, M	5
Aasen, IE	1
Brunner, JF	1
Karlstad, Ø	1
Furu, K	2
Bahmanyar, S	1
Martikainen, JE	1
Kieler, H	1
Pottegård, A	1
Li, Y	1
Gao, J	8
He, S	1
Zhang, Y	5
Wang, Q	1
Kapellen, TM	1
Reimann, R	1
Kiess, W	1
Kostev, K	1
Isiten, HN	1
Cebi, M	1
Sutcubasi Kaya, B	1
Metin, B	1
Tarhan, N	1
Mattingly, GW	2
Anderson, RH	1
Harrison, C	1
Charles, J	1
Britt, H	1
Madaan, V	1
Krishnan, S	6
McGough, JJ	3
Pedersen, SJ	1
Howland, RH	2
Horrobin, SL	1
McNair, NA	1
Kirk, IJ	1
Waldie, KE	1
Cormier, E	1
Goodman, DW	3
Biederman, J	7
Yan, TC	2
McQuillin, A	1
Thapar, A	1
Hunt, SP	2
Stanford, SC	2
Gurling, H	1
Najib, J	1
Hollis, C	2
Potts, L	3
Sayal, K	2
de Soysa, R	1
Taylor, E	6
Williams, T	2
Cowles, BJ	1
Keen, D	1
Hadijikoumi, I	1
Weber, J	1
Siddiqui, MA	1
Dopheide, JA	1
Greenfield, SA	1
Rostain, AL	1
Cranswick, N	1
Bilbow, A	1
Clifford, S	1
DeSoysa, R	1
Planner, C	1
Blader, JC	1
Schooler, NR	1
Pliszka, SR	1
Kafantaris, V	1
Jun, A	3
Popovic, B	1
Bhattacharya, P	1
Sivaswamy, L	1
May, DE	1
Kratochvil, CJ	1
Hamidovic, A	1
Dlugos, A	1
Young, J	2
Mattingly, G	2
Squires, L	5
Adler, L	1
Niebler, GE	1
Ermer, J	1
Homolka, R	1
Martin, P	1
Buckwalter, M	1
Purkayastha, J	1
Roesch, B	1
Boellner, SW	2
Stark, JG	1
Spencer, TJ	3
Glatt, SJ	3
Antonucci, D	1
Kunins, C	1
Manos, M	1
Kerney, DL	1
Hood, B	1
Nowicki, MJ	1
Moon, E	1
Pucci, M	1
Sevak, RJ	1
Stoops, WW	1
Rush, CR	1
Giblin, JM	1
Strobel, AL	1
Wigal, T	5
Giblin, J	3
Roman, MW	1
Murray, DW	1
Albrecht, MA	1
Martin-Iverson, MT	1
Price, G	1
Lee, J	1
Iyyalol, R	1
Hoppenbrouwers, CJ	1
Mooren, GC	1
van den Heuvel, JJ	1
Op de Coul, ME	1
van Trotsenburg, PA	1
Brown, TE	3
Wigal, SB	6
Wong, AA	2
Stehli, A	4
Steinberg-Epstein, R	3
Lerner, MA	2
Landgraf, JM	1
Koffarnus, MN	1
Katz, JL	1
Maltas, S	1
Crinella, F	1
Steinhoff, K	1
Lakes, K	1
Schuck, S	1
Dew, RE	1
Bizot, JC	1
David, S	1
Trovero, F	1
Ginsberg, L	3
Turgay, A	3
Chae, S	1
Patel, A	1
Calarge, C	1
Farmer, C	1
DiSilvestro, R	1
Arnold, LE	13

Trial	Phase	Enrollment	Study Type	Start Date	Status
Efficacy of Lisdexamfetamine Dimesylate for Promoting Occupational Success in Young Adults With Attention-deficit/Hyperactivity Disorder[NCT03446885]	Phase 4	22 participants (Actual)	Interventional	2018-04-01	Completed
A Phase III, Open-Label, Extension, Multi-Center, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Adolescents Aged 13-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)[NCT00764868]	Phase 3	269 participants (Actual)	Interventional	2008-11-13	Completed
A Multi-Center, Open Label, Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder[NCT03337646]	Phase 4	48 participants (Actual)	Interventional	2018-09-26	Active, not recruiting
Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD[NCT01220440]	Phase 4	36 participants (Actual)	Interventional	2006-01-31	Completed
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 3	336 participants (Actual)	Interventional	2008-11-17	Completed
A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-controlled, Parallel Group Study Evaluating the Safety and Efficacy of SPD489 on Executive Function (Self-Regulation) Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) Report[NCT01101022]	Phase 4	161 participants (Actual)	Interventional	2010-05-19	Completed
A Phase 3b, Double-blind, Randomised, Active-controlled, Parallel Group Study to Assess the Time to Response of Lisdexamfetamine Dimesylate to Atomoxetine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disor[NCT01106430]	Phase 3	267 participants (Actual)	Interventional	2010-06-28	Completed
A Phase I, Randomized, Double Blind, Three-Period Crossover, Estimation Study Using Lisdexamfetamine Dimesylate, Immediate Release Mixed Amphetamine Salts and Placebo to Evaluate the Utility of a Standardized Computer Battery of Tests in Adults With Atten[NCT01010750]	Phase 1	18 participants (Actual)	Interventional	2010-01-05	Completed
Does Pharmacological Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults Enhance Parenting Performance?[NCT01127607]	Phase 4	38 participants (Actual)	Interventional	2010-11-30	Completed
The Effects of Chiropractic Care on Behavior, Neurological Function and Quality of Life in Children With Attention Deficit Hyperactivity Disorder: A Randomized Controlled Pilot Study[NCT03849807]		56 participants (Actual)	Interventional	2019-02-02	Completed
A Phase III, Double-blind, Placebo-controlled, Randomised Withdrawal, Multicentre, Extension, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention- Deficit/Hyperactivity Disorder (ADHD)[NCT00784654]	Phase 3	276 participants (Actual)	Interventional	2009-01-27	Completed
Evaluation of Pharmacokinetics and Profile of Clinical Response of Subacute Lisdexamfetamine Dimesylate (Vyvanse) Treatment vs. Clinical Response to Subacute Immediate Release Mixed Amphetamine Salt Therapy in Adult ADHD[NCT01070394]	Phase 4	40 participants (Actual)	Interventional	2010-02-28	Completed
A Phase 4, Double-Blind, Multi-Center, Placebo-Controlled, Randomized Withdrawal, Safety and Efficacy Study of SPD489 in Adults Aged 18-55 With Attention-Deficit/Hyperactivity Disorder (ADHD)[NCT00877487]	Phase 4	123 participants (Actual)	Interventional	2009-04-30	Completed
A Multicenter, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of AR11 (Amphetamine Sulfate) in Pediatric Patients (Ages 6-12) With ADHD in a Laboratory Classroom[NCT01986062]	Phase 4	97 participants (Actual)	Interventional	2013-12-31	Completed
A Phase III, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel-Group, Forced Dose Titration, Safety and Efficacy Study of NRP104 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)[NCT00334880]	Phase 3	420 participants (Actual)	Interventional	2006-05-31	Completed
Double-Blind, Placebo-Controlled Trial of Flexible Dose Divalproex Sodium Adjunctive to Stimulant Treatment for Aggressive Children With Attention-Deficit Hyperactivity Disorder[NCT00228046]	Phase 4	40 participants (Anticipated)	Interventional	2004-01-31	Completed
A Prospective, Open-Label, Multi-Center, Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) 20-70mg in Children Aged 6-12 Diagnosed With ADHD[NCT00500071]	Phase 4	318 participants (Actual)	Interventional	2007-06-28	Completed
Pharmacologic Augmentation of Neurocognition and Cognitive Training in Psychosis[NCT02634684]	Phase 2	82 participants (Actual)	Interventional	2014-07-01	Completed
A Phase 2, Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Treatment, 3-Period, Crossover Study With One Week Per Treatment and Once-a-Day Dosing of Either NRP104, Adderall XR, or Placebo in Children Aged 6 to 12 Years With Attention-Deficit H[NCT00557011]	Phase 2	52 participants (Actual)	Interventional	2004-09-30	Completed
A Phase 3, Randomized, Multi-Center, Double-Blind, Parallel-Group, Placebo-Controlled Study of NRP104 in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder[NCT00556296]	Phase 3	297 participants (Actual)	Interventional	2004-10-31	Completed
A Phase IIIb Randomized, Double-Blind, Multicenter, Placebo-Controlled, Dose Optimization, Crossover, Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)[NCT00697515]	Phase 3	142 participants (Actual)	Interventional	2008-07-18	Completed
Multimodal Treatment Study of Children With ADHD[NCT00000388]	Phase 4	0 participants	Interventional	1998-09-30	Completed
A Phase III, Randomized, Double-blind, Multi-center, Placebo-Controlled, Parallel-Group, Safety and Efficacy Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).[NCT00150579]	Phase 3	240 participants	Interventional	2005-01-27	Completed
A Phase III, Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-Group, Safety and Efficacy Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).[NCT00152022]	Phase 3	412 participants	Interventional	2005-04-25	Completed
The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading[NCT00733356]	Phase 4	42 participants (Actual)	Interventional	2008-07-31	Completed
A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Forced-dose Titration, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Adolescents Aged 13-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)[NCT00735371]	Phase 3	314 participants (Actual)	Interventional	2008-10-08	Completed
A Long-Term, Open-Label, and Single-Arm Study of NRP104 30 mg, 50 mg, or 70 mg Per Day in Adults With Attention Deficit Hyperactivity Disorder (ADHD)[NCT00337285]	Phase 3	349 participants (Actual)	Interventional	2006-07-31	Completed
A Phase I, Open-Label, Randomized, Four Period Crossover Drug Interaction Study to Evaluate the Pharmacokinetic Profiles of VYVANSE™ and ADDERALL XR When Each is Administered Alone and in Combination With the Proton Pump Inhibitor Prilosec OTC™ in Healthy[NCT00746733]	Phase 1	24 participants (Actual)	Interventional	2008-09-08	Completed
Effects of Vyvanse on the Behavioral, Academic, and Psychosocial Functioning of College Students With ADHD[NCT01342445]	Phase 4	50 participants (Actual)	Interventional	2009-09-30	Completed
Acute Effects of Prescription Stimulant Medication on Cognition and Mood in College Students With and Without ADHD[NCT03935646]	Phase 2	40 participants (Anticipated)	Interventional	2020-02-11	Recruiting
Could a Strength- Based Treatment Improve Self-management in Adults With Attention Deficit Hyperactivity Disorder[NCT04832737]		23 participants (Actual)	Interventional	2021-09-06	Completed
Social Skills Training and Standard Treatment Versus Standard Treatment of Children With ADHD - Attention Deficit Hyperactivity Disorder. Attachment Problems Among Children With ADHD[NCT00937469]		55 participants (Actual)	Interventional	2009-08-31	Completed
The Effects of Vyvanse on the Driving Performance of Young Adults With ADHD: A Randomized, Double-Blind, Placebo-Controlled Study[NCT00801229]	Phase 4	75 participants (Actual)	Interventional	2008-12-31	Completed
Therapeutic Use of Repetitive Transcranial Magnetic Stimulation (rTMS) in Pediatric Autism Spectrum Disorder (ASD) and Attention Deficit Hyperactivity Cohorts (ADHD): a Randomized, Sham-controlled Study.[NCT06069323]		80 participants (Anticipated)	Interventional	2023-06-01	Recruiting
Cognitive Restructuring in ADHD: Functional Training[NCT02827188]		46 participants (Actual)	Interventional	2016-09-26	Completed
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)	Interventional	2021-02-08	Completed
A Phase IV, Dose Optimized, Open Label, Evaluation of the Effect Foquest® (Methylphenidate HCl Controlled Release) on Sleep in Children Aged 6-12 With Attention Deficit Hyperactivity Disorder[NCT04741516]	Phase 4	41 participants (Actual)	Interventional	2020-12-01	Active, not recruiting
Pharmacological Treatment of Rett Syndrome by Stimulation of Synaptic Maturation With Recombinant Human IGF-1(Mecasermin [rDNA] Injection)[NCT01777542]	Phase 2	30 participants (Actual)	Interventional	2013-01-31	Completed
Atomoxetine for Attention Deficits in Adults With Mild HD: A Randomized, Placebo-Controlled Crossover Study[NCT00368849]	Phase 2	20 participants (Actual)	Interventional	2005-11-30	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

In addition to ratings of the interview performance, the rater also will complete the five-item inattentive/overactive (I/O) factor of the Iowa Conners rating scale (Atkins, Pelham, & Licht, 1989; Loney & Milich, 1982; Pelham, Milich, Murphy, & Murphy, 1989). The five items are rated on a scale of Not at all (0) to Very Much (3) and the sum of these items represents the score. The dependent measure will be the score averaged across raters. Scores can range from 0-3 on each item, and the average score of the 5 items was used. Higher scores reflect greater inattentive/overactivity-related behaviors. (NCT03446885)
Timeframe: during interventional study session, 1 day in duration

Objective Observation of Workplace Productivity

Intervention	score on a scale (Mean)
Placebo	2.13
Vyvanse	2.01

The dependent measures from this aspect of the study are the number of items completed correctly out of the total number of assigned items (i.e., 225). Thus, the score reflects the percentage of items correctly completed out of the 225 assigned and scores could range from 0-100. (NCT03446885)
Timeframe: during interventional study session, 1 day in duration

Ratings of Job Application Quality

Intervention	score on a scale (Mean)
Placebo	65.60
Vyvanse	68.45

"Three independent coders will review each de-identified application. Following the review of the application, coders will complete a rating form that asks them to make an overall evaluation regarding whether the person was an acceptable job candidate for an interview using a scale of 1 (definitely not) to 5 (definitely). Average rating across coders will be used as the dependent measure." (NCT03446885)
Timeframe: during interventional study session, 1 day in duration

Ratings of Job Interview Performance

Intervention	score on a scale (Mean)
Placebo	3.40
Vyvanse	3.56

Three coders who are unaware of the study participant identities or group status will view the job interview videotape and completed a form. Raters will provide a rating of their overall impression of the interview behavior ranging from a score of one (Poor) to four (Outstanding). The average score of the coders will be utilized as a dependent measure. (NCT03446885)
Timeframe: during interventional study session, 1 day in duration

Change From Baseline (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up to 52 Weeks

Intervention	score on a scale (Mean)
Placebo	3.17
Vyvanse	3.33

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. (NCT00764868)
Timeframe: Baseline and up to 52 weeks

Change From Baseline (From the Antecedent Study, SPD489-305) in the Youth Quality of Life Instrument-Research Version (YQOL-R) Total Score at up to 52 Weeks

Intervention	Units on a scale (Mean)
Lisdexamfetamine Dimesylate (LDX)	-26.2

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. (NCT00764868)
Timeframe: Baseline and Up to 52 weeks

Percent of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)

Intervention	Units on a scale (Mean)
Lisdexamfetamine Dimesylate (LDX)	3.9

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

Intervention	Percent of participants (Number)
Lisdexamfetamine Dimesylate (LDX)	87.2

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

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

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

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

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

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

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

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

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

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

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

Intervention	T-scores (Least Squares Mean)
Lisdexamfetamine Dimesylate (LDX)	8.6
Methylphenidate Hydrochloride	7.1
Placebo	-0.2

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

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

Intervention	Scores on a scale (Least Squares Mean)
Lisdexamfetamine Dimesylate (LDX)	-0.3
Methylphenidate Hydrochloride	-0.3
Placebo	0.0

Columbia-Suicide Severity Rating Scale (C-SSRS)

Intervention	percentage of participants (Number)
Lisdexamfetamine Dimesylate (LDX)	78.0
Methylphenidate Hydrochloride	60.6
Placebo	14.4

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

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

Intervention	participants (Number)
	Suicidal ideation	Non-suicidal self injurious behavior
Lisdexamfetamine Dimesylate (LDX)	1	1
Methylphenidate Hydrochloride	0	0
Placebo	0	0

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

Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 10 Weeks

Intervention	Scores on a scale (Mean)
	Baseline	Up to 7 weeks
Lisdexamfetamine Dimesylate (LDX)	0.811	0.878
Methylphenidate Hydrochloride	0.822	0.887
Placebo	0.806	0.843

The ADHD-RS 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. Lower scores indicate reduction in symptoms. (NCT01101022)
Timeframe: Baseline and up to 10 weeks

Change From Baseline in Conner's Adult ADHD Rating Scale-Observer: Short Version (CAARS-O:S) ADHD Index T-score at up to 10 Weeks

Intervention	Scores on a scale (Least Squares Mean)
SPD489	-21.4
Placebo	-10.3

The CAARS-O:S is an assessment tool with prompts provided to an observer who describes ADHD-related symptoms in an adult subject. The 26-item scale is scored on a 4-point scale from 0 (not at all) to 3 (very much, very frequently). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. (NCT01101022)
Timeframe: Baseline and up to 10 weeks

Change From Baseline in Subject-reported Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at up to 10 Weeks

Intervention	T-scores (Least Squares Mean)
SPD489	-11.3
Placebo	-5.8

BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. (NCT01101022)
Timeframe: Baseline and up to 10 weeks

Percent of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at up to 10 Weeks

Intervention	T-scores (Least Squares Mean)
SPD489	-22.3
Placebo	-11.1

Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks

Intervention	Percent of participants (Number)
SPD489	78.5
Placebo	34.7

The AIM-A was developed to assess impact of core ADHD symptoms on daily functioning and quality of life. For multi-item scales, subjects respond to items using a Likert scale with responses ranging from 1 (strongly agree) to 5 (strongly disagree). Scores were computed by deriving the mean of the item sets and transforming the scale score on a continuum from 0 to 100 using a standard formula. Higher scores indicate a better quality of life. (NCT01101022)
Timeframe: Baseline and up to 10 weeks

Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Total Score at up to 10 Weeks

Intervention	Scores on a scale (Least Squares Mean)
	Performance and Daily Functioning	Impact of symptoms: Daily Interference	Impact of symptoms: Bother/Concern	Relationships/Communication
Placebo	17.2	15.7	15.8	13.4
SPD489	38.8	30.6	29.3	21.2

AAQoL is a validated 29-item scale consisting of 4 subscales. The AAQoL yields a total score and 4 subscale scores. Subjects rate each item on a 5-point Likert scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale with higher scores indicating better quality of life. (NCT01101022)
Timeframe: Baseline and up to 10 weeks

Change From Baseline in AIM-A Multi-Item Scales of Living With ADHD and General Well-being Score at up to 10 Weeks

Intervention	Scores on a scale (Least Squares Mean)
	Life Productivity	Psychological Health	Life Outlook	Relationships	Total Score
Placebo	17.0	7.2	6.0	9.8	11.1
SPD489	38.0	19.3	18.5	17.1	25.9

Change From Baseline in AIM-A Quality of Life Questions 1 and 4 Scores at up to 10 Weeks

Intervention	Scores on a scale (Least Squares Mean)
	Living with ADHD	General Well-being
Placebo	4.9	9.0
SPD489	14.0	19.7

Question 1: 'On a scale of 1 to 10, how would you rate the overall quality of life right now?' It is rated on a scale of 1 (worst) to 10 (best). Higher scores representing a more positive rating. Question 4: 'How much do you agree with this statement: Over the past few weeks, I've had more good days than bad days?' This is rated on a scale of 1 (strongly agree) to 5 (strongly disagree). Lower scores represent better quality of life. (NCT01101022)
Timeframe: Baseline and up to 10 weeks

Change From Baseline in CAARS-O:S Factor-derived Subscale T-scores at up to 10 Weeks

Intervention	Scores on a scale (Least Squares Mean)
	Question 1	Question 4
Placebo	1.0	-0.4
SPD489	1.6	-1.0

Change From Baseline in Informant-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks

Intervention	T-scores (Least Squares Mean)
	Inattention/Memory Problems	Hyperactivity/Restlessness	Impulsivity/Emotional Liability	Problems with Self-concept
Placebo	-4.9	-5.0	-4.0	-3.3
SPD489	-10.0	-9.1	-8.0	-7.7

BRIEF-A clinical subscales items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. (NCT01101022)
Timeframe: Baseline and up to 10 weeks

Change From Baseline in Informant-reported BRIEF-A T-scores at up to 10 Weeks

Intervention	T-scores (Least Squares Mean)
	Inhibit	Shift	Emotional control	Self-monitor	Initiate	Working memory	Plan/Organize	Task monitor	Organization of materials
Placebo	-5.8	-4.3	-4.6	-4.6	-3.2	-5.7	-5.0	-3.4	-3.0
SPD489	-10.2	-9.1	-5.9	-6.8	-8.6	-12.0	-9.9	-9.7	-6.2

BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. (NCT01101022)
Timeframe: Baseline and up to10 weeks

Change From Baseline in Subject-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks

Intervention	T-scores (Least Squares Mean)
	Global Executive Composite	Behavioral Regulation Index	Metacognition Index
Placebo	-5.3	-5.5	-4.6
SPD489	-10.2	-8.6	-10.3

Change From Baseline in Subject-reported BRIEF-A T-scores at up to 10 Weeks

Intervention	T-scores (Least Squares Mean)
	Inhibit	Shift	Emotional control	Self-monitor	Initiate	Working memory	Plan/Organize	Task monitor	Organization of materials
Placebo	-9.5	-7.8	-5.7	-8.4	-8.6	-11.9	-9.9	-10.8	-7.6
SPD489	-17.8	-14.5	-10.9	-16.6	-17.9	-23.2	-20.8	-20.1	-16.5

BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Global Executive Composite was reported as the Primary Outcome. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. (NCT01101022)
Timeframe: Baseline and up to 10 weeks

Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline

Intervention	T-scores (Mean)
	Behavioral Regulation Index	Metacognition Index
Placebo	-9.2	-11.2
SPD489	-17.5	-22.8

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) (NCT01101022)
Timeframe: Baseline

Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at up to 10 Weeks

Intervention	Percent of participants (Number)
	Normal, not at all ill	Borderline mentally ill	Mildly ill	Moderately ill	Markedly ill	Severely ill	Among the most extremely ill
Placebo	0	0	0	42.7	49.3	8.0	0
SPD489	0	0	0	48.1	38.0	13.9	0

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) (NCT01101022)
Timeframe: Up to 10 weeks post-dose

Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF

Intervention	Percent of participants (Number)
	Normal, not at all ill	Borderline mentally ill	Mildly ill	Moderately ill	Markedly ill	Severely ill	Among the most extremely ill
Placebo	6.7	16.0	10.7	37.3	25.3	4.0	0
SPD489	13.9	38.0	21.5	15.2	8.9	2.5	0

ADHD-RS-IV consists of 18 items scored on a 4-point scale 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. (NCT01106430)
Timeframe: Baseline and 9 weeks

Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks

Intervention	units on a scale (Least Squares Mean)
Lisdexamfetamine Dimesylate	-26.1
Atomoxetine Hydrochloride	-19.7

Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks

Intervention	units on a scale (Mean)
Lisdexamfetamine Dimesylate	-10.7
Atomoxetine Hydrochloride	-7.9

Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks

Intervention	units on a scale (Least Squares Mean)
Lisdexamfetamine Dimesylate	-0.35
Atomoxetine Hydrochloride	-0.27

Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF)

Intervention	units on a scale (Mean)
Lisdexamfetamine Dimesylate	0.920
Atomoxetine Hydrochloride	0.922

Time to First Response

Intervention	percentage of participants (Number)
Lisdexamfetamine Dimesylate	81.7
Atomoxetine Hydrochloride	63.6

Time to first response was defined as a Clinical Global Impression-Improvement (CGI-I) value of 1 (very much improved) or 2 (much improved) first recorded following first dose of investigational product. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT01106430)
Timeframe: 9 weeks

Columbia-Suicide Severity Rating Scale (C-SSRS)

Intervention	Days (Median)
Lisdexamfetamine Dimesylate	12.0
Atomoxetine Hydrochloride	21.0

C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. (NCT01106430)
Timeframe: 9 weeks

Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1

Intervention	participants (Number)
	Suicidal ideation	Suicidal behavior
Atomoxetine Hydrochloride	0	0
Lisdexamfetamine Dimesylate	0	0

UKU-SERS-Clin is composed of 48 items each of which asks about a single side effect. Each side effect is rated based on a 4-point scale ranging from 0 (no or doubtful presence) to 3 (the least favorable rating). The rating is independent of whether the symptom is regarded as related to the investigational product. (NCT01106430)
Timeframe: 9 weeks

CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index

Intervention	participants (Number)
	Weight Loss	Reduced Duration of Sleep	Asthenia/Lassitude/Increased Fatigability	Tension/Inner Unrest	Nausea/Vomiting	Sleepiness/Sedation	Reduced Salivation	Headache-Tension Headache	Concentration Difficulties	Failing Memory	Depression	Increased Duration of Sleep	Increased Dream Activity	Emotional Indifference	Dystonia	Rigidity	Hypokinesia/Akinesia	Hyperkinesia Logic	Tremor	Akathisia	Paraesthesias	Accomodation Disturbances	Increased Salivation	Diarrhea	Constipation	Micturition Disturbances	Polyuria/Polydipsia	Orthostatic Dizziness	Palpitations/Tachycardia	Increased Tendency to Sweating	Rash-Morbiliform	Rash-Petechial	Rash-Urticarial	Rash-Cannot be Classified	Pruritus	Weight Gain	Headache-Migraine	Headache-Other Forms
Atomoxetine Hydrochloride	19	16	29	22	26	35	6	17	92	21	10	12	8	10	1	1	0	3	1	2	0	2	2	9	5	1	2	9	5	5	1	0	1	2	7	0	2	10
Lisdexamfetamine Dimesylate	46	29	25	20	19	16	16	15	75	10	6	12	3	12	0	0	1	2	3	0	1	0	1	6	9	0	3	10	1	3	0	1	1	1	4	1	2	11

Consists of 12 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50. (NCT01010750)
Timeframe: 2 and 14 hours post-dose on Day 7

CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness

Intervention	Units on a scale (Mean)
	2 hours post-dose	14 hours post-dose
LDX 50 mg	64.82	66.56
MAS-IR 20 mg	63.90	63.09
Placebo	64.59	64.85

Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50. (NCT01010750)
Timeframe: 2 and 14 hours post-dose on Day 7

CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability

Intervention	Units on a scale (Mean)
	2 hours post-dose	14 hours post-dose
LDX 50 mg	64.21	65.08
MAS-IR 20 mg	63.62	63.41
Placebo	63.28	65.74

CAARS-S:S Subscale T-Score: Problems With Self-Concept

Intervention	Units on a scale (Mean)
	2 hours post-dose	14 hours post-dose
LDX 50 mg	55.46	57.82
MAS-IR 20 mg	54.58	51.53
Placebo	54.66	55.78

Conners Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) Subscale Total Score (T-Score): Inattention/Memory Problems

Intervention	Units on a scale (Mean)
	2 hours post-dose	14 hours post-dose
LDX 50 mg	58.71	59.68
MAS-IR 20 mg	59.78	59.54
Placebo	58.40	59.68

Power of Attention Score

Intervention	Units on a scale (Mean)
	2 hours post-dose	14 hours post-dose
LDX 50 mg	66.16	65.78
MAS-IR 20 mg	63.39	64.45
Placebo	64.92	66.33

The Power of Attention score reflects the ability to focus attention, and is calculated as the sum of the reaction time, measured in milliseconds, from 3 attention tests (Simple Reaction Time, Choice Reaction Time, and Digit Vigilance Speed). Faster performance (lower times) reflects more intense concentration. A decrease in the Power of Attention score indicates improvement. (NCT01010750)
Timeframe: pre-dose and at 1, 2, 3, 4, 5, 8, 12, 14 and 16 hours post-dose on Day 7

ADHD Severity Clinical Global Impressions Severity Subscale

Intervention	milliseconds (Mean)
	half an hour prior to dosing	1 hour post-dose	2 hours post-dose	3 hours post-dose	4 hours post-dose	5 hours post-dose	8 hours post-dose	12 hours post-dose	14 hours post-dose	16 hours post-dose
LDX 50 mg	1260.7	1244.6	1315.5	1219.1	1225.9	1179.6	1212.0	1232.4	1199.3	1202.6
MAS-IR 20 mg	1324.1	1307.4	1255.0	1229.6	1236.5	1251.4	1259.3	1239.3	1270.1	1255.9
Placebo	1272.8	1253.1	1296.2	1301.0	1275.4	1330.3	1304.5	1262.1	1270.5	1270.3

clinician rated measure of ADHD symptom severity in adult participants. The severity subscale is scored from 1 (normal) to 7 (extremely ill).At endpoint, the medication group (N=10) was compared to the placebo group (N=13). (NCT01127607)
Timeframe: study endpoint- end of period II (between subjects trial)

Barkley Home Situations Questionnaire (HSQ)

Intervention	units on a scale (Mean)
Placebo Arm	3.78
Treatment Arm	2.36

Self completed by adult participants. Measures their child's functioning in the evening by asking them to report whether or not their child had problems in developmentally important areas. Number of problems per child are counted and counts are then averaged for each group with higher numbers representing more problems. At endpoint, the medication group (N=9) was compared to the placebo group (N=10). (NCT01127607)
Timeframe: study endpoint- end of period II (between subjects trial)

Parenting Locus of Control (PLC)

Intervention	number of child problems endorsed (Mean)
Placebo Arm	9.30
Treatment Arm	8.67

"self completed parenting measure of the degree to which parents feel they can influence their child's behavior. Measure consists of 25 items each rated using a Likert scales that ranges from 1 (strongly disagree) to 5 (strongly agree). Range is 25 to 125 with higher scores indicating greater parental control over their child's behavior (desired outcome). At endpoint, the medication group (N=9) was compared to the placebo group (N=13)." (NCT01127607)
Timeframe: study endpoint- end of period II (between subjects trial)

Parenting Stress Index (PSI)--Total Stress

measures change in stress of parent child interactions and completed by the participant. The PSI is a measure of the source and degree of parenting stress (Abidin, 1995), which contains 120 items which are rated on a 1 (strongly disagree) to 5 (strongly agree) scale. 101 of these items are used to compute a total stress score (reported below) as the other 19 report on specific life stressors. Range is 101 to 505, for which higher scores indicate higher levels of stress. At endpoint, the medication group (N=9) was compared to the placebo group (N=13). (NCT01127607)
Timeframe: study endpoint- end of period II (between subjects trial)

Pittsburgh Side Effect Rating Scale

rates 13 potential adverse events of central nervous system stimulant medications on a 0-3 likert scale with 0=none 1=mild severity, 2=moderate severity, 3=severe severity. Form completed by participants at end of med optimization phase. Mean severity rating then averaged across 13 categories. This compares mean side effect severity at unmedicated baseline state vs. on optimal dose at week 3. Analysis includes all participants completing medication optimization. (NCT01127607)
Timeframe: baseline and end of dose optimization phase/week 4

Pittsburgh Side Effect Rating Scale Mean Severity Rating.

rates 13 potential adverse events of Central Nervous System (CNS) stimulants on a 0-3 likert scale with 0=none 1=mild severity, 2=moderate severity, 3=severe severity. Form completed by participants. Mean severity rating then averaged across 13 categories.At endpoint, the medication group (N=10) was compared to the placebo group (N=13). (NCT01127607)
Timeframe: study endpoint- end of period II (between subjects trial)

Resting Pulse

measured at last assessment visit when at rest using an automated blood pressure machine; results reported in beats per minute. At endpoint, the medication group (N=8) was compared to the placebo group (N=9). (NCT01127607)
Timeframe: study endpoint- end of period II (between subjects trial)

Sheehan Disability Scale (SDS)

The SDS consists of 3 self rated items assessing the degree to which symptoms affect work/school, social life, and family/home responsibilities. Items are rated on a 0 (not at all) to 10 (extremely) scale. Items were averaged into an overall disability score with range of 0 to 10 with higher scores indicating more severe disability. At endpoint, the medication group (N=9) was compared to the placebo group (N=13). (NCT01127607)
Timeframe: study endpoint- end of period II (between subjects trial)

Sheehan Disability Scale (SDS)

The SDS consists of 3 self rated items assessing the degree to which symptoms affect work/school, social life, and family/home responsibilities. Items are rated on a 0 (not at all) to 10 (extremely) scale. Items were averaged into an overall disability score with range of 0 to 10 with higher scores indicating more severe disability.Within subject comparison of no medication baseline vs. optimal dose medication. (NCT01127607)
Timeframe: baseline and week 4

Weight

Weight measured on calibrated scale; participant measured without shoes or heavy clothing (jackets, sweaters, etc...). reported in kilograms.At endpoint, the medication group (N=9) was compared to the placebo group (N=11). (NCT01127607)
Timeframe: study endpoint- end of period II (between subjects trial)

Adult ADHD Rating Scale (ADHD RS)

measures change in all DSM (Diagnostic and Statistics Manual) IV ADHD symptoms on a 0 (least severe) to 3 (most severe) scale. Inattention and hyperactive/impulsive subscales each consist of 9 items with range of 0 to 27. Total Score consists of all 18 items rated 0 to 3 with range of 0 to 54. For all, higher scores indicate more symptoms. All information obtained during clinician interview of patient. At endpoint, the medication group (N=11) was compared to the placebo group (N=13). (NCT01127607)
Timeframe: study endpoint- end of period II (between subjects trial)

Adult ADHD Rating Scale Completed at the End of the Med Optimization Phase

Measures change in all DSM IV ADHD symptoms on a 0 (least severe) to 3 (most severe) scale. All information obtained during clinician interview of patient. Inattention and hyperactive/impulsive subscales each consist of 9 items with range of 0 to 27. Total Score consists of all 18 items (sum of two subscales) rated 0 to 3 with range of 0 to 54. For all, higher scores indicate more symptoms. (NCT01127607)
Timeframe: baseline and end of med optimization phase/week 4

Alabama Parenting Questionnaire (APQ)

"measures change in parenting practices.The APQ is a 42-item measure (each item ranges from 1/always to 5/never) on which parents are asked to indicate the frequency with which they implement the following parenting practices: involvement (10 items range 10-50- higher scores mean more parental involvement), positive parenting (6 items with range of 6 to 30 and higher scores indicate greater use of praise), poor monitoring/supervision (10 items with range of 10 to 50 and higher scores indicate less supervision/monitoring), inconsistent discipline(6 items with range of 6 to 30 and higher scores indicate greater problems with inconsistent discipline), and corporal punishment (3 items with range of 3-15 and greater scores indicate more use of corporal punishment). Items are rated on a 5-point scale, ranging from 1 (never) to 5 (always). Items summed into composite scales.~At endpoint, the medication group (N=9) was compared to the placebo group (N=13)." (NCT01127607)
Timeframe: study endpoint- end of period II (between subjects trial)

Alabama Parenting Questionnaire (APQ)

"measures change in parenting practices.The APQ is a 42-item measure (each item ranges from 1/always to 5/never) on which parents are asked to indicate the frequency with which they implement the following parenting practices: involvement (10 items range 10-50- higher scores mean more parental involvement), positive parenting (6 items with range of 6 to 30 and higher scores indicate greater use of praise), poor monitoring/supervision (10 items with range of 10 to 50 and higher scores indicate less supervision/monitoring), inconsistent discipline(6 items with range of 6 to 30 and higher scores indicate greater problems with inconsistent discipline), and corporal punishment (3 items with range of 3-15 and greater scores indicate more use of corporal punishment). Items are rated on a 5-point scale, ranging from 1 (never) to 5 (always). Items summed into composite scales.~Within subject comparison of no medication baseline vs. optimal dose medication." (NCT01127607)
Timeframe: baseline and week 4

Brown Attention Deficit Scale (BAADS)

"Measures executive functioning using 40 items each rated using a Likert Scale that ranges from 0 (never) to 3 (almost daily). Activation, Attention and effort subscales are 9 items each with range of 0-27. Affect scale is 7 items (range 0-21), memory is 6 items (range 0-18) and total score is 40 items (range 0-120). All raw scores are then reported as T scores based on normative data with higher T scores indicating worse executive functioning. At endpoint, the medication group (N=10) was compared to the placebo group (N=13)." (NCT01127607)
Timeframe: study endpoint- end of period II (between subjects trial)

Disruptive Behavior Disorder Rating Scale (DBD)

measures externalizing symptoms in children.measures externalizing symptoms in children completed by their primary caretaker who was a participant in the study. The DBD (Pelham et al., 1992) assessed DSM symptoms of ADHD, ODD, and CD from 0 (not at all) to 3 (very much). The DBD includes symptoms of DSM-III and DSM-IV ADHD, Oppositional Defiant Disorder (ODD) and Conduct Disorder (CD).At endpoint, the medication group (N=10) was compared to the placebo group (N=12). (NCT01127607)
Timeframe: study endpoint- end of period II (between subjects trial)

Disruptive Behavior Disorders Rating Scale (DBD)

Parent ratings of their child's symptoms of attention-deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), and conduct disorder (CD). Measure consists of 45 items each rated on a Likert scale that ranges from 0 (not at all) to 3 (very much). Items are averaged to form adhd-inattention, adhd-hyperactive/impulsive, ODD, and CD scores.Within subject comparison of no medication baseline vs. optimal dose medication. ADHD subscale consists of 20 items with range of 0 to 60. ODD subscale consists of 9 items with range of 0 to 27. CD subscale consists of 15 items with range of 0 to 45. For all subscales, higher scores indicate more severe symptoms. (NCT01127607)
Timeframe: baseline and week 4

Dyadic Parent-Child Interaction Coding System (DPICS)

Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors with each parent-child dyad counted as one participant. Average number of behaviors per group were computed.This outcome was part of period I- the within subject comparison of all participating subjects once on placebo (n=26) and once with all subjects on active medication (N=26). (the 27th participant completed this phase but partial data was lost due to mechanical failure with video equipment so their data was not included). All adult participants received both placebo and active medication in this phase that comprised all of period 1. (NCT01127607)
Timeframe: weeks 4 and weeks 5 (period I within subjects trial)

Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Counts

Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages

Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors with each parent-child dyad counted as one participant. Percentages of behaviors as a function of total verbalizations (for praise, negative talk, demanding) or as a function of commands and questions (for impatient and responsive) were computed. This outcome was part of period I- the within subject comparison of all participating subjects once on placebo (n=26) and once with all subjects on active medication (N=26). (the 27th participant completed this phase but partial data was lost due to mechanical failure with video equipment so their data was not included). All adult participants received both placebo and active medication in this phase that comprised all of period 1. (NCT01127607)
Timeframe: weeks 4 and weeks 5 (period I within subjects trial)

Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages

Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors. Percentages of behaviors as a function of total verbalizations (for praise, negative talk, demanding) or as a function of commands and questions (for impatient and responsive) were computed.Three subjects dropped prior to completing this assessment and one participant completed the other endpoint measures but not the DPICS, which is why the total N for this outcome is 23 at study endpoint. At end of period II (study endpoint), the medication group (n=10) was compared to the placebo group (N=13). (NCT01127607)
Timeframe: study endpoint- end of period II (between subjects trial)

Impairment Rating Scale (IRS)

"Parent ratings of their child's functioning and need for treatment in developmentally important domains. Ratings are completed using visual-analogue scales that are anchored at the low end by no problems / no need for treatment and at the high end by extreme problem / definitely needs treatment. Visual analogue ratings for each subscale were converted to 0 to 6 scales with higher values indicating greater impairment and lower values indicating less impairment for each subscale.Within subject comparison of no medication baseline vs. optimal dose medication." (NCT01127607)
Timeframe: baseline and week 4

Impairment Rating Scale (IRS)

measures global functioning of child rated by the parent who was the participant in the study. The IRS is a 7 item measure that uses visual-analogue scales to evaluate the child's problem level and need for treatment in developmentally important areas, such as peer relationships, adult-child relationships, academic performance. Each subscale including overall severity is scored from 0 (no problem) to 6 (extreme problem) with higher scores indicating more impairment. At endpoint, the medication group (N=10) was compared to the placebo group (N=13). (NCT01127607)
Timeframe: study endpoint- end of period II (between subjects trial)

Impairment Rating Scale (IRS)

self rated measure of global impairment of adult participants derived from the child IRS. The IRS-A assesses impairment overall and in specific domains, including interpersonal relationships, academic performance, and self-esteem, and includes adult-specific domains of functioning, such as employment and romantic relationships. The IRS-A assesses current problems and need for treatment. Each subscale is rated from 0 (no problem) to 6 (extreme problem).At endpoint, the medication group (N=11) was compared to the placebo group (N=13). Overall Impairment is its own subscale and not a composite score of the others. (NCT01127607)
Timeframe: study endpoint- end of period II (between subjects trial)

Pittsburgh Side Effects Rating Scale - Percent Present for All Reported Adverse Events Occurring at a Rate of 5% or More

Self report of side effects measured during dose titration using the Pittsburgh Side Effects Rating Scale. Consists of 13 items each rated using 0(none) to 3 (severe) scales. Items endorsed as 1 (mild) or above were counted as present. Information on additional adverse events not part of the PSERS was collected by direct interview of the participants. All side effects occurring at a frequency of 5% or more are reported. Initial side effect data is reported for all participants entering pre-randomization med optimization phase who took medication (n=36) vs those formally enrolled (N=27). Also, side effect data for the med titration phase is entered per dose rather than per participant. For example, a person trying the 30, 50 and 70mg dose is entered is entered 4 times (no med as well) vs. just once. This is why baseline N is higher than for other outcomes collected at weeks 4 and 8 where data was only available for those completing the pre-randomization med optimization phase (N=27). (NCT01127607)
Timeframe: end of medication optimization phase/week 4

Resting Blood Pressure

Measured at rest at last assessment visit using an automated blood pressure machine; results reported in mmHG. At endpoint, the medication group (N=9) was compared to the placebo group (N=10). (NCT01127607)
Timeframe: study endpoint- end of period II (between subjects trial)

Social Skills Rating System (SSRS)

"Measures child's interactions with peers and adults. Items rated using Likert scales that range from 0 (never) to 2 (often).At week 8, the medication group (N=10) was compared to the placebo group (N=11). There are two subscales: Problem Behaviors (18 items rated between 0-2 for total score range of 0 to 36) and Social Skills (40 items rated 0-2 with range for total score of 0-80). The total scores for these scales are reported as standard scores, with a population mean of 100 and standard deviation of 15. For problem behavior higher scores indicate worse behavior whereas for social skills, higher scores indicate more social (or better behavior)." (NCT01127607)
Timeframe: study endpoint- end of period II (between subjects trial)

Change From Open-Label Baseline in The Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at Endpoint (Week-26) of The Open-label Period

Change From Open-Label Baseline in The Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Endpoint (Week-26) of The Open-label Period

Change From Open-label Baseline in The Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at Endpoint (Week-26) of The Open-label Period

Change From Open-label Baseline in The Health Utilities Index-2 (HUI-2) Scores at Endpoint (Week-26) of The Open-label Period, LOCF

Change From Open-Label Baseline in The Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Endpoint (Week-26) of The Open-label Period

Change From Randomized Withdrawal Baseline in BPRS-C Total Score at Endpoint of The Randomized Withdrawal Period

Change From Randomized Withdrawal Baseline in The ADHD-RS-IV Total Score at Endpoint of The Randomized Withdrawal Period

Change From Randomized Withdrawal Baseline in The CHIP-CE:PRF Global T-score at Endpoint of The Randomized Withdrawal Period

Change From Randomized Withdrawal Baseline in The HUI-2 Scores at Endpoint of The Randomized Withdrawal Period

Change From Randomized Withdrawal Baseline in The WFIRS-P Global Score at Endpoint of The Randomized Withdrawal Period

Percent of Participants With Improvement on Clinical Global Impression - Improvement (CGI-I) at Endpoint (Week-26) of The Open-label Period

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. Improvement includes CGI-I categories of very much improved and much improved. No improvement includes all other assessed categories. (NCT00784654)
Timeframe: At Week 26

Percent of Participants With Treatment Failures at End of The Randomized Withdrawal Period

Treatment failure defined as 50% increase (worsening) in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) total score and >= 2 point increase (worsening) in the Clinical Global Impression-Severity of Illness (CGI-S) score observed at any visit during the randomized withdrawal period compared to the respective scores at baseline of randomized withdrawal period. Subjects without an endpoint value were classed as treatment failures. (NCT00784654)
Timeframe: Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)

C-SSRS During the Randomized Withdrawal Period

Columbia-Suicide Severity Rating Scale (C-SSRS) During The Open-label Period

Percent of Participants With CGI-S at Endpoint of The Randomized Withdrawal Period, Last Observation Carried Forward (LOCF)

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) (NCT00784654)
Timeframe: At endpoint of the randomized withdrawal period (Up to 6 weeks)

Percent of Participants With CGI-S at Open-label Baseline

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). (NCT00784654)
Timeframe: Open-label baseline

Percent of Participants With CGI-S at Randomized Withdrawal Baseline

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) (NCT00784654)
Timeframe: Randomized withdrawal baseline

Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Endpoint (Week-26) of The Open-label Period

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) (NCT00784654)
Timeframe: At Week 26

Attention Deficit Hyperactivity Disorder- Rating Scale (ADHS-RS)

"The ADHD-RS with adult ADHD prompts is a semi-structured scale that consists of 18 items that directly correspond to the 18 DSM-IV symptoms of ADHD, and is designed to assess current symptomatology19.~Each item is scored on a 4-point scale ranging from 0 (none) to 3 (severe).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. A score of 0-16 means Unlikely to have ADHD; a score of 17-23 Likely to Have ADHD ; 24 or greater-Highly Likely to have ADHD" (NCT01070394)
Timeframe: 12 weeks

Correlation Between AMRS (In Clinic) and ADHD-RS

To correlate symptom rebound through a single day (assessed via the AMRS) with a global (ADHD-RS) measure of efficacy of LDX treatment. AMRS and ADHD-RD scores obtained on Day 0 and Day 12 will be correlated. The Pearson's correlation coefficients for the In-Clinic assessment will be presented for Visits 0 and 12. (NCT01070394)
Timeframe: Visits 0 and 12

Correlation Between In-Clinic AMRS and ASRS v.1.1 Symptom Checklist

To correlate symptom rebound through a single day (assessed via the AMRS) with a self assessment of ADHD Symptoms. A Pearson's correlation coefficient will be presented. AMRS and self assessment of ADHD scores obtained on Day 0 and Day 12 will be correlated. The Pearson's correlation coefficients for the In-Clinic assessment will be presented for Visits 0 and 12. (NCT01070394)
Timeframe: Baseline to Week 12

Change in Correlation Between AMRS and TASS

To correlate symptom rebound through a single day (assessed via the AMRS) with a time-sensitive (TASS) measure of efficacy of LDX treatment. A Pearson's correlation coefficient will be presented. AMRS and TASS scores obtained on Day 0 and Day 12 will be correlated. The Pearson's correlation coefficients for the In-Clinic assessment will be presented for Visits 0 and 12. (NCT01070394)
Timeframe: Visits 0 and 12

Change in Measure of Smoothness of Effect Using Adult ADHD Medications Smoothness of Effect Scale (AMSES)

The Adult ADHD Medication Smoothness of Effect Scale (AMSES) is a 6-item, frequency-based, self-report scale that was recently developed to assess the consistency and duration of effect of ADHD medication throughout the day. The AMSES compares the effectiveness of ADHD medication shortly after dosing with the effectiveness later in the day. Respondents are asked to rate how frequently the effective-ness of their medication was the same 2 hr post-dose as it was 4, 6, 8, 10, and 12 hr post-dose on a 0 to 4 scale (0 = never, 1 = rarel, 2 = sometimes, 3 = often, 4 = very often). In addition, respondents rate how frequently the delivery of their medication was consistent and smooth throughout the day on a visual analog scale ranging from 0 (never) to 100 (very often). (NCT01070394)
Timeframe: Visits 0 and 12

Change in Symptom Rebound Score Using the Adult ADHD Medication Rebound Scale (AMRS).

To evaluate the symptom rebound throughout a single day (assessed via the AMRS) with LDX treatment. Scoring on the AMRS based on 38 items, each scored 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe). The lowest scored units on a scale for 1 individual is 0, the highest 114. The scores reported below are Mean scores for 33 patients analyzed. (NCT01070394)
Timeframe: Week 0 to Week 12

Psychometric Validation of AMRS

To perform secondary psychometric validations of the AMRS using Cronbach's alpha coefficients. (NCT01070394)
Timeframe: Weeks 0-12

Psychometric Validation of AMSES

To perform secondary psychometric validations of the AMSES using Cronbach's alpha coefficients. (NCT01070394)
Timeframe: Weeks 0-12

Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 6 Weeks

The ADHD-RS 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. (NCT00877487)
Timeframe: Up to 6 weeks

Percent of Treatment Failures at up to 6 Weeks

Treatment failure defined as > or equal to 50% increase in the ADHD-RS with adult prompts total score and a > or equal to 2 point increase in the CGI-S score. (NCT00877487)
Timeframe: Up to 6 weeks

Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) (NCT00877487)
Timeframe: Up to 6 weeks

SKAMP-Combined Scores

Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale [SKAMP]-combined scores measured during Laboratory Classroom Days. The SKAMP scale is a validated subjective measure of ADHD symptoms in a laboratory classroom, comprised of 13 items on which subjects are rated according to a 7 point scale (0=normal to 6=maximal impairment); maximum score 78. The SKAMP-combined score is obtained by summing the rating values for each of the 13 items, whereby the higher the SKAMP score, the greater the impairment. (NCT01986062)
Timeframe: 2 hours post-dose

PERM-P Scores - Number of Problems Attempted

Permanent Product Measure of Performance (PERMP) assessments measured during Laboratory Classroom Days. The PERMP is an individualized, five-page math exam consisting of 400 problems. Subjects are instructed to complete as many math problems as possible in 10 minutes. Performance is evaluated using the number of problems attempted (maximum score = 400) and the number of problems correct (maximum score = 400). (NCT01986062)
Timeframe: 0.75, 2, 4, 6, 8, and 10 hours post-dose

PERM-P Scores - Number of Problems Correct

SKAMP Subscale - Attention Scores

The SKAMP scale is a validated subjective measure of ADHD symptoms. It is comprised of 13 items (grouped under the subcategories of attention, deportment, quality of work, and compliance) on which subjects are rated according to a 7-point scale (0 = normal to 6 = maximal impairment). The SKAMP-Attention subscale score is comprised of four of the 13 items with a maximum score of 24. (NCT01986062)
Timeframe: 0.75, 2, 4, 6, 8, and 10 hours post-dose

SKAMP Subscale - Deportment Scores

The SKAMP scale is a validated subjective measure of ADHD symptoms. It is comprised of 13 items (grouped under the subcategories of attention, deportment, quality of work, and compliance) on which subjects are rated according to a 7-point scale (0 = normal to 6 = maximal impairment). The SKAMP-Deportment subscale score is comprised of four of the 13 items with a maximum score of 24. (NCT01986062)
Timeframe: 0.75, 2, 4, 6, 8, and 10 hours post-dose

SKAMP-Combined Scores

Change From Baseline in Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks

Expression and Emotional Scale for Children (EESC) consists of 29 items rated on a scale from 1 (not true at all) to 5 (very much true). Lower scores reflect better emotional outcomes. (NCT00500071)
Timeframe: Baseline and 7 weeks

Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 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. (NCT00500071)
Timeframe: Baseline and 7 weeks

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

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 or 2 on the scale. (NCT00500071)
Timeframe: 7 weeks

Number of Participants With Improvement onParent Global Assessment (PGA)

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. (NCT00500071)
Timeframe: 7 weeks

Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks

Behavior Rating Inventory of Executive Function (BRIEF) is an 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning. (NCT00500071)
Timeframe: Baseline and 7 weeks

Weekly Change From Baseline in Total ADHD-RS-IV Score

MATRICS Consensus Cognitive Battery Performance (MCCB)

The T-score indicates the performance on a neurocognitive battery of tests. Higher score reflects better performance. (NCT02634684)
Timeframe: two visits, 1 week apart, each visit lasting approximately 6 hours

Prepulse Inhibition (PPI)

"PPI was assessed with 42 trials of 6 types: 118 dB 40 ms pulse alone (P) & the same P preceded 10, 20, 30, 60, or 120 ms by a prepulse (pp) 16 dB over background. Startle magnitude (SM), habituation, latency & latency facilitation were measured to interpret changes in PPI.~%PPI = 100 x [(SM on P trials) - (SM on pp+P trials)] / SM on P trials. Example:~SM on P trials = 80 units SM on pp+P trials = 30 units %PPI = 100 x (80-30)/80 = 100 x 50/80 = 62.5%~Greater %PPI mean the reflex has been inhibited to a greater extent in the presence of a pp.~%PPI can't exceed 100: when SM on pp+P trials = 0, then %PPI = 100 x (SM on P trials - 0)/SM on P trials = 100 x 1 = 100%.~However, %PPI can theoretically be infinitely negative since SM on pp+P trials could be infinitely large (prepulse facilitiation (PPF)), i.e. SM is potentiated in the presence of a pp. PPF is normal at very short & very long pp intervals, but not within a species-specific physiological range of intervals." (NCT02634684)
Timeframe: two visits, 1 week apart, each visit lasting approximately 6 hours

Targeted Cognitive Training (TCT): PositScience, Inc.

"Auditory discrimination learning: Subjects identify direction (up vs. down) of 2 consecutive sound sweeps. Parameters (e.g. inter-sweep interval, sweep duration) are established for subjects to maintain 80% correct responses. On screen and test days, subjects complete 1h of TCT. Analytic software yields the key measures: auditory processing speed (APS) and APS learning. APS is the shortest inter-stimulus interval at which a subject performs to criteria and APS learning is the difference (ms) between the first APS and the best APS of the subsequent trials. A smaller APS reflects better discrimination (i.e., subject correctly identified frequency sweep direction despite a smaller ms gap between stimuli) and a larger ms value for APS learning reflects more learning, i.e., faster APS with repeated trials. Limits for APS are capped at 0-to-1000 ms; values for APS learning are capped at (-) 1000-to-APS." (NCT02634684)
Timeframe: two visits, 1 week apart, each visit lasting approximately 6 hours

ADHD-RS With Prompts Total Score in the Crossover Phase

The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) 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. (NCT00697515)
Timeframe: 7 days

Change From Baseline in Adult ADHD Impact Module (AIM-A) Question 1 Score at 26 Days in the Dose Optimization Phase

AIM-A is a quality of life instrument. Question 1 is 'On a scale of 1 to 10, how would you rate the overall quality of life right now?' It is rated on a scale of 1 (worst) to 10 (best). (NCT00697515)
Timeframe: Baseline and 26 days

Change From Baseline in AIM-A Question 4 Score at 26 Days in the Dose Optimization Phase

AIM-A is a quality of life instrument. Question 4 is 'How much do you agree with this statement: Over the past few weeks, I've had more good days than bad days?' This is rated on a scale of 1 (strongly agree) to 5 (strongly disagree). (NCT00697515)
Timeframe: Baseline and 26 days

Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale With Prompts (ADHD-RS) Total Score at up to 28 Days in the Dose Optimization Phase

Change From Baseline in Diastolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase

Change From Baseline in Electrocardiogram Results (QTcF Interval) at 7 Days in the Crossover Phase

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. (NCT00697515)
Timeframe: Baseline and 7 days

Change From Baseline in Pulse Rate at Up to 28 Days in the Dose Optimization Phase

Change From Baseline in Systolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase

Change From Baseline in the Brown Attention Deficit Disorder Scale (BADDS) Total Scores at 26 Days in the Dose Optimization Phase

The BADDS assessment consists of 40 items rated on a scale from 0 (never) to 3 (almost daily). The total score ranges from 0 to 120 with increasing scores indicating more severe impairment. (NCT00697515)
Timeframe: Baseline and 26 days

Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase

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. (NCT00697515)
Timeframe: 7 days

Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Dose Optimization Phase

Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase

The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance. (NCT00697515)
Timeframe: 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7

Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) (NCT00697515)
Timeframe: Baseline

Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase

MSQ is a survey rating the subject's level of satisfaction with the study treatment medication. (NCT00697515)
Timeframe: 26 days

PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase

PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase

PERMP Total Score by Timepoint in the Crossover Phase

Gray Oral Reading Rest, Fourth Edition (GORT-4)

"The GORT-4 evaluates oral reading rate, accuracy and comprehension. Both Forms A and B were used.Half of the subjects randomly were tested on From A at baseline and the other half were tested with Form B.~The GORT-4 is a standardized measure/test. Scores provided are standard scores, which range from 1 to 20, with a Mean of 10 and Standard Deviation of 3. A higher score means better reading performance. There was no total score used or calculated in this study." (NCT00733356)
Timeframe: baseline and final day (lab school Assessments)

Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 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. (NCT00735371)
Timeframe: Baseline and 1, 2, 3 and 4 weeks

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

Youth Quality of Life-Research Version (YQOL-R) Total Score

Change in ADHD-RS-IV Total Score From Baseline at Up to One Year

Change in PSQI Total Score From Baseline at Up to One Year

Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire consisting of 18 items which generates seven component scores on a scale from 0 (better sleep) to 3 (worse sleep) resulting in a global score of 0-21, where a higher number reflects worse sleep quality. (NCT00337285)
Timeframe: up to 1 year

Number of Participants With Improvement on CGI-I

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 1 and 2 on the scale. (NCT00337285)
Timeframe: Up to 1 year

Area Under the Steady-state Plasma Concentration-time Curve (AUC) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC

d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity. (NCT00746733)
Timeframe: 0 through 96 hours after dosing

AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC

AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC

Total amphetamine is the d- and l-amphetamines. (NCT00746733)
Timeframe: 0 through 96 hours after dosing

Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC

l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity. (NCT00746733)
Timeframe: 0 through 96 hours after dosing

Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC

Total amphetamine is the d- and l-amphetamines. (NCT00746733)
Timeframe: 0 through 96 hours after dosing

Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC

d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity. (NCT00746733)
Timeframe: 0 through 96 hours after dosing

T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC

l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity. (NCT00746733)
Timeframe: 0 through 96 hours after dosing

T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC

Total amphetamine is the d- and l-amphetamines. (NCT00746733)
Timeframe: 0 through 96 hours after dosing

Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC

d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity. (NCT00746733)
Timeframe: 0 through 96 hours after dosing

Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC

d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity. (NCT00746733)
Timeframe: 0 through 96 hours after dosing

Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC

l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity. (NCT00746733)
Timeframe: 0 through 96 hours after dosing

Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC

Total amphetamine is the d- and l-amphetamines. (NCT00746733)
Timeframe: 0 through 96 hours after dosing

Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC

(NCT00746733)
Timeframe: Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing

DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC

Question 1: How much do you feel the drug now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs. (NCT00746733)
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing

DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC

Question 3: Do you dislike the drug effect you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs. (NCT00746733)
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing

Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.

Question 2: How much do you like the effects you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs. (NCT00746733)
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing

Electrocardiogram Results (QTcF Interval) for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC

Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC

(NCT00746733)
Timeframe: Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing

Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC

(NCT00746733)
Timeframe: Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing

Behavior Rating Inventory of Executive Function - Adult (BRIEF-A)

BRIEF-A is a standardized self-report measure that captures adults' views of their own self-regulation in their everyday environment. Metacognition Index T-scores (mean = 50; standard deviation = 10) were used as dependent measures with higher scores representing greater deficit in planning/organizational skills critical for college success. (NCT01342445)
Timeframe: after receiving Placebo or LDX for 1 week

Conners Adult ADHD Rating Scale - Short Version (CAARS)

CAARS ADHD Index, adult self-report measure of ADHD symptoms. T-scores (mean = 50; standard deviation = 10) for all subscales on the short version were used as dependent measures with higher scores representing greater ADHD symptomatology (and ultimately a worse outcome in this study). (NCT01342445)
Timeframe: after receiving Placebo or LDX for 1 week

"Participants Experiencing Collisions During Surprise Events in Driving Simulator"

"Initial results from a one hour driving simulation in the MIT AgeLab Driving Simulator as compared to second session in the simulator following a 6-week trial on Lisdexamfetamine or placebo. During the simulation, surprise events, designed to test the participant's attention and driving, occurred. This outcome presents the difference in number of collisions experience by individuals treated with Vyvanse or Placebo." (NCT00801229)
Timeframe: 6 weeks

Aberrant Behavior Checklist - Community Edition (ABC-C)

"The ABC-C is a global behavior checklist implemented for the measurement of drug and other treatment effects in populations with intellectual disability. Behavior based on 58 items that describe various behavioral problems.~Each item is rated on the parents perceived severity of the behavior. The answer options for each item are:~0 = Not a problem~= Problem but slight in degree~= Moderately serious problem~= Severe in degree~The measure is broken down into the following subscales with individual ranges as follows:~Subscale I (Irritability): 15 items, score range = 0-45 Subscale II (Lethargy): 16 items, score range = 0-48 Subscale III (Stereotypy): 7 items, score range = 0-21 Subscale IV (Hyperactivity): 16 items, score range = 0-48 Subscale V (Inappropriate Speech) was not included in the breakdown because it was not applicable (no participants in the study had verbal language)." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

Anxiety, Depression, and Mood Scale (ADAMS)

"Remaining subscales of the ADAMS that are not primary outcome measures include: Manic/hyperactive, Depressed mood, General anxiety, Obsessive/compulsive behavior.~The range for each subscale is as follows:~Manic/Hyperactive Behavior: 0-15 Depressed Mood: 0-21 General Anxiety: 0-21 Obsessive/Compulsive Behavior: 0-9~The higher the score for each subscale, the more problematic the behavior." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

Anxiety, Depression, and Mood Scale (ADAMS) - Social Avoidance Subscale

"The ADAMS is completed by the parent/caregiver/LAR and consists of 29 items which are scored on a 4-point rating scale that combines frequency and severity ratings. The instructions ask the rater to describe the individual's behavior over the last six months on the following scale: 0 if the behavior has not occurred, 1 if the behavior occurs occasionally or is a mild problem, 2 if the behavior occurs quite often or is moderate problem, or 3 if the behavior occurs a lot or is a severe problem.~The Social Avoidance subscale of the ADAMS will be used as a primary outcome measure for this trial. The range for this subscale is 0-21. The higher the subscale score, the more problematic the behavior." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

Clinical Global Impression - Improvement (CGI-I)

"Each time the patient was seen after the study intervention was initiated, the clinician compared the patient's overall clinical condition to the CGI-S score obtained at the baseline (visit 1) visit. Based on information collected, the clinician determined if any improvement occurred on the following 7-point scale: 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 possible range for reported scores is 1-7." (NCT01777542)
Timeframe: Every 10 weeks during each of the two 20-week treatment periods

Clinical Global Impression - Severity (CGI-S)

"This scale is used to judge the severity of the subject's disease prior to entry into the study. The clinician will rate the severity of behavioral symptoms at baseline on a 7-point scale from not impaired to the most impaired.~The scores that correspond to each possible grouping are as follows: 1=Normal, not at all impaired; 2=Borderline impaired; 3=Mildly impaired; 4=Moderately impaired; 5=Markedly impaired; 6=Severely impaired; 7=The most impaired.~The possible range for reported scores is 1-7." (NCT01777542)
Timeframe: Every 10 weeks during each of the two 20-week treatment periods

Communication and Symbolic Behavior Scales - Developmental Profile (CSBS-DP)

"The CSBS-DP was designed to measure early communication and symbolic skills in infants and young children (that is, functional communication skills of 6 month to 2 year olds). The CSBS-DP measures skills from three composites: (a) Social (emotion, eye gaze, and communication); (b) Speech (sounds and words); and (c) Symbolic (understanding and object use) and asks about developmental milestones. The data reported are the composite scores for these three categories.~The possible scores for the three composite categories are as follows:~Social Composite = 0-48; Speech Composite = 0-40; Symbolic Composite = 0-51.~A higher score indicates more advanced abilities in that area." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

Kerr Clinical Severity Scale

"The Kerr clinical severity scale (Kerr scale) is a quantitative measure of global disease severity. The Kerr scale is a summation of individual items related to Rett syndrome phenotypic characteristics. The items are based on the severity or degree of abnormality of each characteristic on a discrete scale (0, 1, 2) with the highest level corresponding to the most severe or most abnormal presentations.~The possible range of scores is 0-48. The higher the score, the more severe the symptoms." (NCT01777542)
Timeframe: At the start and end of each 20-week treatment period

Mullen Scales of Early Learning (MSEL)

"The MSEL is a standardized developmental test for children ages 3 to 68 months consisting of five subscales: gross motor, fine motor, visual reception, expressive language, and receptive language.~The raw score is reported for each subscale domain. The potential score ranges are as follows:~Visual Reception: 33 items, score range=0-50, Fine Motor: 30 items, score range= 0-49, Receptive Language: 33 items, score range= 0-48, Expressive Language: 28 items, score range= 0-50. The gross motor subscale was not included in this population.~A higher raw score indicates more advanced abilities in that section." (NCT01777542)
Timeframe: At the start and end of each 20-week treatment period

Parent Targeted Visual Analog Scale (PTSVAS) - Scale 1

"The parent or caretaker identifies the three most troublesome, RTT-specific, target symptoms, such as inattention or breath-holding. This allows the problems that are of concern to parents and the family to be targeted in the trial. In this study the caregiver will choose three target symptoms at baseline and then rate changes in severity of each target symptom on a visual analog scale (VAS).~The VAS is a 10 cm line, where a target symptom is anchored on one end with the description the best it has ever been and on the other with the description the worst it has ever been. The parent was asked to marked on the line where they felt their child's symptoms currently fit best. This mark was measured as recorded as a numeric value from 0.00-10.00 cm. The higher the value, the worse the symptom." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

Parent Targeted Visual Analog Scale (PTSVAS) - Scale 2

Parent Targeted Visual Analog Scale (PTSVAS) - Scale 3

Parental Global Impression - Improvement (PGI-I)

"As part of each visit after the study intervention was initiated, the parent/caregiver was asked to compare the patient's overall clinical condition to the score obtained at the baseline (visit 1) visit. Based on information collected, the clinician determined if any improvement occurred on the following 7-point scale: 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 possible range for reported scores is 1-7." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

Parental Global Impression - Severity (PGI-S)

"The PGI-S is the parent version of the CGI-S. Parents/caregivers/LAR are asked to rate the severity of their child's symptoms at baseline on a 7-point scale from not at all impaired to the most impaired. The parents/caregivers/LAR will complete the PGI-S at each study visit.~The scores that correspond to each possible grouping are as follows:~1=Normal, not at all impaired; 2=Borderline impaired; 3=Mildly impaired; 4=Moderately impaired; 5=Markedly impaired; 6=Severely impaired; 7=The most impaired.~The possible range for reported scores is 1-7." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

Quantitative Measures of Respiration: Apnea Index

"Respiratory data was collected using non-invasive respiratory inductance plethysmography from a BioCapture® recording device. BioCapture® is a child-friendly measurement device that can record from 1 to 12 physiological signal transducers in a time-locked manner. It can be configured with the pediatric chest and abdominal plethysmography bands and the 3 lead ECG signals we plan to use for monitoring cardiac safety throughout the study. Each transducer is placed on the patient independently to provide a customized fit that yields the highest signal quality for each patient irrespective of body shape and proportion. The transducer signals captured by the BioCapture® are transmitted wirelessly to a laptop computer where all signals are displayed in real-time.~The apnea index is given as apneas/hour. Data on apneas greater than or equal to 10 seconds are displayed below. The higher the frequency of apnea, the more severe the breathing abnormality." (NCT01777542)
Timeframe: Every 10 weeks during each of the two 20-week treatment periods

Rett Syndrome Behavior Questionnaire (RSBQ)

"The RSBQ is a parent-completed measure of abnormal behaviors typically observed in individuals with RTT. Each item, grouped into eight subscales, is scored on a Likert scale of 0-2, according to how well the item describes the individual's behavior. A score of 0 indicates the described item is not true, a score of 1 indicates the described item is somewhat or sometimes true, and a score of 2 indicates the described item is very true or often true.~The total sum of each subscale is reported. The higher the score, the more severe the symptoms of that subscale in the participant.~The range for each subscale is as follows:~General Mood: 0-16 Body rocking and expressionless face: 0-14 Hand behaviors: 0-12 Breathing Problems: 0-10 Repetitive Face Movements: 0-8 Night-time behaviors: 0-6 Walking Standing: 0-4~The fear/anxiety subscale was used as a primary outcome measure in this study and results can be found in that section." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

Rett Syndrome Behavior Questionnaire (RSBQ) - Fear/Anxiety Subscale

"The RSBQ is an informant/parent-completed measure of abnormal behaviors typically observed in individuals with RTT, which is completed by a parent/caregiver/LAR. Each item, grouped into eight domains/factors: General mood, Breathing problems, Body rocking and expressionless face, Hand behaviors, Repetitive face movements, Night-time behaviors, Fear/anxiety and Walking/standing), is scored on a Likert scale of 0-2, according to how well the item describes the individual's behavior. A score of 0 indicates the described item is not true, a score of 1 indicates the described item is somewhat or sometimes true, and a score of 2 indicates the described item is very true or often true.~The total sum of items in each subscale is reported.~For the fear/anxiety subscale, the sum total could be between 0-8. The higher the sum total score, the greater the frequency of fear/anxiety behaviors." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

Vineland Adaptive Behavior Scales, Second Edition (VABS-II)

"The VABS-II is a survey designed to assess personal and social functioning. Within each domain (Communication, Daily Living Skills, Socialization, and Motor Skills), items can given a score of 2 if the participant successfully performs the activity usually; a 1 if the participant successfully performs the activity sometimes, or needs reminders; a 0 if the participant never performs the activity, and a DK if the parent/caregiver is unsure of the participant's ability for an item.~The raw scores in each sub-domain are reported and the ranges for these are as follows: [Communication Domain], Receptive Language=0-40, Expressive Language=0-108, Written Language=0-50; [Daily Living Skills Domain], Personal=0-82, Domestic=0-48, Community=0-88; [Socialization Domain], Interpersonal Relationships=0-76, Play and Leisure Time=0-62, Coping Skills=0-60; [Motor Skills Domain]: Gross Motor Skills=0-80, Fine Motor Skills=0-72.~A higher score indicates more advanced abilities." (NCT01777542)
Timeframe: At the start and end of each 20-week treatment period

Attention Composite Score

The attention composite comprises performance on Wechsler Adult Intelligence Scale III Symbol-Digit and Letter Number Sequencing Subtests, Trail Making Test Part A, computerized simple-choice reaction time, and computerized working memory (i.e., 2-Back). The composite score is the average combined z score for each test. Higher, positive values indicate better than average performance and negative and lower values indicate worse than average. The outcome reported was change in score from baseline for each treatment arm. (NCT00368849)
Timeframe: There are two time points for this measure: baseline and after 4 weeks of treatment

Conners' Adult Attention Rating Scale (CAARS)

The Conners' Adult Attention Rating Scale (CAARS) is one of the most frequently used self-rating measures for adult Attention Deficit Hyperactivity Disorder (ADHD) and was given as a self-report measure of attention. It has 66 items with each item ranging from 0 to 3 points. Higher total scores represent greater impairment. The outcome reported was change in score from baseline for each treatment arm. (NCT00368849)
Timeframe: There are two time points for this measure: baseline and after 4 weeks of treatment

Executive Composite Score

The executive composite comprises performance on Trail Making Test Part B, Stroop Color and Word Test, and the Controlled Oral Word Association Test (i.e., Verbal Fluency). The composite score is the average combined z score for each test. Positive values indicate better than average performance and negative values worse than average. The outcome reported was change in score from baseline for each treatment arm. (NCT00368849)
Timeframe: There are two time points for this measure: baseline and after 4 weeks of treatment

Symptom Checklist-90-Revised (SCL-90-R)

Psychiatric symptoms were evaluated with the Symptom Checklist-90-Revised, a self report measure of psychiatric symptoms. The measure produces raw scores and normed scores (T scores Mean = 50), with higher values representing greater impairment. The outcome reported was change in score from baseline for each treatment arm. (NCT00368849)
Timeframe: There are two time points for this measure: baseline and after 4 weeks of treatment

Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score

Although changes in motor symptoms were not hypothesized, the Unified Huntington Disease Rating Scale motor examination was administered at every visit. An experienced motor rater completes a motor examination and rates the participant on several motor tasks. Total score ranges from 0 - 124, with higher scores indicating a worse outcome. The outcome reported was change in score from baseline for each treatment arm. (NCT00368849)
Timeframe: There are two time points for this measure: baseline and after 4 weeks of treatment

Intervention	units on a scale (Mean)
Unmedicated	0.04
Optimal Dose of Medication	0.26

Intervention	units on a scale (Mean)
	Inattention	Hyperactive/Impulsive	Total Score
Placebo Arm	17.85	14.77	32.62
Treatment Arm	8.82	5.64	14.46

Intervention	scores on a scale (Mean)
	Inattention Symptoms	Hyperactive/Impulsive Symptoms	Total symptoms
Optimal Dose of Medication	9.77	8.00	17.77
Unmedicated	23.12	17.81	40.85

Intervention	units on a scale (Mean)
	Positive parenting	Parental involvement	Poor monitoring/supervision	Inconsistent discipline	Corporal punishment use
Placebo Arm	24.85	39.38	12.23	12.46	4.69
Treatment Arm	24.33	37.78	12.33	14.22	3.89

Intervention	units on a scale (Mean)
	Parent Involvement	Positive parenting	Poor monitoring and poor supervision	Inconsistent discipline	Corporal punishment
Optimal Dose of Medication	38.82	25.58	13.58	14.62	4.42
Unmedicated	37.83	25.42	14.25	15.79	4.79

Intervention	t score (Mean)
	Activation Scale t-score	Attention Scale t-score	Effort scale t-score	Affect scale t-score	Memory scale t-score	Total scale t-score
Placebo Arm	73.38	75.54	72.46	63.46	74.38	76.08
Treatment Arm	66.4	65.10	61.20	53.20	13.79	63.30

Intervention	units on a scale (Mean)
	Inattention	Hyperactive/Impulsive	Oppositional-defiant	Conduct disorder
Placebo Arm	1.64	1.25	1.04	0.17
Treatment Arm	1.60	1.09	0.76	0.15

Intervention	units on a scale (Mean)
	ADHD-hyperactive/impulsive symptom score	ADHD-inattentive symptom score	ODD symptom score	CD symptom score
Optimal Dose of Medication	1.34	1.85	1.12	0.18
Unmedicated	1.55	2.11	1.17	0.16

Intervention	behaviors (Mean)
	Verbalizations	Commands	inappropriate child behavior
Medication - Homework Task	45.2	8.7	2.5
Medication Non-academic Task	48.6	8.3	3.8
Placebo - Homework Task	61.7	15.4	6.1
Placebo - Non-academic Task	58.2	14.8	3.3

Intervention	Percentage of behaviors (Mean)
	Parent praise	Parent negative talk	Parent demandingness	Parent impatient	Parent responsive
Medication - Homework Task	3.6	14.4	19.3	31.2	75.9
Medication Non-academic Task	2.2	9.1	19.2	32.6	79.8
Placebo - Homework Task	2.6	4.7	24.1	39.2	83.2
Placebo - Non-academic Task	3.0	4.0	25.7	42.5	74.8

Intervention	units on a 0 to 6 scale (Mean)
	Child's peer relationship impairment	Child's sibling relationship impairment	Child's parent relationship impairment	Child's academic impairment	Child's self-esteem impairment	Child's family impairment	Child's overall impairment
Optimal Dose of Medication	2.21	2.68	3.79	3.29	3.54	3.87	3.42
Unmedicated	2.75	2.82	3.67	3.75	3.92	4.00	3.63

Intervention	units on a scale (Mean)
	Impairment with peers	Impairment with siblings	Impairment interferes with parents' relationship	Academic impairment	Self-esteem impairment	General family impairment	Overall severity
Placebo Arm	2.62	2.17	3.15	3.15	3.00	3.08	2.62
Treatment Arm	2.20	2.30	3.10	2.60	3.40	2.90	2.70

Intervention	units on a scale (Mean)
	Impairment with peers	Impairment with parents	General family impairment	Academic impairment	Self-esteem impairment	Overall impairment
Placebo Arm	2.38	2.46	2.77	3.60	2.77	3.00
Treatment Arm	1.91	1.30	2.27	1.83	2.00	2.55

Intervention	Percent of participants (Number)
	Motor tics	Buccal-lingual movement	picking at skin	worried/anxious	dull, tired, listless	headaches	stomachaches	crabby, irritiable	tearful, sad, depressed	socially withdrawn	loss of appetite	trouble sleeping	dry mouth
30 mg Lisdexamfetamine	0	19.4	11.1	36.1	16.7	36.1	16.7	27.8	13.9	8.3	52.8	30.6	30.6
50 mg Lisdexamfetamine	0	28.6	14.3	14.3	9.5	28.6	4.8	23.8	19.0	0.0	66.7	33.3	38.1
70 mg Lisdexamfetamine	11.8	23.5	5.9	17.6	11.8	29.4	29.4	23.5	11.8	0.0	70.6	35.3	70.5
No Medication	0	2.6	13.2	13.2	10.5	5.3	0.0	10.5	7.9	5.3	0.0	10.5	0.0

Intervention	mm Hg (Mean)
	systolic BP	diastolic BP
Placebo Arm	123.40	76.10
Treatment Arm	122.33	75.11

Intervention	standard scores (Mean)
	Social Skills Total Standard Score	Problem Behavior Total Standard Score
Placebo Arm	86.64	113.81
Treatment Arm	89.90	111.80

Intervention	Scores on a scale (Mean)
Lisdexamfetamine Dimesylate (LDX)(Randomized Period)	-17.1
Placebo (Randomized Period)	-9.1

Intervention	Scores on a scale (Least Squares Mean)
Lisdexamfetamine Dimesylate (LDX)(Randomized Period)	1.2
Placebo (Randomized Period)	13.8

Intervention	T-scores (Least Squares Mean)
Lisdexamfetamine Dimesylate (LDX)(Randomized Period)	1.1
Placebo (Randomized Period)	-5.4

Intervention	Scores on a scale (Mean)
Lisdexamfetamine Dimesylate (LDX)(Randomized Period)	-0.005
Placebo (Randomized Period)	-0.046

Intervention	Scores on a scale (Least Squares Mean)
Lisdexamfetamine Dimesylate (LDX)(Randomized Period)	0.01
Placebo (Randomized Period)	0.20

Intervention	participants (Number)
	Suicidal ideation	Suicidal behavior
Lisdexamfetamine Dimesylate (LDX)(Open-label Period)	1	0

Intervention	number of problems attempted (Mean)
	0.75 hours post-dose	2.0 hours post-dose	4.0 hours post-dose	6.0 hours post-dose	8.0 hours post-dose	10.0 hours post-dose
AR11 (Amphetamine Sulfate)	111.6	113.4	113.2	101.3	98.2	95.2
Placebo	91.2	85.7	85.1	74.9	76.4	76.3

Intervention	units on a scale (Mean)
	0.75 hours post-dose	4 hours post-dose	6 hours post-dose	8 hours post-dose	10 hours post-dose
AR11 (Amphetamine Sulfate)	11.8	11.6	14.5	16.0	16.5
Placebo	17.3	19.8	20.2	22.0	20.8

Intervention	Units on a scale (Mean)
	Global Executive Composite	Behavioral Recognition Index	Metacognition Index
Vyvanse	-17.9	-15.4	-17.6

Intervention	Units on a scale (Mean)
	Week 1	Week 2	Week 3	Week 4	Week 5	Week 6	Week 7
Vyvanse	-11.3	-17.8	-21.7	-25.4	-27.0	-28.9	-29.8

Intervention	standardized T-score (Mean)
	placebo	amphetamine
Healthy Subjects: 10 mg Amphetamine 1st, Then Placebo	57.870	56.000
Healthy Subjects: Placebo 1st, Then 10 mg Amphetamine	54.476	55.476
Subjects With Schizophrenia: 10 mg Amphetamine 1st, Then Placebo	39.895	38.105
Subjects With Schizophrenia: Placebo 1st, Then 10 mg Amphetamine	31.895	33.842

Intervention	Participants (Number)
	Very satisfied	Moderately satisfied	Not satisfied	Don't know
SPD489	79	44	2	2

Intervention	Units on a scale (Least Squares Mean)
	Over the treatment day	2.0 hours post-dose	4.0 hours post-dose	8.0 hours post-dose	10.0 hours post-dose	12.0 hours post-dose	14.0 hours post-dose
Placebo	142.9	141.0	140.4	141.7	142.7	144.7	146.3
SPD489	154.4	148.4	154.8	153.7	154.8	157.4	157.1

Intervention	Units on a scale (Least Squares Mean)
Lisdexamfetamine Dimesylate (LDX) 30 mg	-18.3
LDX 50 mg	-21.1
LDX 70 mg	-20.7
Placebo	-12.8

Intervention	Units on a scale (Mean)
	Baseline	4 Weeks
LDX 50 mg	80.5	81.3
LDX 70 mg	78.8	81.3
Lisdexamfetamine Dimesylate (LDX) 30 mg	79.3	81.1
Placebo	79.2	81.3