Lisdexamfetamine Dimesylate: A dextroamphetamine drug precursor that also functions as a CENTRAL NERVOUS SYSTEM STIMULANT and DOPAMINE UPTAKE INHIBITOR and is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]
| ID Source | ID |
|---|---|
| PubMed CID | 11597697 |
| CHEMBL ID | 1201178 |
| SCHEMBL ID | 678421 |
| MeSH ID | M0502623 |
| Synonym |
|---|
| vyvanse (tn) |
| lisdexamfetamine mesilate (jan) |
| elvanse (tn) |
| lisdexamfetamine dimesylate (usan) |
| 608137-33-3 |
| D04747 |
| nrp-104 |
| l-lysine-d-amphetamine dimesylate |
| lys-amp |
| spd-489 |
| venvanse |
| lys-d-amp |
| lisdexamfetamine mesilate |
| vyvanse |
| nrp 104 |
| lisdexamfetamine mesylate |
| lis-dexamfetamine dimesylate |
| lisdexamfetamine dimesylate |
| lisdexamphetamine dimesilate |
| CHEMBL1201178 |
| lisdexamfetamine dimethanesulfonate |
| tyvense |
| spd489 |
| lisdexamfetamine dimesilate |
| nrp104 |
| (2s)-2,6-diamino-n-[(1s)-1-methyl-2-phenylethyl]hexanamide dimethanesulfonate |
| sjt761gegs , |
| lisdexamfetamine dimesylate [usan] |
| unii-sjt761gegs |
| spd 489 |
| ldx |
| hexanamide, 2,6-diamino-n-((1s)-1-methyl-2-phenylethyl), (2s), dimethanesulfonate |
| lisdexamfetamine dimesylate [vandf] |
| lisdexamfetamine mesilate [mart.] |
| lisdexamfetamine mesilate [jan] |
| lisdexamfetamine dimethanesulfonate [mi] |
| (2s)-2,6-diamino-n-((1s)-1-methyl-2-phenylethyl)hexanamide dimethanesulphonate |
| hexanamide, 2,6-diamino-n-((1s)-1-methyl-2-phenylethyl), (2s), dimethanesulphonate |
| lisdexamfetamine mesilate [who-dd] |
| lisdexamfetamine dimesylate [orange book] |
| CETWSOHVEGTIBR-FORAGAHYSA-N |
| SCHEMBL678421 |
| DTXSID60209653 , |
| dimesylate, lis-dexamfetamine |
| lis dexamfetamine dimesylate |
| dimesylate, lisdexamfetamine |
| AKOS030254940 |
| ldx;lisdexamfetamine mesilate;lisdexamfetamine mesylate;nrp 104;nrp-104;spd 489 |
| BCP24044 |
| (2s)-2,6-diamino-n-[(2s)-1-phenylpropan-2-yl]hexanamide;methanesulfonic acid |
| Q27289243 |
| dtxcid10132144 |
| lisdexamfetamine mesilate (mart.) |
| lisdexamfetamine dimesylate capsules |
| (2s)-2,6-diamino-n-((1s)-1-methyl-2-phenylethyl)hexanamide dimethanesulfonate |
Lisdexamfetamine dimesylate is a stimulant prodrug with low abuse and diversion potential. It is used in treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults. Lisdexa is a novel prodrug approved in North America, Europe and Brazil for treating ADHD.
Lisdexamfetamine dimesylate treatment for 2 years was not associated with deterioration of cognitive function in children and adolescents with attention-deficit/hyperactivity disorder.
| Excerpt | Reference | Relevance |
|---|---|---|
| "Lisdexamfetamine dimesylate treatment duration was not associated with change in BMI percentile, and the medication was well tolerated." | ( Lisdexamfetamine in Pediatric Binge Eating Disorder: A Retrospective Chart Review. Blom, TJ; Casuto, LL; Cummings, T; Guerdjikova, AI; Matthews, A; McElroy, SL; Mori, N, ) | 0.85 |
| "Lisdexamfetamine dimesylate treatment for 2 years was not associated with deterioration of cognitive function in children and adolescents with attention-deficit/hyperactivity disorder. " | ( Cognitive Function of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder in a 2-Year Open-Label Study of Lisdexamfetamine Dimesylate. Banaschewski, T; Bliss, C; Coghill, DR; Robertson, B; Zuddas, A, 2018) | 2.13 |
2% (53/88) receiving lisdexamfetamine dimesylate had ≥ 1 treatment-emergent adverse event. The most frequent with lisdExam Fetamine dinesylate being dry mouth and headache (both 11%)
Potential for pharmacokinetic drug-drug interactions between GXR and lisdexamfetamine dimesylate (LDX, Vyvanse®; Shire US LLC, Wayne, PA, USA) has not been thoroughly evaluated.
| Excerpt | Reference | Relevance |
|---|---|---|
| " 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." | ( 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) | 0.67 |
| Excerpt | Reference | Relevance |
|---|---|---|
| "The relative bioavailability of oral lisdexamfetamine dimesylate, a prodrug of d-amphetamine, and active d-amphetamine was assessed in an open-label, single-dose, 3-treatment, 3-period, randomized, crossover study in 18 healthy adult volunteers." | ( Relative bioavailability of lisdexamfetamine 70-mg capsules in fasted and fed healthy adult volunteers and in solution: a single-dose, crossover pharmacokinetic study. Krishnan, S; Zhang, Y, 2008) | 0.62 |
| " The intestinal absorption rate for each drug was acquired by deconvolution, using historical intravenous data as reference, and used with the intestinal surface area and the dose remaining in the lumen to estimate the Peff." | ( Human in vivo regional intestinal permeability: quantitation using site-specific drug absorption data. Dahlgren, D; Lennernäs, H; Roos, C; Sjögren, E, 2015) | 0.42 |
| "Relative bioavailability of D-amphetamine (the active moiety) did not differ across administrations, which suggests that emptying an LDX capsule into orange juice or yogurt and consuming it is an alternative to intact capsules." | ( Relative Bioavailabilities of Lisdexamfetamine Dimesylate and D-Amphetamine in Healthy Adults in an Open-Label, Randomized, Crossover Study After Mixing Lisdexamfetamine Dimesylate With Food or Drink. Corcoran, M; Ermer, J; Lasseter, K; Martin, PT, 2016) | 0.72 |
This randomized, double-blind, placebo-controlled study evaluated dose-response relationships of lisdexamfetamine dimesylate when used as augmentation for major depressive disorder in individuals exhibiting inadequate responses to antidepressant monotherapy.
| Timeframe | Studies, This Drug (%) | All Drugs % |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 33 (10.34) | 29.6817 |
| 2010's | 222 (69.59) | 24.3611 |
| 2020's | 64 (20.06) | 2.80 |
| [information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||
According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.
| This Compound (68.79) All Compounds (24.57) |
| Publication Type | This drug (%) | All Drugs (%) |
|---|---|---|
| Trials | 125 (37.88%) | 5.53% |
| Reviews | 67 (20.30%) | 6.00% |
| Case Studies | 24 (7.27%) | 4.05% |
| Observational | 5 (1.52%) | 0.25% |
| Other | 109 (33.03%) | 84.16% |
| [information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Low- and High-dose Range Groups of SPD489 as Adjunctive Treatment to Established Maintenance Doses of Antipsych [NCT01234298] | Phase 3 | 0 participants (Actual) | Interventional | 2012-01-27 | Withdrawn(stopped due to Study was discontinued due to non-safety related business prioritization decisions) | ||
| [NCT01263548] | 45 participants (Actual) | Observational | 2010-10-31 | Completed | |||
| Bariatric Surgery and Pharmacokinetics Lisdexamphetamine: BAR-MEDS Lisdexamphetamine [NCT03497169] | 12 participants (Anticipated) | Observational | 2016-11-02 | Recruiting | |||
| Lisdexamfetamine in Binge Eating Disorder of Moderate or Greater Severity [NCT01090713] | Phase 3 | 50 participants (Actual) | Interventional | 2010-01-31 | Completed | ||
| 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 | ||
| Efficacy of Careful Medication and Tailored Case Management Follow up Treatment for Children With Attention Deficit Hyperactivity Disorder [NCT02142140] | 326 participants (Anticipated) | Interventional | 2012-12-31 | Active, not recruiting | |||
| [NCT02034201] | Phase 1 | 19 participants (Actual) | Interventional | 2014-02-28 | 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 | ||
| A Phase 4, Open-Label, Multicentre, Safety Study of Lisdexamfetamine Dimesylate in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) [NCT01328756] | Phase 4 | 314 participants (Actual) | Interventional | 2011-07-07 | Completed | ||
| [NCT02144415] | Phase 1 | 80 participants (Actual) | Interventional | 2014-05-31 | Completed | ||
| Adjunctive Lisdexamfetamine in Bipolar Depression [NCT01131559] | Phase 3 | 50 participants (Anticipated) | Interventional | 2010-01-31 | Terminated(stopped due to Sponsor halted study.) | ||
| A Phase 3, Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled, Fixed-Dose Safety and Efficacy Study of SPD489 Compared With Placebo in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder [NCT03260205] | Phase 3 | 199 participants (Actual) | Interventional | 2017-09-06 | 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 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Forced-dose Titration Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years With Binge Eating Disorder [NCT01291173] | Phase 2 | 271 participants (Actual) | Interventional | 2011-05-10 | Completed | ||
| Psychostimulant Treatment of TBI-Related Attention Deficits: fMRI Analysis of Neural Mechanisms of Response [NCT01000064] | Phase 3 | 22 participants (Actual) | Interventional | 2009-10-31 | Terminated(stopped due to unable to meet recruitment goals) | ||
| Vyvanse and Glucose Intolerance in Children With ADHD and Obesity [NCT01017263] | Phase 4 | 14 participants (Actual) | Interventional | 2009-12-31 | Terminated(stopped due to Due very high screen fail rate, pre study feasibility not consistent with screened population.) | ||
| The Reinforcing Mechanisms of Smoking in Adult ADHD [NCT00573859] | Phase 1/Phase 2 | 27 participants (Actual) | Interventional | 2006-09-30 | Completed | ||
| Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity [NCT03924193] | Phase 3 | 180 participants (Anticipated) | Interventional | 2019-03-25 | Active, not recruiting | ||
| Multi-Modal Imaging of Psychostimulant Effects on Executive Function Post-RRSO [NCT03187353] | Phase 4 | 69 participants (Actual) | Interventional | 2017-09-22 | Completed | ||
| Adjunctive Lisdexamfetamine in Bipolar Depression [NCT01093963] | Phase 3 | 25 participants (Actual) | Interventional | 2010-01-31 | Terminated(stopped due to Enrollment goals not met) | ||
| 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 | ||
| Treatments for Fathers With Attention Deficit/Hyperactivity Disorder (ADHD) and Their At-Risk Children (Fathers Too) [NCT02675400] | Phase 4 | 19 participants (Actual) | Interventional | 2015-12-31 | Completed | ||
| Endocrine and Emotional Effects of Lisdexamfetamine and d- Amphetamine: a Placebo-controlled Study in Healthy Subjects (LisDexStudy) [NCT02668926] | Phase 1 | 24 participants (Actual) | Interventional | 2016-05-31 | Completed | ||
| Effect of Lisdexamfetamine on Prefrontal Brain Dysfunction in Binge Eating Disorder [NCT02659488] | Phase 2 | 40 participants (Anticipated) | Interventional | 2015-09-30 | Recruiting | ||
| Suicidality, Psychosis or Substance Abuse With Methylphenidate, Atomoxetine, Amphetamine/Dextroamphetamine or Lisdexamfetamine, a Post-authorization Safety Study [NCT04132557] | 430,000 participants (Actual) | Observational | 2019-10-09 | Completed | |||
| A Phase IIIb, Randomized, Double-Blind, Multi-Center, Placebo- Controlled, Dose-Optimization, Cross-Over, Analog Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention-Deficit/Hy [NCT00500149] | Phase 3 | 129 participants (Actual) | Interventional | 2007-06-13 | 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 | ||
| The Effects of Lisdexamfetamine Dimesylate on Cognitive, Metabolic, and Reward Processes in Individuals With Binge-eating Symptoms [NCT04181957] | 22 participants (Actual) | Interventional | 2019-05-01 | Terminated(stopped due to COVID-19) | |||
| 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 | ||
| An In Depth Cardiovascular Study of Lisdexamfetamine (LDX; Vyvanse) in Healthy and Treated Hypertensive Adults With Attention Deficit Hyperactivity Disorder (ADHD) [NCT00753012] | Phase 4 | 24 participants (Actual) | Interventional | 2008-04-30 | 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 Phase IV, Real World, Open-label, Multi-centre Study on the Use of FOQUEST® (Methylphenidate Hydrochloride Controlled-release Capsules) for the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Pediatric and Adult Patients [NCT04152629] | Phase 4 | 257 participants (Actual) | Interventional | 2019-09-19 | Completed | ||
| A Single-Blind, Randomized Study of the Comparative Drug Likeability and Pharmacokinetics of Vyvanse™ and ADDERALL XR® When Administered as a Solution [NCT00776555] | Phase 1 | 3 participants (Actual) | Interventional | 2008-11-21 | Terminated(stopped due to The study was stopped by the sponsor based on a non-safety related business priority decision.) | ||
| 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 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 | ||
| 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 2, Multicenter Study With Open-label & Randomized Double-blind Placebo-controlled Withdrawal Phases to Evaluate the Efficacy, Safety, & Tolerability of SPD489 in Adults With Schizophrenia & Predominant Negative Symptoms Who Are Clinically Stable & [NCT00922272] | Phase 2 | 92 participants (Actual) | Interventional | 2009-09-14 | Completed | ||
| A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Exploratory Efficacy and Safety Study of SPD489 in Adults 18-55 Years With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant [NCT00905424] | Phase 2 | 246 participants (Actual) | Interventional | 2009-07-30 | Completed | ||
| Lisdexamfetamine for the Treatment of Severe Obesity in Children Aged 6 to 12 Years [NCT05416125] | Early Phase 1 | 40 participants (Anticipated) | Interventional | 2023-12-20 | Recruiting | ||
| Study of the Effect of Vyvanse (Lisdexamfetamine Dimesylate) on Sleep in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder (ADHD) [NCT00807222] | 24 participants (Actual) | Interventional | 2008-04-30 | 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 | ||
| 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 | ||
| A Randomized, Phase 3, Double-Blind, Crossover Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD [NCT02555150] | Phase 3 | 40 participants (Anticipated) | Interventional | 2015-09-30 | Completed | ||
| Pilot Study of Vyvanse™ (Lisdexamfetamine Dimesylate) in Adolescents (Ages 11-15) With ADHD and an Older Sibling With ADHD and Substance Dependence [NCT00573534] | Phase 4 | 8 participants (Actual) | Interventional | 2008-03-31 | 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 | ||
| Addition of High Dose Stimulant and Engagement-focused Contingency Management (CM), Alone and in Combination, to Treatment as Usual (TAU) for the Management of Methamphetamine (MA) Use Disorder (ASCME): a Canadian Multi-centre, RCT [NCT05854667] | Phase 2 | 440 participants (Anticipated) | Interventional | 2023-12-05 | Recruiting | ||
| 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 Double-Blind Placebo- and Active-Controlled, Single-Dose Crossover PD and PK Study to Evaluate the Safety, Tolerability and Abuse Liability of IV Administered NRP104 25 mg and 50 mg in Adult Volunteers With Histories of Stimulant Abuse [NCT00247572] | Phase 2 | 12 participants | Interventional | 2005-09-30 | Completed | ||
| Predictors of Healthy Mood and Memory After Oophorectomy [NCT01986764] | 0 participants (Actual) | Interventional | 2013-07-01 | Withdrawn(stopped due to Funding was not obtained for this study and no participants were enrolled.) | |||
| LDX in the Treatment of Executive Function Difficulties in Women After Oophorectomy [NCT01986777] | 0 participants (Actual) | Interventional | 2013-07-31 | Withdrawn(stopped due to Funding not obtained) | |||
| Double-Blind, Placebo-Controlled, Randomized Trial of Adjunctive Lisdexamfetamine Dimesylate in Residual Symptoms of Major Depressive Disorder Partially Responsive to Selective Serotonin or Norepinephrine Reuptake Inhibitor Monotherapy [NCT01148979] | Phase 4 | 35 participants (Actual) | Interventional | 2010-09-30 | 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 | ||
| 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 | ||
| 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 | ||
| 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 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 | ||
| Lis-dexamphetamine (LDX/SPD489)as a Treatment for Smoking Cessation in Nicotine Dependent Individuals With ADHD [NCT00736255] | 32 participants (Actual) | Interventional | 2007-12-31 | Completed | |||
| Lisdexamfetamine Dimesylate in the Treatment of Adult ADHD With Anxiety Disorder Comorbidity [NCT01863459] | Phase 4 | 42 participants (Actual) | Interventional | 2013-04-30 | Completed | ||
| Naturalistic Study of ADHD Medication and Predictors of Treatment Outcome [NCT02136147] | 632 participants (Actual) | Observational [Patient Registry] | 2015-06-30 | Completed | |||
| A Phase 1, Open-label, Drug Interaction Study Evaluating the Pharmacokinetic Profiles of SPD489 and EFFEXOR XR, Administered Alone and in Combination in Healthy Adult Subjects [NCT01235338] | Phase 1 | 80 participants (Actual) | Interventional | 2010-10-28 | Completed | ||
| A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, 12-week, Forced-dose Titration Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 40mg, 100mg, or 160mg as Adjunctive Treatment to Established Maintenance [NCT01738698] | Phase 3 | 4 participants (Actual) | Interventional | 2012-11-01 | Terminated(stopped due to Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized.) | ||
| Open-Label Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence [NCT01490216] | Phase 1 | 43 participants (Actual) | Interventional | 2011-07-31 | Terminated(stopped due to Low enrollment) | ||
| A Double-Blind, Randomized, Placebo and Active-Controlled, Six-Period Crossover Study to Evaluate the Likeability, Safety, and Abuse Liability of NRP104 in Healthy Adult Volunteers With Histories of Stimulant Abuse [NCT00248092] | Phase 1/Phase 2 | 36 participants | Interventional | 2006-01-31 | Completed | ||
| The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading [NCT00733356] | Phase 4 | 42 participants (Actual) | Interventional | 2008-07-31 | Completed | ||
| A Magnetic Resonance Spectroscopy and fMRI Study of the Effects of Lisdexamfetamine on Bipolar Depression [NCT01051440] | Phase 4 | 2 participants (Actual) | Interventional | 2010-02-28 | Terminated(stopped due to Slow enrollment) | ||
| A Phase 2, Randomized, Double-Blind, Single Center, Parallel Group, Placebo and Active Comparator, Controlled Study to Evaluate the Pharmacodynamic Profile of Single Doses of SPD489 in Healthy Adult Male Subjects Undergoing a Nocturnal Period of Acute Sle [NCT01096680] | Phase 2 | 135 participants (Actual) | Interventional | 2010-04-05 | Completed | ||
| A Phase 1, Open-label, Randomized, Three-period Crossover Drug Interaction Study Evaluating the Pharmacokinetic Profiles of SPD503 and VYVANSE, Administered Alone and in Combination in Healthy Adult Volunteers [NCT00919867] | Phase 1 | 42 participants (Actual) | Interventional | 2009-06-24 | 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 | ||
| Attention & Memory Impairments in Menopausal Women: A Possible Role for Vyvanse? [NCT01324024] | Phase 4 | 35 participants (Actual) | Interventional | 2011-05-31 | Completed | ||
| Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence [NCT01486810] | Phase 1/Phase 2 | 17 participants (Actual) | Interventional | 2011-12-31 | Completed | ||
| The Use of Lisdexamfetamine in Clinical Practice at a Danish Child Psychiatric Outpatient Clinic Aimed at School Children (Age 7-13 Years) With Attention Deficit Disorders [NCT04727476] | 413 participants (Actual) | Observational | 2021-01-19 | Active, not recruiting | |||
| Experimental fMRI Study on the Comparison of the Brain Function Effects of a Single Dose of Guanfacine and Lisdexamfetamine Relative to Placebo in Children and Adolescents With ADHD. [NCT03333668] | 20 participants (Anticipated) | Interventional | 2018-10-01 | Active, not recruiting | |||
| A Phase 3b, Randomized, Double-blind, Multicenter, Placebo Controlled, Dose Optimization, Crossover, Analog Classroom, Safety and Efficacy Study of SPD489 in Adolescent Subjects Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)) [NCT01274221] | Phase 3 | 0 participants (Actual) | Interventional | 2011-03-06 | Withdrawn(stopped due to Cancellation was not safety related but a shift in study priorities for Shire.) | ||
| A Randomized Controlled Trial of Methylphenidate Transdermal System (Daytrana), Lisdexamfetamine Dimesylate (Vyvanse), OROS MPH (Concerta), and Mixed Amphetamine Salts Extended Release (Adderall XR) in Children and Adolescents With ADHD [NCT00889915] | Phase 4 | 228 participants (Actual) | Interventional | 2009-04-30 | Completed | ||
| Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b) [NCT04599504] | Phase 2/Phase 3 | 60 participants (Anticipated) | Interventional | 2022-01-02 | Enrolling by invitation | ||
| Efficacy of Lisdexamfetamine in Adults With Attention Deficit Hyperactivity Disorder (ADHD) and Sluggish Cognitive Tempo (SCT) [NCT02635035] | Phase 2 | 38 participants (Actual) | Interventional | 2015-11-30 | Completed | ||
| A Phase 4, Randomized, Double-blind, Multicenter, Parallel-group, Active-controlled, Forced-dose Titration, Safety and Efficacy Study of SPD489 (VYVANSE®) Compared With OROS-MPH (CONCERTA®) With a Placebo Reference Arm, in Adolescents Aged 13-17 Years Wit [NCT01552902] | Phase 4 | 549 participants (Actual) | Interventional | 2012-04-03 | Completed | ||
| A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, 26-week, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 Low Dose Range (40mg, 80mg, 100mg) and High Dose Range (120mg, 140mg, 160mg) [NCT01760889] | Phase 3 | 1 participants (Actual) | Interventional | 2013-02-01 | Terminated(stopped due to Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized) | ||
| Imaging Stimulant vs. Non-Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD) [NCT02259517] | 38 participants (Actual) | Interventional | 2014-09-30 | Terminated(stopped due to Recruitment/enrollment ended early due to the COVID-19 pandemic) | |||
| Objectifying the Day-time Response Variation of (Lis)Dexamphetamine in Adults With ADHD [NCT04946461] | 16 participants (Actual) | Observational | 2021-07-01 | Completed | |||
| LAMAinDiab - Lisdexamphetamine vs Methylphenidate for Pediatric Patients With ADHD and Type 1 Diabetes - a Randomized Cross-over Clinical Trial [NCT05957055] | Phase 2 | 150 participants (Anticipated) | Interventional | 2024-01-01 | Not yet recruiting | ||
| The SPD489-323 Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder [NCT01436162] | Phase 3 | 1,105 participants (Actual) | Interventional | 2011-10-19 | Completed | ||
| Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults With Clinically Significant, Persistent Executive Function Impairments (EFI) and Partial or Full Remission of [NCT00985725] | Phase 2 | 143 participants (Actual) | Interventional | 2009-10-29 | Completed | ||
| A Feasibility Study to Evaluate Lisdexamfetamine Dimesylate (Vyvanse) in Adults With Bulimia Nervosa [NCT03397446] | Phase 2 | 23 participants (Actual) | Interventional | 2018-06-21 | Terminated(stopped due to Loss of resources due to COVID-19 resulted in insufficient funds to complete the trial as planned. However, sufficient data was collected to fulfill the aims of the trial. Discontinuation is not related to the drug, its use, or adverse events.) | ||
| A Phase 3, Long-term, Open-label, Multicenter, 52-week, Flexible-dose Safety Study of SPD489 as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults Who Have Persistent Predomi [NCT01760993] | Phase 3 | 2 participants (Actual) | Interventional | 2013-02-01 | Terminated(stopped due to Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized.) | ||
| A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized-withdrawal Study to Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder [NCT02009163] | Phase 3 | 418 participants (Actual) | Interventional | 2014-01-27 | Completed | ||
| A Phase 4, Randomized, Double-blind, Multicenter, Parallel-group, Active-controlled, Dose-optimization Safety and Efficacy Study of SPD489 (VYVANSE®) Compared With OROS-MPH (CONCERTA®) With a Placebo Reference Arm, in Adolescents Aged 13-17 Years With Att [NCT01552915] | Phase 4 | 464 participants (Actual) | Interventional | 2012-04-17 | Completed | ||
| Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity [NCT03926052] | Phase 3 | 80 participants (Anticipated) | Interventional | 2019-08-07 | Active, not recruiting | ||
| A Phase 1, Randomized, Double-blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending, Multiple Oral Doses of SPD489 (Lisdexamfetamine Dimesylate) in Clinically Stable Adults With Schizophren [NCT01457339] | Phase 1 | 31 participants (Actual) | Interventional | 2011-10-21 | Completed | ||
| Pharmacokinetics of Lisdexamfetamine (Vyvanse®) in Post-bariatric Surgery Patients [NCT03070509] | Phase 4 | 20 participants (Anticipated) | Interventional | 2017-05-12 | Recruiting | ||
| Evaluation of the Effectiveness of the FOCUS ADHD Mobile Health Platform in the Monitoring of Adults With Attention-Deficit/ Hyperactivity Disorder (ADHD) [NCT05551689] | 60 participants (Anticipated) | Interventional | 2021-05-21 | Recruiting | |||
| The SPD489-322 Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder [NCT01436149] | Phase 3 | 1,262 participants (Actual) | Interventional | 2011-10-27 | Completed | ||
| A Phase 2, Multicenter, Double- Blind, Parallel-group, Randomized, Placebo-controlled, Forced-dose Titration, Dose-ranging Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder [NCT01435759] | Phase 2 | 1,197 participants (Actual) | Interventional | 2011-05-31 | Completed | ||
| Use of Lisdexamfetamine Dimesylate in Treatment of Cognitive Impairment (Chronic Fatigue Syndrome): A Double Blind, Placebo Controlled Study [NCT01071044] | Phase 4 | 26 participants (Actual) | Interventional | 2009-11-30 | Completed | ||
| Neurobiological Basis of Response to Vyvanse in Adults With ADHD: an fMRI Study of Brain Activation [NCT01924429] | Phase 4 | 30 participants (Actual) | Interventional | 2013-03-31 | Completed | ||
| A Phase 3, Open-label, Multicenter, 12-month Extension Safety and Tolerability Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Residual Symptoms or Inadequate Response Following Treatmen [NCT01436175] | Phase 3 | 1,570 participants (Actual) | Interventional | 2012-02-27 | Terminated(stopped due to SPD489 failed to demonstrate a benefit as adjunctive treatment to antidepressants. Termination was not related to any new safety findings.) | ||
| The SPD489-344, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disord [NCT01718509] | Phase 3 | 390 participants (Actual) | Interventional | 2012-11-26 | Completed | ||
| Characterization and Sequential Pharmacotherapy of Severe Mood Dysregulation [NCT01714310] | Phase 2 | 34 participants (Actual) | Interventional | 2013-01-31 | Completed | ||
| Lisdexamfetamine Treatment for Cocaine Dependence [NCT00958282] | Phase 2 | 43 participants (Actual) | Interventional | 2009-07-31 | Completed | ||
| A Phase 1, Open-label, Randomized, 3-period Crossover Study Evaluating the Relative Bioavailability of SPD489 When the Contents Are Emptied Into a Soft Food and Orange Juice in Healthy Adult Subjects [NCT01890785] | Phase 1 | 30 participants (Actual) | Interventional | 2013-07-15 | Completed | ||
| Utilizing fMRI to Determine the Effects of Vyvanse® on Memory, Attention, and Brain Activity in Menopausal Women [NCT01977625] | Phase 4 | 18 participants (Actual) | Interventional | 2011-12-31 | Completed | ||
| Examining the Effects of Stimulant Medication on Emotional Lability in Patients With Attention Deficit Hyperactivity Disorder (ADHD) [NCT01415440] | 117 participants (Actual) | Interventional | 2011-08-31 | Completed | |||
| Effects of Lisdexamfetamine on Bradyphrenia in Multiple Sclerosis [NCT01615887] | Phase 2 | 63 participants (Actual) | Interventional | 2009-11-30 | Completed | ||
| Treatment Outcomes With Lisdexamfetamine Dimesylate (Vyvanse) in Children With Traumatic Brain Injury-Related Attention Deficits [NCT02712996] | Phase 4 | 20 participants (Actual) | Interventional | 2017-02-06 | Completed | ||
| Sequencing Treatments for Mothers With ADHD and Their At - Risk Children [NCT01816074] | Phase 4 | 53 participants (Actual) | Interventional | 2012-10-31 | Completed | ||
| A Phase 3, Open-label, Multicenter, 12-Month Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years Diagnosed With Attention-deficit / Hyperactivity Disorder [NCT02466386] | Phase 3 | 113 participants (Actual) | Interventional | 2015-08-21 | Completed | ||
| Effects of Lisdexamfetamine on Cognitive Control and Reward Response in Adolescents and Young Adults With ADHD: Neural and Clinical Outcomes [NCT02170298] | Phase 4 | 6 participants (Actual) | Interventional | 2014-02-28 | Terminated(stopped due to Lack of enrollment) | ||
| The SPD489-343, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disord [NCT01718483] | Phase 3 | 383 participants (Actual) | Interventional | 2012-11-26 | Completed | ||
| A Phase 3, Multicenter, Open-label, 12 Month Extension Safety and Tolerability Study of SPD489 in the Treatment of Adults With Binge Eating Disorder [NCT01657019] | Phase 3 | 604 participants (Actual) | Interventional | 2012-08-21 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
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
| Intervention | Units on a scale (Mean) |
|---|---|
| Vyvanse | -1.3 |
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
| Intervention | Participants (Number) |
|---|---|
| Vyvanse | 290 |
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. (NCT00337285)
Timeframe: up to one year
| Intervention | Units on a scale (Mean) |
|---|---|
| Vyvanse | -24.8 |
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
| Intervention | Units on a scale (Mean) |
|---|---|
| Vyvanse | -7.4 |
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
| Intervention | Units on a scale (Mean) |
|---|---|
| Vyvanse | -28.6 |
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
| Intervention | Participants (Number) |
|---|---|
| Vyvanse | 284 |
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
| Intervention | Participants (Number) |
|---|---|
| Vyvanse | 267 |
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
| Intervention | Units on a scale (Mean) | ||
|---|---|---|---|
| Global Executive Composite | Behavioral Recognition Index | Metacognition Index | |
| Vyvanse | -17.9 | -15.4 | -17.6 |
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 1, 2, 3, 4, 5, 6, and 7 weeks
| 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 |
Duration of effect will be defined as the first time point at which there is a non-significant difference between Vyvanse and placebo after a time point at which there is a significant difference between the two treatment groups as measured by SKAMP Deportment Scores. The degree of impairment is rated from 0 (normal) to 6 (maximal). (NCT00500149)
Timeframe: Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.
| Intervention | scores on a scale (Least Squares Mean) | ||||||
|---|---|---|---|---|---|---|---|
| 1.5 hours | 2.5 hours | 5 hours | 7.5 hours | 10 hours | 12 hours | 13 hours | |
| Placebo | 1.14 | 1.42 | 1.60 | 1.56 | 1.43 | 1.41 | 1.31 |
| Vyvanse | 0.70 | 0.45 | 0.44 | 0.54 | 0.60 | 0.90 | 1.05 |
The onset of effect will be defined as the first assessment time showing statistical significance between Vyvanse and placebo as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Deportment scale. The degree of impairment is rated from 0 (normal) to 6 (maximal). (NCT00500149)
Timeframe: Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.
| Intervention | scores on a scale (Least Squares Mean) | ||||||
|---|---|---|---|---|---|---|---|
| 1.5 hours | 2.5 hours | 5 hours | 7.5 hours | 10 hours | 12 hours | 13 hours | |
| Placebo | 1.14 | 1.42 | 1.60 | 1.56 | 1.43 | 1.41 | 1.31 |
| Vyvanse | 0.70 | 0.45 | 0.44 | 0.54 | 0.60 | 0.90 | 1.05 |
The outcome is the number of subjects who achieved a clinically meaningful reduction in ADHD symptoms. This is defined as a 70% reduction from baseline as measured by change in the ADHD Rating Scale (ADHD-RS). The ADHD RS quantifies symptoms on a 0-3 scale, 0 meaning never present, 1 sometimes, 2 often present, 3 very often present. For this study, the scale was clinician administered using both parent and adolescent to achieve a consensus score, or a best estimate on the clinician's part when consensus could not be achieved (NCT00573534)
Timeframe: up to 24 weeks
| Intervention | participants (Number) | |
|---|---|---|
| much improved (70 percent or more drop in ADHD-RS) | unimproved | |
| Group 1 | 6 | 2 |
This outcome measure integrates data from self report supplied in the Time Line Follow Back (a self report summary of all substance and alcohol use over the previous week or month) with evidence from periodic (weekly to monthly) urine toxicologies. (NCT00573534)
Timeframe: up to 24 weeks
| Intervention | participants (Number) | |
|---|---|---|
| none-low | intermittent | |
| Lisdexamfetamine Plus Family Therapy | 5 | 3 |
In the morning of each monitoring day, approximately 60 minutes after medication or placebo pill administration, participants were asked to either abstain from smoking or smoke their first cigarette of the day 5 minutes prior to starting the CPT. (NCT00573859)
Timeframe: 4 days
| Intervention | errors (Mean) | |||
|---|---|---|---|---|
| ADHD medication + Smoking | ADHD medication + Abstinence | Placebo + Smoking | Placebo + Abstinence | |
| ADHD Medication Versus Placebo | 0.40 | 1.08 | 1.00 | 2.8 |
The Shiffman-Jarvik withdrawal questionnaire measures nicotine withdrawal and was completed after each CPT assessment. The questionnaire consists of 25 items using 8-point scales. Total scores range from 0 to 200 and higher scores reflect higher levels of nicotine withdrawal. (NCT00573859)
Timeframe: 4 days
| Intervention | scores on a scale (Median) | |||
|---|---|---|---|---|
| ADHD medication + Smoking | ADHD medication + Abstinence | Placebo + Smoking | Placebo + Abstinence | |
| ADHD Medication Versus Placebo | 92.7 | 91.3 | 97.0 | 102.0 |
Salivary cotinine was measured across two days on ADHD medication versus two days on placebo. (NCT00573859)
Timeframe: 4 days
| Intervention | ng/ml (Mean) | |
|---|---|---|
| ADHD medication | Placebo | |
| ADHD Medication Versus Placebo | 180.7 | 274.0 |
"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)
| Intervention | units on a scale (Mean) |
|---|---|
| ADHD With Vyvanse Treatment | 8.27 |
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
| 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 |
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. (NCT00735371)
Timeframe: 1, 2, 3 and 4 Weeks
| Intervention | Participants (Number) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX) 30 mg | 44 |
| LDX 50 mg | 53 |
| LDX 70 mg | 57 |
| Placebo | 30 |
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. (NCT00735371)
Timeframe: Baseline and 4 weeks
| 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 |
The CPT is a measure of both vigilance/sustained attention and response inhibition, has good normative data and has been shown to be sensitive to the effects of stimulants. Reaction time variability and commission errors - measures of attentional control and response inhibition have been shown to be sensitive in discriminating individuals with ADHD on active medication versus placebo. (NCT00736255)
Timeframe: Randomization, Visits 1 (day 4), 2 (day 7), 3 (day 11), 4 (day 14), 5 (day 18), 6 (day 21), 7 (day 25), 8 (day 28)
| Intervention | Reaction time in seconds (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Randomization (Visit 0) | Visit 1 (day 4) | Visit 2 (day 7) | Visit 3 (day 11) | Visit 4 (day 14) | Visit 5 (day 18) | Visit 6 (day 21) | Visit 7 (day 25) | Visit 8 (day 28) | |
| LDX and NRT | 5.37 | 5.52 | 5.42 | 4.97 | 4.83 | 5.54 | 4.64 | 5.29 | 4.86 |
| NRT and Placebo | 4.61 | 4.68 | 5.05 | 5.01 | 4.79 | 5.15 | 4.97 | 5.73 | 5.08 |
This is measured by the N-Back test, a cognitive functioning, including working memory test. The test is designed with 4 Load Factors, where the current stimulus matches the one from 'n' steps back or prior in the sequence. The load factor n is adjusted so there is a 'O-back' (i.e. 'n-0'), '1-back' (i.e. 'n-1'), '2-back' (i.e. 'n-2'), and '3-back' (i.e. 'n-3'). When the correct stimulus appears on the screen, the participant then responds on the computer. Missing the stimulus decreases the proportion correct. (NCT00736255)
Timeframe: Randomization, Visits 1 (day 4), 2 (day 7), 3 (day 11), 4 (day 14), 5 (day 18), 6 (day 21), 7 (day 25), 8 (day 28)
| Intervention | proportion correct to stimuli response (Mean) | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization (Visit 0) 0-back _%cor | Randomization (Visit 0) 1-back _%cor | Randomization (Visit 0) 2-back _%cor | Randomization (Visit 0) 3-back _%cor | Visit 1 (day 4) 0-back _%cor | Visit 1 (day 4) 1-back _%cor | Visit 1 (day 4) 2-back _%cor | Visit 1 (day 4) 3-back _%cor | Visit 2 (day 7) 0-back _%cor | Visit 2 (day 7) 1-back _%cor | Visit 2 (day 7) 2-back _%cor | Visit 2 (day 7) 3-back _%cor | Visit 3 (day 11) 0-back _%cor | Visit 3 (day 11) 1-back _%cor | Visit 3 (day 11) 2-back _%cor | Visit 3 (day 11) 3-back _%cor | Visit 4 (day 14) 0-back _%cor | Visit 4 (day 14) 1-back _%cor | Visit 4 (day 14) 2-back _%cor | Visit 4 (day 14) 3-back _%cor | Visit 5 (day 18) 0-back _%cor | Visit 5 (day 18) 1-back _%cor | Visit 5 (day 18) 2-back _%cor | Visit 5 (day 18) 3-back _%cor | Visit 6 (day 21) 0-back _%cor | Visit 6 (day 21) 1-back _%cor | Visit 6 (day 21) 2-back _%cor | Visit 6 (day 21) 3-back _%cor | Visit 7 (day 25) 0-back _%cor | Visit 7 (day 25)1-back _%cor | Visit 7 (day 25) 2-back _%cor | Visit 7 (day 25) 3-back _%cor | Visit 8 (day 28) 0-back _%cor | Visit 8 (day 28) 1-back _%cor | Visit 8 (day 28) 2-back _%cor | Visit 8 (day 28) 3-back _%cor | |
| LDX and NRT | 0.96 | 0.94 | 0.96 | 0.84 | 0.95 | 0.90 | 0.89 | 0.80 | 0.93 | 0.90 | 0.86 | 0.81 | 0.89 | 0.89 | 0.89 | 0.84 | 0.93 | 0.91 | 0.90 | 0.90 | 1.00 | 0.98 | 0.99 | 0.88 | 0.93 | 0.93 | 0.90 | 0.89 | 0.99 | 0.99 | 0.97 | 0.91 | 0.93 | 0.98 | 0.92 | 0.91 |
| NRT and Placebo | 1.00 | 0.99 | 0.95 | 0.80 | 1.00 | 0.99 | 0.96 | 0.83 | 0.92 | 0.95 | 0.92 | 0.81 | 0.99 | 0.99 | 0.95 | 0.90 | 0.99 | 0.99 | 0.95 | 0.89 | 0.99 | 0.99 | 0.98 | 0.92 | 1.00 | 0.98 | 0.96 | 0.87 | 0.99 | 0.99 | 0.95 | 0.88 | 0.99 | 0.98 | 0.95 | 0.84 |
Smoking rates, measured as self-reported cigarettes/day. (NCT00736255)
Timeframe: Randomization, visits 1 (day 4), 2 (day 7), 3 (day 11), 4 (day 14), 5 (day 18), 6 (day 21), 7 (day 25), 8 (day 28)
| Intervention | Cigarettes smoked per day (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Randomization (Visit 0) | Visit 1 (day 4) | Visit 2 (day 7) | Visit 3 (day 11) | Visit 4 (day 14) | Visit 5 (day 18) | Visit 6 (day 21) | Visit 7 (day 25) | Visit 8 (day 28) | |
| LDX and NRT | 6.43 | 3.90 | 3.16 | 2.75 | 2.98 | 3.08 | 3.94 | 4.38 | 4.15 |
| NRT and Placebo | 8.14 | 2.59 | 1.83 | 2.23 | 2.10 | 2.92 | 2.67 | 2.33 | 2.91 |
The primary outcome measure was the proportion of subjects in each treatment group exhibiting sustained, 4-week smoking abstinence, defined as CO levels <= 4 ppm for each post-quit study visit. Subjects who dropped from the study for any reason were considered to have lapsed. (NCT00736255)
Timeframe: 4 weeks
| Intervention | participants (Number) |
|---|---|
| LDX and NRT | 5 |
| NRT and Placebo | 3 |
"T-scores derived from compiled ADHD symptoms from two forms. Specifically the t-scores for the DSM-IV Total subscale, representing ADHD symptoms. This is conducted by the participant and clinician at randomization, visits 2 and 4 (i.e. dose titration visits), Visit 6 (i.e. monitoring visit), and Visit 8 (i.e. final/end of study visit).~The following describes severity of the ADHD symptoms (based upon T-Score):~70+ = Very Much Above Average 66-70 = Much Above Average 61-65 = Above Average 56-60 = Slightly Above Average 45-55 = Average 30-44 = Below Average (Low scores are good)" (NCT00736255)
Timeframe: Randomization, Visits 2 (day 7), 4 (day 14), 6 (day 21), 8 (day 28)
| Intervention | T-score on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Randomization (Visit 0) | Visit 2 (day 7) | Visit 4 (day 14) | Visit 6 (day 21) | Visit 8 (day 28) | |
| LDX and NRT | 67.13 | 63.07 | 58.62 | 52.83 | 54.00 |
| NRT and Placebo | 68.08 | 64.62 | 65.25 | 63.42 | 61.92 |
Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. 1-Very Much Improved through 7-Very Much Worse. (NCT00736255)
Timeframe: Visits 2 (day 7), 4 (day 14), 6 (day 21), 8 (day 28)
| Intervention | score on a scale (Mean) | |||
|---|---|---|---|---|
| Visit 2 (day 7) CGI-I | Visit 4 (day 14) CGI-I | Visit 6 (day 21) CGI_I | Visit 8 (day 28) CGI-I | |
| LDX and NRT | 2.88 | 2.73 | 2.29 | 2.00 |
| NRT and Placebo | 3.50 | 3.38 | 3.31 | 3.15 |
The CPT is a measure of both vigilance/sustained attention and response inhibition, has good normative data and has been shown to be sensitive to the effects of stimulants. Reaction time variability and commission errors - measures of attentional control and response inhibition have been shown to be sensitive in discriminating individuals with ADHD on active medication versus placebo. (NCT00736255)
Timeframe: Randomization, Visits 1 (day 4), 2 (day 7), 3 (day 11), 4 (day 14), 5 (day 18), 6 (day 21), 7 (day 25), 8 (day 28)
| Intervention | Errors of Commission (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Randomization (Visit 0) | Visit 1 (day 4) | Visit 2 (day 7) | Visit 3 (day 11) | Visit 4 (day 14) | Visit 5 (day 18) | Visit 6 (day 21) | Visit 7 (day 25) | Visit 8 (day 28) | |
| LDX and NRT | 15.29 | 13.29 | 13.44 | 14.50 | 13.13 | 15.00 | 12.36 | 14.64 | 14.92 |
| NRT and Placebo | 12.43 | 10.71 | 10.86 | 10.79 | 11.08 | 11.15 | 12.15 | 11.77 | 11.23 |
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
| Intervention | ng/ml (Mean) |
|---|---|
| Adderall XR | 7.91 |
| Adderall XR + Prilosec OTC | 8.10 |
Total amphetamine is the d- and l-amphetamines. (NCT00746733)
Timeframe: 0 through 96 hours after dosing
| Intervention | ng/ml (Mean) |
|---|---|
| Adderall XR | 36.56 |
| Adderall XR + Prilosec OTC | 38.05 |
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
| Intervention | h (Mean) |
|---|---|
| Adderall XR | 11.98 |
| Adderall XR + Prilosec OTC | 13.06 |
Total amphetamine is the d- and l-amphetamines. (NCT00746733)
Timeframe: 0 through 96 hours after dosing
| Intervention | h (Mean) |
|---|---|
| Adderall XR | 10.38 |
| Adderall XR + Prilosec OTC | 11.05 |
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
| Intervention | h (Mean) |
|---|---|
| Vyvanse | 9.7 |
| Adderall XR | 10.25 |
| Vyvanse + Prilosec OTC | 10.4 |
| Adderall XR + Prilosec OTC | 10.91 |
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
| Intervention | h (Mean) |
|---|---|
| Vyvanse | 3.5 |
| Adderall XR | 5.2 |
| Vyvanse + Prilosec OTC | 3.5 |
| Adderall XR + Prilosec OTC | 3.3 |
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
| Intervention | h (Mean) |
|---|---|
| Adderall XR | 5.6 |
| Adderall XR + Prilosec OTC | 3.5 |
Total amphetamine is the d- and l-amphetamines. (NCT00746733)
Timeframe: 0 through 96 hours after dosing
| Intervention | h (Mean) |
|---|---|
| Adderall XR | 5.30 |
| Adderall XR + Prilosec OTC | 3.29 |
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
| Intervention | ng/ml (Mean) |
|---|---|
| Vyvanse | 45.04 |
| Adderall XR | 28.66 |
| Vyvanse + Prilosec OTC | 46.34 |
| Adderall XR + Prilosec OTC | 29.97 |
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
| Intervention | units on a scale (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-dose | 0.5 h | 1 h | 1.5 h | 2 h | 2.5 h | 3 h | 3.5 h | 4 h | 5 h | 6 h | 8 h | 12 h | 24 h | |
| Adderall XR + Prilosec OTC | 1.0 | 1.3 | 1.9 | 2.3 | 3.5 | 3.5 | 2.7 | 2.1 | 2.1 | 1.9 | 1.5 | 1.3 | 1.2 | 1.0 |
| Vyvanse + Prilosec OTC | 1.0 | 1.3 | 2.1 | 5.2 | 6.0 | 6.0 | 5.3 | 4.9 | 3.8 | 3.1 | 3.4 | 3.0 | 4.4 | 1.6 |
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
| Intervention | units on a scale (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-dose | 0.5 h | 1 h | 1.5 h | 2 h | 2.5 h | 3 h | 3.5 h | 4 h | 5 h | 6 h | 8 h | 12 h | 24 h | |
| Adderall XR + Prilosec OTC | 1.0 | 2.1 | 2.0 | 1.8 | 1.4 | 1.4 | 1.2 | 1.3 | 1.3 | 1.3 | 1.2 | 1.1 | 1.2 | 1.0 |
| Vyvanse + Prilosec OTC | 1.0 | 2.0 | 1.8 | 4.3 | 4.5 | 3.8 | 3.4 | 2.6 | 1.8 | 2.3 | 1.6 | 1.6 | 1.3 | 1.1 |
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
| Intervention | units on a scale (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-dose | 0.5 h | 1 h | 1.5 h | 2 h | 2.5 h | 3 h | 3.5 h | 4 h | 5 h | 6 h | 8 h | 12 h | 24 h | |
| Adderall XR + Prilosec OTC | 1.0 | 2.0 | 2.0 | 2.2 | 2.5 | 2.3 | 1.5 | 1.3 | 1.4 | 1.3 | 1.2 | 1.3 | 1.1 | 1.0 |
| Vyvanse + Prilosec OTC | 1.0 | 1.2 | 1.8 | 4.6 | 4.6 | 3.9 | 3.5 | 2.7 | 1.7 | 2.4 | 1.4 | 1.4 | 1.2 | 1.3 |
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. (NCT00746733)
Timeframe: Pre-dose, 2 and 8 hours after dosing
| Intervention | msec (Mean) | ||
|---|---|---|---|
| Pre-dose | 2 h | 8 h | |
| Adderall XR | 398.3 | 394.6 | 393.8 |
| Adderall XR + Prilosec OTC | 399.8 | 396.1 | 394.4 |
| Vyvanse | 399.8 | 395.0 | 390.0 |
| Vyvanse + Prilosec OTC | 399.3 | 397.9 | 395.4 |
(NCT00746733)
Timeframe: Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing
| Intervention | bpm (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Pre-dose | 1 h | 2 h | 4 h | 8 h | 12 h | 24 h | 48 h | 72 h | 96 h | |
| Adderall XR | 69.0 | 70.0 | 75.2 | 74.5 | 79.1 | 82.3 | 74.7 | 74.0 | 73.3 | 70.4 |
| Adderall XR + Prilosec OTC | 71.4 | 73.8 | 80.5 | 78.4 | 81.5 | 82.7 | 76.4 | 75.0 | 72.7 | 73.9 |
| Vyvanse | 70.9 | 69.7 | 78.2 | 79.0 | 84.8 | 86.4 | 79.9 | 73.2 | 72.2 | 70.7 |
| Vyvanse + Prilosec OTC | 73.3 | 73.4 | 83.4 | 84.4 | 87.7 | 89.1 | 80.4 | 75.1 | 72.0 | 72.5 |
(NCT00746733)
Timeframe: Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing
| Intervention | mmHg (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Pre-dose | 1 h | 2 h | 4 h | 8 h | 12 h | 24 h | 48 h | 72 h | 96 h | |
| Adderall XR | 115.3 | 121.0 | 122.2 | 120.8 | 122.4 | 121.9 | 118.1 | 112.6 | 114.8 | 114.5 |
| Adderall XR + Prilosec OTC | 113.9 | 122.6 | 124.7 | 124.2 | 119.2 | 118.4 | 115.6 | 113.6 | 116.0 | 116.1 |
| Vyvanse | 115.6 | 122.8 | 127.9 | 127.6 | 126.0 | 123.4 | 114.0 | 114.6 | 113.7 | 114.0 |
| Vyvanse + Prilosec OTC | 114.8 | 121.7 | 125.5 | 125.2 | 123.5 | 122.2 | 114.7 | 114.4 | 115.1 | 114.8 |
(NCT00746733)
Timeframe: Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing
| Intervention | mmHg (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Pre-dose | 1 h | 2 h | 4 h | 8 h | 12 h | 24 h | 48 h | 72 h | 96 h | |
| Adderall XR | 74.1 | 76.4 | 75.4 | 77.7 | 74.1 | 78.5 | 76.8 | 73.5 | 74.7 | 75.7 |
| Adderall XR + Prilosec OTC | 75.8 | 80.4 | 81.9 | 82.0 | 79.2 | 77.8 | 75.4 | 74.4 | 77.9 | 78.3 |
| Vyvanse | 76.0 | 79.2 | 79.0 | 79.9 | 78.6 | 79.6 | 75.9 | 74.5 | 75.1 | 74.5 |
| Vyvanse + Prilosec OTC | 77.7 | 80.5 | 82.0 | 82.0 | 80.3 | 78.7 | 75.0 | 77.2 | 76.1 | 75.7 |
Total amphetamine is the d- and l-amphetamines. (NCT00746733)
Timeframe: 0 through 96 hours after dosing
| Intervention | ng.h/ml (Mean) |
|---|---|
| Adderall XR | 620.68 |
| Adderall XR + Prilosec OTC | 620.91 |
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
| Intervention | ng.h/ml (Mean) |
|---|---|
| Vyvanse | 626.27 |
| Adderall XR | 473.70 |
| Vyvanse + Prilosec OTC | 687.00 |
| Adderall XR + Prilosec OTC | 472.35 |
(NCT00746733)
Timeframe: 0 through 96 hours after dosing
| Intervention | ng.h/ml (Mean) |
|---|---|
| Adderall XR | 145.28 |
| Adderall XR + Prilosec OTC | 145.83 |
Diastolic blood pressure (DBP) at maximum exertion following 3-6 months of stimulant medication, according to cardiopulmonary exercise testing (CPET) (NCT00753012)
Timeframe: 3-6 months
| Intervention | mmHg (Mean) |
|---|---|
| Normotensive Adults With ADHD | 80.43 |
| Primary Hypertensive Adults With ADHD | 85.00 |
Size of the heart's left ventricle chamber (Left Ventricular End Diastolic Dimension; LVEDD) following 3-6 months of stimulant medication, according to cardiac ultrasound (transthoracic echocardiogram; TTE) (NCT00753012)
Timeframe: 3-6 months
| Intervention | mm (Mean) |
|---|---|
| Normotensive Adults With ADHD | 44.42 |
| Primary Hypertensive Adults With ADHD | 43.57 |
Left ventricle diastolic function index, following 3-6 months of stimulant medication, according to cardiac ultrasound (transthoracic echocardiogram; TTE) (NCT00753012)
Timeframe: 3-6 months
| Intervention | cm/sec/cm/sec (Mean) |
|---|---|
| Normotensive Adults With ADHD | 1.38 |
| Primary Hypertensive Adults With ADHD | 1.36 |
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
| Intervention | T-scores (Least Squares Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX) | 8.6 |
| Methylphenidate Hydrochloride | 7.1 |
| Placebo | -0.2 |
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. (NCT00763971)
Timeframe: Up to 7 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX) | 78.0 |
| Methylphenidate Hydrochloride | 60.6 |
| Placebo | 14.4 |
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
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX) | -0.3 |
| Methylphenidate Hydrochloride | -0.3 |
| Placebo | 0.0 |
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
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX) | -24.5 |
| Methylphenidate Hydrochloride | -18.4 |
| Placebo | -3.2 |
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
| 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
| Intervention | Scores on a scale (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX) | -9.15 |
| Methylphenidate Hydrochloride | -9.71 |
| Placebo | -2.59 |
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
| 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 |
C-SSRS is a 19-item semi-structured interview designed to capture suicide-related thoughts and behaviors. (NCT00763971)
Timeframe: 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 |
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. (NCT00764868)
Timeframe: up to 52 weeks
| Intervention | Percent of participants (Number) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX) | 87.2 |
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
| Intervention | Units on a scale (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX) | 3.9 |
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
| Intervention | Units on a scale (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX) | -26.2 |
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. (NCT00784654)
Timeframe: At open-label baseline and endpoint (Week-26) of the open-label period
| Intervention | T-scores (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | 10.2 |
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. (NCT00784654)
Timeframe: At open-label baseline and endpoint (Week-26) of the open-label period
| Intervention | scores on a scale (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | 0.087 |
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. (NCT00784654)
Timeframe: At open-label baseline and endpoint (Week-26) of the open-label period
| Intervention | scores on a scale (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | -0.43 |
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. (NCT00784654)
Timeframe: Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX)(Randomized Period) | -17.1 |
| Placebo (Randomized Period) | -9.1 |
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. (NCT00784654)
Timeframe: Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX)(Randomized Period) | 1.2 |
| Placebo (Randomized Period) | 13.8 |
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. (NCT00784654)
Timeframe: Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)
| Intervention | T-scores (Least Squares Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX)(Randomized Period) | 1.1 |
| Placebo (Randomized Period) | -5.4 |
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. (NCT00784654)
Timeframe: Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX)(Randomized Period) | -0.005 |
| Placebo (Randomized Period) | -0.046 |
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. (NCT00784654)
Timeframe: Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX)(Randomized Period) | 0.01 |
| Placebo (Randomized Period) | 0.20 |
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. (NCT00784654)
Timeframe: From open-label baseline to Week-26
| Intervention | participants (Number) | |
|---|---|---|
| Suicidal ideation | Suicidal behavior | |
| Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | 1 | 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. (NCT00784654)
Timeframe: Baseline of the randomized withdrawal period to end of the study (Up to 6 weeks)
| Intervention | participants (Number) | |
|---|---|---|
| Suicidal ideation | Suicidal behavior | |
| Lisdexamfetamine Dimesylate (LDX)(Randomized Period) | 0 | 0 |
| Placebo (Randomized Period) | 0 | 0 |
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
| Intervention | percentage of improved participants (Number) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | 79.8 |
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. (NCT00784654)
Timeframe: Open-label baseline and Endpoint (Week-26)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | -26.6 |
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
| Intervention | percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Normal, not at all ill | Borderline mentally ill | Mildly ill | Moderately ill | Markedly ill | Severely ill | Among the most extremely ill | |
| Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | 39.9 | 46.5 | 1.5 | 6.6 | 4.5 | 0.5 | 0.5 |
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
| Intervention | percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Normal, not at all ill | Borderline mentally ill | Mildly ill | Moderately ill | Markedly ill | Severely ill | Among the most extremely ill | |
| Lisdexamfetamine Dimesylate (LDX)(Randomized Period) | 50.0 | 50.0 | 0 | 0 | 0 | 0 | 0 |
| Placebo (Randomized Period) | 46.8 | 53.2 | 0 | 0 | 0 | 0 | 0 |
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)
| Intervention | percentage of participants (Number) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX)(Randomized Period) | 15.8 |
| Placebo (Randomized Period) | 67.5 |
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
| Intervention | percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Normal, not at all ill | Borderline mentally ill | Mildly ill | Moderately ill | Markedly ill | Severely ill | Among the most extremely ill | |
| Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | 0 | 0 | 1.5 | 27.2 | 50.2 | 17.6 | 3.4 |
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)
| Intervention | percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Normal, not at all ill | Borderline mentally ill | Mildly ill | Moderately ill | Markedly ill | Severely ill | Among the most extremely ill | |
| Lisdexamfetamine Dimesylate (LDX)(Randomized Period) | 40.0 | 41.3 | 8.0 | 10.7 | 0 | 0 | 0 |
| Placebo (Randomized Period) | 8.2 | 19.2 | 11.0 | 39.7 | 15.1 | 6.8 | 0 |
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. (NCT00784654)
Timeframe: At open-label baseline and endpoint (Week-26) of the open-label period
| Intervention | Scores on a scale (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX)(Open-label Period) | -13.9 |
"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
| Intervention | participants (Number) |
|---|---|
| Vyvanse | 8 |
| Placebo | 17 |
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
| 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 | 5.0 | 11.7 | 11.7 | 33.3 | 35.0 | 3.3 | 0 |
| SPD489 | 32.1 | 35.7 | 17.9 | 7.1 | 7.1 | 0 | 0 |
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
| Intervention | Percent of participants (Number) |
|---|---|
| SPD489 | 8.9 |
| Placebo | 75.0 |
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
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| SPD489 | 1.6 |
| Placebo | 16.8 |
The CGI-I score at the subject's last study visit at or before Week 6, is one of the 3 secondary endpoints that contribute to the primary endpoint (CGI-E). The CGI-I scale will be used to rate improvement in the subject's condition (benefits) since baseline using the following 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse; 7=very much worse. (NCT00889915)
Timeframe: Measured at each participant's last visit, which can occur at or before Week 6
| Intervention | Units on a scale (Median) |
|---|---|
| Daytrana (Methylphenidate Transdermal System | 2.0 |
| Vyvanse (Lisdexamfetamine Dimesylate) | 2.0 |
| Concerta (Osmotic-release Oral System Methylphenidate) | 2.0 |
| Adderall (Mixed Amphetamine Salts Extended Release) | 2.0 |
The CGI-A score at the subject's last study visit at or before Week 6 is one of the 3 secondary endpoints that contribute to the primary endpoint (CGI-E). The CGI-A will be used to assess the acceptability of the study medication with respect to the subject's experience with the formulation of medication. The 7-point rating for the CGI-A will be: 1=very high acceptability, 2=high acceptability, 3=above average acceptability, 4=average acceptability, 5=low acceptability, 6=very low acceptability, 7=extremely low acceptability (NCT00889915)
Timeframe: Measured at each participant's last visit, which can occur at or before Week 6
| Intervention | Units on a scale (Median) |
|---|---|
| Daytrana (Methylphenidate Transdermal System | 3.0 |
| Vyvanse (Lisdexamfetamine Dimesylate) | 2.0 |
| Concerta (Osmotic-release Oral System Methylphenidate) | 2.0 |
| Adderall (Mixed Amphetamine Salts Extended Release) | 2.0 |
The CGI-E is the value at which the participant's Therapeutic Benefit and Adverse Impact to the study drug intersect. This number is determined by combining each participant's scores for the degree of Therapeutic Benefit versus the degree to which problems with Tolerability and/or Acceptability adversely impact the subject. Participants are then determined to be Responders or Non-responders to the study medication. For example, a subject who is very much improved (CGI-I=1) or much improved (CGI-I=2) therapeutically and whose adverse impact rating is none (score 1,5) or mild (score 2,6) will be categorized as a Responder. All others whose adverse impact rating is moderate (score 3,7,11,15)or outweighs therapeutic effect (score 4,8,12,16) will be categorized as Non-responders to study medication. The CGI scores are totaled for each participant and a mean score is calculated. A median total score was calculated for each treatment group. (NCT00889915)
Timeframe: Measured at each participant's last visit, which can occur at or before Week 6
| Intervention | Units on a scale (Median) |
|---|---|
| Daytrana (Methylphenidate Transdermal System | 7.0 |
| Vyvanse (Lisdexamfetamine Dimesylate) | 5.0 |
| Concerta (Osmotic-release Oral System Methylphenidate) | 6.0 |
| Adderall (Mixed Amphetamine Salts Extended Release) | 6.0 |
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. (NCT00905424)
Timeframe: 6 weeks
| Intervention | Percent of Participants (Number) |
|---|---|
| Antidepressant + SPD489 (Non-remitters) | 60.0 |
| Antidepressant + Placebo (Non-remitters) | 45.3 |
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. (NCT00905424)
Timeframe: 6 weeks
| Intervention | Percent of participants (Number) |
|---|---|
| Antidepressant + SPD489 (Remitters) | 65.2 |
| Antidepressant + Placebo (Remitters) | 52.4 |
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) (NCT00905424)
Timeframe: Augmentation baseline
| 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 | |
| Antidepressant + Placebo (Non-remitters) | 1.6 | 12.5 | 34.4 | 48.4 | 3.1 | 0 | 0 |
| Antidepressant + SPD489 (Non-remitters) | 1.5 | 20.0 | 40.0 | 32.3 | 6.2 | 0 | 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) (NCT00905424)
Timeframe: 6 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 | |
| Antidepressant + Placebo (Non-remitters) | 14.5 | 24.2 | 22.6 | 29.0 | 9.7 | 0 | 0 |
| Antidepressant + SPD489 (Non-remitters) | 27.0 | 31.7 | 30.2 | 9.5 | 1.6 | 0 | 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) (NCT00905424)
Timeframe: Augmentation Baseline
| 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 | |
| Antidepressant + Placebo (Remitters) | 23.8 | 71.4 | 4.8 | 0 | 0 | 0 | 0 |
| Antidepressant + SPD489 (Remitters) | 26.1 | 47.8 | 21.7 | 4.3 | 0 | 0 | 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) (NCT00905424)
Timeframe: 6 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 | |
| Antidepressant + Placebo (Remitters) | 61.9 | 23.8 | 9.5 | 4.8 | 0 | 0 | 0 |
| Antidepressant + SPD489 (Remitters) | 50.0 | 36.4 | 13.6 | 0 | 0 | 0 | 0 |
BRIEF-A is a validated 75-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). There is no range for a total score. Raw scale scores are used to develop interpretive reports. Lower scores reflect better functioning. (NCT00905424)
Timeframe: Augmentation Baseline and 6 weeks
| Intervention | Units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| Global Executive Composite | Behavioral Regulation Index | Metacognition Index | |
| Antidepressant + Placebo (Non-remitters) | -1.7 | -1.7 | -1.5 |
| Antidepressant + SPD489 (Non-remitters) | -4.7 | -3.7 | -4.8 |
BRIEF-A is a validated 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. (NCT00905424)
Timeframe: Augmentation baseline and 6 weeks
| Intervention | Units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| Global Executive Composite | Behavioral Regulation Index | Metacognition Index | |
| Antidepressant + Placebo (Remitters) | -2.7 | -1.5 | -3.4 |
| Antidepressant + SPD489 (Remitters) | -0.9 | -0.4 | -1.1 |
The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression. (NCT00905424)
Timeframe: Augmentation Baseline, 6 weeks
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Antidepressant + SPD489 (Non-remitters) | -4.9 |
| Antidepressant + Placebo (Non-remitters) | -4.0 |
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. (NCT00905424)
Timeframe: Augmentation Baseline, 6 weeks
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Antidepressant + SPD489 (Non-remitters) | -7.1 |
| Antidepressant + Placebo (Non-remitters) | -4.9 |
MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue. (NCT00905424)
Timeframe: Augmentation Baseline and 6 weeks
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Antidepressant + SPD489 (Non-remitters) | -5.3 |
| Antidepressant + Placebo (Non-remitters) | -2.3 |
QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression. (NCT00905424)
Timeframe: Augmentation Baseline and 6 weeks
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Antidepressant + SPD489 (Non-remitters) | -2.4 |
| Antidepressant + Placebo (Non-remitters) | -1.2 |
Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment. (NCT00905424)
Timeframe: Augmentation Baseline, 6 weeks
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Antidepressant + SPD489 (Non-remitters) | -3.7 |
| Antidepressant + Placebo (Non-remitters) | -1.7 |
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. (NCT00905424)
Timeframe: Augmentation Baseline and 6 weeks
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Antidepressant + SPD489 (Remitters) | 0.1 |
| Antidepressant + Placebo (Remitters) | -1.1 |
The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression. (NCT00905424)
Timeframe: Augmentation Baseline and 6 weeks
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Antidepressant + SPD489 (Remitters) | -0.8 |
| Antidepressant + Placebo (Remitters) | -1.6 |
MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue. (NCT00905424)
Timeframe: Augmentation baseline and 6 weeks
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Antidepressant + SPD489 (Remitters) | -4.0 |
| Antidepressant + Placebo (Remitters) | -0.2 |
QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression. (NCT00905424)
Timeframe: Augmentation baseline and 6 weeks
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Antidepressant + SPD489 (Remitters) | -1.9 |
| Antidepressant + Placebo (Remitters) | -0.4 |
Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment. (NCT00905424)
Timeframe: Augmentation Baseline and 6 weeks
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Antidepressant + SPD489 (Remitters) | -1.6 |
| Antidepressant + Placebo (Remitters) | -0.6 |
(NCT00919867)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
| Intervention | ng/ml (Mean) |
|---|---|
| SPD503 Alone | 2.55 |
| SPD503 + Vyvanse | 2.97 |
(NCT00919867)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
| Intervention | hours (Mean) |
|---|---|
| Vyvanse Alone | 11.2 |
| SPD503 + Vyvanse | 11.2 |
(NCT00919867)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
| Intervention | ng*h/ml (Mean) |
|---|---|
| SPD503 Alone | 104.9 |
| SPD503 + Vyvanse | 112.8 |
(NCT00919867)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
| Intervention | ng*h/ml (Mean) |
|---|---|
| Vyvanse Alone | 686.9 |
| SPD503 + Vyvanse | 708.4 |
(NCT00919867)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
| Intervention | hours (Mean) |
|---|---|
| Vyvanse Alone | 4.2 |
| SPD503 + Vyvanse | 3.9 |
(NCT00919867)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
| Intervention | ng/ml (Mean) |
|---|---|
| Vyvanse Alone | 36.48 |
| SPD503 + Vyvanse | 36.50 |
(NCT00919867)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
| Intervention | hours (Mean) |
|---|---|
| SPD503 Alone | 23.5 |
| SPD503 + Vyvanse | 21.4 |
(NCT00919867)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
| Intervention | hours (Mean) |
|---|---|
| SPD503 Alone | 8.6 |
| SPD503 + Vyvanse | 7.9 |
CGI-C permits a global evaluation of the change of the subject's overall schizophrenia condition over time. It 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. (NCT00922272)
Timeframe: Double-blind Phase Week 4
| Intervention | Percent of participants (Number) |
|---|---|
| SPD489 (Double-blind Phase) | 17.2 |
| Placebo (Double-blind Phase) | 27.6 |
CGI-C permits a global evaluation of the change of the subject's overall schizophrenia condition over time. It 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. (NCT00922272)
Timeframe: Open-label Phase Week 10
| Intervention | Percent of participants (Number) |
|---|---|
| SPD489 (Open-label Phase) | 30.0 |
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. (NCT00922272)
Timeframe: Double-blind Randomization Baseline and Week 4 Double-blind Phase
| Intervention | T-scores (Least Squares Mean) | ||
|---|---|---|---|
| Global Executive Composite | Behavioral Recognition Index | Metacognition Index | |
| Placebo (Double-blind Phase) | -1.2 | -1.6 | -0.7 |
| SPD489 (Double-blind Phase) | -1.7 | -0.9 | -2.0 |
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment. (NCT00922272)
Timeframe: Double-blind Randomization Baseline and Week 4 Double-blind Phase
| Intervention | Units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| Positive subscale | Negative subscale | General Psychopathology subscale | |
| Placebo (Double-blind Phase) | -0.1 | -0.1 | -0.9 |
| SPD489 (Double-blind Phase) | 0.5 | 0.9 | 0.9 |
The SANS assesses 5 symptom complexes to rate the negative symptoms of subjects. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. (NCT00922272)
Timeframe: Double-blind Randomization Baseline and Week 4 Double-blind Phase
| Intervention | Units on a scale (Least Squares Mean) | ||||
|---|---|---|---|---|---|
| Affective Flattening | Alogia | Avolition-Apathy | Anhedonia-Asociality | Attention | |
| Placebo (Double-blind Phase) | 0.2 | 0.0 | 0.1 | 0.1 | 0.3 |
| SPD489 (Double-blind Phase) | 0.2 | 0.5 | 0.2 | 0.3 | 0.4 |
UPSA-B assesses skills in 5 areas of life functioning. It contains 2 subscales. Percentages correct on these 2 subscales are multiplied by 50. Thus, scores can range from 0 to 50 on each of these 2 subscales, and total scores can range from 0 to 100. Scores of 75 or higher are associated with independent living. (NCT00922272)
Timeframe: Double-blind Randomization Baseline and Week 4 Double-blind Phase
| Intervention | Scores on a scale (Least Squares Mean) | ||
|---|---|---|---|
| Total Skills | Communication Skills | Financial Skills | |
| Placebo (Double-blind Phase) | 0.0 | -0.6 | 0.9 |
| SPD489 (Double-blind Phase) | -1.5 | -1.5 | -0.3 |
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness. (NCT00922272)
Timeframe: Open-label Baseline and week 10 Open-label Phase
| Intervention | Units on a scale (Mean) | ||
|---|---|---|---|
| Objective | Subjective | Global | |
| SPD489 (Open-label Phase) | 0.0 | 0.0 | 0.0 |
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness. (NCT00922272)
Timeframe: Open-label Baseline and Week 4 Double-blind Phase
| Intervention | Units on a scale (Mean) | ||
|---|---|---|---|
| Objective | Subjective | Global | |
| Placebo (Double-blind Phase) | -0.1 | -0.1 | -0.2 |
| SPD489 (Double-blind Phase) | 0.0 | 0.0 | 0.0 |
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. (NCT00922272)
Timeframe: Open-label Baseline and Week 10 Open-label Phase
| Intervention | T-scores (Mean) | ||
|---|---|---|---|
| Global Executive Composite | Behavioral Recognition Index | Metacognition Index | |
| SPD489 (Open-label Phase) | -3.9 | -3.1 | -3.9 |
Response is defined as reduction in total SANS score of greater than or equal to 20%. The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. (NCT00922272)
Timeframe: Week 10 Open-label Phase
| Intervention | Percent of participants (Number) |
|---|---|
| SPD489 (Open-label Phase) | 52.9 |
The SANS assesses 5 symptom complexes to rate the negative symptoms of subjects. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. (NCT00922272)
Timeframe: Open-label Baseline and Week 10 Open-label Phase
| Intervention | Units on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Affective Flattening | Alogia | Avolition-Apathy | Anhedonia-Asociality | Attention | |
| SPD489 (Open-label Phase) | -0.9 | -0.9 | -0.5 | -0.7 | -0.7 |
UPSA-B assesses skills in 5 areas of life functioning. It contains 2 subscales. Percentages correct on these 2 subscales are multiplied by 50. Thus, scores can range from 0 to 50 on each of these 2 subscales, and total scores can range from 0 to 100. Scores of 75 or higher are associated with independent living. (NCT00922272)
Timeframe: Open-label Baseline and week 10 Open-label Phase
| Intervention | Scores on a scale (Mean) | ||
|---|---|---|---|
| Total Skills | Communication Skills | Financial Skills | |
| SPD489 (Open-label Phase) | 6.2 | 3.7 | 2.5 |
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) (NCT00922272)
Timeframe: Double-blind Randomization Baseline
| 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 (Double-blind Phase) | 0 | 2.9 | 60.0 | 37.1 | 0 | 0 | 0 |
| SPD489 (Double-blind Phase) | 0 | 2.9 | 50.0 | 38.2 | 8.8 | 0 | 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) (NCT00922272)
Timeframe: Week 10 Open-label Phase
| 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 | |
| SPD489 (Open-label Phase) | 0 | 2.9 | 54.3 | 38.6 | 4.3 | 0 | 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) (NCT00922272)
Timeframe: Week 4 Double-blind Phase
| 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 (Double-blind Phase) | 0 | 13.8 | 69.0 | 13.8 | 3.4 | 0 | 0 |
| SPD489 (Double-blind Phase) | 0 | 3.4 | 34.5 | 48.3 | 13.8 | 0 | 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) (NCT00922272)
Timeframe: Open-label Baseline
| 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 | |
| SPD489 (Open-label Phase) | 0 | 0 | 29.3 | 55.4 | 14.1 | 1.1 | 0 |
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment. (NCT00922272)
Timeframe: Open-label Baseline and Week 10 Open-label Phase
| Intervention | Units on a scale (Mean) | ||
|---|---|---|---|
| Positive subscale | Negative subscale | General Psychopathology subscale | |
| SPD489 (Open-label Phase) | -1.0 | -4.8 | -4.0 |
PSQI evaluates 7 areas of quality and pattern of sleep. Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality. (NCT00922272)
Timeframe: Open-label Baseline and Week 4 Double-blind Phase
| Intervention | Units on a scale (Mean) |
|---|---|
| SPD489 (Double-blind Phase) | 0.3 |
| Placebo (Double-blind Phase) | -1.7 |
ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity. (NCT00922272)
Timeframe: Double-blind Randomization Baseline and Week 4 Double-blind Phase
| Intervention | Units on a scale (Mean) |
|---|---|
| SPD489 (Double-blind Phase) | 0.4 |
| Placebo (Double-blind Phase) | -2.9 |
BACS measures attention and speed of processing, and the test score is the total number correct. The measure of the test is the number of correct numerals where subjects write numerals 1-9 as matches to nonmeaningful symbols on a response sheet for 90 seconds, based upon a key provided to them. (NCT00922272)
Timeframe: Double-blind Randomization Baseline and Week 4
| Intervention | correct numerals (Least Squares Mean) |
|---|---|
| SPD489 (Double-blind Phase) | 0.1 |
| Placebo (Double-blind Phase) | -2.7 |
HVLT-R measures verbal learning. Test scores are the total number of words recalled correctly over 3 trials. The test consists of 12 nouns read aloud for 3 consecutive trials and each trial is followed by a recall test. (NCT00922272)
Timeframe: Double-blind Randomization Baseline and week 4 Double-blind Phase
| Intervention | words recalled (Least Squares Mean) |
|---|---|
| SPD489 (Double-blind Phase) | -1.5 |
| Placebo (Double-blind Phase) | 1.0 |
LNS is a test of verbal working memory. Subjects are presented with a sequence of numbers and letters aurally and then asked to tell the rater the numbers first from lowest to highest followed by the letters in alphabetical sequence. The measure is the number of correct sequences. (NCT00922272)
Timeframe: Double-blind Randomization Baseline and Week 4
| Intervention | correct sequences (Least Squares Mean) |
|---|---|
| SPD489 (Double-blind Phase) | -0.1 |
| Placebo (Double-blind Phase) | 1.3 |
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. (NCT00922272)
Timeframe: Double-blind Randomization Baseline and Week 4 Double-blind Phase
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| SPD489 (Double-blind Phase) | 4.5 |
| Placebo (Double-blind Phase) | 2.2 |
ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity. (NCT00922272)
Timeframe: Open-label Baseline and Week 10 Open-label Phase
| Intervention | Units on a scale (Mean) |
|---|---|
| SPD489 (Open-label Phase) | -1.8 |
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression. (NCT00922272)
Timeframe: Open-label Baseline and Week 10 Open-label Phase
| Intervention | Units on a scale (Mean) |
|---|---|
| SPD489 (Open-label Phase) | -0.7 |
HVLT-R measures verbal learning. Test scores are the total number of words recalled correctly over 3 trials. The test consists of 12 nouns read aloud for 3 consecutive trials and each trial is followed by a recall test. (NCT00922272)
Timeframe: Open-label Baseline and Week 10
| Intervention | words recalled (Mean) |
|---|---|
| SPD489 (Open-label Phase) | 0.7 |
LNS is a test of verbal working memory. Subjects are presented with a sequence of numbers and letters aurally and then asked to tell the rater the numbers first from lowest to highest followed by the letters in alphabetical sequence. The measure is the number of correct sequences. (NCT00922272)
Timeframe: Open-label Baseline and week 10 Open-label Phase
| Intervention | correct sequences (Mean) |
|---|---|
| SPD489 (Open-label Phase) | 0.8 |
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. (NCT00922272)
Timeframe: Open-label Baseline and Week 10 Open-label Phase
| Intervention | Units on a scale (Mean) |
|---|---|
| SPD489 (Open-label Phase) | -12.9 |
PSQI evaluates 7 areas of quality and pattern of sleep. Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality. (NCT00922272)
Timeframe: Open-label Baseline and Week 10 Open-label Phase
| Intervention | Units on a scale (Mean) |
|---|---|
| SPD489 (Open-label Phase) | -0.7 |
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment. (NCT00922272)
Timeframe: Open-label Baseline and Week 4 Double-blind Phase
| Intervention | Units on a scale (Mean) |
|---|---|
| SPD489 (Double-blind Phase) | 0.00 |
| Placebo (Double-blind Phase) | 0.00 |
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment. (NCT00922272)
Timeframe: Open-label Baseline and Week 10 Open-label Phase
| Intervention | Units on a scale (Mean) |
|---|---|
| SPD489 (Open-label Phase) | -0.01 |
BACS measures attention and speed of processing, and the test score is the total number correct. The measure of the test is the number of correct numerals where subjects write numerals 1-9 as matches to nonmeaningful symbols on a response sheet for 90 seconds, based upon a key provided to them. (NCT00922272)
Timeframe: Open-label Baseline and week 10 Open-label Phase
| Intervention | correct numerals (Mean) |
|---|---|
| SPD489 (Open-label Phase) | 2.3 |
Response is defined as reduction in total SANS score of greater than or equal to 20%. The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. (NCT00922272)
Timeframe: Week 4 Double-blind Phase
| Intervention | Percent of participants (Number) |
|---|---|
| SPD489 (Double-blind Phase) | 71.4 |
| Placebo (Double-blind Phase) | 82.4 |
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression. (NCT00922272)
Timeframe: Open-label Baseline and Week 4 of Double-blind Phase
| Intervention | Units on a scale (Mean) |
|---|---|
| SPD489 (Double-blind Phase) | -0.1 |
| Placebo (Double-blind Phase) | -0.7 |
"On a weekly basis, patients completed measures of cocaine craving using the Minnesota Cocaine Craving Scale.~The Minnesota Cocaine Craving Scale is a self report questionnaire and ranges from 0 to 100, 0 being very little to 100 being very much." (NCT00958282)
Timeframe: 14 Weeks
| Intervention | units on a scale (Mean) |
|---|---|
| Lisdexamfetamine | 17.5 |
| Placebo | 28.7 |
At each visit, subjects provided urine samples, which were analyzed for benzoylecgonine (BE; a cocaine metabolite). BE was assessed semi-quantitatively using the PROFILE® -V MEDTOXScan® Drugs of Abuse Test System, with cocaine positive tests equaling or exceeding 150 ng/mL. (NCT00958282)
Timeframe: 14 Weeks
| Intervention | percentage of BE urine tests (Mean) |
|---|---|
| Lisdexamfetamine | 86.5 |
| Placebo | 92.4 |
This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning. (NCT00985725)
Timeframe: Baseline and week 9
| Intervention | Scores on a scale (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX) | 2.5 |
| Placebo | 2.4 |
The EWPS quantifies work performance, productivity attitudes and behaviors assessing 25 items on a scale ranging from 0 (high performance) to 4 (lowest performance). Scores range from 0 to 100 with 100 representing lowest productivity. (NCT00985725)
Timeframe: Baseline and up to 9 weeks/Endpoint
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX) | -20.4 |
| Placebo | -15.9 |
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. (NCT00985725)
Timeframe: Baseline and week 9
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX) | -5.0 |
| Placebo | -3.1 |
BRIEF-A is a validated 75-item questionnaire. 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. (NCT00985725)
Timeframe: Baseline and week 9
| Intervention | T-scores (Least Squares Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Behavioral recognition index | Inhibit subscale | Shift subscale | Emotional control subscale | Self-monitor subscale | Metacognition index | Initiate subscale | Working memory subscale | Plan/Organize subscale | Task monitor subscale | Organization of materials subscale | |
| Lisdexamfetamine Dimesylate (LDX) | -17.4 | -13.5 | -16.2 | -13.8 | -13.8 | -21.1 | -19.4 | -20.1 | -18.7 | -16.8 | -15.2 |
| Placebo | -12.3 | -9.3 | -10.6 | -10.1 | -10.7 | -12.2 | -10.8 | -11.0 | -11.3 | -11.9 | -8.2 |
This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning. (NCT00985725)
Timeframe: Baseline and week 9
| Intervention | Scores on a scale (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX) | 2.7 |
| Placebo | 1.6 |
The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. Each of the 12 items is scored using various scales with a total score ranging from 0 (lowest level of health) to 100 (highest level of health). (NCT00985725)
Timeframe: Baseline and week 9
| Intervention | Scores on a scale (Mean) | |
|---|---|---|
| Aggregate physical | Aggregate mental | |
| Lisdexamfetamine Dimesylate (LDX) | -0.10 | 0.69 |
| Placebo | -0.23 | 0.63 |
The Q-LES-Q is a 93-item self-report questionnaire on quality of life and health. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good) with a total score ranging from 93 to 465. Higher scores indicate greater satisfaction. (NCT00985725)
Timeframe: Baseline and up to 9 weeks/Endpoint
| Intervention | Scores on a scale (Mean) | |
|---|---|---|
| Physical health activities | Overall life satisfaction | |
| Lisdexamfetamine Dimesylate (LDX) | 17.9 | 12.1 |
| Placebo | 8.2 | 9.1 |
This measures the speed and accuracy of basic mental functions. Scores are normalized from raw scores and present an age matched score relative to other people in a normative sample. Scores are normalized with a mean of 100 and standard deviation of 15. Scores < 70 indicate likely deficit and impairment, and scores > 110 indicate high function and capacity. Higher scores are better. (NCT00985725)
Timeframe: Baseline and up to 9 weeks/Endpoint
| Intervention | Response scores (Mean) | ||
|---|---|---|---|
| Complex information speed processing index | Executive function index | Neurocognitive index | |
| Lisdexamfetamine Dimesylate (LDX) | 8.7 | 11.0 | 11.5 |
| Placebo | 3.7 | 6.0 | 2.5 |
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. (NCT00985725)
Timeframe: Week 9
| Intervention | percentage of participants (Number) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX) | 60.6 |
| Placebo | 38.9 |
The GAD-7 is a 7-item self-report questionnaire for assessing anxiety severity. Each item is scored using a scale that ranges from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 21. Lower scores indicate a reduction in anxiety. (NCT00985725)
Timeframe: Baseline and week 9
| Intervention | Scores on a scale (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX) | -4.4 |
| Placebo | -3.8 |
The STS is an 8-question clinician-rated assessment of suicidal ideation, suicidal behavior, and accidents. The items are scored on a 5-point Likert scale from 0 (not at all) to 4 (extremely) and summed to produce a total score ranging from 0 to 32. Lower scores indicate reduced suicidal tendencies. (NCT00985725)
Timeframe: Baseline and week 9
| Intervention | Scores on a scale (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX) | -0.1 |
| Placebo | 0.0 |
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. (NCT00985725)
Timeframe: Baseline and week 9
| Intervention | T-scores (Least Squares Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX) | -21.2 |
| Placebo | -13.2 |
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) (NCT00985725)
Timeframe: Up to 9 weeks/Endpoint
| Intervention | percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Normal, not at all ill | Borderline mentally ill | Mildly ill | Moderately ill | Markedly ill | Severely ill | Among the most extremely ill | |
| Lisdexamfetamine Dimesylate (LDX) | 21.7 | 40.6 | 20.3 | 14.5 | 2.9 | 0.0 | 0.0 |
| Placebo | 15.9 | 23.2 | 24.6 | 34.8 | 1.4 | 0.0 | 0.0 |
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) (NCT00985725)
Timeframe: Baseline
| Intervention | percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Normal, not at all ill | Borderline mentally ill | Mildly ill | Moderately ill | Markedly ill | Severely ill | Among the most extremely ill | |
| Lisdexamfetamine Dimesylate (LDX) | 0.0 | 7.0 | 42.3 | 45.1 | 4.2 | 1.4 | 0.0 |
| Placebo | 2.8 | 8.3 | 36.1 | 48.6 | 4.2 | 0.0 | 0.0 |
ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity. (NCT00985725)
Timeframe: Baseline and week 11
| Intervention | Scores on a scale (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate (LDX) | -9.4 |
| Placebo | -5.9 |
"The CAARS:L is an assessment tool that prompts an observer to provide valuable information about the client. This instrument is helpful when considering a diagnosis of ADHD or related problem. High scores on the Inattention/Memory Problems sub-scale may indicate difficulty in concentration, difficulty planning or completing tasks, forgetfulness, absent-mindedness, and/or being disorganized.~T-scores (M = 50, SD = 10) are used to measure ratings with higher t-scores indicating greater inattention and memory problems. When a t-score is around 60, this indicates greater risk." (NCT01000064)
Timeframe: 12 weeks
| Intervention | t-scores (Mean) |
|---|---|
| Vyvanse | 51.25 |
| Placebo | 56.33 |
"The BRIEF-A is a standardized rating scale developed to observe everyday behaviors associated with specific domains of the executive functions in adults ages 18 to 90 years. The Organization of Materials scale measures orderliness of work, living, and storage spaces.~T-scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning on the BRIEF-A, with higher scores indicating more difficulty in a particular area." (NCT01000064)
Timeframe: 12 weeks
| Intervention | t-scores (Mean) |
|---|---|
| Vyvanse | 48.55 |
| Placebo | 56.00 |
"Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition.~CPT-II Preservations represent responses in which reaction time was less than 100 ms; these responses are assumed to be anticipatory, random, or slow/inattentive (i.e., carried over from the previous response) because it is physiologically impossible to respond accurately in so short a time. Higher T-scores, percentiles, and means indicate worse performance." (NCT01000064)
Timeframe: 12 weeks
| Intervention | ms (Mean) |
|---|---|
| Vyvanse | 50.23 |
| Placebo | 59.76 |
Digit Span repeats strings of digits of increasing length said by the examiner in the same (forward) and in reverse (backward) order. It measures working memory and concentration with a range of scaled scores from 1-19, with higher scaled scores indicating better performance when compared to population norms. (NCT01000064)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| Vyvanse | 11.60 |
| Placebo | 9.40 |
"Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition.~CPT-II Hit Reaction Time (RT) Standard Error (SE) measures inattention. Consistency of response times is measured by the standard error for responses to targets. Higher values indicate a greater amount of inattention." (NCT01000064)
Timeframe: 12 weeks
| Intervention | ms (Mean) |
|---|---|
| Vyvanse | 54.26 |
| Placebo | 64.04 |
"Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition.~CPT-II Hit Reaction Time (RT) Block Change measures inattention and vigilance. Lower values indicate less slowing in RT as the test progressed. High T-scores indicate decreased vigilance over time." (NCT01000064)
Timeframe: 12 weeks
| Intervention | t-scores (Mean) |
|---|---|
| Vyvanse | 47.70 |
| Placebo | 54.21 |
"Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition.~CPT-II Hit Reaction Time (RT) Inter-Stimulus Interval (ISI) Change assesses the ability to adapt to changing inter-stimulus intervals. Inter-stimulus intervals refers to the amount of time between presentation of stimuli. High t-scores indicate that RT increased as the ISI increased; negative values indicate that RT decreased as the ISI increased.~Less Hit RT ISI Change indicates less variability in RT depending on the speed of presentation." (NCT01000064)
Timeframe: 12 weeks
| Intervention | t-scores (Mean) |
|---|---|
| Vyvanse | 58.08 |
| Placebo | 65.93 |
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
| 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
| 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 |
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
| 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 |
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
| 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 |
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
| 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
| 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 |
The CGI-I score indicates the clinician's overall assessment of improvement in function from one visit to the next. The single item is scored from 1 to 7 with anchor points ranging from very much improved (1) to very much worse (7). A decrease in score reflects an improvement in functional status. (NCT01051440)
Timeframe: week 1 and week 9
| Intervention | units on a scale (Number) |
|---|---|
| Placebo | 0 |
| Lisdexamfetamine | -2 |
The change in MADRS score from the baseline visit to the week 8 visit is reported. The MADRS is a clinician-rated scale that consists of 10 items rated on a from 0 to 6 (maximum score of 60), with higher scores indicating greater symptom severity. An increase in score indicates a worsening of symptoms whereas a decrease indicates an improvement in symptoms. (NCT01051440)
Timeframe: baseline and 8 weeks
| Intervention | units on a scale (Number) |
|---|---|
| Placebo | 4 |
| Lisdexamfetamine | -22 |
"The CGI-S score reflects the clinician's overall impression of the patient's functional status. The scoring for the single item ranges from 1 with an anchor of normal, not at all ill to 7 with an anchor of among the most extremely ill patients. Thus, higher scores indicate greater severity of symptoms." (NCT01051440)
Timeframe: baseline and week 8
| Intervention | units on a scale (Number) |
|---|---|
| Placebo | 1 |
| Lisdexamfetamine | -2 |
To perform secondary psychometric validations of the AMSES using Cronbach's alpha coefficients. (NCT01070394)
Timeframe: Weeks 0-12
| Intervention | Cronbach's alpha coefficients (Number) | |
|---|---|---|
| In Clinic | Evening | |
| Overall Study | .92 | .87 |
"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
| Intervention | units on a scale (Mean) |
|---|---|
| Overall Study | 13.9 |
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
| Intervention | Pearson's correlation coefficient (Number) |
|---|---|
| Treatment Arm | .66 |
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
| Intervention | Pearson's correlation coefficient (Number) |
|---|---|
| Overall Study | .83 |
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
| Intervention | Pearson's correlation coefficient (Number) | |
|---|---|---|
| In Clinic | Evening | |
| Overall Study | .96 | .96 |
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
| Intervention | units on a scale (Mean) | |
|---|---|---|
| In Clinic | Evening | |
| Overall Study | 1.31 | -3.34 |
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
| Intervention | units on a scale (Mean) | |
|---|---|---|
| In Clinic | Evening | |
| Overall Study | 27.99 | 26.9 |
To perform secondary psychometric validations of the AMRS using Cronbach's alpha coefficients. (NCT01070394)
Timeframe: Weeks 0-12
| Intervention | Cronbach's alpha coefficients (Number) | |
|---|---|---|
| In Clinic | Evening | |
| Overall Study | .99 | .97 |
The Fatigue Severity Scale is designed to measure the impact of fatigue on the life of the subject. It is a nine-question likert scale survey with a raw score range of 0-63. Scores of 36 and above indicate significant fatigue. In this study, we compared the mean change in the Fatigue Severity Scale (FSS) from baseline to endpoint between LDX and placebo treated patients. (NCT01071044)
Timeframe: Every 2 weeks
| Intervention | Scores on a scale (Mean) |
|---|---|
| Treatment Group | 20.92 |
| Control Group | 5.00 |
"The Fibromyalgia Impact Questionnaire (FIQ) is an assessment that quantifies the impact of fibromyalgia on an individual, including questions on pain level, fatigue, sleep disturbance, and psychological distress, among others. The score range is 0 to 100, with higher number indicating higher Fibromyalgia severity/impact.~Below, we compare the mean change in the Fibromyalgia Impact Questionnaire (FIQ) from baseline to week 6 between LDX and placebo treated patients." (NCT01071044)
Timeframe: Every 2 weeks
| Intervention | Scores on a scale (Mean) |
|---|---|
| Treatment Group | 20.90 |
| Control Group | 8.83 |
The McGill Pain Questionniare (Short Form) consists of 15 pain descriptors (11 sensory; 4 affective) which are rated on an intensity scale. 0 = none, 1 = mild, 2 = moderate or 3 = severe. The sum of the intensity scores of the words chosen for sensory, affective and total descriptors are added for a total score. The score range is 0-45. In this study, we compared the change in the Short Form McGill Pain Questionnaire (SF-MPQ) from baseline to week 6 between LDX and placebo treated patients. (NCT01071044)
Timeframe: Every 2 weeks
| Intervention | Scores on a scale (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate | 10.38 |
| Control Group | 2.45 |
The Hamilton Anxiety Scale is a 14-items clinician-rated scale designed to measure anxiety severity. Each of the 14 items is scored from 0 (symptom not persent) to 4 (severe symptom). The total range is 0-56. A total score of less than 17 indicates mild severity, 18-24 indicates mild to moderate severity, and a score of 25-30 indicates moderate to severe symptoms. In this study, we compared the mean change in the Hamilton Anxiety scale from baseline to week 6 between LDX and placebo-treated patients. (NCT01071044)
Timeframe: Every 2 weeks
| Intervention | Scores on a scale (Mean) |
|---|---|
| Treatment Group | 11.31 |
| Control Group | 6.18 |
The Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) is an 18-item scale based on DSM-IV criteria for ADHD. Each item is rated using a likert scale from 0 (none) to 3 (severe), with a total score range of 0-54, with higher scores indicating more symptoms/severity. In this study, we compared mean change in ADHD-RS total score from baseline to endpoint of the study. (NCT01071044)
Timeframe: Every 2 weeks
| Intervention | Scores on a scale (Mean) |
|---|---|
| Treatment Group | 18.17 |
| Control Group | 8.73 |
The BRIEF-A (Behavior Rating Inventory of Executive Function-- Adult Form) is comprised of the following sub-scales: Metacognition Index, Behavioral Regulation Index, Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organziation of Material. These subscales are summed to provide the GEC or Global Executive Composite. Listed below are the mean improvement scores on the GEC index from baseline to endpoint. The Global Executive Composite raw score range is 70-182, with higher scores indicating more compromised executive functioning. The scores listed in the table depict mean improvement on the GEC from the beginning to the end of the study. (NCT01071044)
Timeframe: Every 2 weeks
| Intervention | Scores on a scale (Mean) |
|---|---|
| Treatment Group | 21.38 |
| Control Group | 3.36 |
The Clinical Global Impression (Severity) is a one-item clinician-rated measure. The item is a likert scale on which the clinician rates the subject based on perceived severity of psychopathology, with higher numbers indicating higher severity. In this study, we compared the mean change in severity from baseline to endpoint. (NCT01071044)
Timeframe: Every visit
| Intervention | Scores on a scale (Mean) |
|---|---|
| Treatment Group | 1.92 |
| Control Group | .64 |
PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses. (NCT01096680)
Timeframe: Over a period of 12 hours
| Intervention | msec (Least Squares Mean) |
|---|---|
| SPD489 20 mg | 243.6 |
| SPD489 50 mg | 234.8 |
| SPD489 70 mg | 243.5 |
| Armodafinil 250 mg | 243.7 |
| Placebo | 270.2 |
"The MWT was conducted to determine the subjects' ability to stay awake. Subjects sat in a darkened room and were told to stay awake as long as possible during the 30 minute session. This is an indicator of how well you are able to function and remain alert in quiet times of inactivity. Higher times are better." (NCT01096680)
Timeframe: Over a period of 8 hours
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| SPD489 20 mg | 23.3 |
| SPD489 50 mg | 27.9 |
| SPD489 70 mg | 29.3 |
| Armodafinil 250 mg | 27.6 |
| Placebo | 15.3 |
The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better. (NCT01096680)
Timeframe: Over a period of 15 hours
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| SPD489 20 mg | 4.7 |
| SPD489 50 mg | 4.0 |
| SPD489 70 mg | 3.6 |
| Armodafinil 250 mg | 4.7 |
| Placebo | 5.2 |
PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses. (NCT01096680)
Timeframe: Over a period of 12 hours
| Intervention | msec (Least Squares Mean) | ||||||
|---|---|---|---|---|---|---|---|
| 9:15pm | 11:15pm | 1:15am | 3:15am | 5:15am | 7:15am | 9:15am | |
| Armodafinil 250 mg | 235.5 | 229.3 | 233.0 | 242.5 | 249.5 | 259.1 | 256.7 |
| Placebo | 241.3 | 249.3 | 256.7 | 280.7 | 291.6 | 295.5 | 276.1 |
| SPD489 20 mg | 231.6 | 232.6 | 231.5 | 243.6 | 253.4 | 257.9 | 254.8 |
| SPD489 50 mg | 233.2 | 230.9 | 231.5 | 227.4 | 237.7 | 242.6 | 240.0 |
| SPD489 70 mg | 234.9 | 231.2 | 230.2 | 240.7 | 242.5 | 259.2 | 265.9 |
The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better. (NCT01096680)
Timeframe: Over a period of 15 hours
| Intervention | Units on a scale (Least Squares Mean) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7:50pm | 8:50pm | 9:50pm | 10:50pm | 11:50pm | 12:50am | 1:50am | 2:50am | 3:50am | 4:50am | 5:50am | 6:50am | 7:50am | 8:50am | 9:50am | 10:50am | |
| Armodafinil 250 mg | 2.6 | 2.7 | 3.1 | 2.9 | 3.4 | 3.3 | 3.8 | 4.7 | 5.5 | 6.0 | 6.3 | 6.7 | 6.6 | 6.0 | 5.7 | 6.0 |
| Placebo | 2.8 | 3.0 | 3.1 | 3.7 | 3.9 | 4.5 | 4.7 | 5.7 | 6.4 | 6.6 | 7.1 | 7.3 | 7.2 | 5.4 | 5.9 | 6.2 |
| SPD489 20 mg | 2.9 | 2.7 | 2.9 | 2.8 | 3.2 | 3.6 | 4.0 | 4.5 | 5.2 | 6.1 | 6.7 | 6.7 | 6.5 | 5.9 | 5.6 | 6.2 |
| SPD489 50 mg | 3.0 | 2.7 | 3.1 | 3.2 | 3.1 | 2.9 | 3.2 | 3.7 | 3.9 | 4.4 | 5.1 | 5.7 | 5.5 | 5.0 | 4.6 | 5.4 |
| SPD489 70 mg | 2.6 | 2.6 | 2.6 | 2.4 | 2.5 | 2.6 | 3.0 | 3.5 | 3.7 | 4.2 | 4.6 | 4.8 | 4.7 | 4.4 | 4.5 | 5.0 |
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
| Intervention | Scores on a scale (Least Squares Mean) | |
|---|---|---|
| Living with ADHD | General Well-being | |
| Placebo | 4.9 | 9.0 |
| SPD489 | 14.0 | 19.7 |
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
| 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 |
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
| 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
| 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
| Intervention | T-scores (Least Squares Mean) |
|---|---|
| SPD489 | -22.3 |
| Placebo | -11.1 |
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. (NCT01101022)
Timeframe: Up to 10 weeks post-dose
| 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
| 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
| 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 |
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
| Intervention | Scores on a scale (Least Squares Mean) | |
|---|---|---|
| Question 1 | Question 4 | |
| Placebo | 1.0 | -0.4 |
| SPD489 | 1.6 | -1.0 |
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
| 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
| 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
| 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 |
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
| 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
| 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
| 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
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Lisdexamfetamine Dimesylate | -26.1 |
| Atomoxetine Hydrochloride | -19.7 |
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. (NCT01106430)
Timeframe: Baseline and up to 9 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Lisdexamfetamine Dimesylate | -0.35 |
| Atomoxetine Hydrochloride | -0.27 |
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. (NCT01106430)
Timeframe: up to 9 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate | 0.920 |
| Atomoxetine Hydrochloride | 0.922 |
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. (NCT01106430)
Timeframe: 9 weeks
| 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
| 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
| 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
| 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 |
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. (NCT01106430)
Timeframe: Baseline and up to 9 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate | -10.7 |
| Atomoxetine Hydrochloride | -7.9 |
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)
| 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 |
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)
| Intervention | number of child problems endorsed (Mean) |
|---|---|
| Placebo Arm | 9.30 |
| Treatment Arm | 8.67 |
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)
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo Arm | 3.78 |
| Treatment Arm | 2.36 |
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
| Intervention | units on a scale (Mean) |
|---|---|
| Unmedicated | 0.04 |
| Optimal Dose of Medication | 0.26 |
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)
| Intervention | mm Hg (Mean) | |
|---|---|---|
| systolic BP | diastolic BP | |
| Placebo Arm | 123.40 | 76.10 |
| Treatment Arm | 122.33 | 75.11 |
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
| 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 |
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
| 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 |
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
| Intervention | units on a 0 to 10 scale (Mean) |
|---|---|
| Unmedicated | 6.26 |
| Optimal Dose of Medication | 3.17 |
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)
| 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 |
"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
| 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 |
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)
| Intervention | Percentage of behaviors (Mean) | ||||
|---|---|---|---|---|---|
| Parent praise | Parent negative talk | Parent demandingness | Parent impatient | Parent responsive | |
| Medication - Homework Task | 2.8 | 21.1 | 21.7 | 34.1 | 63.8 |
| Medication Non-academic Task | 5.7 | 12.6 | 12.7 | 26.3 | 77.3 |
| Placebo - Homework Task | 1.2 | 5.3 | 21.8 | 42.4 | 69.8 |
| Placebo - Non-academic Task | 6.0 | 5.9 | 23.5 | 38.7 | 89.7 |
"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)
| 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 |
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)
| 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 |
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. Average number of behaviors per group 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)
| Intervention | behaviors (Mean) | ||
|---|---|---|---|
| Verbalizations | Commands | inappropriate child behavior | |
| Medication - Homework Task | 53.8 | 11.0 | 3.8 |
| Medication Non-academic Task | 40.1 | 4.9 | 1.5 |
| Placebo - Homework Task | 67.2 | 14.5 | 6.8 |
| Placebo - Non-academic Task | 42.1 | 9.0 | 1.4 |
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)
| 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 |
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)
| 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 |
"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)
| 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 |
"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
| 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 |
"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)
| 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 |
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
| 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 |
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)
| 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 |
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)
| Intervention | kg (Mean) |
|---|---|
| Placebo Arm | 76.0 |
| Treatment Arm | 69.62 |
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)
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo Arm | 4.36 |
| Treatment Arm | 2.26 |
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)
| Intervention | bpm (Mean) |
|---|---|
| Placebo Arm | 74.44 |
| Treatment Arm | 77.13 |
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)
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo Arm | 0.28 |
| Treatment Arm | 0.26 |
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)
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo Arm | 241.54 |
| Treatment Arm | 262.67 |
"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)
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo Arm | 79.00 |
| Treatment Arm | 80.00 |
The Montgomery-Asberg Depression Rating Scale Dysphoric Apathy Retardation subfactor (MDAR) is a 5-item subscale of the clinician-administered 10-item Montgomery-Asberg Depression Rating Scale (MADRS). MDAR score can range from 0-30 with a higher score representing a greater severity of depressive symptoms. (NCT01148979)
Timeframe: Baseline to 4 weeks of treatment
| Intervention | scores on a scale (Mean) | ||
|---|---|---|---|
| Baseline Mean MDAR score | Week 4 Mean MDAR score | Change from BL in mean MDAR score | |
| Lisdexamfetamine Dimesylate (Vyvanse) | 13.46 | 6.36 | -7.08 |
| Placebo Adjunct | 12.57 | 9.08 | -3.49 |
(NCT01235338)
Timeframe: Day 15 and Day 30 (24 hour sampling)
| Intervention | ng*hr/ml (Mean) | |
|---|---|---|
| Day 15 | Day 30 | |
| LDX + Venlafaxine XR | 0 | 10673.9 |
| Venlafaxine XR + LDX | 10738.0 | 10342.2 |
(NCT01235338)
Timeframe: Day 15 and Day 30 (24 hour sampling)
| Intervention | ng*hr/ml (Mean) | |
|---|---|---|
| Day 15 | Day 30 | |
| LDX + Venlafaxine XR | 1143.4 | 1135.4 |
| Venlafaxine XR + LDX | 0 | 1049.2 |
(NCT01235338)
Timeframe: Day 15 and Day 30 (24 hour sampling)
| Intervention | ng*hr/ml (Mean) | |
|---|---|---|
| Day 15 | Day 30 | |
| LDX + Venlafaxine XR | 0 | 8061.3 |
| Venlafaxine XR + LDX | 8363.3 | 6955.1 |
(NCT01235338)
Timeframe: Day 15 and Day 30 (24 hour sampling)
| Intervention | ng*hr/ml (Mean) | |
|---|---|---|
| Day 15 | Day 30 | |
| LDX + Venlafaxine XR | 0 | 2839.7 |
| Venlafaxine XR + LDX | 2900.0 | 3202.6 |
(NCT01235338)
Timeframe: Day 15 and Day 30 (24 hour sampling)
| Intervention | ng/ml (Mean) | |
|---|---|---|
| Day 15 | Day 30 | |
| LDX + Venlafaxine XR | 0 | 603.49 |
| Venlafaxine XR + LDX | 624.56 | 588.68 |
d-Amphetamine is the active isomer of Lisdexamfetamine dimesylate (SPD489) and is responsible for the drug's therapeutic activity. (NCT01235338)
Timeframe: Day 15 and Day 30 (24 hour sampling)
| Intervention | ng/ml (Mean) | |
|---|---|---|
| Day 15 | Day 30 | |
| LDX + Venlafaxine XR | 88.91 | 88.91 |
| Venlafaxine XR + LDX | 0 | 85.27 |
Venlafaxine, after oral administration, is metabolized in the liver to an active metabolite, o-Desmethylvenlafaxine. (NCT01235338)
Timeframe: Day 15 and Day 30 (24 hour sampling)
| Intervention | ng/ml (Mean) | |
|---|---|---|
| Day 15 | Day 30 | |
| LDX + Venlafaxine XR | 0 | 413.71 |
| Venlafaxine XR + LDX | 420.55 | 371.54 |
Venlafaxine Hydrochloride is the active ingredient of Effexor XR (NCT01235338)
Timeframe: Day 15 and Day 30 (24 hour sampling)
| Intervention | ng/ml (Mean) | |
|---|---|---|
| Day 15 | Day 30 | |
| LDX + Venlafaxine XR | 0 | 198.5 |
| Venlafaxine XR + LDX | 210.98 | 228.89 |
(NCT01235338)
Timeframe: Baseline and up to 39 days
| Intervention | mmHg (Mean) | |
|---|---|---|
| Baseline | Up to 39 Days | |
| LDX + Venlafaxine XR | 73.69 | 77.85 |
| Venlafaxine XR + LDX | 73.68 | 80.45 |
Lisdexamfetamine dimesylate (SPD489) itself is inactive, but following oral administration is converted to the active isomer, d-amphetamine, that is responsible for the drug's therapeutic activity. (NCT01235338)
Timeframe: Day 15 and Day 30 (24 hour sampling)
| Intervention | ng/ml (Mean) | |
|---|---|---|
| Day 15 | Day 30 | |
| LDX + Venlafaxine XR | 49.06 | 49.84 |
| Venlafaxine XR + LDX | 0 | 50.77 |
(NCT01235338)
Timeframe: Baseline and up to 39 days
| Intervention | bpm (Mean) | |
|---|---|---|
| Baseline | Up to 39 Days | |
| LDX + Venlafaxine XR | 66.24 | 77.47 |
| Venlafaxine XR + LDX | 66.55 | 81.72 |
(NCT01235338)
Timeframe: Baseline and up to 39 days
| Intervention | mmHg (Mean) | |
|---|---|---|
| Baseline | Up to 39 Days | |
| LDX + Venlafaxine XR | 110.17 | 117.82 |
| Venlafaxine XR + LDX | 110.48 | 121.51 |
(NCT01235338)
Timeframe: Day 15 and Day 30 (24 hour sampling)
| Intervention | hours (Mean) | |
|---|---|---|
| Day 15 | Day 30 | |
| LDX + Venlafaxine XR | 1.1 | 1.1 |
| Venlafaxine XR + LDX | 0 | 1.0 |
(NCT01235338)
Timeframe: Day 15 and Day 30 (24 hour sampling)
| Intervention | hours (Mean) | |
|---|---|---|
| Day 15 | Day 30 | |
| LDX + Venlafaxine XR | 0 | 7.1 |
| Venlafaxine XR + LDX | 7.3 | 7.0 |
(NCT01235338)
Timeframe: Day 15 and Day 30 (24 hour sampling)
| Intervention | hours (Mean) | |
|---|---|---|
| Day 15 | Day 30 | |
| LDX + Venlafaxine XR | 3.5 | 3.2 |
| Venlafaxine XR + LDX | 0 | 3.1 |
(NCT01235338)
Timeframe: Day 15 and Day 30 (24 hour sampling)
| Intervention | hours (Mean) | |
|---|---|---|
| Day 15 | Day 30 | |
| LDX + Venlafaxine XR | 0 | 8.5 |
| Venlafaxine XR + LDX | 7.9 | 7.9 |
(NCT01235338)
Timeframe: Day 15 and Day 30 (24 hour sampling)
| Intervention | hours (Mean) | |
|---|---|---|
| Day 15 | Day 30 | |
| LDX + Venlafaxine XR | 0 | 6.0 |
| Venlafaxine XR + LDX | 6.4 | 5.9 |
(NCT01235338)
Timeframe: Day 15 and Day 30 (24 hour sampling)
| Intervention | ng*hr/ml (Mean) | |
|---|---|---|
| Day 15 | Day 30 | |
| LDX + Venlafaxine XR | 65.5 | 63.9 |
| Venlafaxine XR + LDX | 0 | 60.8 |
Subjects are free from binge episodes for 4 weeks. (NCT01291173)
Timeframe: Last 28 days on study
| Intervention | Participants (Number) |
|---|---|
| Placebo | 13 |
| Lisdexamfetamine Dimesylate (SPD489) 30 mg | 22 |
| Lisdexamfetamine Dimesylate (SPD489) 50 mg | 27 |
| Lisdexamfetamine Dimesylate (SPD489) 70 mg | 31 |
The Eating Inventory also known as the Three-Factor Eating Questionnaire is a 51-item self-reported questionnaire intended to assess 3 dimensions of eating behavior: cognitive restraint of eating, disinhibition, and hunger. Cognitive restraint of eating consists of 20 items, disinhibition consists of 16 items, and hunger consists of 15 items. Each item scores either 0 or 1 point for a total score of 0-20 for cognitive restraint of eating, 0-16 for disinhibition, and 0-15 for hunger. A higher score is better for cognitive restraint of eating and lower scores are better for disinhibition and hunger. (NCT01291173)
Timeframe: Baseline and week 11
| Intervention | units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| Cognitive restraint of eating | Disinhibition | Hunger | |
| Lisdexamfetamine Dimesylate (SPD489) 30 mg | 4.4 | -5.6 | -5.3 |
| Lisdexamfetamine Dimesylate (SPD489) 50 mg | 3.8 | -6.3 | -6.0 |
| Lisdexamfetamine Dimesylate (SPD489) 70 mg | 4.3 | -7.2 | -7.8 |
| Placebo | 2.5 | -3.8 | -3.3 |
The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. There are 8 subscales. Four of the subscales has one-item each; the other 4 have two-items each. For each subscale, a mean value was first computed and transformed to a position on a scale ranging from 0-100 (Z-transformation). The aggregate total scores are then transformed into a mean value ranging from 0 (lowest level of health) to 100 (highest level of health). (NCT01291173)
Timeframe: Baseline and week 11
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| Aggregate Physical Score | Aggregate Mental Score | |
| Lisdexamfetamine Dimesylate (SPD489) 30 mg | 2.6 | 5.0 |
| Lisdexamfetamine Dimesylate (SPD489) 50 mg | 2.4 | 5.5 |
| Lisdexamfetamine Dimesylate (SPD489) 70 mg | 3.9 | 4.9 |
| Placebo | 1.3 | 4.9 |
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) (NCT01291173)
Timeframe: up to 11 weeks
| Intervention | Percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Normal, not at all ill | Borderline mentally ill | Mildly ill | Moderately ill | Markedly ill | Severely ill | Among the most extremely ill | |
| Lisdexamfetamine Dimesylate (SPD489) 30 mg | 55.4 | 26.2 | 1.5 | 13.8 | 1.5 | 0 | 1.5 |
| Lisdexamfetamine Dimesylate (SPD489) 50 mg | 60.9 | 23.4 | 6.3 | 7.8 | 1.6 | 0 | 0 |
| Lisdexamfetamine Dimesylate (SPD489) 70 mg | 65.1 | 20.6 | 11.1 | 3.2 | 0 | 0 | 0 |
| Placebo | 37.1 | 19.4 | 12.9 | 24.2 | 6.5 | 0 | 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) (NCT01291173)
Timeframe: Baseline
| Intervention | Percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Normal, not at all ill | Borderline mentally ill | Mildly ill | Moderately ill | Markedly ill | Severely ill | Among the most extremely ill | |
| Lisdexamfetamine Dimesylate (SPD489) 30 mg | 0 | 0 | 0 | 54.5 | 30.3 | 12.1 | 3.0 |
| Lisdexamfetamine Dimesylate (SPD489) 50 mg | 0 | 0 | 3.1 | 59.4 | 29.7 | 6.3 | 1.6 |
| Lisdexamfetamine Dimesylate (SPD489) 70 mg | 0 | 1.6 | 1.6 | 42.9 | 47.6 | 6.3 | 0 |
| Placebo | 0 | 0 | 1.6 | 56.5 | 29.0 | 11.3 | 1.6 |
The BIS-11 is a self-reported 30-item questionnaire that measures impulsiveness using a 4-point Likert scale (rarely/never = 1, occasionally = 2, often = 3, almost always/always = 4). A Total Impulsivity score is calculated by summing the scores for each item. Possible scores range from 30 - 120. Higher scores indicate increased impulsiveness. (NCT01291173)
Timeframe: Baseline and week 11
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -3.1 |
| Lisdexamfetamine Dimesylate (SPD489) 30 mg | -5.8 |
| Lisdexamfetamine Dimesylate (SPD489) 50 mg | -5.2 |
| Lisdexamfetamine Dimesylate (SPD489) 70 mg | -6.9 |
The BES is a 16-item self-reported questionnaire that is designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. The items are summed, with possible scores ranging from 0 to 46. A score of 27 or higher indicates severe binge-eating problems, and a score of 17 or lower designates no binge-eating problems. (NCT01291173)
Timeframe: Baseline and week 11
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -12.2 |
| Lisdexamfetamine Dimesylate (SPD489) 30 mg | -16.1 |
| Lisdexamfetamine Dimesylate (SPD489) 50 mg | -17.6 |
| Lisdexamfetamine Dimesylate (SPD489) 70 mg | -20.6 |
The HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe) with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe, and 31-56 severe anxiety. (NCT01291173)
Timeframe: Baseline and week 11
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -1.5 |
| Lisdexamfetamine Dimesylate (SPD489) 30 mg | -0.9 |
| Lisdexamfetamine Dimesylate (SPD489) 50 mg | -1.1 |
| Lisdexamfetamine Dimesylate (SPD489) 70 mg | -0.6 |
Binge day is defined as a day during which at least 1 binge episode occurs. (NCT01291173)
Timeframe: Baseline and week 11
| Intervention | Log days (Least Squares Mean) |
|---|---|
| Placebo | -1.23 |
| Lisdexamfetamine Dimesylate (SPD489) 30 mg | -1.24 |
| Lisdexamfetamine Dimesylate (SPD489) 50 mg | -1.49 |
| Lisdexamfetamine Dimesylate (SPD489) 70 mg | -1.57 |
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. (NCT01291173)
Timeframe: Baseline and week 11
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -1.7 |
| Lisdexamfetamine Dimesylate (SPD489) 30 mg | -1.9 |
| Lisdexamfetamine Dimesylate (SPD489) 50 mg | -1.3 |
| Lisdexamfetamine Dimesylate (SPD489) 70 mg | -1.6 |
The number of binge episodes per week as assessed by clinical interview based on subject diary. (NCT01291173)
Timeframe: Baseline and up to 11 weeks
| Intervention | Binge Episodes (Mean) |
|---|---|
| Placebo | -4.07 |
| Lisdexamfetamine Dimesylate (SPD489) 30 mg | -4.57 |
| Lisdexamfetamine Dimesylate (SPD489) 50 mg | -5.10 |
| Lisdexamfetamine Dimesylate (SPD489) 70 mg | -5.09 |
The YBOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. A score of 0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; and 32-40 is extreme. (NCT01291173)
Timeframe: Baseline and week 11
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -12.0 |
| Lisdexamfetamine Dimesylate (SPD489) 30 mg | -15.0 |
| Lisdexamfetamine Dimesylate (SPD489) 50 mg | -15.3 |
| Lisdexamfetamine Dimesylate (SPD489) 70 mg | -17.0 |
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. (NCT01291173)
Timeframe: Up to 11 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Placebo | 64.5 |
| Lisdexamfetamine Dimesylate (SPD489) 30 mg | 84.6 |
| Lisdexamfetamine Dimesylate (SPD489) 50 mg | 90.6 |
| Lisdexamfetamine Dimesylate (SPD489) 70 mg | 93.7 |
The 1-week binge response was defined as either a 1-week remission (a 100% reduction of binge episodes from baseline [ie, a cessation of binge eating behavior]), or a marked response (75 to <100% reduction in binge episodes from baseline), or a moderate response (50 to <75% reduction in binge episodes from baseline), or a negative/minimal response (<50% reduction in binge episodes from baseline). The 1-week response was determined at the end of the study utilizing a LOCF approach. (NCT01291173)
Timeframe: Last 7 days on study
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| 1 week remission | Marked response | Moderate response | Negative/Minimal response | |
| Lisdexamfetamine Dimesylate (SPD489) 30 mg | 28 | 20 | 8 | 10 |
| Lisdexamfetamine Dimesylate (SPD489) 50 mg | 33 | 24 | 4 | 3 |
| Lisdexamfetamine Dimesylate (SPD489) 70 mg | 35 | 23 | 1 | 4 |
| Placebo | 23 | 15 | 13 | 11 |
Subjects hear 2 brief narratives, each containing 19-21 informational bits, and are asked to recall as many details as possible immediately after hearing each paragraph (A and B) and again following a 30 minute delay. Subjects receive credit for each informational bit recalled verbatim. Different paragraphs were read at each assessment. The maximum number of correct responses for paragraph A is 19 and the maximum number of correct responses for paragraph B is 21. (NCT01324024)
Timeframe: Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)
| Intervention | units on a scale (Mean) | |||
|---|---|---|---|---|
| Immediate paragraph recall A | Immediate paragraph recall B | Delayed paragraph recall A | Delayed paragraph recall B | |
| Baseline | 7.09 | 6.38 | 4.68 | 7.81 |
| Lisdexamfetamine | 7.48 | 7.45 | 5.90 | 9.77 |
| Placebo | 7.00 | 6.75 | 4.94 | 8.47 |
The BADDS questionnaire is a clinician administered questionnaire that assesses the frequency and severity of five clusters of symptoms reflective of executive dysfunction reported by individuals with ADHD. Participants are asked to rate the frequency and severity of a symptom on a scale from 0 to 3, with 0 meaning that the problem described does not relate to them and 3 indicating that the problem is very true for them and occurs almost daily. The range of severity for the total BADDS score is 0 to 120, with scores of 55 and above being consistent with full-syndrome ADHD. (NCT01324024)
Timeframe: Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)
| Intervention | units on a scale (Mean) |
|---|---|
| Baseline | 35.7 |
| Lisdexamfetamine | 21.2 |
| Sugar Pill | 29.8 |
The Penn Continuous Performance Test is a measure of visual attention and vigilance. In this task, a series of red vertical and horizontal lines flash in a digital numeric frame. The participant must press the spacebar whenever the lines form complete numbers or complete letters. The minimum to maximum score range for this task is 0-60 correct responses, with 60 being a perfect score. This data presented in the outcome measure table reflects the total number of correct responses. (NCT01324024)
Timeframe: Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)
| Intervention | units on a scale (Mean) |
|---|---|
| Baseline | 53.29 |
| Lisdexamfetamine | 56.37 |
| Sugar Pill | 56.21 |
BMI was calculated as (weight [kilogram] per height [square meter]). (NCT01328756)
Timeframe: Baseline (Week 0), LOTA (Week 104)
| Intervention | kilogram per square meter (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate | -0.5 |
(NCT01328756)
Timeframe: Baseline (Week 0), LOTA (Week 104)
| Intervention | kilogram(s) (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate | 2.1 |
The BPRS-C that was designed to provide a characterization of the child and adolescent psychopathology, was used to monitor participant's safety. The BPRS-C assessed 7 independent factors (3 items each), for a total of 21 items that represented behavioural disorders, depression, thinking disturbance, psychomotor excitation, withdrawal retardation, anxiety, and organicity. Each item was rated using a 7-point scale including 0 (not present), 1 (very mild), 2 (mild), 3 (moderate), 4 (moderately severe), 5 (severe), and 6 (extremely severe). Total score is the sum of each item score; range from 0 to 126. Higher score indicated worse psychology. (NCT01328756)
Timeframe: Baseline (Week 0), LOTA (Week 104)
| Intervention | scores on a scale (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate | -10.3 |
The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-S was a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants), evaluated by the Investigator. (NCT01328756)
Timeframe: LOTA (Week 104)
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Normal, not all ill | Borderline mentally ill | Mildly ill | Moderately ill | Markedly ill | Severely ill | Among the most extremely ill participants | |
| Lisdexamfetamine Dimesylate | 73 | 97 | 67 | 39 | 17 | 4 | 2 |
The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-I was a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), evaluated by the Investigator. (NCT01328756)
Timeframe: LOTA (Week 104)
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | |
| Lisdexamfetamine Dimesylate | 141 | 92 | 28 | 20 | 13 | 5 | 0 |
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. It included both serious and non-serious adverse event. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment. (NCT01328756)
Timeframe: Baseline up to 3 days after the last dose of study treatment (up to 2 years)
| Intervention | participants (Number) | |
|---|---|---|
| Any TEAE | Serious TEAE | |
| Lisdexamfetamine Dimesylate | 282 | 28 |
ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria, completed by the Investigator. Each item was scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 sub-scales: hyperactivity/impulsivity (even number items 2-18 with score range of 0 to 27) and inattention (odd number items 1-17 with score range of 0 to 27). Higher scores depicted worse symptoms. (NCT01328756)
Timeframe: Baseline (Week 0), LOTA (Week 104)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate | -25.8 |
(NCT01328756)
Timeframe: Baseline (Week 0), LOTA (Week 104)
| Intervention | mmHg (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate | 3.4 |
(NCT01328756)
Timeframe: Baseline (Week 0), LOTA (Week 104)
| Intervention | milliseconds (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate | -0.6 |
(NCT01328756)
Timeframe: Baseline (Week 0), LOTA (Week 104)
| Intervention | milliseconds (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate | -10.3 |
(NCT01328756)
Timeframe: Baseline (Week 0), LOTA (Week 104)
| Intervention | beats per minute (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate | 7 |
(NCT01328756)
Timeframe: Baseline (Week 0), LOTA (Week 104)
| Intervention | centimeter(s) (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate | 6.1 |
(NCT01328756)
Timeframe: Baseline (Week 0), LOTA (Week 104)
| Intervention | beats per minute (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate | 7.1 |
(NCT01328756)
Timeframe: Baseline (Week 0), LOTA (Week 104)
| Intervention | mmHg (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate | 3.2 |
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
| Intervention | T score (Mean) |
|---|---|
| Placebo | 65.91 |
| LDX 30-mg | 59.23 |
| LDX 50-mg | 57.64 |
| LDX 70-mg | 54.91 |
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
| Intervention | T score (Mean) |
|---|---|
| Placebo | 50.59 |
| LDX 30-mg | 46.86 |
| LDX 50-mg | 47.32 |
| LDX 70-mg | 45.36 |
Brain structure volume measured in mm^3 (NCT01415440)
Timeframe: 12 weeks
| Intervention | mm^3 (Mean) | |||
|---|---|---|---|---|
| Left Hippocampal Volume | Left Amygdala Volume | Right Hippocampal Volume | Right Amygdala Volume | |
| ADHD - Placebo | 3909.85 | 1431.31 | 4048.10 | 1573.57 |
| ADHD - Vyvanse | 4069.72 | 1485.05 | 4206.41 | 1641.88 |
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. CHange in MADRS total score in Augmentsion Baseline to Week 16. (NCT01435759)
Timeframe: Augmentation Baseline (Week 8) to Week 16
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Antidepressant + Double-blind Placebo | -5.4 |
| Antidepressant + Double-blind SPD489 10mg | -6.7 |
| Antidepressant + Double-blind SPD489 30mg | -5.3 |
| Antidepressant + Double-blind SPD489 50mg | -6.1 |
| Antidepressant + Double-blind SPD489 70mg | -6.3 |
(NCT01435759)
Timeframe: From Augmentation Baseline (Week 8) to Week 16
| Intervention | bpm (Mean) |
|---|---|
| Antidepressant + Double-blind Placebo | -0.8 |
| Antidepressant + Double-blind SPD489 10mg | 0.8 |
| Antidepressant + Double-blind SPD489 30mg | 5.3 |
| Antidepressant + Double-blind SPD489 50mg | 4.0 |
| Antidepressant + Double-blind SPD489 70mg | 6.0 |
(NCT01435759)
Timeframe: From Augmentation Baseline (Week 8) to Week 16
| Intervention | mmHg (Mean) |
|---|---|
| Antidepressant + Double-blind Placebo | -0.2 |
| Antidepressant + Double-blind SPD489 10mg | 0.2 |
| Antidepressant + Double-blind SPD489 30mg | 0.5 |
| Antidepressant + Double-blind SPD489 50mg | 3.5 |
| Antidepressant + Double-blind SPD489 70mg | 2.6 |
(NCT01435759)
Timeframe: From Augmentation Baseline (Week 8) to Week 16
| Intervention | mmHg (Mean) |
|---|---|
| Antidepressant + Double-blind Placebo | -0.1 |
| Antidepressant + Double-blind SPD489 10mg | -0.9 |
| Antidepressant + Double-blind SPD489 30mg | -0.1 |
| Antidepressant + Double-blind SPD489 50mg | 2.8 |
| Antidepressant + Double-blind SPD489 70mg | 1.9 |
Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment. (NCT01436149)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Antidepressant + Placebo | -4.3 |
| Antidepressant + SPD489 | -4.7 |
ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity. (NCT01436149)
Timeframe: up to 8 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| Antidepressant + Placebo | 15.1 |
| Antidepressant + SPD489 | 14.7 |
The percentage of subjects who achieved a 25% response (i.e., ≥25% reduction in MADRS total score from Lead-in Baseline, Visit 2; Week 0). A comparison was performed at Visit 14/Early Termination (ET) (Week 16/ET). (NCT01436149)
Timeframe: up to 8 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Antidepressant + Placebo | 65.0 |
| Antidepressant + SPD489 | 74.5 |
The QIDS-SR is a self-administered questionnaire designed to rate depressive symptoms. The scale contains 16 items, each scored using a 4-point scale ranging from 0 (representing the most favorable response [low amount of symptom]) to 3 (representing the least favorable response [frequent/intense symptom]). The total score could range from 0 (no depression) to 27 (very severe depression). Higher scores represent more severe depressive symptoms. (NCT01436149)
Timeframe: up to 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Antidepressant + Placebo | -2.6 |
| Antidepressant + SPD489 | -2.3 |
The short form is a 16-item self-report questionnaire which evaluates general subject satisfaction with health, mood, relationships, functioning in daily life, and the treatment being taken. Overall level of satisfaction is evaluated on a 5-point scale from 1 (very poor) to 5 (very good). The total score ranges from 14-70 (last two items on the form are not included in the total score). A higher score indicates a better quality of life. (NCT01436149)
Timeframe: up to 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Antidepressant + Placebo | 7.2 |
| Antidepressant + SPD489 | 7.0 |
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. (NCT01436149)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Antidepressant + Placebo | -6.3 |
| Antidepressant + SPD489 | -6.1 |
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. (NCT01436149)
Timeframe: Baseline and up to 8 weeks
| Intervention | units on a scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Visit 9 (Week 9) | Visit 10 (Week 10) | Visit 11 (Week 11) | Visit 12 (Week 12) | Visit 13 (Week 14) | Visit 14 (Week 16) | |
| Antidepressant + Placebo | -2.2 | -3.8 | -6.0 | -6.2 | -7.4 | -6.3 |
| Antidepressant + SPD489 | -3.4 | -4.2 | -5.4 | -5.6 | -7.3 | -6.1 |
Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life. (NCT01436149)
Timeframe: up to 8 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| Physical | Mental | |
| Antidepressant + Placebo | 0.69 | 5.59 |
| Antidepressant + SPD489 | -0.81 | 6.5 |
C-SSRS is a semi-structured interview that captures the occurrence, 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 behavior occurred. The assessment is done by the nature of the responses, not by a numbered scale. (NCT01436149)
Timeframe: up to 8 weeks
| Intervention | percentage of participants (Number) | |
|---|---|---|
| ≥1 postive suicidal ideation | ≥1 suicidal attempt | |
| Antidepressant + Placebo | 7.0 | 0.5 |
| Antidepressant + SPD489 | 7.0 | 0 |
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. (NCT01436149)
Timeframe: up to 8 weeks
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Improved | Not Improved | Not Assessed | |
| Antidepressant + Placebo | 53.3 | 46.2 | 0.5 |
| Antidepressant + SPD489 | 55.3 | 44.7 | 0 |
MADRS remission was defined as a MADRS total score of ≤10. A comparison was performed at Visit 14/ET (Week 16/ET). (NCT01436149)
Timeframe: up to 8 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Antidepressant + Placebo | 22.5 |
| Antidepressant + SPD489 | 18.5 |
The percentage of subjects who achieved a 50% response (i.e., ≥50% reduction in MADRS total score from Lead-in Baseline, Visit 2; Week 0). A comparison was performed at Visit 14/ET (Week 16/ET). (NCT01436149)
Timeframe: up to 8 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Antidepressant + Placebo | 38.5 |
| Antidepressant + SPD489 | 41.0 |
The percentage of subjects who achieved a 25% response (i.e. ≥25% reduction in MADRS total score from the Lead-in Baseline, Visit 2). (NCT01436162)
Timeframe: Up to 8 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Antidepressant + SPD489 | 68.9 |
| Antidepressant + Placebo | 74.2 |
The percentage of subjects who achieved a 50% response (i.e. ≥50% reduction in MADRS total score from the Lead-in Baseline, Visit 2). (NCT01436162)
Timeframe: Up to 8 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Antidepressant + SPD489 | 41.6 |
| Antidepressant + Placebo | 37.1 |
Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life. (NCT01436162)
Timeframe: Up to 8 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| Physical | Mental | |
| Antidepressant + Placebo | 0.90 | 5.16 |
| Antidepressant + SPD489 | 1.07 | 6.63 |
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. (NCT01436162)
Timeframe: Up to 8 weeks
| Intervention | units on a scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Week 9 (Visit 9) | Week 10 (Visit 10) | Week 11 (Visit 11) | Week 12 (Visit 12) | Week 14 (Visit 13) | Week 16 (Visit 14) | |
| Antidepressant + Placebo | -2.1 | -4.3 | -5.0 | -5.3 | -6.4 | -6.8 |
| Antidepressant + SPD489 | -2.9 | -4.4 | -5.9 | -6.3 | -6.9 | -7.3 |
ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity. (NCT01436162)
Timeframe: 8 weeks
| Intervention | Score (Mean) |
|---|---|
| Antidepressant + SPD489 | 17.0 |
| Antidepressant + Placebo | 17.2 |
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. (NCT01436162)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Antidepressant + SPD489 | -7.3 |
| Antidepressant + Placebo | -6.8 |
MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue. (NCT01436162)
Timeframe: Up to 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Antidepressant + SPD489 | -6.6 |
| Antidepressant + Placebo | -4.4 |
MADRS remission was defined as a MADRS total score of ≤10. (NCT01436162)
Timeframe: Up to 8 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Antidepressant + SPD489 | 23.0 |
| Antidepressant + Placebo | 17.8 |
The CSFQ-14 is a short-form interview/questionnaire that measures illness- and medication-related changes in sexual functioning. A 5-point Likert scale is used ranging from 1 (never) to 5 (always). The CSFQ-14 total score can range from 14 to 70, with lower scores being associated with worsened sexual functioning. (NCT01436162)
Timeframe: Up to 8 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| Antidepressant + SPD489 | 2.1 |
| Antidepressant + Placebo | 1.0 |
The CSFQ-14 is a short-form interview/questionnaire that measures illness- and medication-related changes in sexual functioning. A 5-point Likert scale is used ranging from 1 (never) to 5 (always). The CSFQ-14 total score can range from 14 to 70, with lower scores being associated with worsened sexual functioning. (NCT01436162)
Timeframe: Up to 8 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| Antidepressant + SPD489 | 3.0 |
| Antidepressant + Placebo | 1.9 |
The ABAC-A is a rater-administered series of activities designed to be sensitive to the critical cognitive deficits in affective disorders and schizophrenia. There are 6 subtests of the ABAC-A: List Learning (verbal memory); Digit Sequencing Task (working memory); Token Motor Task (motor speed); Verbal Fluency; Symbol Coding (attention and processing speed); and Tower of London Test (executive functions). The ABAC-A Composite T-score change from Augmentation Baseline Visit (Visit 8; Week 8) at Visit 14/Early Termination (ET) (Week 16/ET) was analyzed. (NCT01436162)
Timeframe: up to 8 weeks
| Intervention | t-score (Least Squares Mean) |
|---|---|
| Antidepressant + SPD489 | 3.0 |
| Antidepressant + Placebo | 2.5 |
Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment. (NCT01436162)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Antidepressant + SPD489 | -4.9 |
| Antidepressant + Placebo | -4.3 |
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. (NCT01436162)
Timeframe: Up to 8 weeks
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Improved | Not Improved | Not Assessed | |
| Antidepressant + Placebo | 53.5 | 46.5 | 0 |
| Antidepressant + SPD489 | 56.9 | 43.1 | 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. (NCT01436162)
Timeframe: Up to 8 weeks
| Intervention | percentage of participants (Number) | |
|---|---|---|
| ≥1 positive suicidal ideation | ≥1 suicidal attempt | |
| Antidepressant + Placebo | 9.4 | 0.5 |
| Antidepressant + SPD489 | 9.0 | 0 |
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses (NCT01436175)
Timeframe: Week 52/ET
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| No pain or discomfort | Slight pain or discomfort | Moderate pain or discomfort | Severe pain or discomfort | Extreme pain or discomfort | |
| SPD489 + Antidepressant | 715 | 536 | 208 | 68 | 10 |
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses (NCT01436175)
Timeframe: Week 52/ET
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| No problems washing or dressing myself | Slight problems washing or dressing myself | Moderate problems washing or dressing myself | Severe problems washing or dressing myself | Unable to wash or dress myself | |
| SPD489 + Antidepressant | 1304 | 174 | 49 | 9 | 1 |
The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions - 1. How many hours do you usually work or would you usually be expected to work (hrs/week); 2. How many hours did you actually work last week; 3. On average, how many hours do you volunteer per week. Number of hours are reported. (NCT01436175)
Timeframe: Week 52/ET
| Intervention | hours (Mean) | ||
|---|---|---|---|
| Work or usually expect to work (n=337) | Actual work (n=337) | Average volunteer per week (n=86) | |
| SPD489 + Antidepressant | 34.0 | 31.2 | 8.6 |
Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]). (NCT01436175)
Timeframe: Baseline, Week 52/ET
| Intervention | millimeter of mercury(mmHg) (Mean) | |
|---|---|---|
| Baseline (n = 1559) | Change at Week 52/ET (n = 1558) | |
| SPD489 + Antidepressant | 117.6 | 2.4 |
Designed to evaluate the extent to which illness symptoms impact a participant's life in 3 areas: work, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment. Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]). (NCT01436175)
Timeframe: Baseline, Week 52/ET
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Baseline (n=1548) | Change at Week 52/ET (n = 1530) | |
| SPD489 + Antidepressant | 12.7 | -4.3 |
CSFQ-14 is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning. Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]). (NCT01436175)
Timeframe: Baseline, Week 52/ET
| Intervention | units on a scale (Mean) | |||
|---|---|---|---|---|
| Male: Baseline (n=167) | Male: Change at Week 52/ET (n=164) | Female: Baseline (n=341) | Female: Change at Week 52/ET (n=330) | |
| SPD489 + Antidepressant | 46.6 | 1.7 | 37.2 | 2.8 |
Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]). (NCT01436175)
Timeframe: Baseline, Week 52/ET
| Intervention | beats per minute(bpm) (Mean) | |
|---|---|---|
| Baseline (n = 1559) | Change at Week 52/ET (n = 1558) | |
| SPD489 + Antidepressant | 72.7 | 5.2 |
Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]). (NCT01436175)
Timeframe: Baseline, Week 52/ET
| Intervention | mmHg (Mean) | |
|---|---|---|
| Baseline (n = 1559) | Change at Week 52/ET (n = 1558) | |
| SPD489 + Antidepressant | 75.4 | 1.2 |
QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression. The QIDS-SR was only assessed in the SPD489-322 antecedent study. The QIDS-SR total score is calculated as the sum of the highest score on any 1 of Items 1-4, Item 5, the highest score on any 1 of Items 6-9, Items 10-14, the highest score on either Item 15 or 16. (NCT01436175)
Timeframe: Week 52/ET
| Intervention | units on a scale (Mean) |
|---|---|
| SPD489 + Antidepressant | 6.9 |
Participants who did not have Clinical Global Impressions - Severity of Illness (CGI-S) assessed at Week 8 in the antecedent study should not have had CGI-I assessed in this study and were excluded from the summary of CGI-I. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale. (NCT01436175)
Timeframe: Week 52/ET
| Intervention | participants (Number) |
|---|---|
| SPD489 + Antidepressant | 1021 |
EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. EQ-5D-5L Visual Analog Scale score is numbered from 0 to 100, where a score of 100 is the best health a participant can imagine (NCT01436175)
Timeframe: Week 52/ET
| Intervention | units on a scale (Mean) |
|---|---|
| SPD489 + Antidepressant | 75.7 |
ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity. (NCT01436175)
Timeframe: Week 53
| Intervention | units on a scale (Mean) |
|---|---|
| SPD489 + Antidepressant | 14.3 |
The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Number of nights in medical/surgical ward, number of nights in ICU, and number of days a participant received home care in the past month are reported. (NCT01436175)
Timeframe: Week 52/ET
| Intervention | days (Mean) | ||
|---|---|---|---|
| Number of nights in medical/surgical ward (n=4) | Number of nights in ICU (n=4) | Number of days received home care in past month | |
| SPD489 + Antidepressant | 1.3 | 0.0 | 0.0 |
The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions on a 0 to 10 point scale - 1. During past week, how much did depressive symptoms affect work productivity; 2. During past week, how much did depressive symptoms affect regular non-work daily activities. Higher scores indicates more effect of depressive symptoms on work productivity and non-work daily activities. (NCT01436175)
Timeframe: Week 52/ET
| Intervention | units on scale (Mean) | |
|---|---|---|
| Affected work productivity (n= 335) | Affected regular non work daily activities (n=482) | |
| SPD489 + Antidepressant | 2.1 | 2.5 |
The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered the following questions: 1. Were you hospitalized in the past month, 2. Do you work for pay, 3. If you missed time at work last week, please note all the reasons why, 4. Would you say that the past week was typical, like the rest of the 3 weeks this month, in terms of your working hours, 5. Do you do volunteer work (VW), and 6. If you do not receive money for your work and do not participate in volunteer work, the reason is. Number of participants with response is reported. (NCT01436175)
Timeframe: Week 52/ET
| Intervention | participants (Number) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hospitalized in Past Month | Work for Pay | Reason Missing Work Time: Had a Day Off | Reason Missing Work Time: Physically Ill | Reason Missing Work Time: Upset/Depressed/Nervous | Reason Missing Work Time: Other | Past Week Was Typical: Yes | Past Week Was Typical: No, Worked More Hours | Past Week Was Typical: No, Worked Less Hours | Volunteer Work | Reason no Money/VW: Physically Ill | Reason no Money/VW: Upset/Depressed/Nervous | Reason no Money/VW: Cannot Find Work | Reason no Money/VW: Other | Reason no Money/VW: Not Applicable | |
| SPD489 + Antidepressant | 4 | 337 | 24 | 10 | 15 | 36 | 249 | 43 | 45 | 86 | 6 | 30 | 39 | 48 | 348 |
The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions - 1. How many times did you visit the following healthcare providers in the past month: Family doctor/primary care, Non-physician healthcare practitioner (NPHP), Psychiatrist/Psychologist/Counselor (PPC); 2. How many times did you take one of the tests, mentioned below, during the past month: Blood test, CT Scan, X Ray, Renal function, Thyroid function; and 3. How many times did you visit the hospital emergency room (ER), urgent care facility (UCF) or an after-hours clinic (AHC) in the past month. Number of events (visit to health care provider, visit to hospital facilities, and number of times a test was performed) are reported. (NCT01436175)
Timeframe: Week 52/ET
| Intervention | events (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Visit to Family doctor/primary care (n=481) | Visit to NPHP(n=480) | Visit to PPC(n=481) | Test performed: Blood Test (n=480) | Test performed: CT Scan (n=480) | Test performed: X Ray (n=480) | Test performed: Renal function (n=480) | Test performed: Thyroid function (n=480) | Test performed: Other test (n=479) | Visit to Hospital ER, UCF or AHC (n=482) | |
| SPD489 + Antidepressant | 0.2 | 0.1 | 0.1 | 0.2 | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 | 0.0 |
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses (NCT01436175)
Timeframe: Week 52/ET
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| No problems in walking about | Slight problems in walking about | Moderate problems in walking about | Severe problems in walking about | Unable to walk about | |
| SPD489 + Antidepressant | 1193 | 237 | 82 | 24 | 1 |
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses (NCT01436175)
Timeframe: Week 52/ET
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| No problems doing my usual activities | Slight problems doing my usual activities | Moderate problems doing my usual activities | Severe problems doing my usual activities | Unable to do my usual activities | |
| SPD489 + Antidepressant | 800 | 475 | 197 | 55 | 10 |
The Q-LES-Q-SF is a 16-item self-report questionnaire which evaluates general participant satisfaction with health, mood, relationships, functioning in daily life, and their treatment. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total raw score (summary scale score) was calculated by summing item scores 1 to 14 (total raw score range: 14 to 70). Item 15 (satisfaction with medication, raw score range: 1 to 5) and Item 16 (overall satisfaction and contentment; raw score range: 1 to 5) were stand-alone items. For reporting, summary scale, Item 15 and Item 16 raw scores were transformed into percentage maximum possible score which ranged from 0 to 100, where higher scores are indicative of greater enjoyment or satisfaction. (NCT01436175)
Timeframe: Week 52/ET
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Summary Scale (n = 506) | Satisfaction with Medication (n = 478) | Overall Satisfaction and Contentment (n = 506) | |
| SPD489 + Antidepressant | 61.5 | 68.6 | 63.2 |
SF-12V2 is a multi-purpose, 7-item survey that measures 8 domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It is expressed by two summary measures (Aggregate Physical and Aggregate Mental) for which values can range from 0 to 100. A higher score is indicative of a better health state. (NCT01436175)
Timeframe: Week 52/ET
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Aggregate Physical | Aggregate Mental | |
| SPD489 + Antidepressant | 49.1 | 42.7 |
C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviour 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. (NCT01436175)
Timeframe: Week 5 up to Week 52/Early Termination(ET)
| Intervention | participants (Number) | |
|---|---|---|
| Positive Suicidal Ideation | Suicidal Attempt | |
| SPD489 + Antidepressant | 68 | 4 |
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses (NCT01436175)
Timeframe: Week 52/ET
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Not anxious or depressed | Slightly anxious or depressed | Moderately anxious or depressed | Severely anxious or depressed | Extremely anxious or depressed | |
| SPD489 + Antidepressant | 461 | 687 | 289 | 73 | 27 |
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. (NCT01457339)
Timeframe: Day 5 (12-hour sampling period post-dose)
| Intervention | ng/ml (Mean) |
|---|---|
| SPD489 (Lisdexamfetamine Dimesylate)(250 mg) | 181.53 |
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. (NCT01457339)
Timeframe: Day 5 (12-hour sampling period post-dose)
| Intervention | ng/ml (Mean) |
|---|---|
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | 21.93 |
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. (NCT01457339)
Timeframe: Day 5 (12-hour sampling period post-dose)
| Intervention | ng/ml (Mean) |
|---|---|
| SPD489 (Lisdexamfetamine Dimesylate)(70 mg) | 35.02 |
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. (NCT01457339)
Timeframe: Day 5 (12-hour sampling period post-dose)
| Intervention | ng*hr/ml (Mean) |
|---|---|
| SPD489 (Lisdexamfetamine Dimesylate)(100 mg) | 80.5 |
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. (NCT01457339)
Timeframe: Day 5 (12-hour sampling period post-dose)
| Intervention | ng*hr/ml (Mean) |
|---|---|
| SPD489 (Lisdexamfetamine Dimesylate)(150 mg) | 144.9 |
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. (NCT01457339)
Timeframe: Day 5 (12-hour sampling period post-dose)
| Intervention | ng*hr/ml (Mean) |
|---|---|
| SPD489 (Lisdexamfetamine Dimesylate)(200 mg) | 230.2 |
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. (NCT01457339)
Timeframe: Day 5 (12-hour sampling period post-dose)
| Intervention | ng*hr/ml (Mean) |
|---|---|
| SPD489 (Lisdexamfetamine Dimesylate)(250 mg) | 301.5 |
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. (NCT01457339)
Timeframe: Day 5 (12-hour sampling period post-dose)
| Intervention | ng*hr/ml (Mean) |
|---|---|
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | 25.6 |
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. (NCT01457339)
Timeframe: Day 5 (12-hour sampling period post-dose)
| Intervention | ng*hr/ml (Mean) |
|---|---|
| SPD489 (Lisdexamfetamine Dimesylate)(70 mg) | 43.7 |
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | 0.0 |
| SPD489 (Lisdexamfetamine Dimesylate)(100 mg) | 0.0 |
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | 0.0 |
| SPD489 (Lisdexamfetamine Dimesylate)(150 mg) | 0.0 |
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | 0.0 |
| SPD489 (Lisdexamfetamine Dimesylate)(200 mg) | 0.2 |
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | 0.0 |
| SPD489 (Lisdexamfetamine Dimesylate)(250 mg) | 0.0 |
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | 0.0 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | 0.0 |
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | 0.0 |
| SPD489 (Lisdexamfetamine Dimesylate)(70 mg) | 0.0 |
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -0.4 |
| SPD489 (Lisdexamfetamine Dimesylate)(100 mg) | -0.9 |
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -0.7 |
| SPD489 (Lisdexamfetamine Dimesylate)(150 mg) | -1.0 |
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -0.4 |
| SPD489 (Lisdexamfetamine Dimesylate)(200 mg) | -0.6 |
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -0.2 |
| SPD489 (Lisdexamfetamine Dimesylate)(250 mg) | -0.3 |
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | 0.0 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | -0.3 |
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -0.4 |
| SPD489 (Lisdexamfetamine Dimesylate)(70 mg) | -0.7 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Log10 milliseconds (Mean) |
|---|---|
| Placebo | 0.014 |
| SPD489 (Lisdexamfetamine Dimesylate)(100 mg) | -0.047 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Log10 milliseconds (Mean) |
|---|---|
| Placebo | 0.037 |
| SPD489 (Lisdexamfetamine Dimesylate)(150 mg) | -0.039 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Log10 milliseconds (Mean) |
|---|---|
| Placebo | -0.025 |
| SPD489 (Lisdexamfetamine Dimesylate)(200 mg) | -0.049 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Log10 milliseconds (Mean) |
|---|---|
| Placebo | -0.034 |
| SPD489 (Lisdexamfetamine Dimesylate)(250 mg) | -0.048 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Log10 milliseconds (Mean) |
|---|---|
| Placebo | 0.0 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | -0.034 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Log10 milliseconds (Mean) |
|---|---|
| Placebo | 0.017 |
| SPD489 (Lisdexamfetamine Dimesylate)(70 mg) | -0.015 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Number of Errors (Mean) |
|---|---|
| Placebo | 0.9 |
| SPD489 (Lisdexamfetamine Dimesylate)(100 mg) | -15.7 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Number of Errors (Mean) |
|---|---|
| Placebo | 21.1 |
| SPD489 (Lisdexamfetamine Dimesylate)(150 mg) | -11.3 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Number of Errors (Mean) |
|---|---|
| Placebo | -10.3 |
| SPD489 (Lisdexamfetamine Dimesylate)(200 mg) | -16.5 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Number of Errors (Mean) |
|---|---|
| Placebo | -5.0 |
| SPD489 (Lisdexamfetamine Dimesylate)(250 mg) | -13.2 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Number of Errors (Mean) |
|---|---|
| Placebo | -0.9 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | -8.2 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Number of Errors (Mean) |
|---|---|
| Placebo | 8.7 |
| SPD489 (Lisdexamfetamine Dimesylate)(70 mg) | -7.3 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Log10 milliseconds (Mean) |
|---|---|
| Placebo | 0.011 |
| SPD489 (Lisdexamfetamine Dimesylate)(100 mg) | 0.001 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Log10 milliseconds (Mean) |
|---|---|
| Placebo | 0.036 |
| SPD489 (Lisdexamfetamine Dimesylate)(150 mg) | -0.010 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Log10 milliseconds (Mean) |
|---|---|
| Placebo | 0.044 |
| SPD489 (Lisdexamfetamine Dimesylate)(200 mg) | -0.014 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Log10 milliseconds (Mean) |
|---|---|
| Placebo | 0.005 |
| SPD489 (Lisdexamfetamine Dimesylate)(250 mg) | -0.007 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Log10 milliseconds (Mean) |
|---|---|
| Placebo | 0.028 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | 0.001 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Log10 milliseconds (Mean) |
|---|---|
| Placebo | 0.015 |
| SPD489 (Lisdexamfetamine Dimesylate)(70 mg) | 0.006 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Arcsine proportion correct (Mean) |
|---|---|
| Placebo | 0.012 |
| SPD489 (Lisdexamfetamine Dimesylate)(100 mg) | 0.012 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Arcsine proportion correct (Mean) |
|---|---|
| Placebo | 0.026 |
| SPD489 (Lisdexamfetamine Dimesylate)(150 mg) | 0.042 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Arcsine proportion correct (Mean) |
|---|---|
| Placebo | -0.020 |
| SPD489 (Lisdexamfetamine Dimesylate)(200 mg) | 0.046 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Arcsine proportion correct (Mean) |
|---|---|
| Placebo | 0.018 |
| SPD489 (Lisdexamfetamine Dimesylate)(250 mg) | 0.022 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Arcsine proportion correct (Mean) |
|---|---|
| Placebo | 0.025 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | 0.005 |
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | Arcsine proportion correct (Mean) |
|---|---|
| Placebo | 0.015 |
| SPD489 (Lisdexamfetamine Dimesylate)(70 mg) | 0.021 |
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. (NCT01457339)
Timeframe: Baseline and day 5
| Intervention | mmHg (Mean) |
|---|---|
| Placebo | 2.14 |
| SPD489 (Lisdexamfetamine Dimesylate)(100 mg) | 4.55 |
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. (NCT01457339)
Timeframe: Baseline and day 5
| Intervention | mmHg (Mean) |
|---|---|
| Placebo | 2.67 |
| SPD489 (Lisdexamfetamine Dimesylate)(150 mg) | 2.43 |
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. (NCT01457339)
Timeframe: Baseline and day 5
| Intervention | mmHg (Mean) |
|---|---|
| Placebo | 2.76 |
| SPD489 (Lisdexamfetamine Dimesylate)(200 mg) | 3.77 |
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. (NCT01457339)
Timeframe: Baseline and day 5
| Intervention | mmHg (Mean) |
|---|---|
| Placebo | 3.67 |
| SPD489 (Lisdexamfetamine Dimesylate)(250 mg) | 3.79 |
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. (NCT01457339)
Timeframe: Baseline and day 5
| Intervention | mmHg (Mean) |
|---|---|
| Placebo | 2.86 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | 5.22 |
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. (NCT01457339)
Timeframe: Baseline and day 5
| Intervention | mmHg (Mean) |
|---|---|
| Placebo | 2.38 |
| SPD489 (Lisdexamfetamine Dimesylate)(70 mg) | 2.14 |
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -3.6 |
| SPD489 (Lisdexamfetamine Dimesylate)(100 mg) | -3.9 |
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -2.1 |
| SPD489 (Lisdexamfetamine Dimesylate)(150 mg) | -4.7 |
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -2.3 |
| SPD489 (Lisdexamfetamine Dimesylate)(200 mg) | -4.6 |
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -2.3 |
| SPD489 (Lisdexamfetamine Dimesylate)(250 mg) | -2.4 |
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | 0.6 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | -1.9 |
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -2.1 |
| SPD489 (Lisdexamfetamine Dimesylate)(70 mg) | -2.9 |
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. (NCT01457339)
Timeframe: Baseline and day 5
| Intervention | beats/min (Mean) |
|---|---|
| Placebo | 0.19 |
| SPD489 (Lisdexamfetamine Dimesylate)(100 mg) | 5.72 |
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. (NCT01457339)
Timeframe: Baseline and day 5
| Intervention | beats/min (Mean) |
|---|---|
| Placebo | -1.05 |
| SPD489 (Lisdexamfetamine Dimesylate)(150 mg) | 6.41 |
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. (NCT01457339)
Timeframe: Baseline and day 5
| Intervention | beats/min (Mean) |
|---|---|
| Placebo | 2.38 |
| SPD489 (Lisdexamfetamine Dimesylate)(200 mg) | 8.88 |
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. (NCT01457339)
Timeframe: Baseline and day 5
| Intervention | beats/min (Mean) |
|---|---|
| Placebo | 2.06 |
| SPD489 (Lisdexamfetamine Dimesylate)(250 mg) | 12.39 |
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. (NCT01457339)
Timeframe: Baseline and day 5
| Intervention | beats/min (Mean) |
|---|---|
| Placebo | 2.62 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | 3.78 |
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. (NCT01457339)
Timeframe: Baseline and day 5
| Intervention | beats/min (Mean) |
|---|---|
| Placebo | -0.95 |
| SPD489 (Lisdexamfetamine Dimesylate)(70 mg) | 5.07 |
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -7.0 |
| SPD489 (Lisdexamfetamine Dimesylate)(100 mg) | -2.6 |
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -4.0 |
| SPD489 (Lisdexamfetamine Dimesylate)(150 mg) | -3.0 |
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | 1.3 |
| SPD489 (Lisdexamfetamine Dimesylate)(200 mg) | -2.6 |
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -4.2 |
| SPD489 (Lisdexamfetamine Dimesylate)(250 mg) | -3.3 |
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -1.4 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | -1.7 |
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -3.0 |
| SPD489 (Lisdexamfetamine Dimesylate)(70 mg) | -3.1 |
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -0.4 |
| SPD489 (Lisdexamfetamine Dimesylate)(100 mg) | 0.0 |
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -0.3 |
| SPD489 (Lisdexamfetamine Dimesylate)(150 mg) | 0.1 |
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | 0.0 |
| SPD489 (Lisdexamfetamine Dimesylate)(200 mg) | 0.0 |
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | 0.2 |
| SPD489 (Lisdexamfetamine Dimesylate)(250 mg) | 0.0 |
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -0.4 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | 0.0 |
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment. (NCT01457339)
Timeframe: Baseline and Day 5
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -0.6 |
| SPD489 (Lisdexamfetamine Dimesylate)(70 mg) | -0.1 |
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. (NCT01457339)
Timeframe: Baseline and day 5
| Intervention | mmHg (Mean) |
|---|---|
| Placebo | 0.43 |
| SPD489 (Lisdexamfetamine Dimesylate)(100 mg) | 4.96 |
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. (NCT01457339)
Timeframe: Baseline and day 5
| Intervention | mmHg (Mean) |
|---|---|
| Placebo | -2.81 |
| SPD489 (Lisdexamfetamine Dimesylate)(150 mg) | 6.43 |
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. (NCT01457339)
Timeframe: Baseline and day 5
| Intervention | mmHg (Mean) |
|---|---|
| Placebo | -2.38 |
| SPD489 (Lisdexamfetamine Dimesylate)(200 mg) | 5.28 |
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. (NCT01457339)
Timeframe: Baseline and day 5
| Intervention | mmHg (Mean) |
|---|---|
| Placebo | -0.28 |
| SPD489 (Lisdexamfetamine Dimesylate)(250 mg) | 7.36 |
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. (NCT01457339)
Timeframe: Baseline and day 5
| Intervention | mmHg (Mean) |
|---|---|
| Placebo | -0.14 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | 8.94 |
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. (NCT01457339)
Timeframe: Baseline and day 5
| Intervention | mmHg (Mean) |
|---|---|
| Placebo | 1.43 |
| SPD489 (Lisdexamfetamine Dimesylate)(70 mg) | 3.82 |
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. (NCT01457339)
Timeframe: Day 5 (12-hour sampling period post-dose)
| Intervention | ng/ml (Mean) |
|---|---|
| SPD489 (Lisdexamfetamine Dimesylate)(100 mg) | 50.6 |
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. (NCT01457339)
Timeframe: Day 5 (12-hour sampling period post-dose)
| Intervention | ng/ml (Mean) |
|---|---|
| SPD489 (Lisdexamfetamine Dimesylate)(150 mg) | 90.34 |
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. (NCT01457339)
Timeframe: Day 5 (12-hour sampling period post-dose)
| Intervention | ng/ml (Mean) |
|---|---|
| SPD489 (Lisdexamfetamine Dimesylate)(200 mg) | 133.3 |
The mean maximum daily dose of lisdexamfetamine that was maintained for at least 1 week of trial. (NCT01486810)
Timeframe: during 8 weeks of trial or length of participation
| Intervention | mgs/day (Mean) |
|---|---|
| Lisdexamfetamine and Medication Management | 118.1 |
Number of participants achieving and maintained for a seven day period during the trial on the maximum daily dose of 140 mg.. (NCT01486810)
Timeframe: during 1 week of study participation
| Intervention | Participants (Count of Participants) |
|---|---|
| Lisdexamfetamine and Medication Management | 12 |
The Clinical Global Impressions Scale permits a global evaluation of the participant's severity of illness and improvement over time. The scale included a severity of illness item and a global improvement item. The investigator performed the CGI-I to rate the improvement of a participant's ADHD symptoms based on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse.). Percentage of participants with an improved measurement (response of very much improved and much improved) is reported. (NCT01552902)
Timeframe: Week 6
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 50 |
| Lisdexamfetamine Dimesylate | 81.4 |
| Methylphenidate | 71.3 |
(NCT01552902)
Timeframe: Baseline, Week 6
| Intervention | Beats per minute (Mean) |
|---|---|
| Placebo | 2.4 |
| Lisdexamfetamine Dimesylate | 6.7 |
| Methylphenidate | 8.2 |
The ADHD-RS-IV was developed to measure the behaviors of children with ADHD and is commonly used in clinical studies of ADHD. The ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, Higher score = more severe symptoms. (NCT01552902)
Timeframe: Baseline, Week 6
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -17 |
| Lisdexamfetamine Dimesylate | -25.4 |
| Methylphenidate | -22.1 |
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events between first dose of double-blind investigational product and up to 3 days after last dose that were absent before treatment or that worsened relative to pretreatment state. (NCT01552902)
Timeframe: Baseline up to 3 days after last dose (last dose at Week 6)
| Intervention | participants (Number) | |
|---|---|---|
| Participants with TEAEs | Participants with serious TEAEs | |
| Lisdexamfetamine Dimesylate | 145 | 1 |
| Methylphenidate | 129 | 1 |
| Placebo | 49 | 1 |
(NCT01552902)
Timeframe: Baseline, Week 6
| Intervention | millimeter of mercury (mmHg) (Mean) | |
|---|---|---|
| Systolic blood pressure | Diastolic blood pressure | |
| Lisdexamfetamine Dimesylate | 1.5 | 3.4 |
| Methylphenidate | 2.4 | 3.5 |
| Placebo | -1 | -0.1 |
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Higher score indicates more severe symptoms. (NCT01552915)
Timeframe: Baseline and week 8
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -13.4 |
| SPD489 | -25.6 |
| OROS-MPH | -23.5 |
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. (NCT01552915)
Timeframe: Week 8
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 34.8 |
| SPD489 | 83.1 |
| OROS-MPH | 81.0 |
(NCT01552915)
Timeframe: Baseline and up to 8 Weeks
| Intervention | mmHg (Mean) |
|---|---|
| Placebo | -0.8 |
| SPD489 | 2.4 |
| OROS-MPH | 0.4 |
(NCT01552915)
Timeframe: Baseline and up to 8 weeks
| Intervention | bpm (Mean) |
|---|---|
| Placebo | 0.3 |
| SPD489 | 4.7 |
| OROS-MPH | 6.0 |
(NCT01552915)
Timeframe: Baseline and up to 8 weeks
| Intervention | mmHg (Mean) |
|---|---|
| Placebo | -1.2 |
| SPD489 | 2.8 |
| OROS-MPH | 2.2 |
systolic blood pressure (NCT01615887)
Timeframe: 8 weeks
| Intervention | mm hg (millimeters of mercury) (Mean) |
|---|---|
| Lisdexamfetamine Sulfate | 127.3 |
| Sugar Pill | 121.6 |
diastolic blood pressure (NCT01615887)
Timeframe: 8 weeks
| Intervention | mm hg (millimeters of mercury) (Mean) |
|---|---|
| Lisdexamfetamine Sulfate | 75.1 |
| Sugar Pill | 77.7 |
Heart rate (NCT01615887)
Timeframe: 8 weeks
| Intervention | beats/min (Mean) |
|---|---|
| Lisdexamfetamine Sulfate | 72.3 |
| Sugar Pill | 76.9 |
The Symbol Digit Modalities Test (SDMT) presents a series of nine symbols, each paired with a single digit in a key at the top of a stimulus page. Subjects voice the number associated with each symbol as rapidly as possible. The examiner records the total amount of responses completed. The task continues for 90 seconds with the research staff recording responses. The SDMT score ranges from 0 to 110, with higher values representing a better outcome in cognitive processing speed. (NCT01615887)
Timeframe: 8 weeks
| Intervention | score on a scale (Mean) |
|---|---|
| Lisdexamfetamine Sulfate | 36.9 |
| Sugar Pill | 46.8 |
The Brief Visuospatial Memory Test Revised (BVMTR) presents six abstract designs for 10 seconds. The display is removed from view and patients render the stimuli via pencil on paper manual responses. There are three learning trials in which patients attempt to replicate the stimuli previously presented. Patients are given a score for all three trials based on correct location and accuracy of the replicated stimuli. Each trial can be awarded up to 12 points, the sum of total points awarded across all three trials is the total learning score. The BVMT-R total learning score ranges from 0 to 36, with higher values representing a better outcome in visuospatial learning/memory. (NCT01615887)
Timeframe: 8 weeks
| Intervention | score on a scale (Mean) |
|---|---|
| Lisdexamfetamine Sulfate | 15.2 |
| Sugar Pill | 18.7 |
The PASAT is a test requiring attention and vigilance. In this test, the patient listens to a tape recording of digits presented one at a time. The task for the patient is to add each number to the one immediately preceding it. For example, the recording might present the numbers 1, 7, 5, 4. The patient adds the first two numbers (1 + 7) and responds with the number 8. The patient then adds the second two numbers (7 + 5) and responds with the number 12. The patient then adds the third two numbers (5 + 4) and responds with the number 9. This continues for a total of 61 numbers presented in a random order. The patients score is the total number correct out of 60 (Stebbins et al. 2007). The PASAT score ranges from 0 to 60, with higher values representing a better outcome in cognitive processing speed. (NCT01615887)
Timeframe: 8 Weeks
| Intervention | score on a scale (Mean) |
|---|---|
| Lisdexamfetamine Sulfate | 32.0 |
| Sugar Pill | 37.4 |
The California Verbal Learning Test Second Edition (CVLT2) begins with the examiner reading a list of 16 words. Patients listen to the list and report as many of the items as possible. After recall is recorded, the entire list is read again. Altogether, there are five learning trials, the total correct of all trials is summed together creating a total verbal learning score. The CVLT-II total verbal learning score ranges from 0 to 80, with higher values representing a better outcome in verbal learning/memory. (NCT01615887)
Timeframe: 8 weeks
| Intervention | score on a scale (Mean) |
|---|---|
| Lisdexamfetamine Sulfate | 44.9 |
| Sugar Pill | 49.2 |
"Suicidality was assessed by using the C-SSRS, a semi-structured interview designed to capture the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview and rating for the C-SSRS was completed by a clinician who had been successfully trained by the sponsor or designee. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answers to the first 2 ideation questions were yes, the clinician asked questions 3-5. Active suicidal ideation included any participant who answered yes to questions 2-5. If the answers to ideation questions 1 and 2 were no, then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide." (NCT01657019)
Timeframe: 53 weeks
| Intervention | participants (Number) | ||
|---|---|---|---|
| Suicidal behavior | Active suicidal ideation | Non-suicidal self-injurious behavior | |
| All Participants | 0 | 2 | 3 |
The EDE-Q is a 28-item questionnaire measuring eating pathology and is derived directly from the Eating Disorder Examination Interview. The EDE-Q focuses on the past 28 days to assess the main behavioral (eating and purging) and attitudinal features of eating disorders. The 28 items are rated by the participant on a 7-point scale (ranging from 0 to 6), with higher scores indicating increased pathology. The EDE-Q includes 4 subscales: Restraint, Eating Concern, Weight Concern, and Shape Concern. The global score is the average of all 28 items, with a range of 0 to 6. A negative value indicates a favorable result. The values presented are the mean change from baseline. (NCT01657019)
Timeframe: Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)
| Intervention | units on a scale (Mean) | |||
|---|---|---|---|---|
| Visit 4 (Week 4), n=483 | Visit 9 (Week 24), n=391 | Visit 16 (Week 52), n=314 | End of Treatment, n=503 | |
| All Participants | -1.66 | -1.95 | -1.95 | -1.90 |
The CGI rating scales permitted the global evaluation of a participant's condition severity and improvement over time. The CGI-I was performed to rate the improvement of a participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse) and included a 'not assessed' option. The responses were dichotomized into 2 categories (improved or not improved). Improved included very much improved and much improved; not improved included minimally improved, no change, minimally worse, much worse, and very much worse. Not assessed and missing values were excluded from the percentage calculation. (NCT01657019)
Timeframe: Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Visit 1 (Week 1), n=589 | Visit 4 (Week 4), n=572 | Visit 9 (Week 24), n=466 | Visit 16 (Week 52), n=369 | End of Treatment, n=597 | |
| All Participants | 53.7 | 88.5 | 92.7 | 95.4 | 89.9 |
The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the usual activities questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit. (NCT01657019)
Timeframe: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
| Intervention | percentage of participants at ET (Number) | ||||
|---|---|---|---|---|---|
| I have no problems doing my usual activities | I have slight problems doing my usual activities | Moderate problems doing my usual activities | I have severe problems doing my usual activities | I am unable to do my usual activities | |
| All Participants | 88.5 | 8.3 | 2.2 | 0.9 | 0.2 |
(NCT01657019)
Timeframe: 52 weeks
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Any TEAE | Serious TEAEs | |
| All Participants | 84.5 | 2.8 |
The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the self care questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit. (NCT01657019)
Timeframe: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
| Intervention | percentage of participants at ET (Number) | ||||
|---|---|---|---|---|---|
| I have no problems washing or dressing myself | I have slight problems washing or dressing myself | Moderate problems washing or dressing myself | I have severe problems washing or dressing myself | I am unable to wash or dress myself | |
| All Participants | 97.1 | 1.8 | 0.7 | 0.2 | 0.2 |
The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the pain/discomfort questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit. (NCT01657019)
Timeframe: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
| Intervention | percentage of participants at ET (Number) | ||||
|---|---|---|---|---|---|
| I have no pain or discomfort | I have slight pain or discomfort | I have moderate pain or discomfort | I have severe pain or discomfort | I have extreme pain or discomfort | |
| All Participants | 71.2 | 20.9 | 7.0 | 0.9 | 0 |
The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the mobility questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit. (NCT01657019)
Timeframe: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
| Intervention | percentage of participants at ET (Number) | ||||
|---|---|---|---|---|---|
| I have no problems in walking about | I have slight problems in walking about | I have moderate problems in walking about | I have severe problems in walking about | I am unable to walk about | |
| All Participants | 91.2 | 6.8 | 1.4 | 0.4 | 0.2 |
The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the anxiety/depression questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit. (NCT01657019)
Timeframe: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
| Intervention | percentage of participants at ET (Number) | ||||
|---|---|---|---|---|---|
| I am not anxious or depressed | I am slightly anxious or depressed | I am moderately anxious or depressed | I am severely anxious or depressed | I am extremely anxious or depressed | |
| All Participants | 75.9 | 18.7 | 4.5 | 0.9 | 0 |
A parent rated retrospective dimensional assessment of oppositional and aggressive behaviors, with scores ranging from 0-40, and higher scores indicating greater severity. (NCT01714310)
Timeframe: Baseline through week 12.
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| Baseline | Week 4 | |
| Open Lisdexamfetamine | 26.03 | 17.93 |
Heart rate in beats per minute. (NCT01714310)
Timeframe: Baseline through week 12.
| Intervention | beats per minute. (Least Squares Mean) | ||||
|---|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | |
| Open Lisdexamfetamine | 80.84 | 88.15 | 84.33 | 90.71 | 88.45 |
Heart rate in beats per minute. (NCT01714310)
Timeframe: Baseline through week 12.
| Intervention | beats per minute. (Least Squares Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 10 | Week 12 | |
| Fluoxetine | 82.28 | 95.08 | 88.25 | 96.32 | 93.08 | 94.16 | 87.33 | 91.94 | 87.17 | 95.83 | 92.75 |
| Placebo | 84.64 | 85.21 | 81.64 | 85.79 | 83.21 | 83.00 | 90.55 | 90.00 | 85.10 | 82.90 | 90.62 |
A dimensional measure assessed in cms. (NCT01714310)
Timeframe: Baseline through week 12.
| Intervention | cm. (Least Squares Mean) | ||||
|---|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | |
| Open Lisdexamfetamine | 142.37 | 142.35 | 142.43 | 142.59 | 142.59 |
A dimensional measure assessed in cms. (NCT01714310)
Timeframe: Baseline through week 12.
| Intervention | cm. (Least Squares Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 10 | Week 12 | |
| Fluoxetine | 140.25 | 140.05 | 139.95 | 140.26 | 140.56 | 140.11 | 140.21 | 140.55 | 140.81 | 140.83 | 140.98 |
| Placebo | 144.63 | 144.76 | 144.81 | 144.88 | 144.54 | 144.82 | 145.44 | 145.14 | 144.98 | 145.30 | 145.60 |
Teacher completed dimensional measure of ADHD symptoms, with scores ranging from 0 - 30, and higher scores indicating more severe impairment. (NCT01714310)
Timeframe: Baseline through week 3.
| Intervention | units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 3 | |
| Open Lisdexamfetamine | 18.13 | 13.21 | 10.18 | 8.31 |
A dimensional parent report measure of restless-impulsive symptoms, with scores ranging from 0 to 21, and higher scores indicating greater impairment. (NCT01714310)
Timeframe: Baseline through week 3.
| Intervention | units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 3 | |
| Open Lisdexamfetamine | 15.91 | 9.55 | 10.60 | 8.60 |
A sub scale of the Conners Global Index, with scores ranging from 0 - 12, with higher scores indicating more impairment. (NCT01714310)
Timeframe: Baseline to week 3.
| Intervention | units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 3 | |
| Open Lisdexamfetamine | 8.81 | 5.90 | 6.33 | 5.45 |
A dimensional clinician rating of overall SMD related impairment, modified by the National Institute of Mental Health to assess specific domains pertinent to Severe Mood Dysregulation. Minimum score = 1. Maximum score = 7. Higher scores means greater impairment. (NCT01714310)
Timeframe: Baseline through week 12.
| Intervention | units on a scale (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Baseline | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 10 | Week 12 | |
| Fluoxetine | 4.91 | 4.42 | 4.15 | 3.67 | 3.61 | 3.42 | 3.45 | 3.51 |
| Placebo | 3.62 | 4.57 | 3.51 | 3.90 | 3.59 | 3.37 | 3.11 | 3.30 |
A dimensional clinician rating of overall SMD related impairment, modified by the National Institute of Mental Health to assess specific domains pertinent to Severe Mood Dysregulation. Minimum score = 1. Maximum score = 7. Higher scores means greater impairment. (NCT01714310)
Timeframe: Baseline through week 12.
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| Baseline | Week 4 | |
| Open Lisdexamfetamine | 4.30 | 4.31 |
A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity. (NCT01714310)
Timeframe: Baseline through week 12.
| Intervention | units on a scale (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Baseline | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 10 | Week 12 | |
| Fluoxetine | 10.00 | 7.58 | 6.58 | 6.42 | 6.69 | 6.49 | 6.74 | 6.39 |
| Placebo | 8.57 | 7.71 | 6.21 | 5.32 | 6.49 | 5.62 | 4.89 | 5.30 |
A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity. (NCT01714310)
Timeframe: Baseline through week 12.
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| Baseline | Week 4 | |
| Open Lisdexamfetamine | 9.29 | 6.87 |
Diastolic Blood pressure measured in mmHG. (NCT01714310)
Timeframe: Baseline through week 12.
| Intervention | mm Hg. (Least Squares Mean) | ||||
|---|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | |
| Open Lisdexamfetamine | 67.39 | 69.15 | 66.63 | 67.21 | 69.31 |
Percentage improved by treatment group (NCT01714310)
Timeframe: Percentage improved at week 4 for Open Lisdexamfetamine group and at week 12 for fluoxetine and placebo groups.
| Intervention | Participants (Count of Participants) |
|---|---|
| Fluoxetine | 7 |
| Placebo | 7 |
| Open Lisdexamfetamine | 8 |
A dimensional rating of ADHD symptoms, with scores ranging from 0 - 54, and higher scores indicating greater symptom severity. (NCT01714310)
Timeframe: Baseline through week 12.
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| Baseline | Week 4 | |
| Open Lisdexamfetamine | 34.20 | 16.59 |
A dimensional rating of ADHD symptoms, with scores ranging from 0 - 54, and higher scores indicating greater symptom severity. (NCT01714310)
Timeframe: Baseline through week 12.
| Intervention | units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| Baseline | Week 4 | Week 12 | |
| Fluoxetine | 34.50 | 14.92 | 16.29 |
| Placebo | 34.31 | 18.64 | 11.93 |
Parent completed dimensional measure of ADHD symptoms, with score range from 0 - 30 and higher scores indicating more severe symptoms. (NCT01714310)
Timeframe: Baseline through week 3.
| Intervention | units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 3 | |
| Open Lisdexamfetamine | 15.91 | 9.54 | 10.60 | 8.60 |
A parent rated retrospective dimensional assessment of oppositional and aggressive behaviors, with scores ranging from 0-40, and higher scores indicating greater severity. (NCT01714310)
Timeframe: Baseline through week 12.
| Intervention | units on a scale (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Baseline | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 10 | Week 12 | |
| Fluoxetine | 22.23 | 14.44 | 13.72 | 10.00 | 13.19 | 14.09 | 12.61 | 14.29 |
| Placebo | 33.68 | 25.35 | 20.60 | 20.55 | 21.89 | 21.33 | 17.68 | 18.34 |
Diastolic Blood pressure measured in mmHG. (NCT01714310)
Timeframe: Baseline through week 12.
| Intervention | mm Hg. (Least Squares Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 10 | Week 12 | |
| Fluoxetine | 68.86 | 71.33 | 66.00 | 68.74 | 71.17 | 71.17 | 69.58 | 68.14 | 68.06 | 70.81 | 77.11 |
| Placebo | 66.40 | 69.50 | 66.79 | 62.82 | 66.21 | 65.17 | 70.61 | 70.64 | 68.40 | 67.06 | 70.05 |
Weight in kg. (NCT01714310)
Timeframe: Baseline through week 12.
| Intervention | kg. (Least Squares Mean) | ||||
|---|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | |
| Open Lisdexamfetamine | 42.59 | 41.83 | 41.29 | 40.73 | 40.67 |
Weight in kg. (NCT01714310)
Timeframe: Baseline through week 12.
| Intervention | kg. (Least Squares Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 10 | Week 12 | |
| Fluoxetine | 37.96 | 37.29 | 36.96 | 36.55 | 36.20 | 36.08 | 35.73 | 35.30 | 35.08 | 34.61 | 34.73 |
| Placebo | 47.26 | 46.39 | 45.56 | 45.06 | 45.22 | 44.80 | 44.34 | 44.72 | 44.08 | 44.16 | 43.05 |
Systolic Blood Pressure measured in mmHG (NCT01714310)
Timeframe: Baseline through week 12.
| Intervention | mm Hg. (Least Squares Mean) | ||||
|---|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | |
| Open Lisdexamfetamine | 107.40 | 106.03 | 107.48 | 110.73 | 111.77 |
Systolic Blood Pressure measured in mmHG (NCT01714310)
Timeframe: Baseline through week 12.
| Intervention | mm Hg. (Least Squares Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 10 | Week 12 | |
| Fluoxetine | 107.85 | 99.42 | 104.83 | 109.20 | 112.00 | 109.57 | 111.58 | 112.04 | 111.20 | 112.25 | 116.15 |
| Placebo | 106.68 | 111.71 | 110.36 | 109.89 | 110.07 | 104.20 | 108.98 | 112.80 | 110.94 | 105.67 | 113.90 |
ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity. (NCT01718483)
Timeframe: Up to 12 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| PLACEBO | 7.3 |
| SPD489 | 5.7 |
The BES is a self-reported questionnaire containing 16 items designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. Each item is assessed based on 1 of 4 responses, with 1 denoting that a participant has greater control over eating behavior and 4 denoting that a participant had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior. (NCT01718483)
Timeframe: Baseline and Week 12
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| PLACEBO | -8.55 |
| SPD489 | -18.87 |
(NCT01718483)
Timeframe: Baseline and Week 12/ET
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| PLACEBO | -0.094 |
| SPD489 | -0.305 |
(NCT01718483)
Timeframe: Baseline and Week 12/Early termination (ET)
| Intervention | millimole per liter (mmol/L) (Least Squares Mean) |
|---|---|
| PLACEBO | 0.122 |
| SPD489 | -0.077 |
"The FrSBe is a 46-item self-rating scale designed to measure the neurobehavioral traits associated with the 3 primary regions of the prefrontal cortex. Participants were asked to indicate the frequency with which they have engaged in certain behaviors using a rating scale from 1 (almost never) to 5 (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement." (NCT01718483)
Timeframe: Baseline and Week 12
| Intervention | t-scores (Least Squares Mean) |
|---|---|
| PLACEBO | -3.09 |
| SPD489 | -3.40 |
(NCT01718483)
Timeframe: Baseline and Week 12/ET
| Intervention | Percent hemoglobin (Least Squares Mean) |
|---|---|
| PLACEBO | 0.01 |
| SPD489 | -0.02 |
(NCT01718483)
Timeframe: Baseline and Visit 8 (Weeks 11-12)
| Intervention | Binge episodes per week (Least Squares Mean) |
|---|---|
| PLACEBO | -3.49 |
| SPD489 | -5.27 |
The Y-BOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. Reduction in total score indicates improvement. (NCT01718483)
Timeframe: Baseline and Week 12
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| PLACEBO | -8.28 |
| SPD489 | -15.68 |
(NCT01718483)
Timeframe: Baseline and Week 12
| Intervention | percent change (Least Squares Mean) |
|---|---|
| PLACEBO | 0.11 |
| SPD489 | -6.25 |
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. (NCT01718483)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| PLACEBO | 47.3 |
| SPD489 | 82.1 |
Response is based on the reduction in the number of binge eating episodes. Percentage of participants with response was reported. Responses were categorized as follows: 1-week Cessation = 100% reduction in binge episodes during the preceding 7 days. Marked Reduction = 99% to 75% reduction during the time since the previous visit. Moderate Reduction = 74% to 50% reduction during the time since the previous visit. Negative to Minimal Reduction = <50% reduction during the time since the previous visit. (NCT01718483)
Timeframe: Week 12/ET
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| 1-week cessation | Marked Reduction | Moderate Reduction | Negative to Minimal Reduction | |
| PLACEBO | 26.6 | 15.2 | 17.9 | 40.2 |
| SPD489 | 47.1 | 31.6 | 11.8 | 9.6 |
The Eating Inventory also known as the Three-Factor Eating Questionnaire is a 51-item self-reported questionnaire intended to assess 3 dimensions of eating behavior. There are 36 true/false items, 14 items on a 4-point Likert scale (1=eat rarely to 4=always), and 1 item on a 6-point Likert scale (1=eat whatever you want to 6=constantly limiting food intake). Cognitive Restraint score ranges from 0-21. Hunger score ranges from 0-14. Disinhibition score ranges from 0-16. Higher scores denote higher levels of restrained eating, disinhibited eating and predisposition to hunger. (NCT01718483)
Timeframe: Baseline and Week 12
| Intervention | units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| Cognitive Restraint of Eating | Disinhibition of Eating | Perceived Hunger | |
| PLACEBO | 1.63 | -2.12 | -1.90 |
| SPD489 | 3.27 | -6.31 | -6.60 |
C-SSRS is a semi-structured interview that captures the occurrence, 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. Number of participants with suicidal ideation and suicidal behavior were reported. (NCT01718483)
Timeframe: Up to 12 weeks
| Intervention | participants (Number) | |
|---|---|---|
| Suicidal Ideation | Suicidal behavior | |
| PLACEBO | 3 | 0 |
| SPD489 | 2 | 0 |
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various anxiety/depression conditions were reported. (NCT01718483)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Not anxious or depressed | Slightly anxious or depressed | Moderately anxious or depressed | Severely anxious or depressed | Extremely anxious or depressed | |
| PLACEBO | 70.2 | 19.7 | 7.9 | 2.2 | 0 |
| SPD489 | 72.2 | 16.6 | 9.1 | 1.6 | 0.5 |
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various mobility conditions were reported. (NCT01718483)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| No problems walking about | Slight problems walking about | Moderate problems walking about | Severe problems walking about | Unable to walk about | |
| PLACEBO | 82.6 | 14.0 | 2.8 | 0.6 | 0 |
| SPD489 | 87.2 | 10.7 | 2.1 | 0 | 0 |
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various pain/discomfort conditions were reported. (NCT01718483)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| No pain or discomfort | Slight pain or discomfort | Moderate pain or discomfort | Severe pain or discomfort | Extreme pain or discomfort | |
| PLACEBO | 64.6 | 27.5 | 7.3 | 0.6 | 0 |
| SPD489 | 71.1 | 20.9 | 7.5 | 0.5 | 0 |
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various self-care conditions were reported. (NCT01718483)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| No problems washing or dressing | Slight problems washing or dressing | Moderate problems washing or dressing | Severe problems washing or dressing | Unable to wash or dress | |
| PLACEBO | 89.3 | 6.7 | 3.9 | 0 | 0 |
| SPD489 | 95.7 | 3.2 | 1.1 | 0 | 0 |
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various usual activities conditions were reported. (NCT01718483)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| No problems doing usual activities | Slight problems doing usual activities | Moderate problems doing usual activities | Severe problems doing usual activities | Unable to do usual activities | |
| PLACEBO | 78.0 | 14.7 | 6.2 | 1.1 | 0 |
| SPD489 | 87.1 | 9.7 | 3.2 | 0 | 0 |
4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit. (NCT01718483)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| PLACEBO | 14.1 |
| SPD489 | 40.0 |
Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on participant binge diary. (NCT01718483)
Timeframe: Baseline and Visit 8 (Weeks 11-12)
| Intervention | Binge days per week (Least Squares Mean) |
|---|---|
| PLACEBO | -2.51 |
| SPD489 | -3.87 |
(NCT01718509)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| No problems doing usual activities | Slight problems dosin usual activities | Moderate problems doing usual activities | Severe problems doing usual activities | Unable to do usual activities | |
| PLACEBO | 82.1 | 14.3 | 3.0 | 0.6 | 0 |
| SPD489 | 89.9 | 8.3 | 1.2 | 0.6 | 0 |
ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity. Calculated as Baseline (Day 0) - Week 12 ACSA scores. (NCT01718509)
Timeframe: Baseline and Week 12
| Intervention | units on a scale (Mean) |
|---|---|
| PLACEBO | 7.0 |
| SPD489 | 4.6 |
4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit. (NCT01718509)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| PLACEBO | 13.1 |
| SPD489 | 36.2 |
(NCT01718509)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| No problems washing or dressing | Slight problems washing or dressing | Moderate problems washing or dressing | Severe problems washing or dressing | Unable to wash or dress | |
| PLACEBO | 97.0 | 2.4 | 0.6 | 0 | 0 |
| SPD489 | 97.0 | 3.0 | 0 | 0 | 0 |
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. (NCT01718509)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| PLACEBO | 42.9 |
| SPD489 | 86.2 |
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. (NCT01718509)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| No problems in walking about | Slight problems in walking about | Moderate problems walking about | Severe problems walking about | Unable to walk about | |
| PLACEBO | 86.9 | 8.9 | 3.0 | 1.2 | 0 |
| SPD489 | 91.7 | 7.1 | 0.6 | 0.6 | 0 |
(NCT01718509)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Not anxious or depressed | Slightly anxious or depressed | Moderately anxious or depressed | Severely anxious or depressed | Extremely anxious or depressed | |
| PLACEBO | 69.6 | 23.2 | 4.8 | 1.2 | 1.2 |
| SPD489 | 76.3 | 20.7 | 2.4 | 0 | 0.6 |
(NCT01718509)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| No pain or discomfort | Slight pain or discomfort | Moderate pain or discomfort | Severe pain or discomfort | Extreme pain or discomfort | |
| PLACEBO | 75.6 | 18.5 | 3.0 | 3.0 | 0 |
| SPD489 | 76.3 | 20.1 | 3.0 | 0 | 0.6 |
There are 36 true/false items, 14 items on a 4-point Likert scale (1=eat rarely to 4=always), and 1 item on a 6-point Likert scale (1=eat whatever you want to 6=constantly limiting food intake). Cognitive Restraint score ranges from 0-21. Hunger score ranges from 0-14. Disinhibition score ranges from 0-16. Higher scores denote higher levels of restrained eating, disinhibited eating and predisposition to hunger. (NCT01718509)
Timeframe: Baseline and week 12
| Intervention | units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| Cognitive Restraint of Eating | Disinhibition of Eating | Perceived Hunger | |
| PLACEBO | 2.44 | -2.01 | -1.93 |
| SPD489 | 3.71 | -5.61 | -6.14 |
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. (NCT01718509)
Timeframe: Up to 12 weeks
| Intervention | participants (Number) | |
|---|---|---|
| Suicidal ideation | Suicidal behavior | |
| PLACEBO | 0 | 0 |
| SPD489 | 0 | 0 |
(NCT01718509)
Timeframe: Baseline and week 12
| Intervention | percentage change (Least Squares Mean) |
|---|---|
| PLACEBO | -0.15 |
| SPD489 | -5.57 |
The Y-BOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. Reduction in total score indicates improvement. (NCT01718509)
Timeframe: Baseline and week 12
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| PLACEBO | -7.42 |
| SPD489 | -15.36 |
(NCT01718509)
Timeframe: Baseline and Visit 8 Which Spans Weeks 11/12
| Intervention | Binge episodes per week (Least Squares Mean) |
|---|---|
| PLACEBO | -3.31 |
| SPD489 | -5.54 |
Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary. (NCT01718509)
Timeframe: Baseline and Visit 8 Which Spans Weeks 11/12
| Intervention | Binge days per week (Least Squares Mean) |
|---|---|
| PLACEBO | -2.26 |
| SPD489 | -3.92 |
(NCT01718509)
Timeframe: Baseline and up to 12 weeks
| Intervention | Percent (Least Squares Mean) |
|---|---|
| PLACEBO | -0.02 |
| SPD489 | 0.01 |
"The FrSBe is a 46-item self-rating scale designed to measure the neurobehavioral traits associated with the 3 primary regions of the prefrontal cortex. Subjects were asked to indicate the frequency with which they have engaged in certain behaviors using a rating scale from 1 (almost never) to 5 (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement." (NCT01718509)
Timeframe: Baseline and up to 12 weeks
| Intervention | t-scores (Least Squares Mean) |
|---|---|
| PLACEBO | -3.09 |
| SPD489 | -4.05 |
(NCT01718509)
Timeframe: Baseline and up to 12 weeks
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| PLACEBO | 0.062 |
| SPD489 | -0.133 |
(NCT01718509)
Timeframe: Baseline and up to 12 weeks
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| PLACEBO | -0.126 |
| SPD489 | -0.204 |
Response is based on the reduction in the number of binge eating episodes. Responses were categorized as follows: -1-week Cessation = 100% reduction in binge episodes during the preceding 7 days -Marked Reduction = 99% to 75% reduction during the time since the previous visit -Moderate Reduction = 74% to 50% reduction during the time since the previous visit -Negative to Minimal Reduction = <50% reduction during the time since the previous visit (NCT01718509)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| 1-week cessation | Marked reduction | Moderate reduction | Negative to minimal reduction | |
| PLACEBO | 23.9 | 13.4 | 19.7 | 43.0 |
| SPD489 | 55.9 | 22.8 | 16.6 | 4.8 |
The BES is a self-reported questionnaire containing 16 items designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. Each item is assessed based on 1 of 4 responses, with 1 denoting that a subject has greater control over eating behavior and 4 denoting that a subject had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior. (NCT01718509)
Timeframe: Baseline and week 12
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| PLACEBO | -8.24 |
| SPD489 | -17.52 |
Child symptom severity will be assessed using the Clinical Global Impression - Severity (CGI-s) scale. This was collected at Baseline, Week 8 (end of Phase 1) and Week 16 (end of Phase 2). The CGI-S scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse. (NCT01816074)
Timeframe: Baseline, Weeks 8 and 16
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Baseline | Week 8 | Week 16 | |
| BPT Then Maternal Medication | 4.67 | 3.78 | 3.22 |
| Maternal Behavioral Parent Training (BPT) Then Additional BPT | 4.56 | 3.75 | 3.67 |
| Maternal Medication Then Additional Maternal Medication | 4.78 | 4.33 | 4.13 |
| Maternal Medication Then BPT | 4.44 | 3.63 | 3.38 |
The Clinical Global Impression - Severity (CGI-S) scale will be used. This was collected at Baseline, Week 8 (end of Phase 1) and Week 16 (end of Phase 2). The CGI-S scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse. (NCT01816074)
Timeframe: Baseline, Weeks 8 and 16
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Baseline | Week 8 | Week 16 | |
| BPT Then Maternal Medication | 4.45 | 3.80 | 2.56 |
| Maternal Behavioral Parent Training (BPT) Then Additional BPT | 4.50 | 3.67 | 3.86 |
| Maternal Medication Then Additional Maternal Medication | 4.64 | 3.55 | 3.20 |
| Maternal Medication Then BPT | 4.82 | 2.60 | 2.60 |
The Dyadic Parent-Child Interaction Coding System (DPICS) will be used at baseline, week 8, and week 16 to provide an observational measure of positive and negative behaviors of the mother toward the child. Instances of positive (e.g. praise) and negative (e.g. criticism) behaviors are coded by study raters trained to reliability; scores range from 0 to no upper limit. Higher numbers indicate higher instances of the observed behaviors. (NCT01816074)
Timeframe: Baseline, Weeks 8 and 16
| Intervention | instances observed (Mean) | |
|---|---|---|
| Total Positive Parenting | Total Negative Parenting | |
| Behavior Parent Training Then Additional BPT - Baseline | 17.49 | 10.64 |
| Behavior Parent Training Then Additional BPT - Week 16 | 39.52 | 8.85 |
| Behavior Parent Training Then Additional BPT - Week 8 | 34.71 | 9.44 |
| Behavior Parent Training Then Maternal Medication - Baseline | 21.83 | 8.04 |
| Behavior Parent Training Then Maternal Medication - Week 16 | 44.07 | 7.66 |
| Behavior Parent Training Then Maternal Medication - Week 8 | 46.33 | 5.01 |
| Maternal Medication Then Additional Maternal Med - Baseline | 23.61 | 11.33 |
| Maternal Medication Then Additional Maternal Med - Week 16 | 32.56 | 10.51 |
| Maternal Medication Then Additional Maternal Med - Week 8 | 27.17 | 17.01 |
| Maternal Medication Then Behavior Parent Training - Baseline | 41.67 | 8.64 |
| Maternal Medication Then Behavior Parent Training - Week 16 | 51.70 | 5.96 |
| Maternal Medication Then Behavior Parent Training - Week 8 | 31.55 | 13.47 |
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. (NCT01890785)
Timeframe: Up to 96 hours post-dose
| Intervention | ng/ml (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate Mixed in Orange Juice | 24.5 |
| Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt | 32.2 |
| Lisdexamfetamine Dimesylate Intact Capsule Fasting | 38.5 |
d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity. (NCT01890785)
Timeframe: Up to 96 hours post-dose
| Intervention | ng*h/ml (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate Mixed in Orange Juice | 1140.9 |
| Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt | 1110.1 |
| Lisdexamfetamine Dimesylate Intact Capsule Fasting | 1180.2 |
d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity. (NCT01890785)
Timeframe: Up to 96 hours-post-dose
| Intervention | ng/ml (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate Mixed in Orange Juice | 59.1 |
| Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt | 59.0 |
| Lisdexamfetamine Dimesylate Intact Capsule Fasting | 61.0 |
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. (NCT01890785)
Timeframe: Up to 96 hours post-dose
| Intervention | ng*hr/ml (Mean) |
|---|---|
| Lisdexamfetamine Dimesylate Mixed in Orange Juice | 27.0 |
| Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt | 36.0 |
| Lisdexamfetamine Dimesylate Intact Capsule Fasting | 38.3 |
"The Wender-Reimherr adult attention deficit disorder scale (WRAADS): Symptom measure for emotional functioning/lability, generally reported as Sum of Responses (0-2 per item, higher = more impaired).~For this outcome measure, Average scores for particular questions were taken - specifically question 3, question 4, and question 5." (NCT01924429)
Timeframe: Baseline
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Question 3 | Question 4 | Question 5 | |
| Off Drug Then on Drug | 0.94 | 1.47 | 1.82 |
| On Drug Then Off Drug | 0.80 | 1.27 | 1.13 |
"Performance Measures on the Go/No-Go Task assessed by fMRI as a Function of Trial Type, Face Emotion, and Drug Condition in Adults with Attention-Deficit/Hyperactivity Disorder. The Go/No-Go Task is a neuropsychological test that provides a direct measure of number of responses made that are correct or incorrect. It is not a scale. Reported are the percentage of correct responses on that direct performance measure. 0% correct is worse than 100% correct." (NCT01924429)
Timeframe: 8 weeks
| Intervention | percentage correct responses/inhibitions (Mean) | |||||
|---|---|---|---|---|---|---|
| Happy Correct Responses | Happy Correct Inhibitions | Sad Correct Responses | Sad Correct Inhibitions | Neutral Correct Responses | Neutral Correct Inhibitions | |
| Lisdexamfetamine | 97.0 | 87.9 | 88.5 | 86.7 | 95.6 | 79.6 |
| Placebo | 91.7 | 88.7 | 90.3 | 84.4 | 93.2 | 77.5 |
Reaction-time, as measured by the reaction time test Go/No-Go Task as a Function of Trial Type, Face Emotion, and Drug Condition in Adults with Attention-Deficit/Hyperactivity Disorder (NCT01924429)
Timeframe: up to 6 weeks
| Intervention | ms (Mean) | ||
|---|---|---|---|
| Happy | Sad | Neutral | |
| Lisdexamfetamine | 519 | 509 | 533 |
| Placebo | 532 | 533 | 553 |
ADHD symptoms and severity. Norm referenced interview to assess severity and frequency of ADHD symptoms. 18 Items are scored 0-3 to reflect severity and frequency of ADHD symptoms, and a sum is taken. Full range from 0 to 54, with higher number indicating more symptoms and severity. (NCT01924429)
Timeframe: Baseline
| Intervention | units on a scale (Mean) | |
|---|---|---|
| On Drug | Placebo | |
| Off Drug Then on Drug | 13.67 | 31.00 |
| On Drug Then Off Drug | 11.00 | 25.65 |
ADHD symptoms and severity - subscale for Inattentiveness. 9-item scale, each scored 0-3, with total from 0 to 27. Higher score indicates higher level of inattentiveness. (NCT01924429)
Timeframe: 4 weeks and 8 weeks
| Intervention | units on a scale (Mean) | |
|---|---|---|
| On drug | Placebo | |
| Off Drug Then on Drug | 8.83 | 19.2 |
| On Drug Then Off Drug | 7.36 | 18.94 |
"CGI-S: Severity of impairment due to ADHD was measured by the Clinical Global Impressions-Severity scale (CGI-S). Lower scores indicate less severe impairment from symptoms, with a CGI-I=1 indicating the person is normal with no impairment. (1= normal, not ill, 2= minimally ill, 3= mildly ill, 4= moderately ill, 5=markedly ill, 6=severely ill, 7= very severely ill)" (NCT01924429)
Timeframe: baseline
| Intervention | units on a scale (Mean) |
|---|---|
| On Drug Then Off Drug | 4.9 |
| Off Drug Then on Drug | 4.95 |
Clinical Global Impressions - CGI-I: Clinical response was the Clinical Global Impression-Improvement scale (CGI-I). Lower CGI-I scores indicate greater improvement (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). (NCT01924429)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|---|
| On Drug Then Off Drug | 1.88 |
| Off Drug Then on Drug | 2.00 |
Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (0 to 100, with 50 +/-1 SD = 'Normal', higher is worse, more impaired) (NCT01924429)
Timeframe: Baseline
| Intervention | t-score (Mean) |
|---|---|
| On Drug Then Off Drug | 66.64 |
| Off Drug Then on Drug | 73.5 |
ADHD and Related Symptoms Measure (ASRS): self report, reported as Sum of Responses (0-4 per item, higher = more impaired) 0-26 (normal range) and >27 (clinically significant symptoms). (NCT01924429)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|---|
| On Drug Then Off Drug | 83.7 |
| Off Drug Then on Drug | 86 |
Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. BOLD signals were compared from baseline, first intervention and second intervention. (NCT01977625)
Timeframe: 10 weeks
| Intervention | percent change (Mean) |
|---|---|
| Lisdexamfetamine | 0.41 |
| Placebo | -0.11 |
The total BADDS ranged from 0-120 with higher scores meaning greater problems with memory, attention and focus. Difference in BADDS score from Baseline to End of Treatment for each study Arm was calculated. (NCT01977625)
Timeframe: 10 weeks
| Intervention | change in units (Mean) |
|---|---|
| Lisdexamfetamine | -23.36 |
| Placebo | -8.57 |
Relapse status was assessed during the double-blind treatment phase and was defined as having 2 or more binge days per week for 2 consecutive weeks (14 consecutive days) prior to any visit and having an increase in Clinical Global Impressions-Severity (CGI-S) score of 2 or more points compared to the randomized-withdrawal baseline (date of relapse - date of randomization). Binge eating information was captured via a self-report paper diary. The binge diary captured the number of binges per day, total hours per day spent binging, type of binge (at mealtime or at another time other than mealtime), and a description of the binge (amounts and types of foods). Binge frequency was reviewed by the clinician with the subject to confirm reported binge episodes per day. The CGI-S was performed to rate the severity of a subject's condition using a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). (NCT02009163)
Timeframe: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)
| Intervention | days (Median) |
|---|---|
| Placebo (Randomized-withdrawal Period) | NA |
| SPD489 (Randomized-withdrawal Period) | NA |
The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. (NCT02009163)
Timeframe: Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| I have no problems washing or dressing myself | I have slight problems washing or dressing myself | Moderate problems washing or dressing myself | I have severe problems washing or dressing myself | I am unable to wash or dress myself | |
| Open-label Safety Population | 98.7 | 0.8 | 0.3 | 0.3 | 0 |
The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. (NCT02009163)
Timeframe: Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| I have no pain or discomfort | I have slight pain or discomfort | Moderate pain or discomfort | I have severe pain or discomfort | I have extreme pain or discomfort | |
| Open-label Safety Population | 72.3 | 20.9 | 5.3 | 1.3 | 0.3 |
The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. (NCT02009163)
Timeframe: Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| I have no problems in walking about | I have slight problems in walking about | Moderate problems in walking about | I have severe problems in walking about | I am unable to walk about | |
| Open-label Safety Population | 87.9 | 9.8 | 1.5 | 0.8 | 0 |
The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. (NCT02009163)
Timeframe: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| I am not anxious or depressed | I am slightly anxious or depressed | Moderately anxious or depressed | I am severely anxious or depressed | I am extremely anxious or depressed | |
| Placebo (Randomized-withdrawal Period) | 66.4 | 26.7 | 4.3 | 2.6 | 0.0 |
| SPD489 (Randomized-withdrawal Period) | 79.5 | 15.7 | 3.1 | 0.8 | 0.8 |
The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. (NCT02009163)
Timeframe: Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| I am not anxious or depressed | I am slightly anxious or depressed | Moderately anxious or depressed | I am severely anxious or depressed | I am extremely anxious or depressed | |
| Open-label Safety Population | 80.9 | 15.6 | 2.3 | 1.0 | 0.3 |
The CGI-S permits a global evaluation of a subject's condition and severity of symptoms. The CGI-S was performed to rate the severity of a subject's condition based on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). (NCT02009163)
Timeframe: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)
| Intervention | percentage 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 (Randomized-withdrawal Period) | 45.0 | 10.7 | 14.5 | 22.1 | 6.9 | 0.0 | 0.8 |
| SPD489 (Randomized-withdrawal Period) | 81.6 | 11.8 | 2.2 | 2.2 | 2.2 | 0.0 | 0.0 |
"The C-SSRS is a semistructured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. 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 interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answer to the first 2 ideation questions was yes, the clinician asked questions 3-5. Active suicidal ideation included any participant who answered yes to questions 2-5. If the answers to ideation questions 1 and 2 were No, then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide." (NCT02009163)
Timeframe: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)
| Intervention | participants (Number) | ||
|---|---|---|---|
| Suicidal Behavior | Active Suicidal Ideation | Non-Suicidal Self-Injurious Behavior | |
| Placebo (Randomized-withdrawal Period) | 0 | 0 | 0 |
| SPD489 (Randomized-withdrawal Period) | 0 | 0 | 1 |
"The C-SSRS is a semistructured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. 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 interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answer to the first 2 ideation questions was yes, the clinician asked questions 3-5. Active suicidal ideation included any participant who answered yes to questions 2-5. If the answers to ideation questions 1 and 2 were No, then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide." (NCT02009163)
Timeframe: Visit 8 (12 weeks after start of open-label treatment [Week 12])
| Intervention | participants (Number) | ||
|---|---|---|---|
| Suicidal Behavior | Active Suicidal Ideation | Non-Suicidal Self-Injurious Behavior | |
| Open-label Safety Population | 0 | 0 | 2 |
The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. (NCT02009163)
Timeframe: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| I have no problems in walking about | I have slight problems in walking about | Moderate problems in walking about | I have severe problems in walking about | I am unable to walk about | |
| Placebo (Randomized-withdrawal Period) | 83.6 | 14.7 | 1.7 | 0.0 | 0.0 |
| SPD489 (Randomized-withdrawal Period) | 91.3 | 6.3 | 1.6 | 0.8 | 0.0 |
The Y-BOCS-BE measures the obsession of binge eating thoughts and compulsiveness of binge eating behaviors. The scale is a clinician rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). The scale includes questions regarding the amount of time spent on obsessions, impairment or distress experienced, and resistance and control over these thoughts. The same types of questions were asked about compulsions (ie, time spent, interference, etc.).Total scores range from 0 to 40. A total score of 0-7 is sub-clinical, 8-15 is mild, 16-23 is moderate, 24-31 is severe, and 32-40 is extreme. A decrease from baseline in Y-BOCS-BE Total Score represents an improvement in obsession with binge-eating thoughts or compulsiveness of binge-eating behaviors. (NCT02009163)
Timeframe: Randomized-withdrawal baseline (Visit 8; 12 weeks after start of open-label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38])
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo (Randomized-withdrawal Period) | 5.5 |
| SPD489 (Randomized-withdrawal Period) | -0.0 |
A binge day was defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary. Binge eating information was captured via a self-report paper diary. The binge diary captured the number of binges per day, total hours per day spent binging, type of binge (at mealtime or at another time other than mealtime), and a description of the binge (amounts and types of foods). Binge frequency was reviewed by the clinician with the subject to confirm reported binge episodes per day. A negative change from Baseline indicates that binge-related behavior decreased. The randomized -withdrawal-baseline was defined as the weekly average number of binge days for the 14 days prior to the Randomization Visit (Visit 8). (NCT02009163)
Timeframe: Randomized--withdrawal baseline (Visit 8; 12 weeks after start of open- label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38])
| Intervention | days (Least Squares Mean) |
|---|---|
| Placebo (Randomized-withdrawal Period) | 0.63 |
| SPD489 (Randomized--Withdrawal Period) | 0.02 |
The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. (NCT02009163)
Timeframe: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| I have no pain or discomfort | I have slight pain or discomfort | Moderate pain or discomfort | I have severe pain or discomfort | I have extreme pain or discomfort | |
| Placebo (Randomized-withdrawal Period) | 75.0 | 16.4 | 8.6 | 0.0 | 0.0 |
| SPD489 (Randomized-withdrawal Period) | 71.7 | 18.1 | 8.7 | 0.0 | 1.6 |
The ACSA was used in this study to assess potential withdrawal symptoms associated with chronic use of SPD489. The ACSA is a self-completed scale used to assess withdrawal symptoms. The scale has 16 symptom items rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The ACSA total score ranges from 0-64, where a higher score indicates greater withdrawal symptom severity. (NCT02009163)
Timeframe: Visit 21 (26 weeks after randomization [Week 38] or Early Termination) and Visit 22 (7 days post last dose)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Visit 21, n=88, 94 | Visit 22, n=75, 78 | |
| Placebo (Randomized-withdrawal Period) | 7.6 | 4.6 |
| SPD489 (Randomized-withdrawal Period) | 4.9 | 5.3 |
The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. (NCT02009163)
Timeframe: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| I have no problems doing my usual activities | I have slight problems doing my usual activities | Moderate problems doing my usual activities | I have severe problems doing my usual activities | I am unable to do my usual activities | |
| Placebo (Randomized-withdrawal Period) | 79.3 | 16.4 | 2.6 | 0.0 | 1.7 |
| SPD489 (Randomized-withdrawal Period) | 86.6 | 11.0 | 0.8 | 1.6 | 0.0 |
The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. (NCT02009163)
Timeframe: Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| I have no problems doing my usual activities | I have slight problems doing my usual activities | Moderate problems doing my usual activities | I have severe problems doing my usual activities | I am unable to do my usual activities | |
| Open-label Safety Population | 88.9 | 8.1 | 2.3 | 0.8 | 0 |
The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. (NCT02009163)
Timeframe: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| I have no problems washing or dressing myself | I have slight problems washing or dressing myself | Moderate problems washing or dressing myself | I have severe problems washing or dressing myself | I am unable to wash or dress myself | |
| Placebo (Randomized-withdrawal Period) | 98.3 | 0.9 | 0.9 | 0.0 | 0.0 |
| SPD489 (Randomized-withdrawal Period) | 98.4 | 0.8 | 0.8 | 0.0 | 0.0 |
"Brain segmentation volume measured in mm^3. We are reporting the mean difference in brain segmentation volume from baseline (pre-test) to 6 weeks (post-test).~No statistical analysis information is being submitted for the affected outcome measure. No statistical analyses have been performed or would be considered scientifically appropriate because actual enrollment fell well below target enrollment. Enrollment terminated early as a result of the COVID-19 pandemic." (NCT02259517)
Timeframe: Baseline and 6 weeks
| Intervention | mm^3 (Mean) |
|---|---|
| ADHD - Guanfacine | -6137 |
| ADHD - Lisdexamfetamine | 11833 |
Vital sign assessments included blood pressure, pulse and respiratory rate. Number of participants with potentially clinically significant changes in vital signs were reported. (NCT02466386)
Timeframe: Week 52/ET
| Intervention | Participants (Count of Participants) |
|---|---|
| SPD489 | 0 |
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs was defined as AEs that start or deteriorate on or after the date of the first dose of investigational product and no later than 3 days following the last dose of investigational product. (NCT02466386)
Timeframe: From start of study drug administration up to follow-up (Week 53)
| Intervention | Participants (Count of Participants) |
|---|---|
| SPD489 | 86 |
Sleep patterns included sleep diary data and children's sleep habits questionnaire (CSHQ), which was parent report questionnaire designed to screen for the most common sleep problems in children, and consisted of 33 items for scoring and several extra items intended to provide administrators with other potentially useful information about respondents. The instrument evaluates the child's sleep based on behavior within 8 different sub scales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep-disordered breathing, and daytime sleepiness. Each item receives a score from 1 (problem occurs rarely) to 3 (problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: bedtime resistance: 6 to 18, sleep onset delay: 1 to 3, sleep duration: 3 to 9, sleep anxiety: 4 to 12, night walkings: 3 to 9, parasomnias: 7 to 21, sleep-disordered breathing: 3 to 9, and daytime sleepiness: 8 to 24. (NCT02466386)
Timeframe: Week 52/ET
| Intervention | Score on scale (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Bedtime Resistance: Week 52/ET | Sleep-onset Delay: Week 52/ET | Sleep Duration: Week 52/ET | Sleep Anxiety: Week 52/ET | Night Wakings: Week 52/ET | Parasomnias: Week 52/ET | Sleep-disordered Breathing: Week 52/ET | Daytime Sleepiness: Week 52/ET | |
| SPD489 | 8.9 | 1.6 | 3.8 | 5.5 | 4.2 | 8.6 | 3.4 | 10.1 |
Clinical laboratory evaluations included biochemistry and endocrinology, hematology, and urinalysis. Number of participants with potentially clinically significant changes in clinical laboratory values were reported. (NCT02466386)
Timeframe: Week 52/ET
| Intervention | Participants (Count of Participants) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hematology: Eosinophils/Leukocytes: Greater than (>)10% | Hematology: Hematocrit: Less than (<) 0.3 | Hematology: Leukocytes: <3 × 10^9/Liter (L) | Hematology: Leukocytes: >16 × 10^9/L | Hematology: Lymphocytes/leukocytes: >70% | Hematology: Neutrophils: <1 × 10^9/L | Hematology: Neutrophils/leukocytes: <30% | Hematology: Platelets: <75 × 10^9/L | Biochemistry and Endocrinology: Glucose: <3.05 Millimole per liter (mmol/L) | Biochemistry and Endocrinology: Glucose: >8.88 mmol/L | Biochemistry and Endocrinology: Potassium: >5.5 mmol/L | Biochemistry and Endocrinology: Protein: >90 gram per liter (g/L) | Biochemistry and Endocrinology: Thyrotropin: < Lower limit of normal (LLN) | Urinalysis: Ketones: Positive value (excluding trace) | Urinalysis: Occult blood: Positive value (excluding trace) | Urinalysis: Protein: Positive value (excluding trace) | |
| SPD489 | 12 | 2 | 1 | 1 | 1 | 1 | 15 | 1 | 2 | 2 | 1 | 1 | 7 | 15 | 2 | 30 |
"12-lead ECG was evaluated and recorded. ECG variables included heart rate, PR interval, QRS interval, QT interval, and corrected QT interval (QTc). The QTc was calculated using both Bazett (QTcB=QT/[RR]1/2) and Fridericia (QTcF=QT/[RR]1/3) corrections. Here, > = represents greater than or equal to, < represents lesser than and > represents greater than." (NCT02466386)
Timeframe: Week 52/ET
| Intervention | Participants (Count of Participants) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Heart Rate (< 55 Beats per minute) | Heart Rate (> 130 Beats per minute) | PR Interval (>= 200 millisecond [msec]) | QRS Interval (>= 90 msec) | QT Interval (> = 440 msec) | QTcB Interval (> = 440 msec and < 480 msec) | QTcB Interval (>= 480 msec and < 500 msec) | QTcB Interval (>= 500 msec) | QTcF Interval (> = 440 msec and < 480 msec) | QTcF Interval (>= 480 msec and < 500 msec) | QTcF Interval (>= 500 msec) | ECG Interpretation | ECG Abnormality - Rhythm | |
| SPD489 | 0 | 0 | 0 | 3 | 0 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
BMI was derived from height and weight. BMI was normalized by sex and age using the CDC growth charts. BMI percentiles were categorized as: Underweight (BMI < 5th percentile); Healthy weight (BMI 5th percentile up to < 85th percentile); Overweight (BMI 85th percentile < 95th percentile); Obese (BMI >= 95th percentile). Number of participants with shift from baseline in BMI percentile categories at Week 52/ET was reported. (NCT02466386)
Timeframe: Week 52/ET
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| Underweight: Week 52/ET | Healthy Weight: Week 52/ET | Overweight: Week 52/ET | Obese: Week 52/ET | |
| SPD489 | 8 | 78 | 12 | 3 |
ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that required the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). (NCT02466386)
Timeframe: Week 52/ET
| Intervention | Score on a scale (Mean) |
|---|---|
| SPD489 | -24.2 |
C-SSRS was semi-structured interview that captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview included definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. The C-SSRS contained 2 required items pertaining to suicidal ideation, 4 required items pertaining to suicidal behavior, and 1 required item pertaining to non-suicidal but self-injurious behavior. In situations where there was a positive response to the screening questions, there were 8 additional suicidal ideation items and 4 additional suicidal behavior items which were completed. Thus, there was a maximum of 19 items to be completed. Here number of participants responded as yes to suicidal ideation or behaviour were reported. (NCT02466386)
Timeframe: Week 52/ET
| Intervention | Participants (Count of Participants) |
|---|---|
| SPD489 | 0 |
CGI-I was an overall assessment of global symptom improvement by evaluation of the participant's condition severity and improvement over time. Scoring was done based on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), where higher score reported worse condition. The scoring was elaborated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. (NCT02466386)
Timeframe: Week 52/ET
| Intervention | Score on a scale (Mean) |
|---|---|
| SPD489 | 2.0 |
The BAARS-IV Self-Report consists of 27 symptoms that can be rated from 1 (never or rarely) to 4 (very often). The total range of scores is 1-108; a higher score indicates ADHD symptoms at a higher frequency. (NCT02635035)
Timeframe: Baseline, 10 Weeks
| Intervention | score on a scale (Mean) |
|---|---|
| Lisdexamfetamine First | 23.27 |
| Lisdexamfetamine Second | 23.1 |
BFIS is designed to evaluate possible impairment in 15 major domains of psychosocial functioning in adults. The scale for each domain is 0 to 9 where 0 represents no impairment and 9 represents highest impairment. The total range is 0-135; the higher the score, the higher the impairment. (NCT02635035)
Timeframe: Baseline, 10 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| Lisdexamfetamine First | 4.93 |
| Lisdexamfetamine Second | 4.88 |
"The BRIEF Parent Questionnaire is a validated 86-item questionnaire composed of 8 clinical scales that measure different aspects of executive functioning (Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor, Inhibit, Shift, Emotional Control). For each item, parents rate whether the child engages in the behavior never (=1), sometimes (=2), or often (=3). The lowest scale score is 86 (better performance) and the highest is 258 (worse performance). The clinical scales form two broader Indexes (Behavioral Regulation and Metacognition) and an overall score, the Global Executive Composite (GEC). Monitor was reported as the Primary Outcome. Raw scores were converted to z-scores (M=0, SD=+/-1)." (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Lisdexamfetamine (Vyvanse) | 0.34 |
| Placebo | 0.84 |
RCMAS is a self-report, 37-item questionnaire in which children agree (yes = 1) or disagree (no =0) to statements about themselves. A Total Anxiety score is computed based on 28 items, which are divided into 3 anxiety subscales: physiological anxiety (10 items), worry/oversensitivity (11 items), and social concerns/concentration (7 items). The remaining nine items on the RCMAS constitute the Lie (social desirability) subscale. The lowest scale score is 0 and the highest is 37. Raw scores were converted to z-scores (M=0, SD=+/-1). Because scores are derived from affirmative responses, a high score indicates a high level of anxiety or lie on that subscale. (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Vyvanse | -0.3 |
| Placebo | -0.56 |
Digit Span repeats strings of digits of increasing length said by the examiner. Participants were asked to repeat the digits in the same sequence, either forwards or backwards. Every item on Digit Span consists of two trials. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. It measures working memory and concentration with a range of scaled scores from 0-19. Raw scores were converted to z-scores (M=0, SD=+/-1). Higher scores indicate better recall and attention. (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Lisdexamfetamine (Vyvanse) | -0.27 |
| Placebo | -0.29 |
"The BRIEF Parent Questionnaire is a validated 86-item questionnaire composed of 8 clinical scales that measure different aspects of executive functioning (Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor, Inhibit, Shift, Emotional Control). For each item, parents rate whether the child engages in the behavior never (=1), sometimes (=2), or often (=3). The lowest scale score is 86 (better performance) and the highest is 258 (worse performance). The clinical scales form two broader Indexes (Behavioral Regulation and Metacognition) and an overall score, the Global Executive Composite (GEC). Shift was reported as the Primary Outcome. Raw scores were converted to z-scores (M=0, SD=+/-1)." (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Lisdexamfetamine (Vyvanse) | 0.33 |
| Placebo | 1 |
The Child Behavior Checklist (CBCL) is a widely used caregiver report form identifying problem behavior in children. The patient is rated on 113 items scored on a 3-point Likert scale (0=not true; 1=somewhat/sometimes true; 2=very true/often true). CBCL consists of eight empirically-based syndrome subscales. The range of subscale scores (summed) are: Aggressive Behavior (0-36), Anxious/Depressed (0-26), Attention Problems (0-20), Rule-Breaking Behavior (0-34), Somatic Complaints (0-22), Social Problems (0-22), Thought Problems (0-30), and Withdrawn/Depressed (0-16). Raw scores were converted to z-scores (M=0, SD=+/-1). Higher scores indicate more severe symptoms. (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Vyvanse | 0.44 |
| Placebo | 0.76 |
The Child Behavior Checklist (CBCL) is a widely used caregiver report form identifying problem behavior in children. The patient is rated on 113 items scored on a 3-point Likert scale (0=not true; 1=somewhat/sometimes true; 2=very true/often true). CBCL consists of eight empirically-based syndrome subscales. The range of subscale scores (summed) are: Aggressive Behavior (0-36), Anxious/Depressed (0-26), Attention Problems (0-20), Rule-Breaking Behavior (0-34), Somatic Complaints (0-22), Social Problems (0-22), Thought Problems (0-30), and Withdrawn/Depressed (0-16). Raw scores were converted to z-scores (M=0, SD=+/-1). Higher scores indicate more severe symptoms. (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Vyvanse | 0.88 |
| Placebo | 1.37 |
"The BRIEF Parent Questionnaire is a validated 86-item questionnaire composed of 8 clinical scales that measure different aspects of executive functioning (Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor, Inhibit, Shift, Emotional Control). For each item, parents rate whether the child engages in the behavior never (=1), sometimes (=2), or often (=3). The lowest scale score is 86 (better performance) and the highest is 258 (worse performance). The clinical scales form two broader Indexes (Behavioral Regulation and Metacognition) and an overall score, the Global Executive Composite (GEC). Behavior Regulation was reported as the Primary Outcome. Raw scores were converted to z-scores (M=0, SD=+/-1)." (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Lisdexamfetamine (Vyvanse) | -0.04 |
| Placebo | 0.48 |
"The BRIEF Parent Questionnaire is a validated 86-item questionnaire composed of 8 clinical scales that measure different aspects of executive functioning (Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor, Inhibit, Shift, Emotional Control). For each item, parents rate whether the child engages in the behavior never (=1), sometimes (=2), or often (=3). The lowest scale score is 86 (better performance) and the highest is 258 (worse performance). The clinical scales form two broader Indexes (Behavioral Regulation and Metacognition) and an overall score, the Global Executive Composite (GEC). Cognitive Regulation was reported as the Primary Outcome. Raw scores were converted to z-scores (M=0, SD=+/-1)." (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Lisdexamfetamine (Vyvanse) | 0.68 |
| Placebo | 1.33 |
"The BRIEF Parent Questionnaire is a validated 86-item questionnaire composed of 8 clinical scales that measure different aspects of executive functioning (Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor, Inhibit, Shift, Emotional Control). For each item, parents rate whether the child engages in the behavior never (=1), sometimes (=2), or often (=3). The lowest scale score is 86 (better performance) and the highest is 258 (worse performance). The clinical scales form two broader Indexes (Behavioral Regulation and Metacognition) and an overall score, the Global Executive Composite (GEC). Emotion regulation was reported as the Primary Outcome. Raw scores were converted to z-scores (M=0, SD=+/-1)." (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Lisdexamfetamine (Vyvanse) | 0.35 |
| Placebo | 0.94 |
"The BRIEF Self-Report Version assesses an adolescent's (ages 11-18) view of his or her cognitive, emotional, and behavioral functions. It is a validated 55-item questionnaire composed of 8 clinical scales that measure different aspects of executive functioning (Inhibit, Shift, Emotional Control, Monitor, Working Memory, Plan/Organize, Organization of Materials, and Task Completion). For each item, the child rates whether they engage in the behavior never (=1), sometimes (=2), or often (=3). The lowest scale score is 55 (better performance) and the highest is 165 (worse performance). The clinical scales form two broader Indexes (Behavioral Regulation and Metacognition) and an overall score, the Global Executive Composite (GEC). GEC was reported as the Primary Outcome. Raw scores were converted to z-scores (M=0, SD=+/-1)." (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Lisdexamfetamine (Vyvanse) | 0.66 |
| Placebo | 0.59 |
"The BRIEF Parent Questionnaire is a validated 86-item questionnaire composed of 8 clinical scales that measure different aspects of executive functioning (Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor, Inhibit, Shift, Emotional Control). For each item, parents rate whether the child engages in the behavior never (=1), sometimes (=2), or often (=3). The lowest scale score is 86 (better performance) and the highest is 258 (worse performance). The clinical scales form two broader Indexes (Behavioral Regulation and Metacognition) and an overall score, the Global Executive Composite (GEC). GEC was reported as the Primary Outcome. Raw scores were converted to z-scores (M=0, SD=+/-1)." (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Lisdexamfetamine (Vyvanse) | 0.51 |
| Placebo | 1.16 |
The Conners-3 Parent Form is used to obtain the parent's observations about behavior in their child aged 6 to 18 years old. Parents rate the child's behavior on 45 items as not true at all (0) to very much true (3). The lowest scale score is 0 (better behavior) and the highest is 135 (worse behavior). The Conners 3-P includes content Scales of Inattention, Hyperactivity/Impulsivity, Learning Problems, Executive Functioning, Aggression, and Peer/Family Relations. Executive Functioning was reported as the Primary Outcome. All scores were converted to z-scores (M=0, SD=+/-1).Higher T-scores (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Lisdexamfetamine (Vyvanse) | 0.97 |
| Placebo | 1.79 |
Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition. During the CPT-II, letters were presented serially on a screen in a random order. All letters were considered target stimuli, except for the letter 'X' which is a non-target stimulus. Participants responded to target stimuli by pressing the space bar of a computer keyboard (90% of the stimuli) while withholding responses to non-target stimuli (10% of the test). Raw scores were converted to z-scores (M=0, SD=+/-1). Hit Reaction Time (RT) Standard Error (SE) measures response speed consistency. The higher the Overall Standard Error, the greater the inconsistency in the response speed, indicating a greater amount of inattention. (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Vyvanse | 0.14 |
| Placebo | 0.57 |
Conner's Continuous Performance Task (CPT-II) measures sustained attention and response inhibition. During the CPT-II, letters were presented serially on a screen in a random order. All letters were considered target stimuli, except for the letter 'X' which is a non-target stimulus. Participants responded to target stimuli by pressing the space bar of a computer keyboard (90% of the stimuli) while withholding responses to non-target stimuli (10% of the test). Omission errors represented the number of times a participant fails to respond to target letters (all other than 'X'). Raw scores were converted to z-scores (M=0, SD=+/-1). Higher scores indicate greater inattentiveness. (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z score (Mean) |
|---|---|
| Vyvanse | 0.63 |
| Placebo | 1.33 |
"The BRIEF Parent Questionnaire is a validated 86-item questionnaire composed of 8 clinical scales that measure different aspects of executive functioning (Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor, Inhibit, Shift, Emotional Control). For each item, parents rate whether the child engages in the behavior never (=1), sometimes (=2), or often (=3). The lowest scale score is 86 (better performance) and the highest is 258 (worse performance). The clinical scales form two broader Indexes (Behavioral Regulation and Metacognition) and an overall score, the Global Executive Composite (GEC). Inhibit was reported as the Primary Outcome. Raw scores were converted to z-scores (M=0, SD=+/-1)." (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Lisdexamfetamine (Vyvanse) | -0.05 |
| Placebo | 0.42 |
RCMAS is a self-report, 37-item questionnaire in which children agree (yes = 1) or disagree (no =0) to statements about themselves. A Total Anxiety score is computed based on 28 items, which are divided into 3 anxiety subscales: physiological anxiety (10 items), worry/oversensitivity (11 items), and social concerns/concentration (7 items). The remaining nine items on the RCMAS constitute the Lie (social desirability) subscale. The lowest scale score is 0 and the highest is 37. Raw scores were converted to z-scores (M=0, SD=+/-1). Because scores are derived from affirmative responses, a high score indicates a high level of anxiety or lie on that subscale. (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Vyvanse | 0.12 |
| Placebo | -0.23 |
"The BRIEF Parent Questionnaire is a validated 86-item questionnaire composed of 8 clinical scales that measure different aspects of executive functioning (Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor, Inhibit, Shift, Emotional Control). For each item, parents rate whether the child engages in the behavior never (=1), sometimes (=2), or often (=3). The lowest scale score is 86 (better performance) and the highest is 258 (worse performance). The clinical scales form two broader Indexes (Behavioral Regulation and Metacognition) and an overall score, the Global Executive Composite (GEC). Working Memory was reported as the Primary Outcome. Raw scores were converted to z-scores (M=0, SD=+/-1)." (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Lisdexamfetamine (Vyvanse) | 0.96 |
| Placebo | 1.69 |
The Conners-3 Parent Form is used to obtain the parent's observations about behavior in their child aged 6 to 18 years old. Parents rate the child's behavior on 45 items as not true at all (0) to very much true (3). The lowest scale score is 0 (better behavior) and the highest is 135 (worse behavior). The Conners 3-P includes content Scales of Inattention, Hyperactivity/Impulsivity, Learning Problems, Executive Functioning, Aggression, and Peer/Family Relations. Inattention scale was reported as the Primary Outcome. All scores were converted to z-scores (M=0, SD=+/-1). (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Lisdexamfetamine (Vyvanse) | 1.00 |
| Placebo | 1.76 |
Conner's Continuous Performance Task (CPT-II) measures sustained attention and response inhibition. During the CPT-II, letters were presented serially on a screen in a random order. All letters were considered target stimuli, except for the letter 'X' which is a non-target stimulus. Participants responded to target stimuli by pressing the space bar of a computer keyboard (90% of the stimuli) while withholding responses to non-target stimuli (10% of the test). Raw scores were converted to z-scores (M=0, SD=+/-1). Overall hit reaction time is the average speed of correct responses for the entire test. Lower values indicate that responses got quicker as the test progressed. High values indicate a substantial slowing in reaction times. (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Vyvanse | 0.75 |
| Placebo | 1.19 |
Conner's Continuous Performance Task (CPT-II) measures sustained attention and response inhibition. During the CPT-II, letters were presented serially on a screen in a random order. All letters were considered target stimuli, except for the letter 'X' which is a non-target stimulus. Participants responded to target stimuli by pressing the space bar of a computer keyboard (90% of the stimuli) while withholding responses to non-target stimuli (10% of the test). CPT-II Perseverations represent responses in which reaction time was less than 100 ms; these responses are assumed to be anticipatory, random, or slow/inattentive (i.e., carried over from the previous response) because it is physiologically impossible to respond accurately in so short a time. Raw scores were converted to z-scores (M=0, SD=+/-1) to have them on a uniform metric. Higher scores indicate greater inattentiveness. (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Lisdexamfetamine (Vyvanse) | 1.02 |
| Placebo | 0.86 |
"The BRIEF Parent Questionnaire is a validated 86-item questionnaire composed of 8 clinical scales that measure different aspects of executive functioning (Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor, Inhibit, Shift, Emotional Control). For each item, parents rate whether the child engages in the behavior never (=1), sometimes (=2), or often (=3). The lowest scale score is 86 (better performance) and the highest is 258 (worse performance). The clinical scales form two broader Indexes (Behavioral Regulation and Metacognition) and an overall score, the Global Executive Composite (GEC). Initiate was reported as the Primary Outcome. Raw scores were converted to z-scores (M=0, SD=+/-1)." (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Lisdexamfetamine (Vyvanse) | 0.64 |
| Placebo | 1.23 |
The Conners-3 Parent Form is used to obtain the parent's observations about behavior in their child aged 6 to 18 years old. Parents rate the child's behavior on 45 items as not true at all (0) to very much true (3). The lowest scale score is 0 (better behavior) and the highest is 135 (worse behavior). The Conners 3-P includes content Scales of Inattention, Hyperactivity/Impulsivity, Learning Problems, Executive Functioning, Aggression, and Peer/Family Relations. Hyperactivity was reported as the Primary Outcome. All scores were converted to z-scores (M=0, SD=+/-1). (NCT02712996)
Timeframe: 12 weeks
| Intervention | Z-score (Mean) |
|---|---|
| Lisdexamfetamine (Vyvanse) | 0.075 |
| Placebo | 0.71 |
To measure the effects of Lisdexamfetamine on objective report of executive function difficulties functional magnetic resonance imaging (fMRI) were utilized to assess the relative importance of dorsolateral prefrontal cortex (DLPFC) blood oxygen dependent (BOLD) signals during working memory task performance and the effect of LDX on the executive system activation. Measurement of BOLD perecent signal change range is 0 to 2%. Percent signal change is the difference in fMRI signal between the baseline condition (B) and the task condition (T) and calculated here as: percent signal change = (T-B)/B×100%. Higher percent signal change in the DLPFC is generally associated with better executive function. (NCT03187353)
Timeframe: 6 weeks
| Intervention | percentage of signal change (Mean) |
|---|---|
| Lisdexamfetamine (Per Intervention) | .42 |
| Placebo (Per Intervention) | .21 |
To measure the effects of Lisdexamfetamine on objective report of executive function difficulties proton magnetic resonance spectroscopy (1H-MRS) was utilized to assess the relative importance of dorsolateral prefrontal cortex (DLPFC) glutamate (Glut) contrast levels during working memory task performance. Measurement of glutamate contrast range from 0 to 15% with higher levels associated with optimal performance. Glutamate contrast is calculated by: GluCEST contrast (%) = [(Msat(-3ppm) - Msat(+3ppm))/Msat(-3ppm)]*100. (NCT03187353)
Timeframe: 6 weeks
| Intervention | percentage of Glutmate Contrast (Mean) |
|---|---|
| Lisdexamfetamine (Per Intervention) | 8.4 |
| Placebo (Per Intervention) | 8.91 |
The Brown Attention Deficit Disorder Scale (BADDS) (Brown, 1996) is a 40-item questionnaire that assesses five subscales of executive functioning. For each item in the questionnaire, participants reported the extent to which it had been a problem over the last six months (0 = never, 1 = once a week or less, 2 = twice a week, or 3 = almost daily). Total BADDS scores can range from 0-120, with higher scores indicating more self-reported difficulties with executive functioning. Outcome measures are reported as change scores for end of trial (6 weeks) minus baseline. (NCT03187353)
Timeframe: Outcome measure change score represents end of trial (6 weeks) minus baseline.
| Intervention | score on a scale (Mean) |
|---|---|
| Lisdexamfetamine (Per Intervention) | -19.68 |
| Placebo (Per Intervention) | -4.31 |
BMI was derived from height and weight. BMI percentile was normalized by sex and age using the CDC growth charts. BMI percentiles were categorized as: Underweight (BMI < 5th percentile); Healthy weight (BMI 5th percentile up to < 85th percentile); Overweight (BMI 85th percentile < 95th percentile); Obese (BMI >= 95th percentile). Change from baseline in body mass index at Week 6 was reported. (NCT03260205)
Timeframe: Baseline, Week 6
| Intervention | BMI percentile (Mean) |
|---|---|
| Placebo | -1.6 |
| SPD489 5 mg | -0.9 |
| SPD489 10 mg | -5.1 |
| SPD489 20 mg | -6.7 |
| SPD489 30 mg | -7.4 |
CGI-I was an overall assessment of global symptom improvement by evaluation of the participant's condition severity and improvement over time. Scoring was done based on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), where higher score reported worse condition. The scoring was elaborated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. FAS consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD RS IV preschool version total score assessment. (NCT03260205)
Timeframe: Week 6
| Intervention | Score on a scale (Mean) |
|---|---|
| Placebo | 3.4 |
| Pooled SPD489 Doses (10, 20, and 30 mg) | 2.8 |
Body weight was measured in percentile without shoes. Body weight percentile was normalized by sex and age using the Centers for Disease Control and Prevention (CDC) growth charts. Body weight percentiles were categorized as lesser than (<) 5th, 5th to < 95th, and greater than or equal to (>=) 95th percentiles. Change from baseline in body weight at Week 6 was reported. (NCT03260205)
Timeframe: Baseline, Week 6
| Intervention | Weight percentile (Mean) |
|---|---|
| Placebo | -1.1 |
| SPD489 5 mg | -1.0 |
| SPD489 10 mg | -2.8 |
| SPD489 20 mg | -4.8 |
| SPD489 30 mg | -5.8 |
Dose response relationship was evaluated by using the ADHD-RS Preschool Version Total Score. ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that requires the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Dose response analysis set consisted of all participants in the safety analysis set who had at least 1 valid primary efficacy measurement on the randomized target dose level of the investigational product. (NCT03260205)
Timeframe: Baseline, Week 6
| Intervention | Score on a scale (Mean) |
|---|---|
| Placebo | -9.1 |
| SPD489 30 mg | -15.3 |
| SPD489 20 mg | -17.0 |
| SPD489 10 mg | -10.8 |
| SPD489 5 mg | -13.5 |
C-SSRS was semi-structured interview that captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview included definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. The C-SSRS contained 2 required items pertaining to suicidal ideation, 4 required items pertaining to suicidal behavior, and 1 required item pertaining to non-suicidal but self-injurious behavior. In situations where there was a positive response to the screening questions, there were 8 additional suicidal ideation items and 4 additional suicidal behavior items which were completed. Thus, there was a maximum of 19 items to be completed. Here number of participants responded as yes to suicidal ideation or behaviour were reported. (NCT03260205)
Timeframe: Up to Week 6
| Intervention | Participants (Number) |
|---|---|
| Placebo | 0 |
| SPD489 5 mg | 1 |
| SPD489 10 mg | 1 |
| SPD489 20 mg | 1 |
| SPD489 30 mg | 0 |
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a investigational product (IP) and that does not necessarily had a causal relationship with this treatment. TEAEs were defined as AEs that start or deteriorate on or after the date of the first dose of IP and no later than 3 days following the last dose of IP. (NCT03260205)
Timeframe: From start of study drug administration up to follow-up (Week 7)
| Intervention | Participants (Count of Participants) |
|---|---|
| Placebo | 19 |
| SPD489 5 mg | 13 |
| SPD489 10 mg | 15 |
| SPD489 20 mg | 18 |
| SPD489 30 mg | 22 |
Children's Sleep Habits Questionnaire was a tool designed to screen the most common sleep problems in children, and consisted of 33 items for scoring. The instrument evaluated the child's sleep based on behavior within 8 different subscales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night walkings, parasomnias, sleep-disordered breathing, and daytime sleepiness. Each item receives a score from 1 (problem occurs rarely) to 3 (problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: bedtime resistance: 6 to 18, sleep onset delay: 1 to 3, sleep duration: 3 to 9, sleep anxiety: 4 to 12, night walkings: 3 to 9, parasomnias: 7 to 21, sleep-disordered breathing: 3 to 9, daytime sleepiness: 8 to 24, and total disturbance (items from all scales): 33 to 99. (NCT03260205)
Timeframe: Week 6
| Intervention | Score on scale (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Bedtime resistance: Week 6 | Sleep-onset delay: Week 6 | Sleep duration: Week 6 | Sleep anxiety: Week 6 | Night wakings: Week 6 | Parasomnias: Week 6 | Sleep-disordered breathing: Week 6 | Daytime sleepiness: Week 6 | |
| Placebo | 9.7 | 1.7 | 3.9 | 5.7 | 4.7 | 8.6 | 3.5 | 10.9 |
| SPD489 10 mg | 10.3 | 1.8 | 3.9 | 6.5 | 4.6 | 8.8 | 3.3 | 10.3 |
| SPD489 20 mg | 10.2 | 1.8 | 4.1 | 6.5 | 4.3 | 8.2 | 3.4 | 9.8 |
| SPD489 30 mg | 10.3 | 1.8 | 4.1 | 6.4 | 4.1 | 8.4 | 3.5 | 12.4 |
| SPD489 5 mg | 9.4 | 1.7 | 3.9 | 5.8 | 4.2 | 8.9 | 3.6 | 10.9 |
Clinical laboratory evaluations included biochemistry and endocrinology, hematology, and urinalysis. Number of participants with potentially clinically significant changes in clinical laboratory values were reported. ULN in measure data represents upper limit of normal, mcmol/L represents to Micromoles Per Litre, > = represents greater than or equal to. (NCT03260205)
Timeframe: Week 6
| Intervention | Participants (Count of Participants) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eosinophils/Leukocytes: Greater than (>)10% | Lymphocytes/Leukocytes: Greater than (>) 70% | Neutrophils/Leukocytes: Less than (<) 30% | Platelets: >600x10^9/Litre (L) | Alanine aminotransferase: >= 3x ULN | Aspartate aminotransferase: >=3x ULN | Creatinine: >176.8 mcmol/L or >1.5x ULN | Glucose: <3.05 Millimole per liter (mmol/L) | Glucose: >8.88 Millimole per liter (mmol/L) | Potassium: >5.5 Millimole per liter (mmol/L) | Ketones: Positive value (excluding trace) | Occult blood: Positive value (excluding trace) | Protein: Positive value (excluding trace) | |
| Placebo | 1 | 1 | 6 | 0 | 1 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 7 |
| SPD489 10 mg | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 1 | 3 |
| SPD489 20 mg | 5 | 0 | 3 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 3 | 1 | 4 |
| SPD489 30 mg | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 5 |
| SPD489 5 mg | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
Number of participants with potentially clinically significant changes in ECG parameters were reported. QTcF interval represents QT Fridericia's Correction Formula interval, QTcB interval represents QTc corrected by Bazett's in measure data. (NCT03260205)
Timeframe: Week 6
| Intervention | Participants (Count of Participants) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Heart Rate (< 55 Beats per minute) | Heart Rate (> 130 Beats per minute) | QRS Interval (> = 90 millisecond [msec]) | QT Interval (> = 440 msec) | QTcB Interval (> =440 msec and <480 msec) | QTcB Interval (>=480 msec and <500 msec) | QTcB Interval (>=500 msec) | QTcF Interval (> =440 msec and <480 msec) | QTcF Interval (>=480 msec and <500 msec) | QTcF Interval (>=500 msec) | ECG Abnormality - Rhythm | |
| Placebo | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| SPD489 10 mg | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| SPD489 20 mg | 0 | 0 | 1 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| SPD489 30 mg | 0 | 0 | 2 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| SPD489 5 mg | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
Vital sign assessments included blood pressure (systolic and diastolic), average pulse rate. Number of participants with potentially clinically significant changes in vital signs were reported. mmHg represents millimetre of mercury in the outcome measure data. (NCT03260205)
Timeframe: Week 6
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| Pulse: >=130 beats per minute (bpm), Week 6 | Pulse: <=55 bpm, Week 6 | Systolic Blood Pressure (BP): >=120 mmHg, Week 6 | Systolic BP: <75 mmHg, Week 6 | Diastolic BP: >=85 mmHg, Week 6 | Diastolic BP: <40 mmHg, Week 6 | |
| Placebo | 0 | 0 | 0 | 0 | 0 | 0 |
| SPD489 10 mg | 0 | 0 | 0 | 0 | 0 | 0 |
| SPD489 20 mg | 0 | 0 | 1 | 0 | 0 | 0 |
| SPD489 30 mg | 0 | 0 | 0 | 0 | 0 | 0 |
| SPD489 5 mg | 0 | 0 | 0 | 0 | 0 | 0 |
Height was measured in inche without shoes, with the participant stood on a flat surface and with chin parallel to the floor. (NCT03260205)
Timeframe: Baseline, Week 6
| Intervention | Centimeter (Mean) |
|---|---|
| Placebo | 0.7 |
| SPD489 5 mg | 0.7 |
| SPD489 10 mg | 0.7 |
| SPD489 20 mg | 1.0 |
| SPD489 30 mg | 0.5 |
ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that required the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Full analysis set (FAS) consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD RS IV preschool version total score assessment. (NCT03260205)
Timeframe: Baseline, Week 6
| Intervention | Score on a scale (Mean) |
|---|---|
| Placebo | -9.1 |
| Pooled SPD489 Doses (10, 20, and 30 mg) | -14.2 |
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
| Intervention | score on a scale (Mean) |
|---|---|
| Placebo | 3.17 |
| Vyvanse | 3.33 |
"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
| Intervention | score on a scale (Mean) |
|---|---|
| Placebo | 3.40 |
| Vyvanse | 3.56 |
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
| 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
| Intervention | score on a scale (Mean) |
|---|---|
| Placebo | 65.60 |
| Vyvanse | 68.45 |
| Substance | Relationship Strength | Studies | Trials | Classes | Roles |
|---|---|---|---|---|---|
| bupropion Bupropion: A propiophenone-derived antidepressant and antismoking agent that inhibits the uptake of DOPAMINE.. bupropion : An aromatic ketone that is propiophenone carrying a tert-butylamino group at position 2 and a chloro substituent at position 3 on the phenyl ring. | 5.79 | 6 | 0 | aromatic ketone; monochlorobenzenes; secondary amino compound | antidepressant; environmental contaminant; xenobiotic |
| pyridoxine 4,5-bis(hydroxymethyl)-2-methylpyridin-3-ol: structure in first source. vitamin B6 : Any member of the group of pyridines that exhibit biological activity against vitamin B6 deficiency. Vitamin B6 deficiency is associated with microcytic anemia, electroencephalographic abnormalities, dermatitis with cheilosis (scaling on the lips and cracks at the corners of the mouth) and glossitis (swollen tongue), depression and confusion, and weakened immune function. Vitamin B6 consists of the vitamers pyridoxine, pyridoxal, and pyridoxamine and their respective 5'-phosphate esters (and includes their corresponding ionized and salt forms). | 3.23 | 1 | 0 | hydroxymethylpyridine; methylpyridines; monohydroxypyridine; vitamin B6 | cofactor; Escherichia coli metabolite; human metabolite; mouse metabolite; Saccharomyces cerevisiae metabolite |
| phenytoin [no description available] | 2.15 | 1 | 0 | imidazolidine-2,4-dione | anticonvulsant; drug allergen; sodium channel blocker; teratogenic agent |
| acetaminophen Acetaminophen: Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.. paracetamol : A member of the class of phenols that is 4-aminophenol in which one of the hydrogens attached to the amino group has been replaced by an acetyl group. | 2.13 | 1 | 0 | acetamides; phenols | antipyretic; cyclooxygenase 1 inhibitor; cyclooxygenase 2 inhibitor; cyclooxygenase 3 inhibitor; environmental contaminant; ferroptosis inducer; geroprotector; hepatotoxic agent; human blood serum metabolite; non-narcotic analgesic; non-steroidal anti-inflammatory drug; xenobiotic |
| theophylline [no description available] | 2.11 | 1 | 0 | dimethylxanthine | adenosine receptor antagonist; anti-asthmatic drug; anti-inflammatory agent; bronchodilator agent; drug metabolite; EC 3.1.4.* (phosphoric diester hydrolase) inhibitor; fungal metabolite; human blood serum metabolite; immunomodulator; muscle relaxant; vasodilator agent |
| baclofen [no description available] | 3.61 | 2 | 0 | amino acid zwitterion; gamma-amino acid; monocarboxylic acid; monochlorobenzenes; primary amino compound | central nervous system depressant; GABA agonist; muscle relaxant |
| caffeine [no description available] | 3.5 | 1 | 1 | purine alkaloid; trimethylxanthine | adenosine A2A receptor antagonist; adenosine receptor antagonist; adjuvant; central nervous system stimulant; diuretic; EC 2.7.11.1 (non-specific serine/threonine protein kinase) inhibitor; EC 3.1.4.* (phosphoric diester hydrolase) inhibitor; environmental contaminant; food additive; fungal metabolite; geroprotector; human blood serum metabolite; mouse metabolite; mutagen; plant metabolite; psychotropic drug; ryanodine receptor agonist; xenobiotic |
| carvedilol [no description available] | 2.11 | 1 | 0 | carbazoles; secondary alcohol; secondary amino compound | alpha-adrenergic antagonist; antihypertensive agent; beta-adrenergic antagonist; cardiovascular drug; vasodilator agent |
| citalopram Citalopram: A furancarbonitrile that is one of the serotonin uptake inhibitors used as an antidepressant. The drug is also effective in reducing ethanol uptake in alcoholics and is used in depressed patients who also suffer from TARDIVE DYSKINESIA in preference to tricyclic antidepressants, which aggravate dyskinesia.. citalopram : A racemate comprising equimolar amounts of (R)-citalopram and its enantiomer, escitalopram. It is used as an antidepressant, although only escitalopram is active.. 1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrile : A nitrile that is 1,3-dihydro-2-benzofuran-5-carbonitrile in which one of the hydrogens at position 1 is replaced by a p-fluorophenyl group, while the other is replaced by a 3-(dimethylamino)propyl group. | 12.88 | 6 | 4 | 2-benzofurans; cyclic ether; nitrile; organofluorine compound; tertiary amino compound | |
| clonidine Clonidine: An imidazoline sympatholytic agent that stimulates ALPHA-2 ADRENERGIC RECEPTORS and central IMIDAZOLINE RECEPTORS. It is commonly used in the management of HYPERTENSION.. clonidine (amino form) : A clonidine that is 4,5-dihydro-1H-imidazol-2-amine in which one of the amino hydrogens is replaced by a 2,6-dichlorophenyl group. | 5.31 | 3 | 0 | clonidine; imidazoline | |
| desipramine Desipramine: A tricyclic dibenzazepine compound that potentiates neurotransmission. Desipramine selectively blocks reuptake of norepinephrine from the neural synapse, and also appears to impair serotonin transport. This compound also possesses minor anticholinergic activity, through its affinity to muscarinic receptors.. desipramine : A dibenzoazepine consisting of 10,11-dihydro-5H-dibenzo[b,f]azepine substituted on nitrogen with a 3-(methylamino)propyl group. | 3.23 | 1 | 0 | dibenzoazepine; secondary amino compound | adrenergic uptake inhibitor; alpha-adrenergic antagonist; antidepressant; cholinergic antagonist; drug allergen; EC 3.1.4.12 (sphingomyelin phosphodiesterase) inhibitor; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; H1-receptor antagonist; serotonin uptake inhibitor |
| amphetamine Amphetamine: A powerful central nervous system stimulant and sympathomimetic. Amphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulation of release of monamines, and inhibiting monoamine oxidase. Amphetamine is also a drug of abuse and a psychotomimetic. The l- and the d,l-forms are included here. The l-form has less central nervous system activity but stronger cardiovascular effects. The d-form is DEXTROAMPHETAMINE.. 1-phenylpropan-2-amine : A primary amine that is isopropylamine in which a hydrogen attached to one of the methyl groups has been replaced by a phenyl group.. amphetamine : A racemate comprising equimolar amounts of (R)-amphetamine (also known as levamphetamine or levoamphetamine) and (S)-amphetamine (also known as dexamfetamine or dextroamphetamine. | 10.92 | 21 | 2 | primary amine | |
| valproic acid Valproic Acid: A fatty acid with anticonvulsant and anti-manic properties that is used in the treatment of EPILEPSY and BIPOLAR DISORDER. The mechanisms of its therapeutic actions are not well understood. It may act by increasing GAMMA-AMINOBUTYRIC ACID levels in the brain or by altering the properties of VOLTAGE-GATED SODIUM CHANNELS.. valproic acid : A branched-chain saturated fatty acid that comprises of a propyl substituent on a pentanoic acid stem. | 2.57 | 2 | 0 | branched-chain fatty acid; branched-chain saturated fatty acid | anticonvulsant; antimanic drug; EC 3.5.1.98 (histone deacetylase) inhibitor; GABA agent; neuroprotective agent; psychotropic drug; teratogenic agent |
| fenofibrate Pharmavit: a polyvitamin product, comprising vitamins A, D2, B1, B2, B6, C, E, nicotinamide, & calcium pantothene; may be a promising agent for application to human populations exposed to carcinogenic and genetic hazards of ionizing radiation; RN from CHEMLINE | 2.11 | 1 | 0 | aromatic ether; chlorobenzophenone; isopropyl ester; monochlorobenzenes | antilipemic drug; environmental contaminant; geroprotector; xenobiotic |
| fexofenadine fexofenadine: a second generation antihistamine; metabolite of the antihistaminic drug terfenadine; structure in first source; RN refers to HCl. fexofenadine : A piperidine-based anti-histamine compound. | 2.11 | 1 | 0 | piperidines; tertiary amine | anti-allergic agent; H1-receptor antagonist |
| fluoxetine Fluoxetine: The first highly specific serotonin uptake inhibitor. It is used as an antidepressant and often has a more acceptable side-effects profile than traditional antidepressants.. fluoxetine : A racemate comprising equimolar amounts of (R)- and (S)-fluoxetine. A selective serotonin reuptake inhibitor (SSRI), it is used (generally as the hydrochloride salt) for the treatment of depression (and the depressive phase of bipolar disorder), bullimia nervosa, and obsessive-compulsive disorder.. N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine : An aromatic ether consisting of 4-trifluoromethylphenol in which the hydrogen of the phenolic hydroxy group is replaced by a 3-(methylamino)-1-phenylpropyl group. | 5.05 | 4 | 0 | (trifluoromethyl)benzenes; aromatic ether; secondary amino compound | |
| guanfacine Guanfacine: A centrally acting antihypertensive agent with specificity towards ADRENERGIC ALPHA-2 RECEPTORS. | 14.28 | 10 | 1 | acetamides | |
| ketamine Ketamine: A cyclohexanone derivative used for induction of anesthesia. Its mechanism of action is not well understood, but ketamine can block NMDA receptors (RECEPTORS, N-METHYL-D-ASPARTATE) and may interact with sigma receptors.. ketamine : A member of the class of cyclohexanones in which one of the hydrogens at position 2 is substituted by a 2-chlorophenyl group, while the other is substituted by a methylamino group. | 2.13 | 1 | 0 | cyclohexanones; monochlorobenzenes; secondary amino compound | analgesic; environmental contaminant; intravenous anaesthetic; neurotoxin; NMDA receptor antagonist; xenobiotic |
| lorazepam Lorazepam: A benzodiazepine used as an anti-anxiety agent with few side effects. It also has hypnotic, anticonvulsant, and considerable sedative properties and has been proposed as a preanesthetic agent. | 2.54 | 2 | 0 | benzodiazepine | |
| mecamylamine Mecamylamine: A nicotinic antagonist that is well absorbed from the gastrointestinal tract and crosses the blood-brain barrier. Mecamylamine has been used as a ganglionic blocker in treating hypertension, but, like most ganglionic blockers, is more often used now as a research tool. | 3.23 | 1 | 0 | primary aliphatic amine | |
| memantine [no description available] | 4.11 | 2 | 0 | adamantanes; primary aliphatic amine | antidepressant; antiparkinson drug; dopaminergic agent; neuroprotective agent; NMDA receptor antagonist |
| methylphenidate Methylphenidate: A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE.. methylphenidate : A racemate comprising equimolar amounts of the two threo isomers of methyl phenyl(piperidin-2-yl)acetate. A central stimulant and indirect-acting sympathomimetic, is used (generally as the hydrochloride salt) in the treatment of hyperactivity disorders in children and for the treatment of narcolepsy.. methyl phenyl(piperidin-2-yl)acetate : A amino acid ester that is methyl phenylacetate in which one of the hydrogens alpha to the carbonyl group is replaced by a piperidin-2-yl group. | 14.1 | 51 | 5 | beta-amino acid ester; methyl ester; piperidines | |
| metoprolol Metoprolol: A selective adrenergic beta-1 blocking agent that is commonly used to treat ANGINA PECTORIS; HYPERTENSION; and CARDIAC ARRHYTHMIAS.. metoprolol : A propanolamine that is 1-(propan-2-ylamino)propan-2-ol substituted by a 4-(2-methoxyethyl)phenoxy group at position 1. | 2.11 | 1 | 0 | aromatic ether; propanolamine; secondary alcohol; secondary amino compound | antihypertensive agent; beta-adrenergic antagonist; environmental contaminant; geroprotector; xenobiotic |
| midazolam Midazolam: A short-acting hypnotic-sedative drug with anxiolytic and amnestic properties. It is used in dentistry, cardiac surgery, endoscopic procedures, as preanesthetic medication, and as an adjunct to local anesthesia. The short duration and cardiorespiratory stability makes it useful in poor-risk, elderly, and cardiac patients. It is water-soluble at pH less than 4 and lipid-soluble at physiological pH.. midazolam : An imidazobenzodiazepine that is 4H-imidazo[1,5-a][1,4]benzodiazepine which is substituted by a methyl, 2-fluorophenyl and chloro groups at positions 1, 6 and 8, respectively. | 3.88 | 2 | 1 | imidazobenzodiazepine; monofluorobenzenes; organochlorine compound | anticonvulsant; antineoplastic agent; anxiolytic drug; apoptosis inducer; central nervous system depressant; GABAA receptor agonist; general anaesthetic; muscle relaxant; sedative |
| modafinil Modafinil: A benzhydryl acetamide compound, central nervous system stimulant, and CYP3A4 inducing agent that is used in the treatment of NARCOLEPSY and SLEEP WAKE DISORDERS.. modafinil : A racemate comprising equimolar amounts of armodafinil and (S)-modafinil. A central nervous system stimulant, it is used for the treatment of sleeping disorders such as narcolepsy, obstructive sleep apnoea, and shift-work sleep disorder. The optical enantiomers of modafinil have similar pharmacological actions in animals.. 2-[(diphenylmethyl)sulfinyl]acetamide : A sulfoxide that is dimethylsulfoxide in which two hydrogens attached to one of the methyl groups are replaced by phenyl groups, while one hydrogen attached to the other methyl group is replaced by a carbamoyl (aminocarbonyl) group. | 8.35 | 12 | 2 | monocarboxylic acid amide; sulfoxide | |
| nifedipine Nifedipine: A potent vasodilator agent with calcium antagonistic action. It is a useful anti-anginal agent that also lowers blood pressure. | 2.11 | 1 | 0 | C-nitro compound; dihydropyridine; methyl ester | calcium channel blocker; human metabolite; tocolytic agent; vasodilator agent |
| nomifensine Nomifensine: An isoquinoline derivative that prevents dopamine reuptake into synaptosomes. The maleate was formerly used in the treatment of depression. It was withdrawn worldwide in 1986 due to the risk of acute hemolytic anemia with intravascular hemolysis resulting from its use. In some cases, renal failure also developed. (From Martindale, The Extra Pharmacopoeia, 30th ed, p266). nomifensine : An N-methylated tetrahydroisoquinoline carrying phenyl and amino substituents at positions C-4 and C-8, respectively. | 3.23 | 1 | 0 | isoquinolines | dopamine uptake inhibitor |
| omeprazole Omeprazole: A 4-methoxy-3,5-dimethylpyridyl, 5-methoxybenzimidazole derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits an H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.. omeprazole : A racemate comprising equimolar amounts of (R)- and (S)-omeprazole.. 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole : A member of the class of benzimidazoles that is 1H-benzimidazole which is substituted by a [4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl group at position 2 and a methoxy group at position 5. | 10.34 | 2 | 2 | aromatic ether; benzimidazoles; pyridines; sulfoxide | |
| pemoline Pemoline: A central nervous system stimulant used in fatigue and depressive states and to treat hyperkinetic disorders in children.. pemoline : A member of the class of 1,3-oxazoles that is 1,3-oxazol-4(5H)-one which is substituted by an amino group at position 2 and by a phenyl group at position 5. A central nervous system stimulant, it was used to treat hyperactivity disorders in children, but withdrawn from use following reports of serious hepatotoxicity. | 2.11 | 1 | 0 | 1,3-oxazoles | central nervous system stimulant |
| prazosin Prazosin: A selective adrenergic alpha-1 antagonist used in the treatment of HEART FAILURE; HYPERTENSION; PHEOCHROMOCYTOMA; RAYNAUD DISEASE; PROSTATIC HYPERTROPHY; and URINARY RETENTION.. prazosin : A member of the class of piperazines that is piperazine substituted by a furan-2-ylcarbonyl group and a 4-amino-6,7-dimethoxyquinazolin-2-yl group at positions 1 and 4 respectively. | 2.11 | 1 | 0 | aromatic ether; furans; monocarboxylic acid amide; piperazines; quinazolines | alpha-adrenergic antagonist; antihypertensive agent; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor |
| rolipram [no description available] | 2.11 | 1 | 0 | pyrrolidin-2-ones | antidepressant; EC 3.1.4.* (phosphoric diester hydrolase) inhibitor |
| sumatriptan Sumatriptan: A serotonin agonist that acts selectively at 5HT1 receptors. It is used in the treatment of MIGRAINE DISORDERS.. sumatriptan : A sulfonamide that consists of N,N-dimethyltryptamine bearing an additional (N-methylsulfamoyl)methyl substituent at position 5. Selective agonist for a vascular 5-HT1 receptor subtype (probably a member of the 5-HT1D family). Used (in the form of its succinate salt) for the acute treatment of migraine with or without aura in adults. | 2.11 | 1 | 0 | sulfonamide; tryptamines | serotonergic agonist; vasoconstrictor agent |
| terfenadine Terfenadine: A selective histamine H1-receptor antagonist devoid of central nervous system depressant activity. The drug was used for ALLERGY but withdrawn due to causing LONG QT SYNDROME. | 2.11 | 1 | 0 | diarylmethane | |
| dextroamphetamine Dextroamphetamine: The d-form of AMPHETAMINE. It is a central nervous system stimulant and a sympathomimetic. It has also been used in the treatment of narcolepsy and of attention deficit disorders and hyperactivity in children. Dextroamphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulating release of monamines, and inhibiting monoamine oxidase. It is also a drug of abuse and a psychotomimetic.. (S)-amphetamine : A 1-phenylpropan-2-amine that has S configuration. | 20.91 | 181 | 90 | 1-phenylpropan-2-amine | adrenergic agent; adrenergic uptake inhibitor; dopamine uptake inhibitor; dopaminergic agent; neurotoxin; sympathomimetic agent |
| glutamine Glutamine: A non-essential amino acid present abundantly throughout the body and is involved in many metabolic processes. It is synthesized from GLUTAMIC ACID and AMMONIA. It is the principal carrier of NITROGEN in the body and is an important energy source for many cells.. L-glutamine : An optically active form of glutamine having L-configuration.. glutamine : An alpha-amino acid that consists of butyric acid bearing an amino substituent at position 2 and a carbamoyl substituent at position 4. | 3.94 | 2 | 0 | amino acid zwitterion; glutamine family amino acid; glutamine; L-alpha-amino acid; polar amino acid zwitterion; proteinogenic amino acid | EC 1.14.13.39 (nitric oxide synthase) inhibitor; Escherichia coli metabolite; human metabolite; metabolite; micronutrient; mouse metabolite; nutraceutical; Saccharomyces cerevisiae metabolite |
| lysine Lysine: An essential amino acid. It is often added to animal feed.. lysine : A diamino acid that is caproic (hexanoic) acid bearing two amino substituents at positions 2 and 6.. L-lysine : An L-alpha-amino acid; the L-isomer of lysine. | 6.42 | 3 | 3 | aspartate family amino acid; L-alpha-amino acid zwitterion; L-alpha-amino acid; lysine; organic molecular entity; proteinogenic amino acid | algal metabolite; anticonvulsant; Escherichia coli metabolite; human metabolite; micronutrient; mouse metabolite; nutraceutical; plant metabolite; Saccharomyces cerevisiae metabolite |
| diethylpropion Diethylpropion: A appetite depressant considered to produce less central nervous system disturbance than most drugs in this therapeutic category. It is also considered to be among the safest for patients with hypertension. (From AMA Drug Evaluations Annual, 1994, p2290). diethylpropion : An aromatic ketone that is propiophenone in which one of the hydrogens alpha- to the carbonyl is substituted by a diethylamino group. A central stimulant and indirect-acting sympathomimetic, it is an appetite depressant and is used as the hydrochloride as an anoretic in the short term management of obesity. | 3.43 | 1 | 1 | aromatic ketone; tertiary amine | appetite depressant |
| pyrrolidonecarboxylic acid Pyrrolidonecarboxylic Acid: A cyclized derivative of L-GLUTAMIC ACID. Elevated blood levels may be associated with problems of GLUTAMINE or GLUTATHIONE metabolism.. 5-oxo-L-proline : An optically active form of 5-oxoproline having L-configuration. | 3.23 | 1 | 0 | 5-oxoproline; L-proline derivative; non-proteinogenic L-alpha-amino acid | algal metabolite |
| cyclohexanol Cyclohexanols: Monohydroxy derivatives of cyclohexanes that contain the general formula R-C6H11O. They have a camphorlike odor and are used in making soaps, insecticides, germicides, dry cleaning, and plasticizers.. cyclohexanols : An alcohol in which one or more hydroxy groups are attached to a cyclohexane skeleton. | 4.39 | 1 | 1 | cyclohexanols; secondary alcohol | solvent |
| 1,3-benzodioxole 1,3-benzodioxole : A benzodioxole consisting of a benzene ring substituted by a the methylenedioxy group. | 2.13 | 1 | 0 | benzodioxole | |
| isoxazoles Isoxazoles: Azoles with an OXYGEN and a NITROGEN next to each other at the 1,2 positions, in contrast to OXAZOLES that have nitrogens at the 1,3 positions.. isoxazole : A monocyclic heteroarene with a structure consisting of a 5-membered ring containing three carbon atoms and an oxygen and nitrogen atom adjacent to each other. It is the parent of the class of isoxazoles.. isoxazoles : Oxazoles in which the N and O atoms are adjacent. | 3.17 | 1 | 0 | isoxazoles; mancude organic heteromonocyclic parent; monocyclic heteroarene | |
| methamphetamine Methamphetamine: A central nervous system stimulant and sympathomimetic with actions and uses similar to DEXTROAMPHETAMINE. The smokable form is a drug of abuse and is referred to as crank, crystal, crystal meth, ice, and speed.. methamphetamine : A member of the class of amphetamines in which the amino group of (S)-amphetamine carries a methyl substituent. | 6.11 | 5 | 5 | amphetamines; secondary amine | central nervous system stimulant; environmental contaminant; neurotoxin; psychotropic drug; xenobiotic |
| malondialdehyde Malondialdehyde: The dialdehyde of malonic acid.. malonaldehyde : A dialdehyde that is propane substituted by two oxo groups at the terminal carbon atoms respectively. A biomarker of oxidative damage to lipids caused by smoking, it exists in vivo mainly in the enol form. | 2.11 | 1 | 0 | dialdehyde | biomarker |
| lithium carbonate Lithium Carbonate: A lithium salt, classified as a mood-stabilizing agent. Lithium ion alters the metabolism of BIOGENIC MONOAMINES in the CENTRAL NERVOUS SYSTEM, and affects multiple neurotransmission systems. | 2.51 | 2 | 0 | carbonate salt; lithium salt | antimanic drug |
| s,n,n'-tripropylthiocarbamate Reward: An object or a situation that can serve to reinforce a response, to satisfy a motive, or to afford pleasure.. vernolate : A monounsaturated fatty acid anion that is the conjugate base of vernolic acid, obtained by deprotonation of the carboxy group; major species at pH 7.3. | 4.66 | 5 | 1 | tertiary amine | |
| fluorides [no description available] | 2.6 | 1 | 0 | halide anion; monoatomic fluorine | |
| cetylpyridinium chloride anhydrous tserigel: according to first source contains polyvinylbutyral & cetylpyridinium chloride; UD only lists cetylpyridinium chloride as constituent. cetylpyridinium chloride : A pyridinium salt that has N-hexadecylpyridinium as the cation and chloride as the anion. It has antiseptic properties and is used in solutions or lozenges for the treatment of minor infections of the mouth and throat. | 3.43 | 1 | 1 | chloride salt; organic chloride salt | antiseptic drug; surfactant |
| glutamic acid Glutamic Acid: A non-essential amino acid naturally occurring in the L-form. Glutamic acid is the most common excitatory neurotransmitter in the CENTRAL NERVOUS SYSTEM.. glutamic acid : An alpha-amino acid that is glutaric acid bearing a single amino substituent at position 2. | 3.94 | 2 | 0 | glutamic acid; glutamine family amino acid; L-alpha-amino acid; proteinogenic amino acid | Escherichia coli metabolite; ferroptosis inducer; micronutrient; mouse metabolite; neurotransmitter; nutraceutical |
| methyldopa Methyldopa: An alpha-2 adrenergic agonist that has both central and peripheral nervous system effects. Its primary clinical use is as an antihypertensive agent.. alpha-methyl-L-dopa : A derivative of L-tyrosine having a methyl group at the alpha-position and an additional hydroxy group at the 3-position on the phenyl ring. | 3.27 | 1 | 0 | L-tyrosine derivative; non-proteinogenic L-alpha-amino acid | alpha-adrenergic agonist; antihypertensive agent; hapten; peripheral nervous system drug; sympatholytic agent |
| paroxetine Paroxetine: A serotonin uptake inhibitor that is effective in the treatment of depression.. paroxetine : A benzodioxole that consists of piperidine bearing 1,3-benzodioxol-5-yloxy)methyl and 4-fluorophenyl substituents at positions 3 and 4 respectively; the (3S,4R)-diastereomer. Highly potent and selective 5-HT uptake inhibitor that binds with high affinity to the serotonin transporter (Ki = 0.05 nM). Ki values are 1.1, 350 and 1100 nM for inhibition of [3H]-5-HT, [3H]-l-NA and [3H]-DA uptake respectively. Displays minimal affinity for alpha1-, alpha2- or beta-adrenoceptors, 5-HT2A, 5-HT1A, D2 or H1 receptors at concentrations below 1000 nM, however displays weak affinity for muscarinic ACh receptors (Ki = 42 nM). Antidepressant and anxiolytic in vivo. | 3.23 | 1 | 0 | aromatic ether; benzodioxoles; organofluorine compound; piperidines | antidepressant; anxiolytic drug; hepatotoxic agent; P450 inhibitor; serotonin uptake inhibitor |
| simvastatin Simvastatin: A derivative of LOVASTATIN and potent competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It may also interfere with steroid hormone production. Due to the induction of hepatic LDL RECEPTORS, it increases breakdown of LDL CHOLESTEROL.. simvastatin : A member of the class of hexahydronaphthalenes that is lovastatin in which the 2-methylbutyrate ester moiety has been replaced by a 2,2-dimethylbutyrate ester group. It is used as a cholesterol-lowering and anti-cardiovascular disease drug. | 7.13 | 1 | 0 | delta-lactone; fatty acid ester; hexahydronaphthalenes; statin (semi-synthetic) | EC 1.1.1.34/EC 1.1.1.88 (hydroxymethylglutaryl-CoA reductase) inhibitor; EC 3.4.24.83 (anthrax lethal factor endopeptidase) inhibitor; ferroptosis inducer; geroprotector; prodrug |
| idazoxan Idazoxan: A benzodioxane-linked imidazole that has alpha-2 adrenoceptor antagonist activity.. idazoxan : A benzodioxine that is 2,3-dihydro-1,4-benzodioxine in which one of the hydrogens at position 2 has been replaced by a 4,5-dihydro-1H-imidazol-2-yl group. | 2.11 | 1 | 0 | benzodioxine; imidazolines | alpha-adrenergic antagonist |
| atomoxetine hydrochloride Atomoxetine Hydrochloride: A propylamine derivative and selective ADRENERGIC UPTAKE INHIBITOR that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.. atomoxetine hydrochloride : The hydrochloride salt of atomoxetine. | 12.23 | 25 | 3 | hydrochloride | adrenergic uptake inhibitor; antidepressant |
| fosphenytoin fosphenytoin: structure given in first & second source | 2.15 | 1 | 0 | imidazolidine-2,4-dione | |
| ipsapirone [no description available] | 2.11 | 1 | 0 | N-arylpiperazine | |
| duloxetine hydrochloride Duloxetine Hydrochloride: A thiophene derivative and selective NEUROTRANSMITTER UPTAKE INHIBITOR for SEROTONIN and NORADRENALINE (SNRI). It is an ANTIDEPRESSIVE AGENT and ANXIOLYTIC, and is also used for the treatment of pain in patients with DIABETES MELLITUS and FIBROMYALGIA.. (S)-duloxetine hydrochloride : A duloxetine hydrochloride in which the duloxetine moiety has S configuration. | 7.25 | 3 | 2 | duloxetine hydrochloride | antidepressant |
| venlafaxine hydrochloride Venlafaxine Hydrochloride: A cyclohexanol and phenylethylamine derivative that functions as a SEROTONIN AND NORADRENALINE REUPTAKE INHIBITOR (SNRI) and is used as an ANTIDEPRESSIVE AGENT. | 8.83 | 5 | 4 | hydrochloride | |
| fenofibric acid fenofibric acid: RN given refers to parent cpd without isomeric designation; structure. fenofibric acid : A monocarboxylic acid that is 2-methylpropanoic acid substituted by a 4-(4-chlorobenzoyl)phenoxy group at position 2. It is a metabolite of the drug fenofibrate. | 2.11 | 1 | 0 | aromatic ketone; chlorobenzophenone; monocarboxylic acid | drug metabolite; marine xenobiotic metabolite |
| sertraline Sertraline: A selective serotonin uptake inhibitor that is used in the treatment of depression.. sertraline : A member of the class of tetralins that is tetralin which is substituted at positions 1 and 4 by a methylamino and a 3,4-dichlorophenyl group, respectively (the S,S diastereoisomer). A selective serotonin-reuptake inhibitor (SSRI), it is administered orally as the hydrochloride salt as an antidepressant for the treatment of depression, obsessive-compulsive disorder, panic disorder and post-traumatic stress disorder. | 6.15 | 3 | 2 | dichlorobenzene; secondary amino compound; tetralins | antidepressant; serotonin uptake inhibitor |
| rivastigmine [no description available] | 2.11 | 1 | 0 | carbamate ester; tertiary amino compound | cholinergic drug; EC 3.1.1.8 (cholinesterase) inhibitor; neuroprotective agent |
| droxidopa Droxidopa: A synthetic precursor of norepinephrine that is used in the treatment of PARKINSONIAN DISORDERS and ORTHOSTATIC HYPOTENSION.. droxidopa : A serine derivative that is L-serine substituted at the beta-position by a 3,4-dihydroxyphenyl group. A prodrug for noradrenalone, it is used for treatment of neurogenic orthostatic hypotension | 3.23 | 1 | 0 | catechols; L-tyrosine derivative | antihypertensive agent; prodrug; vasoconstrictor agent |
| rx 821002 2-methoxyidazoxan: 2-methoxy analog of idazoxan. 2-methoxyidazoxan : A benzodioxine that is idazoxan substituted at position 2 by a methoxy group. | 2.11 | 1 | 0 | benzodioxine; cyclic ketal; imidazolines | alpha-adrenergic antagonist |
| metadoxine metadoxine: combination of above cpds | 3.23 | 1 | 0 | ||
| 3-methyl-5-(1-methyl-2-pyrrolidinyl)isoxazole 3-methyl-5-(1-methyl-2-pyrrolidinyl)isoxazole: structure in first source | 3.17 | 1 | 0 | ||
| reboxetine Reboxetine: A morpholine derivative that is a selective and potent noradrenaline reuptake inhibitor; it is used in the treatment of DEPRESSIVE DISORDER. | 3.23 | 1 | 0 | aromatic ether | |
| dexmethylphenidate hydrochloride Dexmethylphenidate Hydrochloride: A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER. | 2.52 | 2 | 0 | ||
| pozanicline [no description available] | 3.17 | 1 | 0 | ||
| cocaine Cocaine: An alkaloid ester extracted from the leaves of plants including coca. It is a local anesthetic and vasoconstrictor and is clinically used for that purpose, particularly in the eye, ear, nose, and throat. It also has powerful central nervous system effects similar to the amphetamines and is a drug of abuse. Cocaine, like amphetamines, acts by multiple mechanisms on brain catecholaminergic neurons; the mechanism of its reinforcing effects is thought to involve inhibition of dopamine uptake.. cocaine : A tropane alkaloid obtained from leaves of the South American shrub Erythroxylon coca. | 5.73 | 5 | 1 | benzoate ester; methyl ester; tertiary amino compound; tropane alkaloid | adrenergic uptake inhibitor; central nervous system stimulant; dopamine uptake inhibitor; environmental contaminant; local anaesthetic; mouse metabolite; plant metabolite; serotonin uptake inhibitor; sodium channel blocker; sympathomimetic agent; vasoconstrictor agent; xenobiotic |
| buprenorphine Buprenorphine: A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.. buprenorphine : A morphinane alkaloid that is 7,8-dihydromorphine 6-O-methyl ether in which positions 6 and 14 are joined by a -CH2CH2- bridge, one of the hydrogens of the N-methyl group is substituted by cyclopropyl, and a hydrogen at position 7 is substituted by a 2-hydroxy-3,3-dimethylbutan-2-yl group. It is highly effective for the treatment of opioid use disorder and is also increasingly being used in the treatment of chronic pain. | 3.56 | 2 | 0 | morphinane alkaloid | delta-opioid receptor antagonist; kappa-opioid receptor antagonist; mu-opioid receptor agonist; opioid analgesic |
| D-fructopyranose [no description available] | 3.23 | 1 | 0 | cyclic hemiketal; D-fructose; fructopyranose | sweetening agent |
| nadp [no description available] | 2.03 | 1 | 0 | ||
| ranitidine Ranitidine: A non-imidazole blocker of those histamine receptors that mediate gastric secretion (H2 receptors). It is used to treat gastrointestinal ulcers.. ranitidine : A member of the class of furans used to treat peptic ulcer disease (PUD) and gastroesophageal reflux disease. | 2.11 | 1 | 0 | C-nitro compound; furans; organic sulfide; tertiary amino compound | anti-ulcer drug; drug allergen; environmental contaminant; H2-receptor antagonist; xenobiotic |
| lithium Lithium: An element in the alkali metals family. It has the atomic symbol Li, atomic number 3, and atomic weight [6.938; 6.997]. Salts of lithium are used in treating BIPOLAR DISORDER. | 7.53 | 2 | 0 | alkali metal atom | |
| raclopride Raclopride: A substituted benzamide that has antipsychotic properties. It is a dopamine D2 receptor (see RECEPTORS, DOPAMINE D2) antagonist. | 2.52 | 2 | 0 | salicylamides | |
| sch 23390 SCH 23390: a selective D1-receptor antagonist. SCH 23390 : A benzazepine that is 2,3,4,5-tetrahydro-3-benzazepine bearing a phenyl substituent at position 1, a methyl substituent at position 3, a chloro substituent at position 7 and a hydroxy substituent at position 8. | 2.11 | 1 | 0 | benzazepine | |
| ethylphenidate ethylphenidate: structure given in first source | 2.41 | 1 | 0 | ||
| pulmicort Budesonide: A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.. budesonide : A glucocorticoid steroid having a highly oxygenated pregna-1,4-diene structure. It is used mainly in the treatment of asthma and non-infectious rhinitis and for treatment and prevention of nasal polyposis. | 2.11 | 1 | 0 | 11beta-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; cyclic acetal; glucocorticoid; primary alpha-hydroxy ketone | anti-inflammatory drug; bronchodilator agent; drug allergen |
| nalmefene nalmefene: RN given refers to 5-alpha isomer | 2.11 | 1 | 0 | morphinane alkaloid | |
| naloxone Naloxone: A specific opiate antagonist that has no agonist activity. It is a competitive antagonist at mu, delta, and kappa opioid receptors.. naloxone : A synthetic morphinane alkaloid that is morphinone in which the enone double bond has been reduced to a single bond, the hydrogen at position 14 has been replaced by a hydroxy group, and the methyl group attached to the nitrogen has been replaced by an allyl group. A specific opioid antagonist, it is used (commonly as its hydrochloride salt) to reverse the effects of opioids, both following their use of opioids during surgery and in cases of known or suspected opioid overdose. | 3.58 | 2 | 0 | morphinane alkaloid; organic heteropentacyclic compound; tertiary alcohol | antidote to opioid poisoning; central nervous system depressant; mu-opioid receptor antagonist |
| oxycodone Oxycodone: A semisynthetic derivative of CODEINE.. oxycodone : A semisynthetic opioid of formula C18H21NO4 that is derived from thebaine. It is a moderately potent opioid analgesic, generally used for relief of moderate to severe pain. | 2.05 | 1 | 0 | organic heteropentacyclic compound; semisynthetic derivative | antitussive; mu-opioid receptor agonist; opioid analgesic |
| topiramate Topiramate: A sulfamate-substituted fructose analog that was originally identified as a hypoglycemic agent. It is used for the treatment of EPILEPSY and MIGRAINE DISORDERS, and may also promote weight loss.. topiramate : A hexose derivative that is 2,3:4,5-di-O-isopropylidene-beta-D-fructopyranose in which the hydroxy group has been converted to the corresponding sulfamate ester. It blocks voltage-dependent sodium channels and is used as an antiepileptic and for the prevention of migraine. | 4.18 | 2 | 0 | cyclic ketal; ketohexose derivative; sulfamate ester | anticonvulsant; sodium channel blocker |
| lobeline Lobeline: An alkaloid that has actions similar to NICOTINE on nicotinic cholinergic receptors but is less potent. It has been proposed for a variety of therapeutic uses including in respiratory disorders, peripheral vascular disorders, insomnia, and smoking cessation. | 3.23 | 1 | 0 | ||
| morphine Meconium: The thick green-to-black mucilaginous material found in the intestines of a full-term fetus. It consists of secretions of the INTESTINAL GLANDS; BILE PIGMENTS; FATTY ACIDS; AMNIOTIC FLUID; and intrauterine debris. It constitutes the first stools passed by a newborn. | 3.17 | 1 | 0 | morphinane alkaloid; organic heteropentacyclic compound; tertiary amino compound | anaesthetic; drug allergen; environmental contaminant; geroprotector; mu-opioid receptor agonist; opioid analgesic; plant metabolite; vasodilator agent; xenobiotic |
| dexmedetomidine [no description available] | 7.51 | 2 | 0 | medetomidine | alpha-adrenergic agonist; analgesic; non-narcotic analgesic; sedative |
| naltrexone Naltrexone: Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of NALOXONE. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.. naltrexone : An organic heteropentacyclic compound that is naloxone substituted in which the allyl group attached to the nitrogen is replaced by a cyclopropylmethyl group. A mu-opioid receptor antagonist, it is used to treat alcohol dependence. | 3.59 | 2 | 0 | cyclopropanes; morphinane-like compound; organic heteropentacyclic compound | antidote to opioid poisoning; central nervous system depressant; environmental contaminant; mu-opioid receptor antagonist; xenobiotic |
| dextromethorphan Dextromethorphan: Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.. dextromethorphan : A 6-methoxy-11-methyl-1,3,4,9,10,10a-hexahydro-2H-10,4a-(epiminoethano)phenanthrene in which the sterocenters at positions 4a, 10 and 10a have S-configuration. It is a prodrug of dextrorphan and used as an antitussive drug for suppressing cough. | 3.5 | 1 | 1 | 6-methoxy-11-methyl-1,3,4,9,10,10a-hexahydro-2H-10,4a-(epiminoethano)phenanthrene | antitussive; environmental contaminant; neurotoxin; NMDA receptor antagonist; oneirogen; prodrug; xenobiotic |
| morphinans Morphinans: Compounds based on a partially saturated iminoethanophenanthrene, which can be described as ethylimino-bridged benzo-decahydronaphthalenes. They include some of the OPIOIDS found in PAPAVER that are used as ANALGESICS. | 3.21 | 1 | 0 | isoquinoline alkaloid fundamental parent; morphinane alkaloid | |
| ispronicline ispronicline: a neuronal nicotinic acetylcholine receptor modulator; has antidepressant, neuroprotective, and cognitive effects; structure in first source | 3.23 | 1 | 0 | ||
| rivaroxaban Rivaroxaban: A morpholine and thiophene derivative that functions as a FACTOR XA INHIBITOR and is used in the treatment and prevention of DEEP-VEIN THROMBOSIS and PULMONARY EMBOLISM. It is also used for the prevention of STROKE and systemic embolization in patients with non-valvular ATRIAL FIBRILLATION, and for the prevention of atherothrombotic events in patients after an ACUTE CORONARY SYNDROME.. rivaroxaban : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of 5-chlorothiophene-2-carboxylic acid with the amino group of 4-{4-[(5S)-5-(aminomethyl)-2-oxo-1,3-oxazolidin-3-yl]phenyl}morpholin-3-one. An anticoagulant used for prophylaxis of venous thromboembolism in patients with knee or hip replacement surgery. | 2.15 | 1 | 0 | aromatic amide; lactam; monocarboxylic acid amide; morpholines; organochlorine compound; oxazolidinone; thiophenes | anticoagulant; EC 3.4.21.6 (coagulation factor Xa) inhibitor |
| buprenorphine, naloxone drug combination Buprenorphine, Naloxone Drug Combination: A pharmaceutical preparation that combines buprenorphine, an OPIOID ANALGESICS with naloxone, a NARCOTIC ANTAGONISTS to reduce the potential for NARCOTIC DEPENDENCE in the treatment of pain. It may also be used for OPIOID SUBSTITUTION THERAPY. | 2.05 | 1 | 0 | ||
| mk-0249 MK-0249: a histamine-3 receptor inverse agonist; structure in first source | 3.23 | 1 | 0 | ||
| sodium oxybate Sodium Oxybate: The sodium salt of 4-hydroxybutyric acid. It is used for both induction and maintenance of ANESTHESIA. | 2.05 | 1 | 0 | ||
| quetiapine fumarate Quetiapine Fumarate: A dibenzothiazepine and ANTIPSYCHOTIC AGENT that targets the SEROTONIN 5-HT2 RECEPTOR; HISTAMINE H1 RECEPTOR, adrenergic alpha1 and alpha2 receptors, as well as the DOPAMINE D1 RECEPTOR and DOPAMINE D2 RECEPTOR. It is used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER and DEPRESSIVE DISORDER. | 2.25 | 1 | 0 | fumarate salt | |
| warfarin Warfarin: An anticoagulant that acts by inhibiting the synthesis of vitamin K-dependent coagulation factors. Warfarin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, and atrial fibrillation with embolization. It is also used as an adjunct in the prophylaxis of systemic embolism after myocardial infarction. Warfarin is also used as a rodenticide.. warfarin : A racemate comprising equal amounts of (R)- and (S)-warfarin. Extensively used as both an anticoagulant drug and as a pesticide against rats and mice.. 4-hydroxy-3-(3-oxo-1-phenylbutyl)-1-benzopyran-2-one : A member of the class of coumarins that is 4-hydroxycoumarin which is substituted at position 3 by a 1-phenyl-3-oxo-1-butyl group. | 2.15 | 1 | 0 | benzenes; hydroxycoumarin; methyl ketone | |
| cyclosporine Cyclosporine: A cyclic undecapeptide from an extract of soil fungi. It is a powerful immunosupressant with a specific action on T-lymphocytes. It is used for the prophylaxis of graft rejection in organ and tissue transplantation. (From Martindale, The Extra Pharmacopoeia, 30th ed). | 2.11 | 1 | 0 | ||
| olanzapine Olanzapine: A benzodiazepine derivative that binds SEROTONIN RECEPTORS; MUSCARINIC RECEPTORS; HISTAMINE H1 RECEPTORS; ADRENERGIC ALPHA-1 RECEPTORS; and DOPAMINE RECEPTORS. It is an antipsychotic agent used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER; and MAJOR DEPRESSIVE DISORDER; it may also reduce nausea and vomiting in patients undergoing chemotherapy.. olanzapine : A benzodiazepine that is 10H-thieno[2,3-b][1,5]benzodiazepine substituted by a methyl group at position 2 and a 4-methylpiperazin-1-yl group at position 4. | 2.52 | 2 | 0 | benzodiazepine; N-arylpiperazine; N-methylpiperazine | antiemetic; dopaminergic antagonist; histamine antagonist; muscarinic antagonist; second generation antipsychotic; serotonergic antagonist; serotonin uptake inhibitor |
| Condition | Indicated | Relationship Strength | Studies | Trials |
|---|---|---|---|---|
| Body Weight The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms. | 0 | 14.34 | 12 | 3 |
| Binge-Eating Disorder A disorder associated with three or more of the following: eating until feeling uncomfortably full; eating large amounts of food when not physically hungry; eating much more rapidly than normal; eating alone due to embarrassment; feeling of disgust, DEPRESSION, or guilt after overeating. Criteria includes occurrence on average, at least 2 days a week for 6 months. The binge eating is not associated with the regular use of inappropriate compensatory behavior (i.e. purging, excessive exercise, etc.) and does not co-occur exclusively with BULIMIA NERVOSA or ANOREXIA NERVOSA. (From DSM-IV, 1994) | 1 | 19.18 | 57 | 31 |
| Fasting Hypoglycemia HYPOGLYCEMIA expressed in the postabsorptive state, after prolonged FASTING, or an overnight fast. | 0 | 2.41 | 1 | 0 |
| Cat Diseases Diseases of the domestic cat (Felis catus or F. domesticus). This term does not include diseases of the so-called big cats such as CHEETAHS; LIONS; tigers, cougars, panthers, leopards, and other Felidae for which the heading CARNIVORA is used. | 0 | 2.63 | 2 | 0 |
| Hypoglycemia A syndrome of abnormally low BLOOD GLUCOSE level. Clinical hypoglycemia has diverse etiologies. Severe hypoglycemia eventually lead to glucose deprivation of the CENTRAL NERVOUS SYSTEM resulting in HUNGER; SWEATING; PARESTHESIA; impaired mental function; SEIZURES; COMA; and even DEATH. | 0 | 2.41 | 1 | 0 |
| Rhabdomyolysis Necrosis or disintegration of skeletal muscle often followed by myoglobinuria. | 0 | 2.41 | 1 | 0 |
| ADDH [description not available] | 0 | 21.42 | 218 | 92 |
| Attention Deficit Disorder with Hyperactivity A behavior disorder originating in childhood in which the essential features are signs of developmentally inappropriate inattention, impulsivity, and hyperactivity. Although most individuals have symptoms of both inattention and hyperactivity-impulsivity, one or the other pattern may be predominant. The disorder is more frequent in males than females. Onset is in childhood. Symptoms often attenuate during late adolescence although a minority experience the full complement of symptoms into mid-adulthood. (From DSM-V) | 1 | 23.42 | 218 | 92 |
| Bulimia Nervosa An eating disorder that is characterized by a cycle of binge eating (BULIMIA or bingeing) followed by inappropriate acts (purging) to avert weight gain. Purging methods often include self-induced VOMITING, use of LAXATIVES or DIURETICS, excessive exercise, and FASTING. | 1 | 14.18 | 9 | 0 |
| Arteriosclerosis, Coronary [description not available] | 0 | 2.41 | 1 | 0 |
| Cardiovascular Stroke [description not available] | 0 | 2.41 | 1 | 0 |
| Coronary Artery Disease Pathological processes of CORONARY ARTERIES that may derive from a congenital abnormality, atherosclerotic, or non-atherosclerotic cause. | 0 | 2.41 | 1 | 0 |
| Myocardial Infarction NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION). | 0 | 2.41 | 1 | 0 |
| Amphetamine Abuse [description not available] | 0 | 12.73 | 26 | 22 |
| Alcohol Abuse [description not available] | 0 | 7.55 | 10 | 10 |
| Drug Withdrawal Symptoms [description not available] | 0 | 11.52 | 20 | 20 |
| Alcoholism A primary, chronic disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. The disease is often progressive and fatal. It is characterized by impaired control over drinking, preoccupation with the drug alcohol, use of alcohol despite adverse consequences, and distortions in thinking, most notably denial. Each of these symptoms may be continuous or periodic. (Morse & Flavin for the Joint Commission of the National Council on Alcoholism and Drug Dependence and the American Society of Addiction Medicine to Study the Definition and Criteria for the Diagnosis of Alcoholism: in JAMA 1992;268:1012-4) | 0 | 7.55 | 10 | 10 |
| Substance Withdrawal Syndrome Physiological and psychological symptoms associated with withdrawal from the use of a drug after prolonged administration or habituation. The concept includes withdrawal from smoking or drinking, as well as withdrawal from an administered drug. | 0 | 11.52 | 20 | 20 |
| Amphetamine-Related Disorders Disorders related or resulting from use of amphetamines. | 0 | 12.73 | 26 | 22 |
| Pregnancy The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH. | 0 | 3.52 | 4 | 0 |
| Cadaver A dead body, usually a human body. | 0 | 2.6 | 1 | 0 |
| Hyperphagia Ingestion of a greater than optimal quantity of food. | 0 | 2.6 | 1 | 0 |
| Labhart-Willi Syndrome [description not available] | 0 | 2.6 | 1 | 0 |
| Prader-Willi Syndrome An autosomal dominant disorder caused by deletion of the proximal long arm of the paternal chromosome 15 (15q11-q13) or by inheritance of both of the pair of chromosomes 15 from the mother (UNIPARENTAL DISOMY) which are imprinted (GENETIC IMPRINTING) and hence silenced. Clinical manifestations include MENTAL RETARDATION; MUSCULAR HYPOTONIA; HYPERPHAGIA; OBESITY; short stature; HYPOGONADISM; STRABISMUS; and HYPERSOMNOLENCE. (Menkes, Textbook of Child Neurology, 5th ed, p229) | 0 | 2.6 | 1 | 0 |
| Appetite Disorders [description not available] | 0 | 4.67 | 3 | 0 |
| Anorexia Nervosa An eating disorder that is characterized by the lack or loss of APPETITE, known as ANOREXIA. Other features include excess fear of becoming OVERWEIGHT; BODY IMAGE disturbance; significant WEIGHT LOSS; refusal to maintain minimal normal weight; and AMENORRHEA. This disorder occurs most frequently in adolescent females. (APA, Thesaurus of Psychological Index Terms, 1994) | 0 | 5.44 | 5 | 0 |
| Feeding and Eating Disorders A group of disorders characterized by physiological and psychological disturbances in appetite or food intake. | 1 | 6.67 | 3 | 0 |
| Sleepiness Compelling urge to sleep. | 0 | 4.15 | 2 | 1 |
| Binge Eating [description not available] | 0 | 10.37 | 6 | 2 |
| Bulimia Eating an excess amount of food in a short period of time, as seen in the disorder of BULIMIA NERVOSA. It is caused by an abnormal craving for food, or insatiable hunger also known as ox hunger. | 0 | 5.37 | 6 | 2 |
| Anankastic Personality [description not available] | 0 | 3.59 | 1 | 1 |
| Callous-Unemotional Traits [description not available] | 0 | 3.59 | 1 | 1 |
| Obsessive-Compulsive Disorder An anxiety disorder characterized by recurrent, persistent obsessions or compulsions. Obsessions are the intrusive ideas, thoughts, or images that are experienced as senseless or repugnant. Compulsions are repetitive and seemingly purposeful behavior which the individual generally recognizes as senseless and from which the individual does not derive pleasure although it may provide a release from tension. | 0 | 3.59 | 1 | 1 |
| Conduct Disorder A repetitive and persistent pattern of behavior in which the basic rights of others or major age-appropriate societal norms or rules are violated. These behaviors include aggressive conduct that causes or threatens physical harm to other people or animals, nonaggressive conduct that causes property loss or damage, deceitfulness or theft, and serious violations of rules. The onset is before age 18. (From DSM-IV, 1994) | 0 | 3.59 | 1 | 1 |
| Serotonin Syndrome An adverse drug interaction characterized by altered mental status, autonomic dysfunction, and neuromuscular abnormalities. It is most frequently caused by use of both serotonin reuptake inhibitors and monoamine oxidase inhibitors, leading to excess serotonin availability in the CNS at the serotonin 1A receptor. | 0 | 2.82 | 3 | 0 |
| Abnormal Movements [description not available] | 0 | 2.21 | 1 | 0 |
| Agitation, Psychomotor [description not available] | 0 | 2.21 | 1 | 0 |
| Psychomotor Agitation A feeling of restlessness associated with increased motor activity. This may occur as a manifestation of nervous system drug toxicity or other conditions. | 0 | 2.21 | 1 | 0 |
| Amentia [description not available] | 0 | 3.17 | 1 | 0 |
| Depression, Involutional Form of depression in those MIDDLE AGE with feelings of ANXIETY. | 0 | 11.01 | 13 | 7 |
| Dementia An acquired organic mental disorder with loss of intellectual abilities of sufficient severity to interfere with social or occupational functioning. The dysfunction is multifaceted and involves memory, behavior, personality, judgment, attention, spatial relations, language, abstract thought, and other executive functions. The intellectual decline is usually progressive, and initially spares the level of consciousness. | 0 | 3.17 | 1 | 0 |
| Depressive Disorder, Major Disorder in which five (or more) of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at least one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure. Symptoms include: depressed mood most of the day, nearly every daily; markedly diminished interest or pleasure in activities most of the day, nearly every day; significant weight loss when not dieting or weight gain; Insomnia or hypersomnia nearly every day; psychomotor agitation or retardation nearly every day; fatigue or loss of energy nearly every day; feelings of worthlessness or excessive or inappropriate guilt; diminished ability to think or concentrate, or indecisiveness, nearly every day; or recurrent thoughts of death, recurrent suicidal ideation without a specific plan, or a suicide attempt. (DSM-5) | 1 | 13.01 | 13 | 7 |
| Gelineau Syndrome [description not available] | 0 | 4.38 | 2 | 0 |
| Weight Reduction [description not available] | 0 | 6.99 | 5 | 2 |
| Narcolepsy A condition characterized by recurrent episodes of daytime somnolence and lapses in consciousness (microsomnias) that may be associated with automatic behaviors and AMNESIA. CATAPLEXY; SLEEP PARALYSIS, and hypnagogic HALLUCINATIONS frequently accompany narcolepsy. The pathophysiology of this disorder includes sleep-onset rapid eye movement (REM) sleep, which normally follows stage III or IV sleep. (From Neurology 1998 Feb;50(2 Suppl 1):S2-S7) | 0 | 4.38 | 2 | 0 |
| Weight Gain Increase in BODY WEIGHT over existing weight. | 0 | 2.25 | 1 | 0 |
| Weight Loss Decrease in existing BODY WEIGHT. | 0 | 6.99 | 5 | 2 |
| Autism Spectrum Disorder Wide continuum of associated cognitive and neurobehavioral disorders, including, but not limited to, three core-defining features: impairments in socialization, impairments in verbal and nonverbal communication, and restricted and repetitive patterns of behaviors. (from DSM-V) | 0 | 2.69 | 2 | 0 |
| Bezoars Concretions of swallowed hair, fruit or vegetable fibers, or similar substances found in the alimentary canal. | 0 | 2.25 | 1 | 0 |
| Colonic Inertia Symptom characterized by the passage of stool once a week or less. | 0 | 2.25 | 1 | 0 |
| Foreign Bodies Inanimate objects that become enclosed in the body. | 0 | 2.25 | 1 | 0 |
| Colicky Pain [description not available] | 0 | 2.25 | 1 | 0 |
| Constipation Infrequent or difficult evacuation of FECES. These symptoms are associated with a variety of causes, including low DIETARY FIBER intake, emotional or nervous disturbances, systemic and structural disorders, drug-induced aggravation, and infections. | 0 | 2.25 | 1 | 0 |
| Abdominal Pain Sensation of discomfort, distress, or agony in the abdominal region. | 0 | 2.25 | 1 | 0 |
| Disease Models, Animal Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases. | 0 | 3.08 | 4 | 0 |
| Trichotillomania Compulsion to pull out one's hair. | 0 | 2.25 | 1 | 0 |
| Late Onset Diseases [description not available] | 0 | 2.25 | 1 | 0 |
| Depression Depressive states usually of moderate intensity in contrast with MAJOR DEPRESSIVE DISORDER present in neurotic and psychotic disorders. | 0 | 2.25 | 1 | 0 |
| Cognitive Decline [description not available] | 0 | 4.55 | 1 | 1 |
| Cognitive Dysfunction Diminished or impaired mental and/or intellectual function. | 0 | 4.55 | 1 | 1 |
| Chemical Dependence [description not available] | 0 | 9.37 | 13 | 3 |
| Substance-Related Disorders Disorders related to substance use or abuse. | 1 | 11.37 | 13 | 3 |
| Pyrexia [description not available] | 0 | 2.25 | 1 | 0 |
| Thrombopenia [description not available] | 0 | 2.25 | 1 | 0 |
| Fever An abnormal elevation of body temperature, usually as a result of a pathologic process. | 0 | 2.25 | 1 | 0 |
| Thrombocytopenia A subnormal level of BLOOD PLATELETS. | 0 | 2.25 | 1 | 0 |
| Drug Overdose Accidental or deliberate use of a medication or street drug in excess of normal dosage. | 0 | 2.81 | 3 | 0 |
| Adverse Drug Event [description not available] | 0 | 6.51 | 3 | 1 |
| Drug-Related Side Effects and Adverse Reactions Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals. | 0 | 6.51 | 3 | 1 |
| Chronic Primary Open Angle Glaucoma [description not available] | 0 | 2.31 | 1 | 0 |
| Glaucoma, Open-Angle Glaucoma in which the angle of the anterior chamber is open and the trabecular meshwork does not encroach on the base of the iris. | 0 | 2.31 | 1 | 0 |
| Intraocular Pressure The pressure of the fluids in the eye. | 0 | 2.31 | 1 | 0 |
| Catatonia A neuropsychiatric disorder characterized by one or more of the following essential features: immobility, mutism, negativism (active or passive refusal to follow commands), mannerisms, stereotypies, posturing, grimacing, excitement, echolalia, echopraxia, muscular rigidity, and stupor; sometimes punctuated by sudden violent outbursts, panic, or hallucinations. This condition may be associated with psychiatric illnesses (e.g., SCHIZOPHRENIA; MOOD DISORDERS) or organic disorders (NEUROLEPTIC MALIGNANT SYNDROME; ENCEPHALITIS, etc.). (From DSM-IV, 4th ed, 1994; APA, Thesaurus of Psychological Index Terms, 1994) | 0 | 2.31 | 1 | 0 |
| Cocaine Abuse [description not available] | 0 | 5 | 4 | 2 |
| Cocaine-Related Disorders Disorders related or resulting from use of cocaine. | 0 | 5 | 4 | 2 |
| Cognition Disorders Disorders characterized by disturbances in mental processes related to learning, thinking, reasoning, and judgment. | 0 | 10.61 | 13 | 13 |
| Morbid Obesity [description not available] | 0 | 2.31 | 1 | 0 |
| Obesity, Morbid The condition of weighing two, three, or more times the ideal weight, so called because it is associated with many serious and life-threatening disorders. In the BODY MASS INDEX, morbid obesity is defined as having a BMI greater than 40.0 kg/m2. | 0 | 2.31 | 1 | 0 |
| Behavior Disorders [description not available] | 0 | 3.91 | 2 | 0 |
| Mental Disorders Psychiatric illness or diseases manifested by breakdowns in the adaptational process expressed primarily as abnormalities of thought, feeling, and behavior producing either distress or impairment of function. | 0 | 3.91 | 2 | 0 |
| Recrudescence [description not available] | 0 | 5.86 | 2 | 2 |
| Affective Disorders [description not available] | 0 | 5.69 | 3 | 2 |
| Cardiometabolic Syndrome A cluster of symptoms that are risk factors for CARDIOVASCULAR DISEASES and TYPE 2 DIABETES MELLITUS. The major components not only include metabolic dysfunctions of METABOLIC SYNDROME but also HYPERTENSION, and ABDOMINAL OBESITY. | 0 | 3.09 | 1 | 0 |
| Anxiety Neuroses [description not available] | 0 | 3.09 | 1 | 0 |
| Long Sleeper Syndrome [description not available] | 0 | 4.83 | 2 | 0 |
| Night Eating Syndrome Little or no appetite for breakfast due to eating more food after dinner than during the meal and eating more than half of daily food intake after dinner hour. | 0 | 3.09 | 1 | 0 |
| Anxiety Disorders Persistent and disabling ANXIETY. | 0 | 3.09 | 1 | 0 |
| Obesity A status with BODY WEIGHT that is grossly above the recommended standards, usually due to accumulation of excess FATS in the body. The standards may vary with age, sex, genetic or cultural background. In the BODY MASS INDEX, a BMI greater than 30.0 kg/m2 is considered obese, and a BMI greater than 40.0 kg/m2 is considered morbidly obese (MORBID OBESITY). | 1 | 8.59 | 5 | 1 |
| Sleep Wake Disorders Abnormal sleep-wake schedule or pattern associated with the CIRCADIAN RHYTHM which affect the length, timing, and/or rigidity of the sleep-wake cycle relative to the day-night cycle. | 0 | 4.83 | 2 | 0 |
| Mood Disorders Those disorders that have a disturbance in mood as their predominant feature. | 0 | 5.69 | 3 | 2 |
| Metabolic Syndrome A cluster of symptoms that are risk factors for CARDIOVASCULAR DISEASES and TYPE 2 DIABETES MELLITUS. The major components of metabolic syndrome include ABDOMINAL OBESITY; atherogenic DYSLIPIDEMIA; HYPERTENSION; HYPERGLYCEMIA; INSULIN RESISTANCE; a proinflammatory state; and a prothrombotic (THROMBOSIS) state. | 0 | 3.09 | 1 | 0 |
| Priapism A prolonged painful erection that may lasts hours and is not associated with sexual activity. It is seen in patients with SICKLE CELL ANEMIA, advanced malignancy, spinal trauma; and certain drug treatments. | 0 | 2.15 | 1 | 0 |
| Cold Fingers, Hereditary [description not available] | 0 | 2.17 | 1 | 0 |
| Raynaud Disease An idiopathic vascular disorder characterized by bilateral Raynaud phenomenon, the abrupt onset of digital paleness or CYANOSIS in response to cold exposure or stress. | 0 | 2.17 | 1 | 0 |
| Affective Psychosis, Bipolar [description not available] | 0 | 6.36 | 7 | 2 |
| Bipolar Disorder A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence. | 0 | 6.36 | 7 | 2 |
| Dementia Praecox [description not available] | 0 | 5.36 | 2 | 2 |
| Schizophrenia A severe emotional disorder of psychotic depth characteristically marked by a retreat from reality with delusion formation, HALLUCINATIONS, emotional disharmony, and regressive behavior. | 1 | 7.36 | 2 | 2 |
| Sensitivity and Specificity Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed) | 0 | 4.4 | 1 | 1 |
| Acute Brain Injuries [description not available] | 0 | 3.48 | 1 | 1 |
| Brain Injuries Acute and chronic (see also BRAIN INJURIES, CHRONIC) injuries to the brain, including the cerebral hemispheres, CEREBELLUM, and BRAIN STEM. Clinical manifestations depend on the nature of injury. Diffuse trauma to the brain is frequently associated with DIFFUSE AXONAL INJURY or COMA, POST-TRAUMATIC. Localized injuries may be associated with NEUROBEHAVIORAL MANIFESTATIONS; HEMIPARESIS, or other focal neurologic deficits. | 0 | 3.48 | 1 | 1 |
| Inadequate Sleep [description not available] | 0 | 4.45 | 2 | 2 |
| Poisoning Used with drugs, chemicals, and industrial materials for human or animal poisoning, acute or chronic, whether the poisoning is accidental, occupational, suicidal, by medication error, or by environmental exposure. | 0 | 2.11 | 1 | 0 |
| Glue Abuse [description not available] | 0 | 2.11 | 1 | 0 |
| Heroin Abuse [description not available] | 0 | 2.11 | 1 | 0 |
| Heroin Dependence Strong dependence or addiction, both physiological and emotional, upon HEROIN. | 0 | 2.11 | 1 | 0 |
| Menopause The last menstrual period. Permanent cessation of menses (MENSTRUATION) is usually defined after 6 to 12 months of AMENORRHEA in a woman over 45 years of age. In the United States, menopause generally occurs in women between 48 and 55 years of age. | 0 | 10.42 | 13 | 9 |
| Alcohol Drinking Behaviors associated with the ingesting of ALCOHOLIC BEVERAGES, including social drinking. | 0 | 3.03 | 1 | 0 |
| Kidney Failure A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. | 0 | 2.13 | 1 | 0 |
| Renal Insufficiency Conditions in which the KIDNEYS perform below the normal level in the ability to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal insufficiency can be classified by the degree of kidney damage (as measured by the level of PROTEINURIA) and reduction in GLOMERULAR FILTRATION RATE. | 0 | 2.13 | 1 | 0 |
| Water Intoxication A condition resulting from the excessive retention of water with sodium depletion. | 0 | 2.15 | 1 | 0 |
| Hyponatremia Deficiency of sodium in the blood; salt depletion. (Dorland, 27th ed) | 0 | 2.15 | 1 | 0 |
| Polydipsia Excessive thirst manifested by excessive fluid intake. It is characteristic of many diseases such as DIABETES MELLITUS; DIABETES INSIPIDUS; and NEPHROGENIC DIABETES INSIPIDUS. The condition may be psychogenic in origin. | 0 | 2.15 | 1 | 0 |
| Dyskinesia, Medication-Induced [description not available] | 0 | 2.13 | 1 | 0 |
| Blood Pressure, High [description not available] | 0 | 2.51 | 2 | 0 |
| Tachyarrhythmia [description not available] | 0 | 6.37 | 5 | 3 |
| Dyskinesia, Drug-Induced Abnormal movements, including HYPERKINESIS; HYPOKINESIA; TREMOR; and DYSTONIA, associated with the use of certain medications or drugs. Muscles of the face, trunk, neck, and extremities are most commonly affected. Tardive dyskinesia refers to abnormal hyperkinetic movements of the muscles of the face, tongue, and neck associated with the use of neuroleptic agents (see ANTIPSYCHOTIC AGENTS). (Adams et al., Principles of Neurology, 6th ed, p1199) | 0 | 2.13 | 1 | 0 |
| Hypertension Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more. | 0 | 2.51 | 2 | 0 |
| Tachycardia Abnormally rapid heartbeat, usually with a HEART RATE above 100 beats per minute for adults. Tachycardia accompanied by disturbance in the cardiac depolarization (cardiac arrhythmia) is called tachyarrhythmia. | 0 | 6.37 | 5 | 3 |
| Disruptive, Impulse Control, and Conduct Disorders Disorders whose essential features are the failure to resist an impulse, drive, or temptation to perform an act that is harmful to the individual or to others. Individuals experience an increased sense of tension prior to the act and pleasure, gratification or release of tension at the time of committing the act. | 0 | 2.13 | 1 | 0 |
| Sex Disorders [description not available] | 0 | 2.15 | 1 | 0 |
| Sexual Dysfunction, Physiological Physiological disturbances in normal sexual performance in either the male or the female. | 0 | 2.15 | 1 | 0 |
| Hypertrophy General increase in bulk of a part or organ due to CELL ENLARGEMENT and accumulation of FLUIDS AND SECRETIONS, not due to tumor formation, nor to an increase in the number of cells (HYPERPLASIA). | 0 | 2.13 | 1 | 0 |
| Hyperactivity, Motor [description not available] | 0 | 3.86 | 2 | 1 |
| Anterior Choroidal Artery Infarction [description not available] | 0 | 2.13 | 1 | 0 |
| Depression, Endogenous [description not available] | 0 | 2.13 | 1 | 0 |
| Cerebral Infarction The formation of an area of NECROSIS in the CEREBRUM caused by an insufficiency of arterial or venous blood flow. Infarcts of the cerebrum are generally classified by hemisphere (i.e., left vs. right), lobe (e.g., frontal lobe infarction), arterial distribution (e.g., INFARCTION, ANTERIOR CEREBRAL ARTERY), and etiology (e.g., embolic infarction). | 0 | 2.13 | 1 | 0 |
| Depressive Disorder An affective disorder manifested by either a dysphoric mood or loss of interest or pleasure in usual activities. The mood disturbance is prominent and relatively persistent. | 0 | 2.13 | 1 | 0 |
| Bilateral Headache [description not available] | 0 | 5.53 | 4 | 4 |
| Chronic Insomnia [description not available] | 0 | 9.25 | 7 | 6 |
| Headache The symptom of PAIN in the cranial region. It may be an isolated benign occurrence or manifestation of a wide variety of HEADACHE DISORDERS. | 0 | 5.53 | 4 | 4 |
| Sleep Initiation and Maintenance Disorders Disorders characterized by impairment of the ability to initiate or maintain sleep. This may occur as a primary disorder or in association with another medical or psychiatric condition. | 1 | 11.25 | 7 | 6 |
| Breathlessness [description not available] | 0 | 3.43 | 1 | 1 |
| Dyspnea Difficult or labored breathing. | 0 | 3.43 | 1 | 1 |
| Acute Liver Injury, Drug-Induced [description not available] | 0 | 2.05 | 1 | 0 |
| Eosinophilia, Tropical [description not available] | 0 | 2.05 | 1 | 0 |
| Eosinophilia Abnormal increase of EOSINOPHILS in the blood, tissues or organs. | 0 | 2.05 | 1 | 0 |
| Chemical and Drug Induced Liver Injury A spectrum of clinical liver diseases ranging from mild biochemical abnormalities to ACUTE LIVER FAILURE, caused by drugs, drug metabolites, herbal and dietary supplements and chemicals from the environment. | 0 | 2.05 | 1 | 0 |
| Nicotine Addiction [description not available] | 0 | 3.48 | 1 | 1 |
| Tobacco Use Disorder Tobacco used to the detriment of a person's health or social functioning. Tobacco dependence is included. | 0 | 3.48 | 1 | 1 |
| Smoking Cessation Discontinuing the habit of SMOKING. | 0 | 8.48 | 1 | 1 |
| MS (Multiple Sclerosis) [description not available] | 0 | 3.47 | 1 | 1 |
| Multiple Sclerosis An autoimmune disorder mainly affecting young adults and characterized by destruction of myelin in the central nervous system. Pathologic findings include multiple sharply demarcated areas of demyelination throughout the white matter of the central nervous system. Clinical manifestations include visual loss, extra-ocular movement disorders, paresthesias, loss of sensation, weakness, dysarthria, spasticity, ataxia, and bladder dysfunction. The usual pattern is one of recurrent attacks followed by partial recovery (see MULTIPLE SCLEROSIS, RELAPSING-REMITTING), but acute fulminating and chronic progressive forms (see MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE) also occur. (Adams et al., Principles of Neurology, 6th ed, p903) | 0 | 3.47 | 1 | 1 |
| Altitude Hypoxia Low ambient oxygen tension associated with ALTITUDE. | 0 | 2.07 | 1 | 0 |
| Pulmonary Hypertension [description not available] | 0 | 2.07 | 1 | 0 |
| Altitude Sickness Multiple symptoms associated with reduced oxygen at high ALTITUDE. | 0 | 2.07 | 1 | 0 |
| Hypertension, Pulmonary Increased VASCULAR RESISTANCE in the PULMONARY CIRCULATION, usually secondary to HEART DISEASES or LUNG DISEASES. | 0 | 2.07 | 1 | 0 |
| Chronic Fatigue and Immune Dysfunction Syndrome [description not available] | 0 | 3.87 | 2 | 1 |
| Fatigue Syndrome, Chronic A syndrome characterized by persistent or recurrent fatigue, diffuse musculoskeletal pain, sleep disturbances, and subjective cognitive impairment of 6 months duration or longer. Symptoms are not caused by ongoing exertion; are not relieved by rest; and result in a substantial reduction of previous levels of occupational, educational, social, or personal activities. Minor alterations of immune, neuroendocrine, and autonomic function may be associated with this syndrome. There is also considerable overlap between this condition and FIBROMYALGIA. (From Semin Neurol 1998;18(2):237-42; Ann Intern Med 1994 Dec 15;121(12): 953-9) | 0 | 3.87 | 2 | 1 |
| Addiction, Opioid [description not available] | 0 | 2.99 | 1 | 0 |
| Ache [description not available] | 0 | 2.99 | 1 | 0 |
| Opioid-Related Disorders Disorders related to or resulting from abuse or misuse of OPIOIDS. | 0 | 2.99 | 1 | 0 |
| Pain An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS. | 0 | 2.99 | 1 | 0 |
| Stunted Growth [description not available] | 0 | 3.92 | 1 | 0 |
| Psychoses, Drug [description not available] | 0 | 3.92 | 1 | 0 |
| Absence Seizure [description not available] | 0 | 3.92 | 1 | 0 |
| Childhood Tic Disorders [description not available] | 0 | 3.92 | 1 | 0 |
| Cardiovascular Diseases Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM. | 0 | 3.92 | 1 | 0 |
| Growth Disorders Deviations from the average values for a specific age and sex in any or all of the following: height, weight, skeletal proportions, osseous development, or maturation of features. Included here are both acceleration and retardation of growth. | 0 | 3.92 | 1 | 0 |
| Seizures Clinical or subclinical disturbances of cortical function due to a sudden, abnormal, excessive, and disorganized discharge of brain cells. Clinical manifestations include abnormal motor, sensory and psychic phenomena. Recurrent seizures are usually referred to as EPILEPSY or seizure disorder. | 0 | 3.92 | 1 | 0 |
| Diffuse Myofascial Pain Syndrome [description not available] | 0 | 2.08 | 1 | 0 |
| Fibromyalgia A common nonarticular rheumatic syndrome characterized by myalgia and multiple points of focal muscle tenderness to palpation (trigger points). Muscle pain is typically aggravated by inactivity or exposure to cold. This condition is often associated with general symptoms, such as sleep disturbances, fatigue, stiffness, HEADACHES, and occasionally DEPRESSION. There is significant overlap between fibromyalgia and the chronic fatigue syndrome (FATIGUE SYNDROME, CHRONIC). Fibromyalgia may arise as a primary or secondary disease process. It is most frequent in females aged 20 to 50 years. (From Adams et al., Principles of Neurology, 6th ed, p1494-95) | 0 | 2.08 | 1 | 0 |
| Autotomy Human [description not available] | 0 | 2.03 | 1 | 0 |
| Flushing A transient reddening of the face that may be due to fever, certain drugs, exertion, or stress. | 0 | 3.43 | 1 | 1 |