SPD489 (Lisdexamfetamine dimesylate)

DRUG7 trials

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)Attention-Deficit/Hyperactivity DisorderBinge Eating DisorderMajor Depressive DisorderSchizophreniaSchizophrenia and Predominant Negative Symptoms

Phase 1

Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia

CompletedNCT01457339

ShireSchizophrenia

Start: 2011-10-21End: 2012-01-20Updated: 2021-06-03

Phase 2

Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms

CompletedNCT00922272

ShireSchizophrenia and Predominant Negative Symptoms

Start: 2009-09-14End: 2011-01-20Updated: 2021-06-09

SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder

CompletedNCT00985725

ShireMajor Depressive Disorder

Start: 2009-10-29End: 2011-04-18Updated: 2021-06-08

Phase 3

SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

CompletedNCT01718509

ShireBinge Eating Disorder

Start: 2012-11-26End: 2013-09-20Updated: 2021-07-16

SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

CompletedNCT01718483

ShireBinge Eating Disorder

Start: 2012-11-26End: 2013-09-25Updated: 2021-06-08

Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

CompletedNCT03260205

ShireAttention Deficit Hyperactivity Disorder (ADHD)

Start: 2017-09-06End: 2018-10-23Updated: 2021-06-08

Phase 4

Safety and Efficacy of Vyvanse in Adults With Attention-Deficit/Hyperactivity Disorder

CompletedNCT00877487

ShireAttention-Deficit/Hyperactivity Disorder

Start: 2009-04-30End: 2010-07-08Updated: 2021-06-22

Journal of the American Academy of Child & Adolescent Psychiatry2022-05-1324 citations

A Long-Term, Open-Label Safety and Tolerability Study of Lisdexamfetamine Dimesylate in Children Aged 4–5 Years with Attention-Deficit/Hyperactivity Disorder

Journal of Child and Adolescent Psychopharmacology2022-03-014 citations

Assessment of Amphetamine Withdrawal Symptoms of Lisdexamfetamine Dimesylate Treatment for Adults With Binge-Eating Disorder

The Primary Care Companion For CNS Disorders2020-03-252 citations

Clinical Characteristics and Treatment Response to Lisdexamfetamine Dimesylate Versus Placebo in Adults With Binge Eating Disorder

The Journal of Clinical Psychiatry2019-02-2512 citations

Relationships between clinical scales and binge eating days in adults with moderate to severe binge eating disorder in two Phase III studies.

2018-02-155 citations

Relationship of ADHD Symptoms and Global Illness Severity in Adults Treated with Lisdexamfetamine Dimesylate

Postgraduate Medicine2014-09-011 citations

Lisdexamfetamine dimesylate augmentation in adults with persistent executive dysfunction after partial or full remission of major depressive disorder.

2013-12-0641 citations

Maintenance of efficacy of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: randomized withdrawal design.

2012-06-1234 citations