Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate
|ClinicalTrials.gov Identifier: NCT01106430|
Recruitment Status : Completed
First Posted : April 19, 2010
Results First Posted : June 24, 2013
Last Update Posted : June 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Attention-Deficit/Hyperactivity Disorder||Drug: Lisdexamfetamine Dimesylate Drug: Atomoxetine Hydrochloride||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||267 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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 Disorder (ADHD) Who Have Had an Inadequate Response to Methylphenidate Therapy|
|Study Start Date :||June 2010|
|Primary Completion Date :||July 2012|
|Study Completion Date :||September 2012|
|Experimental: Lisdexamfetamine Dimesylate||
Drug: Lisdexamfetamine Dimesylate
Oral 30, 50, or 70mg once-daily for 9 weeks
Other Name: Vyvanse
|Active Comparator: Atomoxetine Hydrochloride||
Drug: Atomoxetine Hydrochloride
Oral 10mg to 100mg once-daily for 9 weeks
Other Name: Strattera
- Time to First Response [ Time Frame: 9 weeks ]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).
- Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF) [ Time Frame: 9 weeks ]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.
- Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF [ Time Frame: Baseline and 9 weeks ]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.
- Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks [ Time Frame: Baseline and up to 9 weeks ]The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
- Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks [ Time Frame: up to 9 weeks ]HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.
- Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks [ Time Frame: Baseline and up to 9 weeks ]The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.
- Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 9 weeks ]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.
- Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 [ Time Frame: 9 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106430
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|Principal Investigator:||Ralf W Dittmann, MD, PhD||Dept of Child and Adolescent Psychiatry and Psychotherapy, Central Inst of Mental Health|