A Randomized, Double-blind Comparison of Atomoxetine Hydrochloride and Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents With Autism Spectrum Disorder
Overview
- Phase
- Phase 4
- Intervention
- Atomoxetine
- Conditions
- Autistic Disorder
- Sponsor
- Eli Lilly and Company
- Enrollment
- 97
- Locations
- 1
- Primary Endpoint
- ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD (Attention Deficit/Hyperactivity Disorder) symptoms in children and adolescents with ASD (Autism Spectrum Disorder).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Atomoxetine
atomoxetine 0.5 mg/kg/day every day (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks
Intervention: Atomoxetine
Placebo
placebo every day (QD), by mouth (PO) for 8 weeks Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score
Time Frame: Baseline and 8 weeks
Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders, Version IV (DSM-IV) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.
Secondary Outcomes
- ADHD Rating Scale-IV-Parent Version: Investigator Scored Total Score(28 weeks)
- Clinical Global Impressions-ADHD-Improvement (CGI-ADHD - I)(8 weeks, 28 weeks)
- Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)(Baseline, 8 weeks, 28 weeks)
- Sleep Measure Scale(Baseline, 8 weeks, 28 weeks)
- Aberrant Behavior Checklist (ABC)(Baseline, 8 weeks, 28 weeks)
- Children's Social Behavior Questionnaire (CSBQ) Total Score(Baseline, 8 weeks, 28 weeks)
- General Health Questionnaire (GHQ) Total Score(Baseline, 8 weeks, 28 weeks)
- Nijmeegse Ouderlijke Stress Index (NOSI) Total Score(Baseline, 8 weeks, 28 weeks)
- Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Error Rates(Baseline, 8 Weeks)
- Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Reaction Times for Hits and Correct Rejections(Baseline, 8 Weeks)
- Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Standard Deviation of Reaction Times for Hits and Correct Rejections(Baseline, 8 Weeks)
- Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Error Rates(Baseline, 8 Weeks)
- Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Reaction Times for Hits and Correct Rejections(Baseline, 8 Weeks)
- Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Standard Deviation (SD) of Reaction Times for Hits and Correct Rejections(Baseline, 8 weeks)
- Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Accuracy(Baseline, 8 weeks)
- Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Stability of Movement(Baseline, 8 weeks)
- Amsterdam Neuropsychological Tasks (ANT): Go/No-Go Response Inhibition Task - Error Rates(Baseline, 8 weeks)
- Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Error Rates(Baseline, 8 weeks)
- Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Reaction Times(Baseline, 8 weeks)
- Cytochrome P450 2D6 Genotype(baseline)