Atomoxetine Versus Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents With Autism Spectrum Disorder

Official Title: “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”

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).

Intervention(s) in this Clinical Trial

• Drug: Atomoxetine
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 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
• Placebo Comparator: 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

Primary Measures

• ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score
  • Time Frame: Baseline and 8 weeks
    Safety Issue?: No

Secondary Measures

• Clinical Global Impressions-ADHD-Improvement (CGI-ADHD - I)
  • Time Frame: 8 weeks, 28 weeks
    Safety Issue?: No
• Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)
  • Time Frame: Baseline, 8 weeks, 28 weeks
    Safety Issue?: No
• ADHD Rating Scale-IV-Parent Version: Investigator Scored Total Score
  • Time Frame: 28 weeks
    Safety Issue?: No
• Sleep Measure Scale
  • Time Frame: Baseline, 8 weeks, 28 weeks
    Safety Issue?: No
• Aberrant Behavior Checklist (ABC)
  • Time Frame: Baseline, 8 weeks, 28 weeks
    Safety Issue?: No
• Children's Social Behavior Questionnaire (CSBQ) Total Score
  • Time Frame: Baseline, 8 weeks, 28 weeks
    Safety Issue?: No
• General Health Questionnaire (GHQ) Total Score
  • Time Frame: Baseline, 8 weeks, 28 weeks
    Safety Issue?: No
• Nijmeegse Ouderlijke Stress Index (NOSI) Total Score
  • Time Frame: Baseline, 8 weeks, 28 weeks
    Safety Issue?: No
• Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Error Rates
  • Time Frame: Baseline, 8 Weeks
    Safety Issue?: No
• Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Reaction Times for Hits and Correct Rejections
  • Time Frame: Baseline, 8 Weeks
    Safety Issue?: No
• Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Standard Deviation of Reaction Times for Hits and Correct Rejections
  • Time Frame: Baseline, 8 Weeks
    Safety Issue?: No
• Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Error Rates
  • Time Frame: Baseline, 8 Weeks
    Safety Issue?: No
• Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Reaction Times for Hits and Correct Rejections
  • Time Frame: Baseline, 8 Weeks
    Safety Issue?: No
• Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Standard Deviation (SD) of Reaction Times for Hits and Correct Rejections
  • Time Frame: Baseline, 8 weeks
    Safety Issue?: No
• Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Accuracy
  • Time Frame: Baseline, 8 weeks
    Safety Issue?: No
• Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Stability of Movement
  • Time Frame: Baseline, 8 weeks
    Safety Issue?: No
• Amsterdam Neuropsychological Tasks (ANT): Go/No-Go Response Inhibition Task - Error Rates
  • Time Frame: Baseline, 8 weeks
    Safety Issue?: No
• Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Error Rates
  • Time Frame: Baseline, 8 weeks
    Safety Issue?: No
• Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Reaction Times
  • Time Frame: Baseline, 8 weeks
    Safety Issue?: No
• Cytochrome P450 2D6 Genotype
  • Time Frame: baseline
    Safety Issue?: No

Inclusion Criteria (most important):

• ASD (autistic disorder or Asperger's disorder or Pervasive Developmental Disorder -
• Not Otherwise Specified [PDD NOS])
• Criteria A through D for Attention-Deficit/Hyperactivity Disorder (ADHD)
• At least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the ADHD Rating Scale-IV-Parent Version
• Intelligence quotient (IQ) score > 60

Exclusion Criteria (most important):

• weight under 20 kg
• Patients who meet Diagnostic and Statistical Manual of Mental Disorders Fourth
• Edition, Text Revision (DSM-IV-TR) criteria for ASD other than Autistic Disorder, PDD-NOS or Asperger's Disorder;history of Bipolar I or II disorder, schizophrenia, another psychotic disorder, substance abuse;Have a significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, or seizure disorder identified by history, physical examination, or laboratory tests; Patients who have taken (or are currently taking) anticonvulsants for seizure control.
• patients at serious suicidal risk.
• Contraindication to the use of atomoxetine
• Patients who in the investigator's judgment are likely to need psychotropic medications apart from the drug. Patients who at any time during Study Period II are likely to begin a structured psychotherapy, likely to require hospitalization (i.e.
• in-patient treatment) or likely to be dismissed from in-patient treatment.
• Psychotherapy (including hospitalization) initiated at least 2 months prior to study participation is acceptable; however, after study participation has begun, only during Study Period III supportive or educational therapy is permitted.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Eli Lilly and Company Industry

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00380692

Study ID Number: 10483

ClinicalTrials.gov Identifier: NCT00380692

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Lilly Clinical Trial Registry