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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

• Drug: Atomoxetine
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • atomoxetine 0.5 mg/kg/day QD, 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: B
  • placebo QD, 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
  • Time Frame: 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: 8 weeks, 28 weeks
    Safety Issue?: No
• ADHD Rating Scale-IV-Parent Version: investigator scored
  • Time Frame: 28 weeks
    Safety Issue?: No
• Treatment-emergent adverse events (TEAEs)
  • Time Frame: 8 weeks, 28 weeks
    Safety Issue?: Yes
• Sleep measure scale
  • Time Frame: 8 weeks, 28 weeks
    Safety Issue?: No
• Aberrant Behavior Checklist (ABC)
  • Time Frame: 8 weeks, 28 weeks
    Safety Issue?: No
• Children's Social Behavior Questionnaire (CSBQ)
  • Time Frame: 8 weeks, 28 weeks
    Safety Issue?: No
• Amsterdam Neuropsychological Tasks (ANT)
  • Time Frame: 8 weeks, 28 weeks
    Safety Issue?: No
• General Health Questionnaire (GHQ)
  • Time Frame: 8 weeks, 28 weeks
    Safety Issue?: No
• Nijmeegse Ouderlijke Stress Index (NOSI)
  • Time Frame: 8 weeks, 28 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 PDD NOS)
• Criteria A through D for 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
• IQ score > 60

Exclusion Criteria (most important):

• weight under 20 kg
• Patients who meet 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 Sponsor: Eli Lilly and Company

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 January 08, 2009

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