Official Title: “Long-Term Olanzapine Treatment in Children With Autism”

This study will determine the short- and long-term safety and effectiveness of the drug olanzapine (Zyprexa®) for reducing symptoms of autism in children.

Study Type: Interventional

Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2009

Autism is a serious childhood disorder that can significantly impair functioning and development. Educational and psychosocial programs are standard treatments for autistic children, but drug therapy is often needed as well. Haloperidol is the drug most commonly prescribed for symptoms of autism. However, long-term administration of haloperidol has been associated with adverse effects such as blurred vision, constipation, and nausea. The investigation of alternative drug treatments is necessary. This study will determine whether the antipsychotic drug olanzapine may be a safe and effective alternative to haloperidol for treating symptoms of autism in children.

This study will last 36 weeks and will comprise 2 phases. In Phase I, participants will be randomly assigned to receive either olanzapine or placebo for 12 weeks. Participants who do not respond to treatment will complete their participation in the study. Participants who respond to their assigned Phase I treatment will continue onto Phase II. All Phase II participants will receive olanzapine daily for 6 months. Self-report scales and checklists will be used to assess participants after each phase; these measures will be completed by participants and their parents.

Intervention(s) in this Clinical Trial

• Drug: Olanzapine
  • Olanzapine tablets, dosed once or twice per day, dosage 2.5 to 20 mg per day

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • Participants will take open olanzapine for up to 20 additional weeks after phase 1.

Primary Measures

• Children's Psychiatric Rating Scale
  • Time Frame: Measured monthly throughout the study
    Safety Issue?: No

Secondary Measures

• Aberrant Behavior Checklist
  • Time Frame: Measured monthly throughout the study
    Safety Issue?: No
• Clinical Global Impressions
  • Time Frame: Measured monthly throughout the study
    Safety Issue?: No
• Treatment Emergent Symptoms Scale
  • Time Frame: Measured monthly throughout the study
    Safety Issue?: Yes
• Olanzapine Untoward Effects Checklist
  • Time Frame: Measured monthly throughout the study
    Safety Issue?: Yes
• Abnormal Involuntary Movement Scale
  • Time Frame: Measured monthly throughout the study
    Safety Issue?: Yes
• Neurological Rating Scale
  • Time Frame: Measured monthly throughout the study
    Safety Issue?: Yes

Inclusion Criteria:

• Diagnosis of autism
• Parent or guardian willing to provide informed consent

Exclusion Criteria:

• Uncontrolled seizure disorder
• Medical illness other than autism affecting the whole body
• Obesity
• History of psychosis
• Impairment of voluntary movement
• History of olanzapine treatment

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Years

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Mental Health (NIMH)

Overall Clinical Trial Officials and Contacts

Richard P. Malone, MD Principal Investigator Drexel University College of Medicine  

Overall Contact: Richard P. Malone, MD 215-831-4058 rmalone@drexelmed.edu

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00183404

Study ID Number: R01 MH73524

ClinicalTrials.gov Identifier: NCT00183404

Health Authority: United States: Federal Government