Long-Term Olanzapine Treatment in Children With Autism

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

Detailed Description
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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.

Official Title
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Long-Term Olanzapine Treatment in Children With Autism

Conditions
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Autism

Intervention / Treatment
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* Drug: Olanzapine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olanzapine<br>Participants will take open olanzapine for up to 20 additional weeks after phase 1. | Drug: Olanzapine<br>* Olanzapine tablets, dosed once or twice per day, dosage 2.5 to 20 mg per day<br>* Other names: Open Olanzapine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Psychiatric Rating Scale |  | Measured monthly throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aberrant Behavior Checklist |  | Measured monthly throughout the study | 
| Clinical Global Impressions |  | Measured monthly throughout the study | 
| Treatment Emergent Symptoms Scale |  | Measured monthly throughout the study | 
| Olanzapine Untoward Effects Checklist |  | Measured monthly throughout the study | 
| Abnormal Involuntary Movement Scale |  | Measured monthly throughout the study | 
| Neurological Rating Scale |  | Measured monthly throughout the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Treatment, Child, Olanzapine