Autism Clinical Trial
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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