Long-Term Olanzapine Treatment in Children With Autism

Drexel University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Autism

Treatments: Drug: Olanzapine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00183404

DDTR B2-NDA

R01MH073524 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 32 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Olanzapine

Experimental group

Description:

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

Treatment:

Drug: Olanzapine