Long-Term Olanzapine Treatment in Children With Autism

Phase 2

Completed

• Conditions: Autism
• Interventions: Drug: Olanzapine

• Registration Number: NCT00183404
• Lead Sponsor: Drexel University

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2011-07
• Study Completion: 2011-10
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-14
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Olanzapine	Olanzapine	Participants will take open olanzapine for up to 20 additional weeks after phase 1.

Primary Outcome Measures

Name	Time	Method
Children's Psychiatric Rating Scale	Measured monthly throughout the study

Secondary Outcome Measures

Name	Time	Method
Olanzapine Untoward Effects Checklist	Measured monthly throughout the study
Treatment Emergent Symptoms Scale	Measured monthly throughout the study
Neurological Rating Scale	Measured monthly throughout the study
Aberrant Behavior Checklist	Measured monthly throughout the study
Clinical Global Impressions	Measured monthly throughout the study
Abnormal Involuntary Movement Scale	Measured monthly throughout the study

Trial Locations

Locations (1)

Drexel University College of Medicine at Friends Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States