Long-Term Olanzapine Treatment in Children With Autism

Autism Clinical Trial

Official title:

Long-Term Olanzapine Treatment in Children With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183404
• Other study ID #: R01MH073524
• Secondary ID: R01MH073524DDTR
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 13, 2005
• Last updated: August 14, 2014
• Start date: September 2004
• Est. completion date: October 2011

Study information

• Verified date: August 2014
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Drexel University College of Medicine at Friends Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Psychiatric Rating Scale		Measured monthly throughout the study	No
Secondary	Aberrant Behavior Checklist		Measured monthly throughout the study	No
Secondary	Clinical Global Impressions		Measured monthly throughout the study	No
Secondary	Treatment Emergent Symptoms Scale		Measured monthly throughout the study	Yes
Secondary	Olanzapine Untoward Effects Checklist		Measured monthly throughout the study	Yes
Secondary	Abnormal Involuntary Movement Scale		Measured monthly throughout the study	Yes
Secondary	Neurological Rating Scale		Measured monthly throughout the study	Yes