Long-Term Olanzapine Treatment in Children With Autism - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 13, 2005

Last Updated Date

April 29, 2009

Start Date ^†

September 2004

Current Primary Outcome Measures ^†

Children's Psychiatric Rating Scale [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00183404 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Aberrant Behavior Checklist [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: No ]
Clinical Global Impressions [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: No ]
Treatment Emergent Symptoms Scale [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: Yes ]
Olanzapine Untoward Effects Checklist [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: Yes ]
Abnormal Involuntary Movement Scale [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: Yes ]
Neurological Rating Scale [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Aberrant Behavior Checklist
Clinical Global Impressions

Descriptive Information

Brief Title ^†

Long-Term Olanzapine Treatment in Children With Autism

Official Title ^†

Long-Term Olanzapine Treatment in Children With Autism

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 Phase

Phase II, Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Autism

Intervention ^†

Drug: Olanzapine

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

October 2009

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Gender

Both

Ages

3 Years to 12 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Richard P. Malone, MD	215-831-4058	rmalone@drexelmed.edu
Contact: Melissa Lech, BSN	215-831-4058	mlech@drexelmed.edu

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00183404

Responsible Party

Richard P. Malone, MD, Drexel University College of Medicine

Secondary IDs ^††

DDTR B2-NDA

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

Investigators ^†

Principal Investigator:

Richard P. Malone, MD

Drexel University College of Medicine

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.