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Long-Term Olanzapine Treatment in Children With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00183404
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 15, 2014
Information provided by (Responsible Party):

September 13, 2005
September 16, 2005
August 15, 2014
September 2004
July 2011   (Final data collection date for primary outcome measure)
Children's Psychiatric Rating Scale [ Time Frame: Measured monthly throughout the study ]
Effectiveness of olanzapine, as measured by the Children's Psychiatric Rating Scale
Complete list of historical versions of study NCT00183404 on ClinicalTrials.gov Archive Site
  • Aberrant Behavior Checklist [ Time Frame: Measured monthly throughout the study ]
  • Clinical Global Impressions [ Time Frame: Measured monthly throughout the study ]
  • Treatment Emergent Symptoms Scale [ Time Frame: Measured monthly throughout the study ]
  • Olanzapine Untoward Effects Checklist [ Time Frame: Measured monthly throughout the study ]
  • Abnormal Involuntary Movement Scale [ Time Frame: Measured monthly throughout the study ]
  • Neurological Rating Scale [ Time Frame: Measured monthly throughout the study ]
  • Aberrant Behavior Checklist
  • Clinical Global Impressions
Not Provided
Not Provided
Long-Term Olanzapine Treatment in Children With Autism
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.

Phase 2
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: Olanzapine
Olanzapine tablets, dosed once or twice per day, dosage 2.5 to 20 mg per day
Other Name: Open Olanzapine
Experimental: Olanzapine
Participants will take open olanzapine for up to 20 additional weeks after phase 1.
Intervention: Drug: Olanzapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
October 2011
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
3 Years to 12 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
R01MH073524( U.S. NIH Grant/Contract )
R01MH073524 ( U.S. NIH Grant/Contract )
DDTR B2-NDA ( Other Grant/Funding Number: NIH )
Not Provided
Not Provided
Drexel University
Drexel University
National Institute of Mental Health (NIMH)
Principal Investigator: Richard P. Malone, MD Drexel University College of Medicine
Drexel University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP