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Long-Term Olanzapine Treatment in Children With Autism

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Drexel University Identifier:
First received: September 13, 2005
Last updated: August 14, 2014
Last verified: August 2014
This study will determine the short- and long-term safety and effectiveness of the drug olanzapine (Zyprexa®) for reducing symptoms of autism in children.

Condition Intervention Phase
Autism Drug: Olanzapine Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Olanzapine Treatment in Children With Autism

Resource links provided by NLM:

Further study details as provided by Drexel University:

Primary Outcome Measures:
  • Children's Psychiatric Rating Scale [ Time Frame: Measured monthly throughout the study ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: September 2004
Study Completion Date: October 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olanzapine
Participants will take open olanzapine for up to 20 additional weeks after phase 1.
Drug: Olanzapine
Olanzapine tablets, dosed once or twice per day, dosage 2.5 to 20 mg per day
Other Name: Open Olanzapine

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.


Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00183404

United States, Pennsylvania
Drexel University College of Medicine at Friends Hospital
Philadelphia, Pennsylvania, United States, 19124
Sponsors and Collaborators
Drexel University
National Institute of Mental Health (NIMH)
Principal Investigator: Richard P. Malone, MD Drexel University College of Medicine
  More Information

Responsible Party: Drexel University Identifier: NCT00183404     History of Changes
Other Study ID Numbers: R01MH073524 ( U.S. NIH Grant/Contract )
DDTR B2-NDA ( Other Grant/Funding Number: NIH )
Study First Received: September 13, 2005
Last Updated: August 14, 2014

Keywords provided by Drexel University:
Drug Treatment

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents processed this record on September 21, 2017