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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
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Drexel University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Autism Drug: Olanzapine Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Olanzapine Treatment in Children With Autism
Study Start Date : September 2004
Actual Primary Completion Date : July 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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

Secondary Outcome Measures :
  1. Aberrant Behavior Checklist [ Time Frame: Measured monthly throughout the study ]
  2. Clinical Global Impressions [ Time Frame: Measured monthly throughout the study ]
  3. Treatment Emergent Symptoms Scale [ Time Frame: Measured monthly throughout the study ]
  4. Olanzapine Untoward Effects Checklist [ Time Frame: Measured monthly throughout the study ]
  5. Abnormal Involuntary Movement Scale [ Time Frame: Measured monthly throughout the study ]
  6. Neurological Rating Scale [ Time Frame: Measured monthly throughout the study ]

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183404


Locations
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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)
Investigators
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Principal Investigator: Richard P. Malone, MD Drexel University College of Medicine
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT00183404    
Other Study ID Numbers: R01MH073524 ( U.S. NIH Grant/Contract )
R01MH073524 ( U.S. NIH Grant/Contract )
DDTR B2-NDA ( Other Grant/Funding Number: NIH )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: August 2014
Keywords provided by Drexel University:
Drug Treatment
Child
Olanzapine
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Olanzapine
Antiemetics
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