Long-Term Olanzapine Treatment in Children With Autism - NCT00183404-19124 (Clinical Trial 129316)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy129316.aspx
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Philadelphia |
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State:
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PA |
| Zip Code: |
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19124 |
| Conditions: |
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Autism |
| Purpose: |
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This study will determine the short- and long-term safety and effectiveness of the drug
olanzapine (Zyprexa®) for reducing symptoms of autism in children.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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Drexel University College of Medicine at Friends Hospital
Philadelphia, PA 19124
United States
Primary Contact:
Richard P. Malone, MD
Email: rmalone@drexelmed.edu
Phone: 215-831-4058
Secondary Contact:
Richard P. Malone, MD
Email: rmalone@drexelmed.edu
Phone: 215-831-4058 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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