Long-Term Olanzapine Treatment in Children With Autism
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 13, 2005 | ||||||||
| Last Updated Date | April 29, 2009 | ||||||||
| Start Date ICMJE | September 2004 | ||||||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Children's Psychiatric Rating Scale [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Effectiveness of olanzapine, as measured by the Children's Psychiatric Rating Scale | ||||||||
| Change History | Complete list of historical versions of study NCT00183404 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Long-Term Olanzapine Treatment in Children With Autism | ||||||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Autism | ||||||||
| Intervention ICMJE | Drug: Olanzapine
Olanzapine tablets, dosed once or twice per day, dosage 2.5 to 20 mg per day
Other Name: Open Olanzapine |
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| Study Arm (s) | 1
Participants will take open olanzapine for up to 20 additional weeks after phase 1.
Intervention: Drug: Olanzapine |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | October 2009 | ||||||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 3 Years to 12 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00183404 | ||||||||
| Other Study ID Numbers ICMJE | R01 MH073524, DDTR B2-NDA | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Richard P. Malone, MD, Drexel University College of Medicine | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | April 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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