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| Descriptive Information Fields | |||||||||
| Brief Title † | Long-Term Olanzapine Treatment in Children With Autism | ||||||||
| Official Title † | 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 Phase | Phase II, Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Children's Psychiatric Rating Scale [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Aberrant Behavior Checklist [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: No ] Clinical Global Impressions [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: No ] Treatment Emergent Symptoms Scale [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: Yes ] Olanzapine Untoward Effects Checklist [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: Yes ] Abnormal Involuntary Movement Scale [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: Yes ] Neurological Rating Scale [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: Yes ] |
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| Condition † | Autism | ||||||||
| Intervention † | Drug: Olanzapine | ||||||||
| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 40 | ||||||||
| Start Date † | September 2004 | ||||||||
| Completion Date | September 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 3 Years to 12 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00183404 | ||||||||
| Organization ID | R01 MH73524 | ||||||||
| Secondary IDs †† | DDTR B2-NDA | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | April 2008 | ||||||||
| First Received Date † | September 13, 2005 | ||||||||
| Last Updated Date | April 16, 2008 | ||||||||
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