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NCT00584701 · ClinicalTrials.gov registry record · Phase 2
Pharmacogenomics in Autism Treatment
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT00584701 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 49 participants.
The verdict
NCT00584701, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
Autism is a complex neurodevelopmental disorder that is thought to involve an interaction between multiple and variable susceptibility genes, environmental factors, and epigenetic effects. Great concern has been raised about the marked increase in the prevalence of autism spectrum disorders in the last decade. Risperidone, the most studied atypical antipsychotic used in children, has been shown to improve severe behavioral difficulties in over half of children with autism who have these difficulties. However, not all children with autism and severe behavioral problems respond to risperidone, and for a few, it has significant side effects. Two controlled studies and numerous open-label and long term studies in children with autism spectrum disorders using the atypical antipsychotic risperidone show a significant decrease of associated serious behavioral problems. The use of atypical antipsychotics is of great concern, however, because of their significant side effects and the fact that only two-thirds of children positively respond. Ways to predict response, appropriate dosage and serious side effects are needed.
Interventions
- DRUG Risperidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00584701
The ClinicalTrials.gov registry entry for NCT00584701 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Risperidone is the first listed.
NCT00584701 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00584701 about?
NCT00584701 is a clinical study titled "Pharmacogenomics in Autism Treatment". Autism is a complex neurodevelopmental disorder that is thought to involve an interaction between multiple and variable susceptibility genes, environmental factors, and epigenetic effects. Great concern has been raised about the marked increase in the prevalence of autism spectrum disorders in the l...
What is the current status of trial NCT00584701?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2008-01. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00584701?
The interventions under investigation include: Risperidone (DRUG).
Who is sponsoring clinical trial NCT00584701?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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