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NCT00515320 · ClinicalTrials.gov registry record · Phase 3
Study of Fluoxetine in Autism
A Phase 3 study of Autistic Disorder, sponsored by Neuropharm.
- Completed
- Registry status
- Phase 3
- Development phase
- 158
- Enrollment target
- 17
- Study locations
NCT00515320: Completed Phase 3 study of Autistic Disorder, sponsored by Neuropharm.
NCT00515320 is a Phase 3 study of Autistic Disorder that has completed, run by Neuropharm. The registered enrollment target is 158 participants, above the 108-participant average among 27 other Autistic Disorder trials with a reported enrollment target (46% higher). The trial reports 17 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00515320, a Phase 3 study of Autistic Disorder, has completed, sponsored by Neuropharm.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 158 participants
- Enrollment target
- 17
- Study locations
Study Summary
The purpose of this study is to assess the effect of fluoxetine orally dissolving tablets (ODT) on the repetitive behaviors core domain in children and adolescents with Autistic Disorder. The study will also investigate the effect of fluoxetine on the improvement of symptoms and the effects on daily living of the patient's family.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Fluoxetine
Study Locations (17)
Illinois
- University of Illinois - Chicago
- AMR-Baber Research Inc. - Naperville
New York
- Long Island Jewish Hospital - Bethpage
- Mount Sinai School of Medicine - New York
Arizona
- Southwest Autism Research and Resource Centre - Phoenix
California
- University of California Davis - Sacramento
Florida
- University of Florida, Department of Psychiatry - Gainesville
Georgia
- Institute for Behavioral Medicine - Smyrna
Massachusetts
- Harvard Medical School - Medford
Michigan
- Children's Hospital of Michigan - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2007-08 |
| Est. Completion | 2009-01 |
| Phase | Phase 3 |
What the finished NCT00515320 record still lists
NCT00515320 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, above the 108-participant average among 27 other Autistic Disorder trials with a reported enrollment target (46% higher).
The record links to 1 condition, with Autistic Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00515320 lists 17 locations in 15 states (Illinois, New York, Arizona).
Frequently Asked Questions
What is clinical trial NCT00515320 about?
NCT00515320 is a clinical study titled "Study of Fluoxetine in Autism". The purpose of this study is to assess the effect of fluoxetine orally dissolving tablets (ODT) on the repetitive behaviors core domain in children and adolescents with Autistic Disorder. The study will also investigate the effect of fluoxetine on the improvement of symptoms and the effects on daily...
What is the current status of trial NCT00515320?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 158 participants. The study started on 2007-08. Estimated completion is 2009-01.
What conditions does trial NCT00515320 study?
This clinical trial studies the following conditions: Autistic Disorder.
What interventions are being tested in trial NCT00515320?
The interventions under investigation include: Placebo (DRUG), Fluoxetine (DRUG).
Who is sponsoring clinical trial NCT00515320?
This trial is sponsored by Neuropharm, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00515320 being conducted?
This trial has 17 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autistic Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00515320's enrollment target sits among peer trials
158 7th of 27 higher than 21 of 27 other Autistic Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autistic Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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