Trials / Completed
CompletedNCT00515320
Study of Fluoxetine in Autism
Study Of Fluoxetine In Autism: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group 14-Week Study To Investigate The Effect Of Fluoxetine Orally Dissolving Tablet (ODT) On Repetitive Behaviors In Childhood And Adolescent Autistic Disorder.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 158 (actual)
- Sponsor
- Neuropharm · Industry
- Sex
- All
- Age
- 5 Years – 17 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fluoxetine | Once daily oral dispersible tablet 2mg 9mg or 18mg |
| DRUG | Placebo | Oral dispersible tablet placebo |
Timeline
- Start date
- 2007-08-01
- Primary completion
- 2009-01-01
- Completion
- 2009-01-01
- First posted
- 2007-08-13
- Last updated
- 2012-04-27
Locations
17 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00515320. Inclusion in this directory is not an endorsement.