Clinical Trial: Study of Fluoxetine in Autism

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Study Of Fluoxetine In Autism: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group 14-Week Study To Investigate The Effect Of Fluoxetine Orally Dissolving Table

Brief 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.

Detailed Summary:
Sponsor: Neuropharm

Current Primary Outcome: The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score. [ Time Frame: Throughout the study ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The time and dose related course of therapeutic effects [ Time Frame: Throughout the study ]
  • The inter-relationship between these effects in the context of global clinical changes. [ Time Frame: Throughout the study ]
  • The indirect effects on patient caregivers of the dose regime in these subjects compared to placebo during treatment. [ Time Frame: Throughout the study ]
  • Safety measures will be physical examination, vital signs, EKG/ECG & clinical laboratory tests. [ Time Frame: Throughout the study ]


Original Secondary Outcome: Same as current

Information By: Neuropharm

Dates:
Date Received: August 10, 2007
Date Started: August 2007
Date Completion:
Last Updated: April 26, 2012
Last Verified: April 2012