Study of Fluoxetine in Autism

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2009

Interventions

  • Drug: Fluoxetine
    • Once daily oral dispersible tablet 2mg 9mg or 18mg
  • Drug: Placebo
    • Oral dispersible tablet placebo

Arms, Groups and Cohorts

  • Experimental: Fluoxetine
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score.
    • Time Frame: Throughout the study

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • Meets DSM-IV criteria for autistic disorder, . – CYBOCS-PDD score of at least 10 at screening. Exclusion Criteria:

  • Diagnosis of Asperger Syndrome or Pervasive Developmental Disorder Not Otherwise Specified, Rett Syndrome, Childhood Disintegrative Disorder. – Patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behaviour therapy within 8 weeks prior to enrolment. – Patients who are currently taking fluoxetine or who have previously taken it are not eligible for the study. Other protocol-defined Inclusion/Exclusion criteria may apply.

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Neuropharm
  • Collaborator
    • Autism Speaks
  • Provider of Information About this Clinical Study
    • Sponsor

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