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.

Neuropharm17 sites in 1 country158 target enrollmentAugust 2007

ConditionsAutistic Disorder

InterventionsFluoxetine Placebo

DrugsFluoxetine Placebo

Overview

Phase: Phase 3
Intervention: Fluoxetine
Conditions: Autistic Disorder
Sponsor: Neuropharm
Enrollment: 158
Locations: 17
Primary Endpoint: The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score.
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

January 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Neuropharm

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Fluoxetine

Intervention: Fluoxetine

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score.

Time Frame: Throughout the study

Secondary Outcomes

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