Study of Fluoxetine in Autism

Autistic Disorder Clinical Trial

— SOFIA  

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 Tablet (ODT) On Repetitive Behaviors In Childhood And Adolescent Autistic Disorder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00515320
• Other study ID #: NPL-2008-4-AUTUS-004
• Status: Completed
• Phase: Phase 3
• First received: August 10, 2007
• Last updated: April 26, 2012
• Start date: August 2007
• Est. completion date: January 2009

Study information

• Verified date: April 2012
• Source: Neuropharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autistic Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Long Island Jewish Hospital	Bethpage	New York
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Illinois	Chicago	Illinois
United States	Ohio State University	Columbus	Ohio
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	University of Florida, Department of Psychiatry	Gainesville	Florida
United States	Red Oak Psychiatry Associates	Houston	Texas
United States	Center for Psychiatry and Behavioral Medicine	Las Vegas	Nevada
United States	Harvard Medical School	Medford	Massachusetts
United States	AMR-Baber Research Inc.	Naperville	Illinois
United States	Mount Sinai School of Medicine	New York	New York
United States	Southwest Autism Research and Resource Centre	Phoenix	Arizona
United States	Western Psychiatric Institute and Clinic/ Merck Child Outpatient Clinic	Pittsburgh	Pennsylvania
United States	University of California Davis	Sacramento	California
United States	Seattle Children's Hosptial University of Washington	Seattle	Washington
United States	Institute for Behavioral Medicine	Smyrna	Georgia
United States	CRCNJ	Voorhees	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Neuropharm	Autism Speaks

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score.		Throughout the study
Secondary	The time and dose related course of therapeutic effects		Throughout the study
Secondary	The inter-relationship between these effects in the context of global clinical changes.		Throughout the study
Secondary	The indirect effects on patient caregivers of the dose regime in these subjects compared to placebo during treatment.		Throughout the study
Secondary	Safety measures will be physical examination, vital signs, EKG/ECG & clinical laboratory tests.		Throughout the study

External Links

•   www.autismspeaks.org