Study of Fluoxetine in Autism (SOFIA)

April 26, 2012 updated by: Neuropharm

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Southwest Autism Research and Resource Centre
    • California
      • Sacramento, California, United States, 95817
        • University of California Davis
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida, Department of Psychiatry
    • Georgia
      • Smyrna, Georgia, United States, 30080
        • Institute for Behavioral Medicine
    • Illinois
      • Chicago, Illinois, United States, 60637-1448
        • University of Illinois
      • Naperville, Illinois, United States, 60563
        • AMR-Baber Research Inc.
    • Massachusetts
      • Medford, Massachusetts, United States, 02155
        • Harvard Medical School
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Children's Hospital of Michigan
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Center for Psychiatry and Behavioral Medicine
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • CRCNJ
    • New York
      • Bethpage, New York, United States, 11714
        • Long Island Jewish Hospital
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15203
        • Western Psychiatric Institute and Clinic/ Merck Child Outpatient Clinic
    • Texas
      • Houston, Texas, United States, 77090
        • Red Oak Psychiatry Associates
    • Washington
      • Seattle, Washington, United States, 98105-0371
        • Seattle Children's Hosptial University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Oral dispersible tablet placebo
Experimental: Fluoxetine
Drug: Fluoxetine
Once daily oral dispersible tablet 2mg 9mg or 18mg
Other Names:
  • NPL-2008

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
The time and dose related course of therapeutic effects
Time Frame: Throughout the study
Throughout the study
The inter-relationship between these effects in the context of global clinical changes.
Time Frame: Throughout the study
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
Throughout the study
Safety measures will be physical examination, vital signs, EKG/ECG & clinical laboratory tests.
Time Frame: Throughout the study
Throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuropharm

Collaborators

Autism Speaks

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

August 10, 2007

First Submitted That Met QC Criteria

August 10, 2007

First Posted (Estimate)

August 13, 2007

Study Record Updates

Last Update Posted (Estimate)

April 27, 2012

Last Update Submitted That Met QC Criteria

April 26, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPL-2008-4-AUTUS-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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