Study of Fluoxetine in Autism (SOFIA)

This study has been completed.
Sponsor:
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
Neuropharm
ClinicalTrials.gov Identifier:
NCT00515320
First received: August 10, 2007
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Autistic Disorder
Drug: Fluoxetine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Neuropharm:

Primary Outcome Measures:
  • The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The time and dose related course of therapeutic effects [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • The inter-relationship between these effects in the context of global clinical changes. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • The indirect effects on patient caregivers of the dose regime in these subjects compared to placebo during treatment. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Safety measures will be physical examination, vital signs, EKG/ECG & clinical laboratory tests. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 158
Study Start Date: August 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluoxetine Drug: Fluoxetine
Once daily oral dispersible tablet 2mg 9mg or 18mg
Other Name: NPL-2008
Placebo Comparator: Placebo Drug: Placebo
Oral dispersible tablet placebo

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515320

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

Additional Information:
No publications provided

Responsible Party: Neuropharm
ClinicalTrials.gov Identifier: NCT00515320     History of Changes
Other Study ID Numbers: NPL-2008-4-AUTUS-004
Study First Received: August 10, 2007
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Neuropharm:
Autism
children
adolescent
Fluoxetine
Autistic Disorder
Repetitive behavior
SSRI
Selective Serotonin Reuptake Inhibitor

Additional relevant MeSH terms:
Disease
Autistic Disorder
Pathologic Processes
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014