Working… Menu

Study of Fluoxetine in Autism (SOFIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00515320
Recruitment Status : Completed
First Posted : August 13, 2007
Last Update Posted : April 27, 2012
Autism Speaks
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Autistic Disorder Drug: Fluoxetine Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : August 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score. [ Time Frame: Throughout the study ]

Secondary Outcome Measures :
  1. The time and dose related course of therapeutic effects [ Time Frame: Throughout the study ]
  2. The inter-relationship between these effects in the context of global clinical changes. [ Time Frame: Throughout the study ]
  3. The indirect effects on patient caregivers of the dose regime in these subjects compared to placebo during treatment. [ Time Frame: Throughout the study ]
  4. Safety measures will be physical examination, vital signs, EKG/ECG & clinical laboratory tests. [ Time Frame: Throughout the study ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00515320

Show Show 17 study locations
Sponsors and Collaborators
Autism Speaks
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Neuropharm Identifier: NCT00515320    
Other Study ID Numbers: NPL-2008-4-AUTUS-004
First Posted: August 13, 2007    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012
Keywords provided by Neuropharm:
Autistic Disorder
Repetitive behavior
Selective Serotonin Reuptake Inhibitor
Additional relevant MeSH terms:
Layout table for MeSH terms
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors