Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
158 participants
INTERVENTIONAL
2007-08-31
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Fluoxetine
Fluoxetine
Once daily oral dispersible tablet 2mg 9mg or 18mg
Placebo
Placebo
Oral dispersible tablet placebo
Interventions
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Fluoxetine
Once daily oral dispersible tablet 2mg 9mg or 18mg
Placebo
Oral dispersible tablet placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* CYBOCS-PDD score of at least 10 at screening.
Exclusion Criteria
* 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.
5 Years
17 Years
ALL
No
Sponsors
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Autism Speaks
OTHER
Neuropharm
INDUSTRY
Responsible Party
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Locations
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Southwest Autism Research and Resource Centre
Phoenix, Arizona, United States
University of California Davis
Sacramento, California, United States
University of Florida, Department of Psychiatry
Gainesville, Florida, United States
Institute for Behavioral Medicine
Smyrna, Georgia, United States
University of Illinois
Chicago, Illinois, United States
AMR-Baber Research Inc.
Naperville, Illinois, United States
Harvard Medical School
Medford, Massachusetts, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, United States
CRCNJ
Voorhees Township, New Jersey, United States
Long Island Jewish Hospital
Bethpage, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Western Psychiatric Institute and Clinic/ Merck Child Outpatient Clinic
Pittsburgh, Pennsylvania, United States
Red Oak Psychiatry Associates
Houston, Texas, United States
Seattle Children's Hosptial University of Washington
Seattle, Washington, United States
Countries
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References
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Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.
Herscu P, Handen BL, Arnold LE, Snape MF, Bregman JD, Ginsberg L, Hendren R, Kolevzon A, Melmed R, Mintz M, Minshew N, Sikich L, Attalla A, King B, Owley T, Childress A, Chugani H, Frazier J, Cartwright C, Murphy T; Autism Speaks Autism Clinical Trials Network. The SOFIA Study: Negative Multi-center Study of Low Dose Fluoxetine on Repetitive Behaviors in Children and Adolescents with Autistic Disorder. J Autism Dev Disord. 2020 Sep;50(9):3233-3244. doi: 10.1007/s10803-019-04120-y.
Related Links
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www.autismspeaks.org
Other Identifiers
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NPL-2008-4-AUTUS-004
Identifier Type: -
Identifier Source: org_study_id
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