Study of Fluoxetine in Autism
SOFIA
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.
1 other identifier
interventional
158
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2007
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 10, 2007
CompletedFirst Posted
Study publicly available on registry
August 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedApril 27, 2012
April 1, 2012
1.4 years
August 10, 2007
April 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score.
Throughout the study
Secondary Outcomes (4)
The time and dose related course of therapeutic effects
Throughout the study
The inter-relationship between these effects in the context of global clinical changes.
Throughout the study
The indirect effects on patient caregivers of the dose regime in these subjects compared to placebo during treatment.
Throughout the study
Safety measures will be physical examination, vital signs, EKG/ECG & clinical laboratory tests.
Throughout the study
Study Arms (2)
Fluoxetine
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Meets DSM-IV criteria for autistic disorder, .
- CYBOCS-PDD score of at least 10 at screening.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuropharmlead
- Autism Speakscollaborator
Study Sites (17)
Southwest Autism Research and Resource Centre
Phoenix, Arizona, 85006, United States
University of California Davis
Sacramento, California, 95817, United States
University of Florida, Department of Psychiatry
Gainesville, Florida, 32611, United States
Institute for Behavioral Medicine
Smyrna, Georgia, 30080, United States
University of Illinois
Chicago, Illinois, 60637-1448, United States
AMR-Baber Research Inc.
Naperville, Illinois, 60563, United States
Harvard Medical School
Medford, Massachusetts, 02155, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, 89128, United States
CRCNJ
Voorhees Township, New Jersey, 08043, United States
Long Island Jewish Hospital
Bethpage, New York, 11714, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
Ohio State University
Columbus, Ohio, 43210, United States
Western Psychiatric Institute and Clinic/ Merck Child Outpatient Clinic
Pittsburgh, Pennsylvania, 15203, United States
Red Oak Psychiatry Associates
Houston, Texas, 77090, United States
Seattle Children's Hosptial University of Washington
Seattle, Washington, 98105-0371, United States
Related Publications (2)
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.
PMID: 37811711DERIVEDHerscu 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.
PMID: 31267292DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2007
First Posted
August 13, 2007
Study Start
August 1, 2007
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
April 27, 2012
Record last verified: 2012-04