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Completed Phase 3 Interventional

Study of Fluoxetine in Autism

ClinicalTrials.gov ID: NCT00515320

Public ClinicalTrials.gov record NCT00515320. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 6:23 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00515320
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Neuropharm
Industry
Enrollment
158 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
5 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2007 (Type not available)
Primary completion
Jan 2009 (Actual)
Completion
Jan 2009 (Actual)
Last update posted
Apr 27, 2012

2007 – 2009

United States locations

U.S. sites
17
U.S. states
15
U.S. cities
17
Facility City State ZIP Site status
Southwest Autism Research and Resource Centre Phoenix Arizona 85006 —
University of California Davis Sacramento California 95817 —
University of Florida, Department of Psychiatry Gainesville Florida 32611 —
Institute for Behavioral Medicine Smyrna Georgia 30080 —
University of Illinois Chicago Illinois 60637-1448 —
AMR-Baber Research Inc. Naperville Illinois 60563 —
Harvard Medical School Medford Massachusetts 02155 —
Children's Hospital of Michigan Detroit Michigan 48201 —
Center for Psychiatry and Behavioral Medicine Las Vegas Nevada 89128 —
CRCNJ Voorhees Township New Jersey 08043 —
Long Island Jewish Hospital Bethpage New York 11714 —
Mount Sinai School of Medicine New York New York 10029 —
University of North Carolina Chapel Hill North Carolina 27514 —
Ohio State University Columbus Ohio 43210 —
Western Psychiatric Institute and Clinic/ Merck Child Outpatient Clinic Pittsburgh Pennsylvania 15203 —
Red Oak Psychiatry Associates Houston Texas 77090 —
Seattle Children's Hosptial University of Washington Seattle Washington 98105-0371 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00515320, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 27, 2012 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00515320 live on ClinicalTrials.gov.

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