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NCT00515320 · ClinicalTrials.gov registry record · Phase 3

Study of Fluoxetine in Autism

A Phase 3 study of Autistic Disorder, sponsored by Neuropharm.

Completed
Registry status
Phase 3
Development phase
158
Enrollment target
17
Study locations

NCT00515320 is a Phase 3 study of Autistic Disorder that has completed, run by Neuropharm. The registered enrollment target is 158 participants, above the 108-participant average among 27 other Autistic Disorder trials with a reported enrollment target (46% higher). The trial reports 17 study locations across 15 states.

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The verdict

NCT00515320, a Phase 3 study of Autistic Disorder, has completed, sponsored by Neuropharm.

COMPLETED
Registry status
Phase 3
Development phase
158 participants
Enrollment target
17
Study locations

Study 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.

Conditions Studied

Autistic Disorder

Interventions

  • DRUG Placebo
  • DRUG Fluoxetine

Study Locations (17)

Illinois

  • University of Illinois - Chicago
  • AMR-Baber Research Inc. - Naperville

New York

  • Long Island Jewish Hospital - Bethpage
  • Mount Sinai School of Medicine - New York

Arizona

  • Southwest Autism Research and Resource Centre - Phoenix

California

  • University of California Davis - Sacramento

Florida

  • University of Florida, Department of Psychiatry - Gainesville

Georgia

  • Institute for Behavioral Medicine - Smyrna

Massachusetts

  • Harvard Medical School - Medford

Michigan

  • Children's Hospital of Michigan - Detroit

Trial Details

FieldValue
Enrollment Target 158 participants
Start Date 2007-08
Est. Completion 2009-01
Phase Phase 3

Sponsor

Neuropharm

4 total trials

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What the Registry Record Tells You About NCT00515320

The ClinicalTrials.gov registry entry for NCT00515320 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 108-participant average among 27 other Autistic Disorder trials with a reported enrollment target (46% higher). The listed sponsor is Neuropharm, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Autistic Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00515320 reports 17 study locations spanning 15 distinct geographic areas - top geographies include Illinois, New York, Arizona.

Frequently Asked Questions

What is clinical trial NCT00515320 about?

NCT00515320 is a clinical study titled "Study of Fluoxetine in Autism". 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...

What is the current status of trial NCT00515320?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 158 participants. The study started on 2007-08. Estimated completion is 2009-01.

What conditions does trial NCT00515320 study?

This clinical trial studies the following conditions: Autistic Disorder.

What interventions are being tested in trial NCT00515320?

The interventions under investigation include: Placebo (DRUG), Fluoxetine (DRUG).

Who is sponsoring clinical trial NCT00515320?

This trial is sponsored by Neuropharm, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00515320 being conducted?

This trial has 17 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.