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Study of Fluoxetine in Autism

NCT00515320 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2012-04-27

No results posted yet for this 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

  • Autistic Disorder

Interventions

DRUG

Fluoxetine

Once daily oral dispersible tablet 2mg 9mg or 18mg

DRUG

Placebo

Oral dispersible tablet placebo

Sponsors & Collaborators

  • Autism Speaks

    collaborator OTHER

  • Neuropharm

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00515320 on ClinicalTrials.gov