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Extended Management and Measurement of Autism

NCT00787111 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2010-02-23

No results posted yet for this study

Summary

This open-label research study will continue to monitor the safety of fluoxetine in children after their completion of a previous double-blind placebo controlled clinical study, with fluoxetine. The study will also look at the effect of fluoxetine on IQ (Intelligence Quotient) over an 18 month period.

Conditions

  • Autistic Disorder

Interventions

DRUG

Fluoxetine (prozac)

Formulation: ODT

Sponsors & Collaborators

  • Autism Speaks

    collaborator OTHER

  • Neuropharm

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States

Study Locations

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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 NCT00787111 on ClinicalTrials.gov