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Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder

NCT00592852 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-01-28

Study results available
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Summary

This will be a 12-week open-label pilot treatment study for children and adolescents (ages 6-17) who meet DSM-IV criteria for bipolar disorder (BPD) and obsessive-compulsive disorder (OCD) who are adequately mood stabilized on a stable regimen based on standard clinical care. Specific hypotheses are as follows:

Hypothesis 1: Children and adolescents with comorbid OCD and BPD who have achieved adequate mood stabilization using a naturalistic clinical practice approach, will benefit from an FDA-approved selective seratonin reuptake inhibitor (SSRI) on their OCD symptoms in a clinically meaningful way without exacerbation of bipolar symptoms.

Conditions

  • Pediatric Bipolar Disorder
  • Pediatric OCD

Interventions

DRUG

fluoxetine

capsules, dose range of 10mgQD - 60mgQD, given daily for 12 weeks

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Gagan Joshi, MD · MGH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2010-09-30
Completion
2010-09-30

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 NCT00592852 on ClinicalTrials.gov