drugset / Trial / NCT00592852

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

NCT00592852

Phase 4 Terminated 13 enrolled Massachusetts General Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2005-12
Primary completion
2010-09
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluoxetine Small molecule 10 mg
Subject Fluoxetine Small molecule 60 mg