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

Pediatric Bipolar Disorder Clinical Trial

Official title: A Pilot Treatment Study of Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder

Status Terminated

Clinical Trial 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.

Clinical Trial Description

As no systemic data is available regarding the efficacy and safety of selective serotonin reuptake inhibitors (SSRI) in the treatment of OCD+BPD children, it calls for a preliminary open pilot treatment study to explore these issues as a logical first step that could lead to systematic randomized controlled trials in the future. SSRI's are the first line and most commonly used anti-OCD agents. It remains unknown, which of the standard SSRIs is least activating for youth with BPD. Fluoxetine along with fluvoxamine and sertraline are FDA approved for the treatment of OCD in children. Fluoxetine remains the most extensively studied SSRI in children. We will test the safety and efficacy of fluoxetine in children and adolescents with BPD and OCD.

The proposed study includes 1.) the use of a 12-week design to document the response rate and 2.) careful assessment of safety and tolerability ;

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Compulsive Behavior
• Disease
• Obsessive-Compulsive Disorder
• Pediatric Bipolar Disorder
• Pediatric OCD

• NCT number: NCT00592852
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Terminated
• Phase: Phase 4
• Start date: December 2005
• Completion date: September 2010