Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder
|ClinicalTrials.gov Identifier: NCT00592852|
Recruitment Status : Terminated (Slow subject recruitment.)
First Posted : January 14, 2008
Results First Posted : March 6, 2012
Last Update Posted : November 20, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Bipolar Disorder Pediatric OCD||Drug: fluoxetine||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Treatment Study of Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
capsules, dose range of 10mgQD - 60mgQD, given daily for 12 weeks
Other Name: Prozac
- Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [ Time Frame: weekly ]This sale measures impairment on 5 items relating to Obsessions from 0 (none) to 4 (extreme) and 5 item relating to Compulsions from 0 (none) to 4 (extreme). These scores are totaled for a range of 0 (least impaired) to 40 (most impaired).
- Young Mania Rating Scale (YMRS) [ Time Frame: weekly ]This scale measures mania symptoms in children and adolescents using 11 items rated from 0 (least severe) to 4 (most severe), although 4 items are rated from 0-8. The minimum (least severe) possible score is 0, and the maximum (most severe) possible score is 60.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592852
|United States, Massachusetts|
|Massachusetts General Hospital|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||Gagan Joshi, MD||MGH|