Pediatric Bipolar Disorder Clinical Trial
Official title:
A Pilot Treatment Study of Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder
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.
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
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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