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Sponsored by: |
Massachusetts General Hospital |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00592852 |
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 SSRI on their OCD symptoms in a clinically meaningful way without exacerbation of bipolar symptoms.
Condition | Intervention | Phase |
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Pediatric Bipolar Disorder Pediatric OCD |
Drug: fluoxetine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | A Pilot Treatment Study of Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder |
Estimated Enrollment: | 20 |
Study Start Date: | December 2005 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: fluoxetine
capsules, dose range of 10mgQD - 60mgQD, given daily for 12 weeks
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As no systemic data is available regarding the efficacy and safety of 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
Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Meghan Kotarski, BS | 617-503-1051 | mkotarski@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Cambridge, Massachusetts, United States, 02138 |
Principal Investigator: | Gagan Joshi, MD | MGH |
Responsible Party: | MGH ( Gagan Joshi, MD ) |
Study ID Numbers: | 2005-P-001840 |
Study First Received: | December 28, 2007 |
Last Updated: | January 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00592852 |
Health Authority: | United States: Institutional Review Board |
bipolar disorder obsessive compulsive disorder Prozac |
Fluoxetine Affective Disorders, Psychotic Anxiety Disorders Mental Disorders Bipolar Disorder |
Mood Disorders Psychotic Disorders Serotonin Obsessive-Compulsive Disorder |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors |
Pharmacologic Actions Pathologic Processes Serotonin Agents Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |