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| Tracking Information | |||||
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| First Received Date ICMJE | December 28, 2007 | ||||
| Last Updated Date | September 30, 2009 | ||||
| Start Date ICMJE | December 2005 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
CY-BOCs [ Time Frame: weekly ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00592852 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
YMRS [ Time Frame: weekly ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder | ||||
| Official Title ICMJE | A Pilot Treatment Study of Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder | ||||
| Brief 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 SSRI on their OCD symptoms in a clinically meaningful way without exacerbation of bipolar symptoms. |
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| Detailed Description | 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 |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: fluoxetine | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | December 2010 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Years to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00592852 | ||||
| Responsible Party | Gagan Joshi, MD, Massachusetts General Hospital | ||||
| Study ID Numbers ICMJE | 2005-P-001840 | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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