Levetiracetam in the Management of Bipolar Depression
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Yale University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Yale University
Collaborator:
Stanley Medical Research Institute
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00566150
First received: November 29, 2007
Last updated: July 31, 2008
Last verified: July 2008
| Tracking Information | |||||||||
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| First Received Date ICMJE | November 29, 2007 | ||||||||
| Last Updated Date | July 31, 2008 | ||||||||
| Start Date ICMJE | October 2005 | ||||||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change in depressive symptom scores from baseline. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00566150 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Levetiracetam in the Management of Bipolar Depression | ||||||||
| Official Title ICMJE | Levetiracetam in the Management of Bipolar Depression | ||||||||
| Brief Summary | A 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the effects of levetiracetam on depressive symptoms in bipolar depressed patients. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Bipolar Depression | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | October 2008 | ||||||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00566150 | ||||||||
| Other Study ID Numbers ICMJE | 05T-681, HIC#0508000506 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Zubin Bhagwagar, Yale University | ||||||||
| Study Sponsor ICMJE | Yale University | ||||||||
| Collaborators ICMJE | Stanley Medical Research Institute | ||||||||
| Investigators ICMJE |
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| Information Provided By | Yale University | ||||||||
| Verification Date | July 2008 | ||||||||
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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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