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Sponsors and Collaborators: |
Yale University Stanley Medical Research Institute |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00566150 |
A 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the effects of levetiracetam on depressive symptoms in bipolar depressed patients.
Condition | Intervention |
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Bipolar Depression |
Drug: Levetiracetam Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Levetiracetam in the Management of Bipolar Depression |
Estimated Enrollment: | 50 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator |
Drug: Levetiracetam
Flexible dose up to 2500mg per day, for 6 weeks.
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P: Placebo Comparator |
Drug: Placebo
Flexible dose up to 2500mg per day, for 6 weeks.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kathleen Maloney, BA | 203-974-7496 | kathleen.maloney@yale.edu |
Contact: Jason Chen, BA | 203-974-7559 | jason.chen.jc64@yale.edu |
United States, Connecticut | |
Yale University School of Medicine | Recruiting |
New Haven, Connecticut, United States, 06519 | |
Principal Investigator: Zubin Bhagwagar, MD PhD |
Principal Investigator: | Zubin Bhagwagar, MD PhD | Yale University |
Responsible Party: | Yale University ( Zubin Bhagwagar ) |
Study ID Numbers: | 05T-681, HIC#0508000506 |
Study First Received: | November 29, 2007 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00566150 |
Health Authority: | United States: Institutional Review Board |
Keppra Levetiracetam Anticonvulsant Depression Bipolar Disorder |
Affective Disorders Mood Disorders Double Blind Acute Antidepressant Effects |
Affective Disorders, Psychotic Depression Mental Disorders Bipolar Disorder Mood Disorders |
Piracetam Etiracetam Psychotic Disorders Depressive Disorder Behavioral Symptoms |
Nootropic Agents Therapeutic Uses Physiological Effects of Drugs Protective Agents |
Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |