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
Stanley Medical Research Institute
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
First received: November 29, 2007
Last updated: July 31, 2008
Last verified: July 2008

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
Bipolar Depression
Drug: Levetiracetam
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Levetiracetam in the Management of Bipolar Depression

Resource links provided by NLM:

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Change in depressive symptom scores from baseline. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in depressive symptom scores from baseline. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Number of subjects who achieve remission. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change in ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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
Active Comparator: A Drug: Levetiracetam
Flexible dose up to 2500mg per day, for 6 weeks.
Other Name: Keppra
Placebo Comparator: P Drug: Placebo
Flexible dose up to 2500mg per day, for 6 weeks.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • DSM-IV diagnosis of bipolar disorder
  • Presence of a current major depressive episode on the SCID
  • Score of 17 or great on the HDRS
  • Capable of giving voluntary written consent

Exclusion Criteria:

  • Significant current substance dependence/abuse within 3 months preceding the trial
  • Active suicidal ideation
  • Pregnant/lactating mothers
  • Significant medical history
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566150

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         
Sponsors and Collaborators
Yale University
Stanley Medical Research Institute
Principal Investigator: Zubin Bhagwagar, MD PhD Yale University
  More Information

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zubin Bhagwagar, Yale University
ClinicalTrials.gov Identifier: NCT00566150     History of Changes
Other Study ID Numbers: 05T-681, HIC#0508000506
Study First Received: November 29, 2007
Last Updated: July 31, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Bipolar Disorder
Affective Disorders
Mood Disorders
Double Blind
Acute Antidepressant Effects

Additional relevant MeSH terms:
Bipolar Disorder
Depressive Disorder
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders
Central Nervous System Agents
Neuroprotective Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 08, 2015