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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
Sponsor:
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
History of Changes
  Purpose

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:

U.S. FDA Resources

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.

  Eligibility

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

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

Contacts
Contact: Kathleen Maloney, BA 203-974-7496 kathleen.maloney@yale.edu
Contact: Jason Chen, BA 203-974-7559 jason.chen.jc64@yale.edu

Locations
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
Investigators
Principal Investigator: Zubin Bhagwagar, MD PhD Yale University
  More Information

Publications:

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:
Keppra
Levetiracetam
Anticonvulsant
Depression
Bipolar Disorder
 Affective Disorders
Mood Disorders
Double Blind
Acute Antidepressant Effects

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

ClinicalTrials.gov processed this record on May 19, 2013