Levetiracetam in the Management of Bipolar Depression

This study is currently recruiting participants.

Verified by Yale University, July 2008

First Received: November 29, 2007 Last Updated: July 31, 2008 History of Changes

Sponsor:	Yale University
Collaborator:	Stanley Medical Research Institute
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00566150

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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Levetiracetam in the Management of Bipolar Depression

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Levetiracetam

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

Muralidharan A, Bhagwagar Z. Potential of levetiracetam in mood disorders: a preliminary review. CNS Drugs. 2006;20(12):969-79. Review.

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 History of Changes
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:

Nootropic Agents
Depression
Bipolar Disorder
Physiological Effects of Drugs
Depressive Disorder
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Behavioral Symptoms

Affective Disorders, Psychotic
Mental Disorders
Therapeutic Uses
Mood Disorders
Piracetam
Etiracetam
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 27, 2009