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

First Received on November 29, 2007. Last Updated on 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:	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:

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
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:

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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Saricicek A, Maloney K, Muralidharan A, Ruf B, Blumberg HP, Sanacora G, Lorberg B, Pittman B, Bhagwagar Z. Levetiracetam in the management of bipolar depression: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Jun;72(6):744-50. Epub 2010 Oct 19.

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 February 12, 2012