Levetiracetam in the Management of Bipolar Depression - Full Text View

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

MedlinePlus related topics:

Bipolar Disorder Depression

ChemIDplus related topics:

Levetiracetam

U.S. FDA Resources

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

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
First Received:	November 29, 2007
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00566150
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

Study placed in the following topic categories:

Affective Disorders, Psychotic

Depression

Mental Disorders

Bipolar Disorder

Mood Disorders

Piracetam

Etiracetam

Psychotic Disorders

Depressive Disorder

Behavioral Symptoms

Additional relevant MeSH terms:

Nootropic Agents

Therapeutic Uses

Physiological Effects of Drugs

Protective Agents

Neuroprotective Agents

Central Nervous System Agents

Pharmacologic Actions

Anticonvulsants

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Yale University Stanley Medical Research Institute
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00566150