Levetiracetam in the Management of Bipolar Depression - Tabular View

Tracking Information

First Received Date ^ICMJE

November 29, 2007

Last Updated Date

July 31, 2008

Start Date ^ICMJE

October 2005

Estimated Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00566150 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Levetiracetam in the Management of Bipolar Depression

Official Title ^ICMJE

Levetiracetam in the Management of Bipolar Depression

Brief Summary

A 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the effects of levetiracetam on depressive symptoms in bipolar depressed patients.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Condition ^ICMJE

Bipolar Depression

Intervention ^ICMJE

Drug: Levetiracetam
Drug: Placebo

Study Arms / Comparison Groups

Publications *

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

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2008

Estimated Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00566150

Responsible Party

Zubin Bhagwagar, Yale University

Study ID Numbers ^ICMJE

05T-681, HIC#0508000506

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

Stanley Medical Research Institute

Investigators ^ICMJE

Principal Investigator:

Zubin Bhagwagar, MD PhD

Yale University

Information Provided By

Yale University

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP