Levetiracetam in the Management of Bipolar Depression

Not Applicable

Completed

• Conditions: Bipolar Depression
• Interventions: Drug: Placebo; Drug: Levetiracetam

• Registration Number: NCT00566150
• Lead Sponsor: Yale University

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

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2007-11-29
• Study First Submitted QC: 2007-11-30
• Study First Posted: 2007-12-03
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2009-10-02
• Results First Submitted QC: 2015-09-29
• Results First Posted: 2015-11-01
• Status Verified: 2016-08
• Last Update Submitted: 2020-03-27
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Levetiracetam	Levetiracetam	-

Primary Outcome Measures

Name	Time	Method
Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6.	Baseline to week 6	Change is observed value at each visit minus baseline value. HDRS-21 is a 21-item instrument measuring depression. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Who Achieve Remission.	Week 6	Remission response is measured as an HDRS-21 total score is less than or equal to 7.; HDRS-21 measures range of depressive symptoms. Endpoint is LOCF.
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6.	Baseline to week 6	Change is observed value at each visit minus baseline value. MADRS is a 10-item instrument measuring depression: scale range between 0(normal) - 6(most abnormal)for each item. Total possible score is 0 - 60.
Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at Week 6.	Baseline to week 6	Change is observed value at each visit minus baseline value. CGI-BP depression severity is an instrument which measures severity of depression in bipolar disorder. Scale range: 1=normal, not ill; 7=very severely ill

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States