NCT00566150CompletedNot Applicable
Levetiracetam in the Management of Bipolar Depression
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Levetiracetam
Active Comparator
Intervention: Levetiracetam (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6.
Time Frame: 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 Outcomes
- Number of Subjects Who Achieve Remission.(Week 6)
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6.(Baseline to week 6)
- Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at Week 6.(Baseline to week 6)
Investigators
Study Sites (1)
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