Levetiracetam in the Management of Bipolar Depression

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

Official Title
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Levetiracetam in the Management of Bipolar Depression

Conditions
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Bipolar Depression

Intervention / Treatment
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* Drug: Levetiracetam
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levetiracetam<br> | Drug: Levetiracetam<br>* Flexible dose up to 2500mg per day, for 6 weeks.<br>* Other names: Keppra;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Flexible dose up to 2500mg per day, for 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at 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. | Baseline to week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at 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. | Baseline to week 6 | 
| Number of Subjects Who Achieve Remission. | 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. | Week 6 | 
| Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at 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 | Baseline to week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Keppra, Levetiracetam, Anticonvulsant, Depression, Bipolar Disorder, Affective Disorders, Mood Disorders, Double Blind, Acute Antidepressant Effects