Levetiracetam in the Management of Bipolar Depression

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-08-31

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.

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Detailed Description

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Conditions

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Bipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Levetiracetam

Group Type ACTIVE_COMPARATOR

Levetiracetam

Intervention Type DRUG

Flexible dose up to 2500mg per day, for 6 weeks.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Flexible dose up to 2500mg per day, for 6 weeks.

Interventions

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Levetiracetam

Flexible dose up to 2500mg per day, for 6 weeks.

Intervention Type DRUG

Placebo

Flexible dose up to 2500mg per day, for 6 weeks.

Intervention Type DRUG

Other Intervention Names

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Keppra

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No