Levetiracetam in the Management of Bipolar Depression

Yale University

Status: Completed

Conditions: Bipolar Depression

Treatments: Drug: Levetiracetam; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00566150

0508000506

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups, including a placebo group

Levetiracetam

Active Comparator group

Treatment:

Drug: Levetiracetam

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo