Levetiracetam in the management of bipolar depression: a randomized, double-blind, placebo-controlled trial

J Clin Psychiatry. 2011 Jun;72(6):744-50. doi: 10.4088/JCP.09m05659gre. Epub 2010 Oct 19.

Abstract

Objective: To study the efficacy of adjunctive levetiracetam therapy compared with placebo in the treatment of subjects with depression with bipolar disorder.

Method: This double-blind, placebo-controlled clinical trial randomly assigned outpatients with bipolar disorder type I and type II who were experiencing a major depressive episode (Structured Clinical Interview for DSM-IV Axis I Disorders-Clinician Version criteria) to treatment with either placebo or adjunctive levetiracetam (up to 2,500 mg/d flexibly dosed) for 6 weeks. The subjects were recruited from October 2005 to June 2008. The primary efficacy measure was mean change from baseline to week 6 in the Hamilton Depression Rating Scale (21-item). Secondary efficacy assessments included the Montgomery-Åsberg Depression Rating Scale, the Beck Depression Inventory, the Clinical Global Impressions-Bipolar Version scale, the Hamilton Anxiety Rating Scale, and the Young Mania Rating Scale.

Results: Of 42 subjects randomly assigned to placebo or drug, 32 received at least 1 postbaseline assessment and thus were included in the analysis. The mean (SD) levetiracetam daily dose at endpoint evaluation was 1,132 (425) mg/d. There was no significant difference in the mean change from baseline to week 6 in the Hamilton Depression Rating Scale scores for levetiracetam compared with placebo. There were no significant differences in any of the secondary outcome measures.

Conclusions: Levetiracetam adjunctive therapy was not superior to placebo in the short-term treatment of subjects with depression with bipolar disorder in the population studied.

Trial registration: Clinicaltrials.gov Identifier: NCT00566150.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antidepressive Agents / therapeutic use*
  • Bipolar Disorder / drug therapy*
  • Double-Blind Method
  • Female
  • Humans
  • Levetiracetam
  • Male
  • Middle Aged
  • Piracetam / analogs & derivatives*
  • Piracetam / therapeutic use
  • Psychiatric Status Rating Scales
  • Time Factors
  • Treatment Outcome

Substances

  • Antidepressive Agents
  • Levetiracetam
  • Piracetam

Associated data

  • ClinicalTrials.gov/NCT00566150