Effects of asenapine in bipolar I patients meeting proxy criteria for moderate-to-severe mixed major depressive episodes: a post hoc analysis.

Abstract

OBJECTIVE:

Depression is the predominant psychosocial and suicide burden in bipolar disorder, yet there is a paucity of evidence-based treatments for bipolar depression.

METHODS:

This post hoc subgroup analysis of data pooled from two 3-week, randomized, placebo- and olanzapine-controlled trials (December 2004-April 2006, N = 489 and November 2004-April 2006, N = 488) examined a subgroup of patients meeting criteria for moderate-to-severe mixed major depressive episodes, defined using DSM-IV-TR criteria for mixed episodes (mania and major depression simultaneously) with a baseline Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 20.

RESULTS:

Decreases in MADRS scores (least squares mean [SE]), the a priori primary outcome, were significantly greater in the asenapine group than in the placebo group from baseline to day 7 (-11.02 [1.82] vs -4.78 [1.89]; P = .0195), day 21 (-14.03 [2.01] vs -7.43 [2.09]; P = .0264), and endpoint (-10.71 [1.76] vs -5.19 [1.98]; P = .039). Decreases in MADRS scores with asenapine were significantly greater than with olanzapine from baseline to day 7 (-6.26 [1.47]; P = .0436). Decreases in Young Mania Rating Scale mean total score were greater with asenapine than with placebo or olanzapine at all time points assessed. A significantly greater reduction from baseline to day 21 in the Short Form-36 mental component summary score was observed with asenapine, but not olanzapine, compared with placebo (16.57 vs 5.97; P = .0093). Asenapine was generally well tolerated.

CONCLUSIONS:

These data provide support for the potential efficacy of asenapine in mixed major depressive episodes; however, these data cannot be linearly extrapolated to nonmixed major depression.

• Authors: Michael Berk, John W G Tiller, Jun Zhao, Lakshmi N Yatham, Gin S Malhi, Emmanuelle Weiller
• Journal: The Journal of clinical psychiatry (J Clin Psychiatry) Vol. 76 Issue 6 Pg. 728-34 (Jun 2015) ISSN: 1555-2101 [Electronic] United States
• PMID: 25612216 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © Copyright 2015 Physicians Postgraduate Press, Inc.

Chemical References

• Antipsychotic Agents
• Dibenzocycloheptenes
• Heterocyclic Compounds, 4 or More Rings
• Benzodiazepines
• asenapine
• Olanzapine

Topics

• Adult
• Aged
• Analysis of Variance
• Antipsychotic Agents (adverse effects, therapeutic use)
• Benzodiazepines (adverse effects, therapeutic use)
• Bipolar Disorder (complications, drug therapy)
• Depressive Disorder, Major (complications, drug therapy)
• Dibenzocycloheptenes
• Double-Blind Method
• Female
• Heterocyclic Compounds, 4 or More Rings (adverse effects, therapeutic use)
• Humans
• Male
• Middle Aged
• Multicenter Studies as Topic
• Olanzapine
• Randomized Controlled Trials as Topic
• Retrospective Studies
• Treatment Outcome
• Young Adult