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Effects of asenapine in bipolar I patients meeting proxy criteria for moderate-to-severe mixed major depressive episodes: a post hoc analysis.
J Clin Psychiatry. 2015 Jun; 76(6):728-34.JC

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+Show Affiliations

School of Medicine, Deakin University, 1 Gheringhap St, Geelong, VIC 3220, Australia mikebe@barwonhealth.org.au.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25612216

Citation

Berk, Michael, et al. "Effects of Asenapine in Bipolar I Patients Meeting Proxy Criteria for Moderate-to-severe Mixed Major Depressive Episodes: a Post Hoc Analysis." The Journal of Clinical Psychiatry, vol. 76, no. 6, 2015, pp. 728-34.
Berk M, Tiller JW, Zhao J, et al. Effects of asenapine in bipolar I patients meeting proxy criteria for moderate-to-severe mixed major depressive episodes: a post hoc analysis. J Clin Psychiatry. 2015;76(6):728-34.
Berk, M., Tiller, J. W., Zhao, J., Yatham, L. N., Malhi, G. S., & Weiller, E. (2015). Effects of asenapine in bipolar I patients meeting proxy criteria for moderate-to-severe mixed major depressive episodes: a post hoc analysis. The Journal of Clinical Psychiatry, 76(6), 728-34. https://doi.org/10.4088/JCP.13m08827
Berk M, et al. Effects of Asenapine in Bipolar I Patients Meeting Proxy Criteria for Moderate-to-severe Mixed Major Depressive Episodes: a Post Hoc Analysis. J Clin Psychiatry. 2015;76(6):728-34. PubMed PMID: 25612216.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of asenapine in bipolar I patients meeting proxy criteria for moderate-to-severe mixed major depressive episodes: a post hoc analysis. AU - Berk,Michael, AU - Tiller,John W G, AU - Zhao,Jun, AU - Yatham,Lakshmi N, AU - Malhi,Gin S, AU - Weiller,Emmanuelle, PY - 2013/10/04/received PY - 2014/05/16/accepted PY - 2015/1/23/entrez PY - 2015/1/23/pubmed PY - 2015/9/25/medline SP - 728 EP - 34 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 76 IS - 6 N2 - 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. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/25612216/Effects_of_asenapine_in_bipolar_I_patients_meeting_proxy_criteria_for_moderate_to_severe_mixed_major_depressive_episodes:_a_post_hoc_analysis_ L2 - http://www.psychiatrist.com/jcp/article/pages/2015/v76n06/v76n0607.aspx DB - PRIME DP - Unbound Medicine ER -