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Effect of asenapine on manic and depressive symptoms in bipolar I patients with mixed episodes: results from post hoc analyses.
J Affect Disord. 2013 Feb 15; 145(1):62-9.JA

Abstract

BACKGROUND

The efficacy of agents useful for mania is largely unproven in patients with mixed episodes.

METHODS

The efficacy of asenapine in the treatment of mixed episodes was assessed using post hoc analyses on pooled data from two identically designed 3-week, randomized, double-blind, flexible dose, placebo- and olanzapine-controlled trials and their 9-week, double-blind olanzapine-controlled extension study. Efficacy was measured by changes on Young Mania Rating Scale (YMRS) and Montgomery-Åsberg Depression Rating Scale (MADRS) total scores, and was analysed through analysis of covariance on observed cases of the intent-to-treat dataset.

RESULTS

In the intent-to-treat population, 295 patients had a DSM-IV-TR mixed episode (placebo: 66; olanzapine: 122; asenapine: 107) in the 3-week trials. Of these, 102 patients (olanzapine: 56; asenapine: 46) entered the 9-week extension study. At week 3, decreases in YMRS and MADRS total scores, were significantly (p<0.01) greater with asenapine (YMRS: -15.0; MADRS: -8.2) versus placebo (YMRS: -11.5; MADRS: -4.5); olanzapine did not separate from placebo (YMRS: -13.3; MADRS: -6.5). At week 12, further decreases in YMRS and MADRS total scores were observed with asenapine (YMRS: -22.4; MADRS: -11.9); non-statistically different from olanzapine (YMRS: -20.2; MADRS: -7.9).

LIMITATIONS

Results are from post hoc analyses of trials that were not designed to specifically evaluate mixed episodes.

CONCLUSIONS

These exploratory analyses provide supportive evidence for the efficacy of asenapine in treating the associated symptoms of mania and depression in bipolar I patients with mixed episodes.

Authors+Show Affiliations

Hospital Ste Marguerite, 270 Bd Sainte Marguerite, 13274 Marseille, France. jazorin@ap-hm.frNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

22868059

Citation

Azorin, J M., et al. "Effect of Asenapine On Manic and Depressive Symptoms in Bipolar I Patients With Mixed Episodes: Results From Post Hoc Analyses." Journal of Affective Disorders, vol. 145, no. 1, 2013, pp. 62-9.
Azorin JM, Sapin C, Weiller E. Effect of asenapine on manic and depressive symptoms in bipolar I patients with mixed episodes: results from post hoc analyses. J Affect Disord. 2013;145(1):62-9.
Azorin, J. M., Sapin, C., & Weiller, E. (2013). Effect of asenapine on manic and depressive symptoms in bipolar I patients with mixed episodes: results from post hoc analyses. Journal of Affective Disorders, 145(1), 62-9. https://doi.org/10.1016/j.jad.2012.07.013
Azorin JM, Sapin C, Weiller E. Effect of Asenapine On Manic and Depressive Symptoms in Bipolar I Patients With Mixed Episodes: Results From Post Hoc Analyses. J Affect Disord. 2013 Feb 15;145(1):62-9. PubMed PMID: 22868059.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of asenapine on manic and depressive symptoms in bipolar I patients with mixed episodes: results from post hoc analyses. AU - Azorin,J M, AU - Sapin,C, AU - Weiller,E, Y1 - 2012/08/04/ PY - 2012/04/25/received PY - 2012/07/13/revised PY - 2012/07/13/accepted PY - 2012/8/8/entrez PY - 2012/8/8/pubmed PY - 2013/11/10/medline SP - 62 EP - 9 JF - Journal of affective disorders JO - J Affect Disord VL - 145 IS - 1 N2 - BACKGROUND: The efficacy of agents useful for mania is largely unproven in patients with mixed episodes. METHODS: The efficacy of asenapine in the treatment of mixed episodes was assessed using post hoc analyses on pooled data from two identically designed 3-week, randomized, double-blind, flexible dose, placebo- and olanzapine-controlled trials and their 9-week, double-blind olanzapine-controlled extension study. Efficacy was measured by changes on Young Mania Rating Scale (YMRS) and Montgomery-Åsberg Depression Rating Scale (MADRS) total scores, and was analysed through analysis of covariance on observed cases of the intent-to-treat dataset. RESULTS: In the intent-to-treat population, 295 patients had a DSM-IV-TR mixed episode (placebo: 66; olanzapine: 122; asenapine: 107) in the 3-week trials. Of these, 102 patients (olanzapine: 56; asenapine: 46) entered the 9-week extension study. At week 3, decreases in YMRS and MADRS total scores, were significantly (p<0.01) greater with asenapine (YMRS: -15.0; MADRS: -8.2) versus placebo (YMRS: -11.5; MADRS: -4.5); olanzapine did not separate from placebo (YMRS: -13.3; MADRS: -6.5). At week 12, further decreases in YMRS and MADRS total scores were observed with asenapine (YMRS: -22.4; MADRS: -11.9); non-statistically different from olanzapine (YMRS: -20.2; MADRS: -7.9). LIMITATIONS: Results are from post hoc analyses of trials that were not designed to specifically evaluate mixed episodes. CONCLUSIONS: These exploratory analyses provide supportive evidence for the efficacy of asenapine in treating the associated symptoms of mania and depression in bipolar I patients with mixed episodes. SN - 1573-2517 UR - https://www.unboundmedicine.com/medline/citation/22868059/Effect_of_asenapine_on_manic_and_depressive_symptoms_in_bipolar_I_patients_with_mixed_episodes:_results_from_post_hoc_analyses_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0165-0327(12)00532-0 DB - PRIME DP - Unbound Medicine ER -