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Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension.
J Clin Psychopharmacol. 2012 Feb; 32(1):46-55.JC

Abstract

In a 12-week randomized, placebo-controlled study evaluating the efficacy and safety of adjunctive asenapine, bipolar I disorder patients experiencing manic or mixed episodes despite pretreatment with lithium or valproate monotherapy were treated with flexible-dose, twice-daily asenapine 5 or 10 mg (n = 158) or placebo (n = 166). The primary efficacy end point was change from baseline Young Mania Rating Scale (YMRS) total score at week 3. Secondary outcomes included YMRS response and remission and Clinical Global Impression for Bipolar Disorder and Montgomery-Asberg Depression Rating Scale score changes. Patients completing the core study were eligible for a 40-week double-blind extension assessing safety and tolerability. Adjunctive asenapine significantly improved mania versus placebo at week 3 (primary end point) and weeks 2 to 12. The YMRS response rates were similar at week 3 but significantly better with asenapine at week 12. The YMRS remission rates and changes from baseline on Clinical Global Impression for Bipolar Disorder for mania and overall illness were significantly better with asenapine at weeks 3 and 12. No other statistically significant differences on secondary outcomes were observed. Only a small number of patients entered the extension, making firm statistical conclusions on efficacy difficult. Treatment-emergent adverse events reported by 5% or more of asenapine patients and at twice the incidence of placebo were sedation, somnolence, depression/depressive symptoms, oral hypoesthesia, and increased weight in the 12-week core study. Adjunctive asenapine to lithium or valproate was more effective than mood stabilizer monotherapy in the core study and was well tolerated for up to 52 weeks.

Authors+Show Affiliations

Merck, Rahway, NJ 07065, USA. armin.szegedi@merck.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

22198448

Citation

Szegedi, Armin, et al. "Asenapine as Adjunctive Treatment for Acute Mania Associated With Bipolar Disorder: Results of a 12-week Core Study and 40-week Extension." Journal of Clinical Psychopharmacology, vol. 32, no. 1, 2012, pp. 46-55.
Szegedi A, Calabrese JR, Stet L, et al. Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension. J Clin Psychopharmacol. 2012;32(1):46-55.
Szegedi, A., Calabrese, J. R., Stet, L., Mackle, M., Zhao, J., & Panagides, J. (2012). Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension. Journal of Clinical Psychopharmacology, 32(1), 46-55. https://doi.org/10.1097/JCP.0b013e31823f872f
Szegedi A, et al. Asenapine as Adjunctive Treatment for Acute Mania Associated With Bipolar Disorder: Results of a 12-week Core Study and 40-week Extension. J Clin Psychopharmacol. 2012;32(1):46-55. PubMed PMID: 22198448.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension. AU - Szegedi,Armin, AU - Calabrese,Joseph R, AU - Stet,Let, AU - Mackle,Mary, AU - Zhao,Jun, AU - Panagides,John, AU - ,, PY - 2011/12/27/entrez PY - 2011/12/27/pubmed PY - 2012/5/24/medline SP - 46 EP - 55 JF - Journal of clinical psychopharmacology JO - J Clin Psychopharmacol VL - 32 IS - 1 N2 - In a 12-week randomized, placebo-controlled study evaluating the efficacy and safety of adjunctive asenapine, bipolar I disorder patients experiencing manic or mixed episodes despite pretreatment with lithium or valproate monotherapy were treated with flexible-dose, twice-daily asenapine 5 or 10 mg (n = 158) or placebo (n = 166). The primary efficacy end point was change from baseline Young Mania Rating Scale (YMRS) total score at week 3. Secondary outcomes included YMRS response and remission and Clinical Global Impression for Bipolar Disorder and Montgomery-Asberg Depression Rating Scale score changes. Patients completing the core study were eligible for a 40-week double-blind extension assessing safety and tolerability. Adjunctive asenapine significantly improved mania versus placebo at week 3 (primary end point) and weeks 2 to 12. The YMRS response rates were similar at week 3 but significantly better with asenapine at week 12. The YMRS remission rates and changes from baseline on Clinical Global Impression for Bipolar Disorder for mania and overall illness were significantly better with asenapine at weeks 3 and 12. No other statistically significant differences on secondary outcomes were observed. Only a small number of patients entered the extension, making firm statistical conclusions on efficacy difficult. Treatment-emergent adverse events reported by 5% or more of asenapine patients and at twice the incidence of placebo were sedation, somnolence, depression/depressive symptoms, oral hypoesthesia, and increased weight in the 12-week core study. Adjunctive asenapine to lithium or valproate was more effective than mood stabilizer monotherapy in the core study and was well tolerated for up to 52 weeks. SN - 1533-712X UR - https://www.unboundmedicine.com/medline/citation/22198448/Asenapine_as_adjunctive_treatment_for_acute_mania_associated_with_bipolar_disorder:_results_of_a_12_week_core_study_and_40_week_extension_ L2 - http://dx.doi.org/10.1097/JCP.0b013e31823f872f DB - PRIME DP - Unbound Medicine ER -