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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.

Author(s): Szegedi A, Calabrese JR, Stet L, Mackle M, Zhao J, Panagides J; Apollo Study Group.

Collaborators: D'Souza R, Farnbach R, Byss M, Brod H, Hanuskova V, Miklos T, Mohr P, Stankova PZ, Labem Un, Chattterji R, Pradesh M, Krishnamachari S, Pinto C, Venkata PS, Sharma N, Rao ST, Desai N, Kim CE, Lee CU, Shim JC, Aleksandrovsky YA, Avedisova AS, Gurovich IY, Morozova MA, Popov MY, Reznik AM, Smulevich AB, Yakhim K, Ivanets NN, Andrusenko MP, Ponomarev OA, Neznanov NG, Chiu NY, Yang YK, Shiah IS, Chantarasak V, Sanichwankul K, Mai C, Benington S, Chakos MH, Fuller WC, Krishnasastry CS, Kunovac J, Jacobson AF, Brar SB, Flaherty DH, Siddiqi F, Gajwani P, Pujol AG, Hashmi AM, Litman RE, Nguyen DH, Aaronson ST, Vilvar S, Biunno MJ, Shekar A, Punjwani SS, Stedman ML, Glass SJ, Nair CJ, Norbert M, Shiwach R, Gregory K, Bailey CE, Mech AW, Zimbroff DL, Garcia DJ Jr, Bari MA, Burdine V, Segal SD, Mofsen RS, Brannon GE, Kwentus JA, DeSilva H, Sokolski KN, Burdick EP, Malik MA.

Affiliation(s): Merck, Rahway, NJ 07065, USA. armin.szegedi@merck.com

Publication date & source: 2012, J Clin Psychopharmacol. , 32(1):46-55

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.

Page last updated: 2013-02-10

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