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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

Авторы:

Szegedi A. Calabrese J.R. Stet L. Mackle M., Gurovich I.Ya.

Издание:

Journal of Clinical Psychopharmacology

Год издания:

2012

Номер:

Vol. 32, Issue 1

Страницы:

46-55

Язык:

English

Аннотация:

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.

Добавил:

Администратор С.А.Т. 2013-12-17

Ключевые слова:

placebo-controlled study, asenapine, bipolar disorder, placebo, psychiatry

Файл скачали: 0

Просмотров публикации: 368

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