Long-term safety and tolerability of asenapine: A double-blind, uncontrolled, long-term extension trial in adults with an acute manic or mixed episode associated with bipolar I disorder.-临床诊疗知识库

Long-term safety and tolerability of asenapine: A double-blind, uncontrolled, long-term extension trial in adults with an acute manic or mixed episode associated with bipolar I disorder.

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作者：

Terence A, Ketter；Suresh, Durgam；Ronald, Landbloom；Mary, Mackle；Xiao, Wu；Maju, Mathews

来源：

Journal of affective disorders 2017 年 207卷

标签：

Asenapine Bipolar disorder Mania Mixed episodes Safety Tolerability

Asenapine (ASN) is approved in the United States as monotherapy and adjunctive therapy (to lithium or valproate) in adults with bipolar mania, and as monotherapy in pediatric patients with bipolar mania. This is the first long-term study evaluating safety and tolerability of ASN fixed doses in this population.After completing a 3-week, randomized, placebo (PBO)-controlled acute trial, patients could enroll in this 26-week, fixed-dose (5 or 10mg twice daily), double-blind extension study. Select predefined treatment-emergent adverse events (TEAEs) and metabolic parameters were reported.Overall, 164 patients were treated; 88 completed the study. The incidence of ≥1 TEAE was greater for PBO/ASN 5mg (68.3

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