کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
6231693 1608151 2015 7 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Cariprazine in the treatment of acute mania in bipolar I disorder: A double-blind, placebo-controlled, Phase III trial
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی روانپزشکی و بهداشت روانی
پیش نمایش صفحه اول مقاله
Cariprazine in the treatment of acute mania in bipolar I disorder: A double-blind, placebo-controlled, Phase III trial
چکیده انگلیسی

BackgroundThis Phase III, randomized, double-blind, placebo-controlled study investigated the efficacy and tolerability of flexibly-dosed cariprazine in patients with acute manic or mixed episodes associated with bipolar I disorder.MethodsPatients were randomized to 3 weeks of double-blind treatment with cariprazine 3-12 mg/day (n=158) or placebo (n=154). The primary efficacy parameter was change from baseline to Week 3 in Young Mania Rating Scale (YMRS) total score. The secondary efficacy parameter was change from baseline to Week 3 in Clinical Global Impressions-Severity (CGI-S) score.ResultsMean change from baseline to Week 3 in YMRS total score was significantly greater for patients receiving cariprazine 3-12 mg/day versus placebo (P=0.0004). Significant differences between groups in YMRS total score mean change were observed by Day 4 (first postbaseline assessment) and maintained throughout double-blind treatment (all assessments, P<0.01). Cariprazine also demonstrated statistically significant superiority over placebo on YMRS response (≥50% improvement: cariprazine, 58.9%; placebo, 44.1%; P=0.0097) and remission (YMRS total score≤12: cariprazine, 51.9%; placebo, 34.9%; P=0.0025) and mean change in CGI-S (P=0.0027) score and Positive and Negative Syndrome Scale (PANSS) (P=0.0035) total score. The most common cariprazine-related (≥10% and twice placebo) treatment emergent adverse events (TEAEs) were akathisia, extrapyramidal disorder, tremor, dyspepsia, and vomiting. Mean change from baseline in metabolic parameters were generally small and similar between groups.LimitationsLack of active comparator arm; short duration of study.ConclusionIn this study, cariprazine 3-12 mg/day was effective and generally well tolerated in the treatment of manic and mixed episodes associated with bipolar I disorder.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Affective Disorders - Volume 174, 15 March 2015, Pages 296-302
نویسندگان
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