Kane John M, Peters-Strickland Timothy, Baker Ross A, Hertel Peter, Eramo Anna, Jin Na, Perry Pamela P, Gara Michelle, McQuade Robert D, Carson William H, Sanchez Raymond
The Zucker Hillside Hospital, 75-59 263rd St, Kaufmann Bldg, Ste 103, Glen Oaks, NY 11004-1100
J Clin Psychiatry. 2014 Nov;75(11):1254-60. doi: 10.4088/JCP.14m09168.
To evaluate aripiprazole once-monthly (AOM), a long-acting injectable suspension of aripiprazole, as acute treatment in patients with schizophrenia (DSM-IV-TR).
Adults experiencing an acute psychotic episode were randomized to 12 weeks of double-blind treatment with AOM 400 mg or placebo (October 2012-August 2013). The primary efficacy outcome was change from baseline to endpoint (week 10) in Positive and Negative Syndrome Scale (PANSS) total score. The key secondary efficacy outcome was change from baseline in Clinical Global Impressions-Severity of Illness scale (CGI-S) score. Secondary efficacy outcomes included change from baseline in PANSS positive and negative subscale and Personal and Social Performance Scale (PSP) scores. The study took place from October 2012 through August 2013.
Patients (N = 340; 79% male, 66% black) were randomized to AOM (n = 168) or placebo (n = 172). Least squares (LS) mean change from baseline to endpoint (week 10) favored AOM versus placebo in PANSS total (treatment difference, -15.1 [95% CI, -19.4 to -10.8]; P < .0001) and CGI-S (treatment difference, -0.8 [95% CI, -1.1 to -0.6]; P < .0001) scores, as it did at all other timepoints through 12 weeks (all P ≤ .0005). LS mean change from baseline in PANSS positive and negative subscale and PSP scores favored AOM versus placebo (P < .0001). Common (> 10%) treatment-emergent adverse events (AOM vs. placebo) were increased weight (16.8% vs 7.0%), headache (14.4% vs. 16.3%), and akathisia (11.4% vs 3.5%).
Symptoms and functioning improved with AOM 400 mg versus placebo in patients with acute schizophrenia, with acceptable safety and tolerability. These data suggest that AOM 400 mg is a viable treatment option for patients experiencing an acute schizophrenia episode.
ClinicalTrials.gov identifier: NCT01663532.
评估阿立哌唑每月一次注射剂（AOM），一种长效阿立哌唑注射混悬液，作为精神分裂症（DSM-IV-TR）患者的急性治疗药物。
经历急性精神病发作的成年人被随机分配接受12周的双盲治疗，分别给予400mg AOM或安慰剂（2012年10月至2013年8月）。主要疗效指标是阳性和阴性症状量表（PANSS）总分从基线到终点（第10周）的变化。关键次要疗效指标是临床总体印象-疾病严重程度量表（CGI-S）评分从基线的变化。次要疗效指标包括PANSS阳性和阴性子量表以及个人和社会功能量表（PSP）评分从基线的变化。该研究于2012年10月至2013年8月进行。
患者（N = 340；79%为男性，66%为黑人）被随机分配至AOM组（n = 168）或安慰剂组（n = 172）。从基线到终点（第10周）的最小二乘（LS）均值变化显示，AOM组在PANSS总分（治疗差异，-15.1 [95% CI，-19.4至-10.8]；P <.0001）和CGI-S评分（治疗差异，-0.8 [95% CI，-1.1至-0.6]；P <.0001）方面优于安慰剂组，在第12周的所有其他时间点也是如此（所有P≤.0005）。PANSS阳性和阴性子量表以及PSP评分从基线的LS均值变化显示，AOM组优于安慰剂组（P <.0001）。常见（> 10%）的治疗中出现的不良事件（AOM组与安慰剂组相比）包括体重增加（16.8%对7.0%）、头痛（14.4%对16.3%）和静坐不能（11.4%对
