Clinical Development, Forest Research Institute, an Allergan affiliate, Harborside Financial Center, Plaza V, Jersey City, NJ 07311
J Clin Psychiatry. 2015 Dec;76(12):e1574-82. doi: 10.4088/JCP.15m09997.
This phase 3 study evaluated the efficacy, safety, and tolerability of cariprazine in patients with acute exacerbation of schizophrenia.
This multinational, randomized, double-blind, placebo- and active-controlled study was conducted from April 2010 to December 2011. Patients who met DSM-IV-TR criteria for schizophrenia were randomized to placebo (n = 153), cariprazine 3 mg/d (n = 155), cariprazine 6 mg/d (n = 157), or aripiprazole 10 mg/d (n = 152) for 6 weeks of double-blind treatment. The primary and secondary efficacy parameters were mean change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impressions-Severity of Illness (CGI-S) score, respectively.
Least squares mean differences (LSMDs) in PANSS total score change at week 6 significantly favored cariprazine 3 and 6 mg/d versus placebo (LSMD [95% CI]: 3 mg/d, -6.0 [-10.1 to -1.9], adjusted P = .0044; 6 mg/d, -8.8 [-12.9 to -4.7], adjusted P < .0001). Cariprazine 3 and 6 mg/d were also associated with significant improvements relative to placebo in CGI-S scores (LSMD [95% CI]: 3 mg/d, -0.4 [-0.6 to -0.2], adjusted P = .0044; 6 mg/d, -0.5 [-0.7 to -0.3], adjusted P < .0001). Significant differences from placebo were also observed with aripiprazole on the PANSS (LSMD [95% CI]: -7.0 [-11.0 to -2.9], P = .0008) and CGI-S (LSMD [95% CI]: -0.4 [-0.6 to -0.2], P = .0001). Common treatment-emergent adverse events (≥ 10%) were insomnia (all groups), akathisia (cariprazine 6 mg/d), and headache (placebo, cariprazine 6 mg/d).
This study supports the efficacy, safety, and tolerability of cariprazine 3 and 6 mg/d in the treatment of patients with acute exacerbation of schizophrenia.
ClinicalTrials.gov identifier: NCT01104766.
这项 3 期研究评估了卡利拉嗪在精神分裂症急性加重患者中的疗效、安全性和耐受性。
这项多中心、随机、双盲、安慰剂和阳性对照研究于 2010 年 4 月至 2011 年 12 月进行。符合 DSM-IV-TR 精神分裂症标准的患者被随机分配至安慰剂（n=153）、卡利拉嗪 3mg/d（n=155）、卡利拉嗪 6mg/d（n=157）或阿立哌唑 10mg/d（n=152），进行 6 周的双盲治疗。主要和次要疗效参数分别为阳性和阴性综合征量表（PANSS）总分自基线至第 6 周的变化的最小二乘均数差值（LSMD）和临床总体印象-严重程度（CGI-S）评分。
第 6 周时 PANSS 总分变化的最小二乘均数差值（LSMD）明显优于卡利拉嗪 3mg/d 和 6mg/d 与安慰剂相比（LSMD[95%CI]：3mg/d，-6.0[-10.1 至-1.9]，调整 P=.0044；6mg/d，-8.8[-12.9 至-4.7]，调整 P<.0001）。与安慰剂相比，卡利拉嗪 3mg/d 和 6mg/d 也与 CGI-S 评分的显著改善相关（LSMD[95%CI]：3mg/d，-0.4[-0.6 至-0.2]，调整 P=.0044；6mg/d，-0.5[-0.7 至-0.3]，调整 P<.0001）。阿立哌唑在 PANSS（LSMD[95%CI]：-7.0[-11.0 至-2.9]，P=.0008）和 CGI-S（LSMD[95%CI]：-0.4[-0.6 至-0.2]，P=.0001）上也观察到与安慰剂的显著差异。≥10%的常见治疗中出现的不良事件（TEAE）包括失眠（所有组）、静坐不能（卡利拉嗪 6mg/d）和头痛（安慰剂、卡利拉嗪 6mg/d）。
这项研究支持卡利拉嗪 3mg/d 和 6mg/d 治疗精神分裂症急性加重患者的疗效、安全性和耐受性。
ClinicalTrials.gov 标识符：NCT01104766。
