Janssen Scientific Affairs, LLC, New Jersey, USA.
Janssen Research and Development LLC, New Jersey, USA.
Int J Neuropsychopharmacol. 2022 Mar 17;25(3):238-251. doi: 10.1093/ijnp/pyab071.
This double-blind (DB), randomized, parallel-group study was designed to evaluate efficacy and safety of paliperidone palmitate 6-month (PP6M) formulation relative to paliperidone palmitate 3-month (PP3M) formulation in patients with schizophrenia.
Following screening, patients entered an open-label (OL) maintenance phase and received 1 injection cycle of paliperidone palmitate 1-month (PP1M; 100 or 150 mg eq.) or PP3M (350 or 525 mg eq.). Clinically stable patients were randomized (2:1) to receive PP6M (700 or 1000 mg eq., gluteal injections) or PP3M (350 or 525 mg eq.) in a 12-month DB phase; 2 doses of PP6M (corresponding to doses of PP1M and PP3M) were chosen.
Overall, 1036 patients were screened, 838 entered the OL phase, and 702 (mean age: 40.8 years) were randomized (PP6M: 478; PP3M: 224); 618 (88.0%) patients completed the DB phase (PP6M: 416 [87.0%]; PP3M: 202 [90.2%]). Relapse rates were PP6M, 7.5% (n = 36) and PP3M, 4.9% (n = 11). The Kaplan-Meier estimate of the difference (95% CI) between treatment groups (PP6M - PP3M) in the percentages of patients who remained relapse free was -2.9% (-6.8%, 1.1%), thus meeting noninferiority criteria (95% CI lower bound is larger than the pre-specified noninferiority margin of -10%). Secondary efficacy endpoints corroborated the primary analysis. Incidences of treatment-emergent adverse events were similar between PP6M (62.1%) and PP3M (58.5%). No new safety concerns emerged.
The efficacy of a twice-yearly dosing regimen of PP6M was noninferior to that of PP3M in preventing relapse in patients with schizophrenia adequately treated with PP1M or PP3M.
Clinical Trials.gov identifier: NCT03345342.
本项双盲（DB）、随机、平行组研究旨在评估棕榈酸帕利哌酮 6 个月（PP6M）制剂相对于棕榈酸帕利哌酮 3 个月（PP3M）制剂在精神分裂症患者中的疗效和安全性。
筛选后，患者进入开放标签（OL）维持期，并接受 1 个周期的棕榈酸帕利哌酮 1 个月（PP1M；100 或 150mg 当量）或 PP3M（350 或 525mg 当量）注射。病情稳定的患者按 2:1 随机（DB 期，12 个月）接受 PP6M（700 或 1000mg 当量，臀部注射）或 PP3M（350 或 525mg 当量）治疗；选择了 2 种 PP6M 剂量（对应于 PP1M 和 PP3M 剂量）。
共有 1036 名患者接受筛选，838 名进入 OL 期，702 名（平均年龄：40.8 岁）被随机分组（PP6M：478 名；PP3M：224 名）；618 名（88.0%）患者完成了 DB 期（PP6M：416[87.0%]；PP3M：202[90.2%]）。PP6M 组和 PP3M 组的复发率分别为 7.5%（n=36）和 4.9%（n=11）。治疗组（PP6M-PP3M）无复发患者百分比的 Kaplan-Meier 估计差值（95%CI）为-2.9%（-6.8%，1.1%），因此符合非劣效性标准（95%CI 下限大于预设的-10%非劣效性边界）。次要疗效终点证实了主要分析结果。PP6M（62.1%）和 PP3M（58.5%）的治疗出现不良事件发生率相似。未出现新的安全性问题。
在充分接受 PP1M 或 PP3M 治疗的精神分裂症患者中，PP6M 每半年给药 1 次的疗效不劣于 PP3M，可预防复发。
ClinicalTrials.gov 标识符：NCT03345342。
