Garrido-Sánchez Lucía, Gómez-Revuelta Marcos, Ortiz-García de la Foz Víctor, Pelayo-Terán José María, Juncal-Ruiz María, Ruiz-Veguilla Miguel, Mayoral-Van Son Jacqueline, Ayesa-Arriola Rosa, Vázquez-Bourgon Javier, Crespo-Facorro Benedicto
University Hospital Virgen del Rocío, Department of Psychiatry, Seville, Spain.
University of Seville, Seville, Spain.
Int J Neuropsychopharmacol. 2022 Nov 17;25(11):900-911. doi: 10.1093/ijnp/pyac047.
Antipsychotic choice for the acute phase of a first episode of psychosis (FEP) is of the utmost importance since it may influence long-term outcome. However, head-to-head comparisons between second-generation antipsychotics remain scarce. The aim of this study was to compare the effectiveness in the short term of aripiprazole and risperidone after FEP outbreak.
From February 2011 to October 2018, a prospective, randomized, open-label study was undertaken. Two hundred-sixty-six first-episode drug-naïve patients were randomly assigned to aripiprazole (n = 136) or risperidone (n = 130) and followed-up for 12 weeks. The primary effectiveness measure was all-cause treatment discontinuation. In addition, an analysis based on intention-to-treat principle was conducted to assess clinical efficacy.
The overall dropout rate at 12 weeks was small (6.39%). Effectiveness measures were similar between treatment arms as treatment discontinuation rates (χ 2 = 0,409; P = .522), and mean time to all-cause discontinuation (log rank χ 2 = -1.009; P = .316) showed no statistically significant differences. Despite no statistically significant differences between groups regarding clinical efficacy, aripiprazole required higher chlorpromazine equivalent dosage (χ 2 = 2.160; P = .032) and extended mean time (W = 8183.5; P = .008) to reach clinical response. Sex-related adverse events and rigidity were more frequent in the risperidone group, whereas sialorrhea was on the aripiprazole group.
No differences regarding effectiveness were found between aripiprazole and risperidone for the short-phase treatment of FEP. Despite the importance of efficacy during this phase, differences in side effect profiles and patient's preferences are essential factors that may lead clinical decisions for these patients.
CLINICALTRIALS.GOV: NCT02532491. Effectiveness of Second-Generation Antipsychotics in First Episode Psychosis Patients: 1-year Follow-up (PAFIP3_1Y).
首次发作精神病（FEP）急性期的抗精神病药物选择至关重要，因为它可能影响长期预后。然而，第二代抗精神病药物之间的直接比较仍然很少。本研究的目的是比较FEP发作后阿立哌唑和利培酮在短期内的有效性。
2011年2月至2018年10月，进行了一项前瞻性、随机、开放标签研究。266例首次发作且未用过药的患者被随机分配至阿立哌唑组（n = 136）或利培酮组（n = 130），并随访12周。主要有效性指标是全因治疗中断。此外，基于意向性分析原则进行分析以评估临床疗效。
12周时的总体脱落率较低（6.39%）。治疗组间的有效性指标相似，如治疗中断率（χ² = 0.409；P = 0.522）以及全因中断的平均时间（对数秩检验χ² = -1.009；P = 0.316）均无统计学显著差异。尽管两组间在临床疗效方面无统计学显著差异，但阿立哌唑达到临床反应需要更高的氯丙嗪等效剂量（χ² = 2.160；P = 0.032）和更长的平均时间（W = 8183.5；P = 0.008）。利培酮组与性别相关的不良事件和僵硬更为常见，而阿立哌唑组流涎更为常见。
阿立哌唑和利培酮在FEP短期治疗中的有效性无差异。尽管此阶段疗效很重要，但副作用特征和患者偏好的差异是可能影响这些患者临床决策的关键因素。
NCT02532491。第二代抗精神病药物在首发精神病患者中的有效性：1年随访（PAFIP3_1Y）。
