Adjunctive Aripiprazole Treatment for Risperidone-Induced Hyperprolactinemia: An 8-Week Randomized, Open-Label, Comparative Clinical Trial

ObjectiveThe present study aimed to evaluate the efficacy and safety of adjunctive aripiprazole treatment in schizophrenia patients with risperidone-induced hyperprolactinemia.MethodsOne hundred and thirteen patients who were receiving a stable dose of risperidone were randomly assigned to either adjunctive aripiprazole treatment (10 mg/day) (aripiprazole group) or no additional treatment (control group) at a 1:1 ratio for 8 weeks. Schizophrenia symptoms were measured using the Positive and Negative Syndrome Scale (PANSS). Rating scales and safety assessments (RSESE, BARS, UKU) were performed at baseline and at weeks 4 and 8. Serum levels of prolactin were determined at baseline and at weeks 2, 4, 6 and 8. Metabolic parameters were determined at baseline and again at weeks 4 and 8.ResultsOne hundred and thirteen patients were enrolled in this study, and 107 patients completed the study (54 in the aripiprazole group, and 53 in the control group). PANSS-total scores in the aripiprazole group decreased significantly at week 4 (P = 0.003) and week 8 (P = 0.007) compared with the control group. PANSS-negative scores in the aripiprazole group also decreased significantly at week 4 (P = 0.005) and week 8 (PPPPPConclusionsAdjunctive aripiprazole treatment may be beneficial in reducing serum levels of prolactin and improving negative symptoms in schizophrenia patients with risperidone-induced hyperprolactinemia.Trial Registrationchictr.org ChiCTR-IOR-15006278【研究目的】本研究旨在评估辅助使用阿立哌唑（aripiprazole）治疗利培酮（risperidone）诱导高催乳素血症（hyperprolactinemia）精神分裂症患者的疗效与安全性。 【研究方法】本研究纳入113名接受稳定剂量利培酮治疗的精神分裂症患者，以1:1的比例随机分为两组：辅助阿立哌唑治疗组（阿立哌唑组，每日10mg）与无额外治疗对照组（对照组），干预周期共8周。采用阳性与阴性症状量表（Positive and Negative Syndrome Scale, PANSS）评定精神分裂症症状；于基线、第4周及第8周完成评定量表评估与安全性评价（RSESE、巴恩斯静坐不能评定量表（Barnes Akathisia Rating Scale, BARS）、临床不良反应评定量表（Udvalg for Kliniske Undersøgelser, UKU））；于基线、第2、4、6、8周检测血清催乳素水平；于基线、第4周及第8周检测代谢参数。 【研究结果】本研究共纳入113名患者，最终107名患者完成试验（阿立哌唑组54名，对照组53名）。与对照组相比，阿立哌唑组的PANSS总分在第4周（P=0.003）及第8周（P=0.007）均显著降低。阿立哌唑组的PANSS阴性量表得分在第4周（P=0.005）及第8周亦显著降低。 【研究结论】辅助阿立哌唑治疗可有效降低利培酮诱导高催乳素血症精神分裂症患者的血清催乳素水平，并改善其阴性症状。 【试验注册】中国临床试验注册中心（chictr.org）：ChiCTR-IOR-15006278