From the Department of Pharmacotherapy, Student Research Committee, Faculty of Pharmacy, Mazandaran University of Medical Sciences.
Neuroscience Research Center; Psychiatric Department, School of Medicine, Kerman University of Medical Sciences, Kerman.
J Clin Psychopharmacol. 2021;41(1):25-30. doi: 10.1097/JCP.0000000000001324.
PURPOSE/BACKGROUND: It is well documented that one of the pathophysiological mechanisms of negative symptoms in patients with schizophrenia is hypofunction of N-methyl-d-aspartate receptors. This double-blind, placebo-controlled clinical trial was designed to assess the efficacy and safety of nanocurcumin as an adjuvant agent on psychotic symptoms, especially negative symptoms, in patients with chronic schizophrenia.
METHODS/PROCEDURES: Fifty-six inpatients with stable chronic schizophrenia and predominant negative symptoms were randomized in a 1:1 ratio to nanocurcumin soft gel capsule (160 mg/d) and control groups, along with their antipsychotic regimen for 16 weeks. The efficacy of treatment was assessed by Positive and Negative Syndrome Scale, Calgary Depression Scale for Schizophrenia, Clinical Global Impressions-Severity, and Clinical Global Impressions-Improvement scales. Extrapyramidal symptoms were evaluated by Simpson-Angus Scale and Barnes Akathisia Rating Scale. Patients were assessed at baseline and weeks 4, 8, 12, and 16 after the medication started.
FINDINGS/RESULTS: No significant differences were observed in demographic or clinical variables between both groups at baseline. The nanocurcumin group showed significantly greater improvement on the negative subscale (P = 0.05), the general psychopathology subscale (P < 0.001), the positive subscale (P = 0.004), total Positive and Negative Syndrome Scale (P < 0.001), Clinical Global Impressions-Severity (P < 0.001), and Clinical Global Impressions-Improvement scores (P < 0.001) in comparison with the control group at the endpoint. Extrapyramidal symptom rating scales and Calgary Depression Scale for Schizophrenia and frequency of other adverse effects were comparable between 2 groups.
IMPLICATIONS/CONCLUSIONS: The present study indicates nanocurcumin as a safe and potential adjunctive treatment strategy for treatment of primary negative symptoms of schizophrenia.
目的/背景：有大量文献记录了精神分裂症患者阴性症状的一种病理生理学机制是 N-甲基-D-天冬氨酸受体功能低下。本项双盲、安慰剂对照临床试验旨在评估纳米姜黄素作为辅助药物治疗慢性精神分裂症患者精神症状，尤其是阴性症状的疗效和安全性。
方法/程序：56 名稳定的慢性精神分裂症且以阴性症状为主的住院患者，按 1:1 的比例随机分为纳米姜黄素软胶囊（160mg/d）组和对照组，并在他们的抗精神病药物治疗方案的基础上进行 16 周的治疗。采用阳性和阴性症状量表（Positive and Negative Syndrome Scale，PANSS）、精神分裂症的卡尔加里抑郁量表（Calgary Depression Scale for Schizophrenia）、临床总体印象严重程度量表（Clinical Global Impressions-Severity，CGI-S）和临床总体印象改善量表（Clinical Global Impressions-Improvement，CGI-I）评估治疗效果。采用辛普森-安格斯量表（Simpson-Angus Scale）和巴恩斯静坐不能评定量表（Barnes Akathisia Rating Scale）评估锥体外系症状。在开始用药后的第 4、8、12 和 16 周对患者进行评估。
结果/发现：两组患者在基线时的人口统计学或临床变量无显著差异。纳米姜黄素组在阴性症状量表子量表（P=0.05）、一般精神病症状量表子量表（P＜0.001）、阳性症状量表（P=0.004）、阳性和阴性症状量表总分（P＜0.001）、临床总体印象严重程度量表（P＜0.001）和临床总体印象改善量表（P＜0.001）上的改善明显优于对照组。两组之间的锥体外系症状评定量表和精神分裂症的卡尔加里抑郁量表以及其他不良反应的频率无显著差异。
意义/结论：本研究表明纳米姜黄素是一种安全且有潜力的辅助治疗策略，可用于治疗精神分裂症的主要阴性症状。
