CNS Unit, BR Trials - Clinical Research, São Paulo, Brazil; LiNC - Laboratory of Integrative Neuroscience, Department of Psychiatry, Universidade Federal de São Paulo, Sao Paulo, Brazil.
CNS Unit, BR Trials - Clinical Research, São Paulo, Brazil; LiNC - Laboratory of Integrative Neuroscience, Department of Psychiatry, Universidade Federal de São Paulo, Sao Paulo, Brazil.
Schizophr Res. 2021 May;231:70-72. doi: 10.1016/j.schres.2021.03.005. Epub 2021 Mar 24.
Sodium nitroprusside (SNP) has shown efficacy in schizophrenia in early stages of the disease in a previous study, but in more recent studies it has not shown efficacy in patients with longer disease duration. In present study, we evaluated the efficacy of repeated-dose SNP in treatment-resistant schizophrenia.
This was a double-blind, randomized, placebo-controlled trial. Twenty DSM-IV schizophrenia subjects, aged 18-60 years, with a history of nonresponse to ≥2 trials of antipsychotics of adequate dose and duration (≥6 weeks) were enrolled. Participants received SNP or placebo 4-hour infusions at 0.5 μg/kg/min. A total of 4 infusions and 4 follow-up evaluations, with an interval of 2 weeks, were performed. Severity of symptoms were assessed by using Positive and Negative Syndrome Scale (PANSS), Brief Psychiatric Rating Scale (BPRS-18) and Clinical Global Impression (CGI) scales.
SNP and placebo groups did not differ at baseline or in change from baseline for PANSS-total (F = 0.525; p = 0.841), PANSS-positive (F = 0.32; p = 0.958), PANSS-negative (F = 1.05; p = 0.483), BPRS (F = 0.615; p = 0.734), or CGI-S (F = 1.11; p = 0.416) scores. SNP was well tolerated and showed a good safety profile.
Although preliminary, the present findings suggest that SNP is not efficacious in TRS, reinforcing previous studies that have not demonstrated symptom improvement in chronic schizophrenia subjects. At this time, it is conceivable to speculate that efficacy of SNP might be restricted to early stages of disease.
先前的研究表明，硝普钠（SNP）在疾病早期对精神分裂症有效，但在最近的研究中，它对疾病持续时间较长的患者没有疗效。本研究评估了重复剂量 SNP 治疗难治性精神分裂症的疗效。
这是一项双盲、随机、安慰剂对照试验。纳入 20 名 DSM-IV 精神分裂症患者，年龄 18-60 岁，既往对至少 2 种足量、足够疗程（≥6 周）的抗精神病药物治疗无反应。参与者接受 SNP 或安慰剂 4 小时输注，速率为 0.5μg/kg/min。共进行 4 次输注和 4 次随访评估，间隔 2 周。使用阳性和阴性综合征量表（PANSS）、简明精神病评定量表（BPRS-18）和临床总体印象量表（CGI）评估症状严重程度。
SNP 组和安慰剂组在基线时或从基线变化的 PANSS 总分（F=0.525；p=0.841）、PANSS 阳性症状（F=0.32；p=0.958）、PANSS 阴性症状（F=1.05；p=0.483）、BPRS（F=0.615；p=0.734）或 CGI-S（F=1.11；p=0.416）评分上均无差异。SNP 耐受良好，安全性良好。
尽管初步研究结果表明 SNP 对 TRS 无效，但与先前的研究结果一致，这些研究表明 SNP 不能改善慢性精神分裂症患者的症状。此时，我们可以推测 SNP 的疗效可能仅限于疾病的早期阶段。
