The authors assessed the efficacy, safety, and tolerability of MIN-101, a compound with affinities for sigma-2 and 5-HT_2A receptors and no direct dopamine affinities, in comparison with placebo in treating negative symptoms in stabilized patients with schizophrenia.

The trial enrolled 244 patients who had been symptomatically stable for at least 3 months and had scores of at least 20 on the negative subscale of the Positive and Negative Syndrome Scale (PANSS). After at least 5 days’ withdrawal from all antipsychotic medication, patients were randomly assigned to receive placebo or 32 mg/day or 64 mg/day of MIN-101 for 12 weeks. The primary outcome measure was the PANSS negative factor score (pentagonal structure model). Secondary outcome measures were PANSS total score and scores on the Clinical Global Impressions Scale (CGI), the Brief Negative Symptom Scale, the Brief Assessment of Cognition in Schizophrenia, and the Calgary Depression Scale for Schizophrenia.

A statistically significant difference in PANSS negative factor score was observed, with lower scores for the MIN-101 32 mg/day and 64 mg/day groups compared with the placebo group (effect sizes, d=0.45 and d=0.57, respectively). Supporting these findings were similar effects on several of the secondary outcome measures, such as the PANSS negative symptom, total, and activation factor scores, the CGI severity item, and the Brief Negative Symptom Scale. There were no statistically significant differences in PANSS positive scale score between the MIN-101 and placebo groups. No clinically significant changes were observed in vital signs, routine laboratory values, weight, metabolic indices, and Abnormal Involuntary Movement Scale score.

MIN-101 demonstrated statistically significant efficacy in reducing negative symptoms and good tolerability in stable schizophrenia patients.

与安慰剂相比，MIN-101是一种具有sigma-2和5-HT _2A受体亲和力且无直接多巴胺亲和力的化合物，在安慰剂治疗稳定的精神分裂症患者的阴性症状方面，他们评估了其有效性，安全性和耐受性。

该试验招募了244名在至少3个月内症状稳定且在阳性和阴性综合征量表（PANSS）的阴性子量表上得分至少为20的患者。从所有抗精神病药物中撤出至少5天后，患者被随机分配接受安慰剂或32 mg /天或64 mg /天的MIN-101，持续12周。主要结局指标是PANSS阴性因子评分（五边形结构模型）。次要结局指标是PANSS总分和临床总体印象量表（CGI），消极症状症状量表，精神分裂症认知简要评估以及卡尔加里精神分裂症抑郁量表的得分。

观察到PANSS阴性因子评分有统计学上的显着差异，MIN-101组32毫克/天和64毫克/天的得分低于安慰剂组（效应量分别为d = 0.45和d = 0.57）。支持这些发现的是对几种次要结局指标的相似影响，例如PANSS阴性症状，总和激活因子评分，CGI严重程度项目以及简要阴性症状量表。MIN-101组和安慰剂组之间的PANSS阳性量表得分无统计学差异。在生命体征，常规实验室检查值，体重，代谢指标和非自愿运动量表评分方面均未观察到临床上的显着变化。

MIN-101在稳定的精神分裂症患者中显示出在减轻阴性症状和良好耐受性方面的统计学显着功效。