University of Miami Miller School of Medicine, Miami, FL, USA.
Minerva Neurosciences, Waltham, MA, USA.
Schizophr Res. 2024 Sep;271:246-252. doi: 10.1016/j.schres.2024.07.011. Epub 2024 Jul 25.
Negative symptoms are a source of disability in schizophrenia, but criteria for identifying patients for clinical trials are in flux. Minimum severity for negative symptoms is paired with a definition of minimal psychosis to identify predominant negative symptoms. Two previous successful negative symptoms treatment studies used very different severity and selection criteria. We compared the prevalence of participants meeting those two criteria in a large outpatient sample of participants with schizophrenia. Data from 867 outpatients with schizophrenia who participated in one of four NIMH-funded studies were analyzed. Common data elements included diagnoses, the PANSS, and an assessment of everyday functioning. We compared previous criterion for premoninant negative symptoms based on low levels of agitation and psychosis and different cut-offs for negative symptoms severity. 57 % of the participants met the agitation-based criteria for low scores and 33 % met the psychosis-based criteria. 18 % met total PANSS score ≥ 20 and 8 % met ≥24 prominent negative symptoms criteria. 14 % met low agitation and PANSS≥20 and 2 % met the low psychosis and negative symptoms ≥24 criteria. Participants who met all predominant criteria had more impairments in social functioning (all p < .001, all d > 0.37). Criteria for predominant negative symptoms from previous clinical trials identify widely different numbers of cases, with criteria for negative symptom severity and low symptoms both impacting. All criteria yield the expected profile of relatively specific social deficits. Even in unselected populations who participated in complex research protocols, 14 % meet low- agitation based criteria for predominant negative symptoms and many more participants would be expected to meet criteria with enrichment for the presence of negative symptoms.
阴性症状是精神分裂症致残的一个根源，但用于确定临床试验患者的标准却在不断变化。阴性症状的最低严重程度与最小精神症状的定义相匹配，以确定主要的阴性症状。之前两项成功的阴性症状治疗研究使用了非常不同的严重程度和选择标准。我们比较了一个大型精神分裂症门诊样本中符合这两个标准的参与者的患病率。对参加四项 NIMH 资助研究之一的 867 名精神分裂症门诊患者的数据进行了分析。常见的数据分析包括诊断、PANSS 和日常功能评估。我们比较了以前基于低激越和精神病学标准和不同的阴性症状严重程度标准的主要阴性症状的标准。57%的参与者符合低评分激越的标准，33%符合精神病学标准。18%的参与者符合 PANSS 总分≥20，8%符合≥24 个明显阴性症状标准。14%的参与者符合低激越和 PANSS≥20，2%符合低精神病学和阴性症状≥24 标准。符合所有主要标准的参与者在社会功能方面的障碍更多（所有 p<0.001，所有 d>0.37）。以前临床试验中的主要阴性症状标准确定了广泛不同数量的病例，阴性症状严重程度和低症状都有影响。所有标准都产生了预期的相对特定的社会缺陷特征。即使在参加复杂研究方案的未选择人群中，也有 14%的人符合低激越的主要阴性症状标准，预计更多的参与者会符合有阴性症状的标准。
