Mattila Taina, Koeter Maarten, Wohlfarth Tamar, Storosum Jitschak, van den Brink Wim, de Haan Lieuwe, Derks Eske, Leufkens Hubertus, Denys Damiaan
Medicines Evaluation Board, Utrecht, The Netherlands;
Department of Psychiatry, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
Schizophr Bull. 2015 May;41(3):637-43. doi: 10.1093/schbul/sbu172. Epub 2014 Dec 20.
To examine the consequences and validity of changes in Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnostic criteria for schizophrenia, eg, omission of subtypes, using a large dataset of double-blind, randomized, placebo-controlled schizophrenia trials.
Data from 22 short-term efficacy registration trials of second generation antipsychotics for the treatment of acute psychotic episodes in patients with schizophrenia (N = 5233), submitted to the Dutch regulatory authority were analyzed. We examined whether patients in these pre-DSM-5 trials met the diagnostic criteria for schizophrenia according to DSM-5. Using linear regression, we examined differences in effect size between DSM-IV subtypes and between DSM-5 symptom dimensions.
Over 99.5% of the patients met DSM-5 diagnostic criteria for schizophrenia and no differences in effect size were found between schizophrenia subtypes (P = .65). Symptom dimensions that respond best to treatment with second generation antipsychotics were hallucinations, delusions, disorganized speech, and mania (Hedge's g -0.23 to -0.31).
Results of clinical trials in patients with pre-DSM-5 schizophrenia also apply to patients diagnosed with DSM-5 schizophrenia. Omission of the classic subtypes is justified as they are not predictive of response to treatment. The DSM-5 C-RDPSS scale adds valuable information to the categorical diagnosis of schizophrenia, which is relevant for antipsychotic response.
使用大量双盲、随机、安慰剂对照的精神分裂症试验数据集,研究《精神疾病诊断与统计手册》(DSM)-5中精神分裂症诊断标准变化的后果和有效性,例如亚型的省略。
分析提交给荷兰监管机构的22项第二代抗精神病药物治疗精神分裂症患者急性精神病发作的短期疗效注册试验数据(N = 5233)。我们检查了这些DSM-5之前试验中的患者是否符合DSM-5的精神分裂症诊断标准。使用线性回归,我们检查了DSM-IV亚型之间以及DSM-5症状维度之间效应大小的差异。
超过99.5%的患者符合DSM-5精神分裂症诊断标准,精神分裂症亚型之间未发现效应大小的差异(P = 0.65)。对第二代抗精神病药物治疗反应最佳的症状维度是幻觉、妄想、言语紊乱和躁狂(赫奇斯g值为-0.23至-0.31)。
DSM-5之前精神分裂症患者的临床试验结果也适用于诊断为DSM-5精神分裂症的患者。经典亚型的省略是合理的,因为它们不能预测治疗反应。DSM-5 C-RDPSS量表为精神分裂症的分类诊断增加了有价值的信息,这与抗精神病药物反应相关。