Miller T J, Zipursky R B, Perkins D, Addington J, Woods S W, Hawkins K A, Hoffman R, Preda A, Epstein I, Addington D, Lindborg S, Marquez E, Tohen M, Breier A, McGlashan T H
Yale University, New Haven, CT, USA.
Schizophr Res. 2003 May 1;61(1):19-30. doi: 10.1016/s0920-9964(02)00440-1.
The first double-blind placebo-controlled clinical trial of an atypical neuroleptic medication is being conducted in symptomatic treatment-seeking patients meeting new diagnostic criteria for a putative prodromal syndrome. This identifies them as being at high risk for developing psychosis in the near future. The study aims include prevention of psychosis onset and disability, as well as palliation of ongoing symptomatology. The purpose of this report is to describe the study's "prodromally symptomatic" sample at baseline, i.e., at intake immediately prior to randomization and prior to receiving study medication. Sixty treatment-seeking patients meeting prodromal inclusion criteria were recruited across four sites: New Haven, CT (n=39), Toronto, Ontario (n=9), Calgary, Alberta (n=6), and Chapel Hill, NC (n=6). The sample was young (median age 16), largely male (65%), and came from families with high titers of serious mental illness (44%). Most patients (93%) met criteria for the Attenuated Positive Symptom (APS) prodromal syndrome and presented with significant but nonpsychotic suspiciousness, perceptual aberrations, unusual thought content, and conceptual disorganization. They presented with minimal to mild affective symptoms and substance use/abuse, but they were quite functionally compromised (mean Global Assessment of Functioning (GAF) score=42). The prodromal sample was compared with other clinical-trial samples of adolescent depression, adolescent mania, and first episode schizophrenia. Prodromal patients proved not to be depressed or manic. They were less severely ill than untreated first episode schizophrenia but more severely ill than treated first episode schizophrenia. While not psychotically disabled, these patients nevertheless present with a clinical syndrome. Subsequent reports will detail the effects of drug versus placebo on prodromal symptoms, neuropsychological profile, and the rate of conversion to psychosis.
一项非典型抗精神病药物的双盲安慰剂对照临床试验正在针对符合一种假定前驱综合征新诊断标准的有症状且寻求治疗的患者中进行。这将他们识别为在不久的将来有发展为精神病的高风险人群。该研究目标包括预防精神病发作和残疾，以及缓解当前症状。本报告的目的是描述该研究基线时即随机分组前和接受研究药物前即刻入组时的“前驱症状性”样本。在四个地点招募了60名符合前驱纳入标准且寻求治疗的患者：康涅狄格州纽黑文（n = 39）、安大略省多伦多（n = 9）、艾伯塔省卡尔加里（n = 6）和北卡罗来纳州教堂山（n = 6）。样本较为年轻（中位年龄16岁），大部分为男性（65%），且来自严重精神疾病患病率高的家庭（44%）。大多数患者（93%）符合轻度阳性症状（APS）前驱综合征标准，表现出明显但非精神病性的猜疑、知觉异常、异常思维内容和概念紊乱。他们有轻微至中度的情感症状和物质使用/滥用情况，但功能严重受损（平均功能总体评估（GAF）评分 = 42）。将前驱样本与青少年抑郁症、青少年躁狂症和首发精神分裂症的其他临床试验样本进行了比较。前驱患者被证明既非抑郁也非躁狂。他们的病情比未治疗的首发精神分裂症患者轻，但比接受治疗的首发精神分裂症患者重。虽然没有达到精神病性残疾，但这些患者仍呈现出一种临床综合征。后续报告将详细阐述药物与安慰剂对前驱症状、神经心理学特征以及发展为精神病的转化率的影响。
