Schimmelmann Benno Graf, Mehler-Wex Claudia, Lambert Martin, Schulze-zur-Wiesch Constanze, Koch Eginhard, Flechtner Hans Henning, Gierow Baerbel, Maier Joachim, Meyer Eberhard, Schulte-Markwort Michael
Department of Child and Adolescent Psychiatry, University of Duisburg-Essen, Virchowstrasse 174, 45147 Essen, Germany.
J Child Adolesc Psychopharmacol. 2007 Dec;17(6):768-78. doi: 10.1089/cap.2007.0048.
The aim of this study was to investigate the effectiveness, tolerability, and safety of quetiapine in adolescents with schizophrenia, schizophreniform, and schizoaffective disorders in a prospective open-label study.
A total of 56 subjects (all-subjects-treated, AST), ages 12-17, received 200-800 mg of quetiapine per day (forced titration to 400 mg within week 1; median study dose 600 mg/day at week 6) in Germany, 2002 through 2004. Primary outcome measure was the change of Positive and Negative Syndrome Scale (PANSS) total score (based on the intent-to-treat (ITT) population, n = 52), secondary outcome measures were changes of PANSS subscales, severity of illness, subjective wellbeing, and safety/tolerability (the latter based on the AST population). Correlates of PANSS response (=50% reduction in PANSS total score) and discontinuation due to lack of effectiveness were analyzed by Cox regression analyses.
Twenty-seven subjects (48%) completed the study; 17 subjects (30%) were discontinued due to lack of effectiveness. A significant reduction of PANSS total score (last observation carried forward, LOCF; p < 0.0001; effect size = 0.92) and of secondary effectiveness outcomes were detected. In all, 34.6% fulfilled the PANSS response criterion, correlated with the degree of PANSS total change within week 1. Somnolence (21.4%) and fatigue (17.9%) were the most frequent adverse events. A significant mean weight gain (6.2 kg) and mean decrease in total serum thyroxine (2.5 ng/dl) were detected.
In this sample of mostly drug-naïve patients with early-onset schizophrenia spectrum disorders, significant reductions in PANSS total and positive scores were detected. Controlled studies are needed to confirm these findings. The significant weight gain with its potentially severe medical consequences must be weighed against quetiapine's effectiveness.
本前瞻性开放标签研究旨在调查喹硫平治疗青少年精神分裂症、分裂样精神病及分裂情感性障碍的有效性、耐受性和安全性。
2002年至2004年在德国，共有56名年龄在12至17岁的受试者（所有接受治疗的受试者，AST），每天服用200 - 800毫克喹硫平（第1周内强制滴定至400毫克；第6周时研究剂量中位数为600毫克/天）。主要结局指标是阳性和阴性症状量表（PANSS）总分的变化（基于意向性治疗（ITT）人群，n = 52），次要结局指标是PANSS各子量表的变化、疾病严重程度、主观幸福感以及安全性/耐受性（后者基于AST人群）。通过Cox回归分析来分析PANSS反应（= PANSS总分降低50%）的相关因素以及因疗效不佳而停药的情况。
27名受试者（48%）完成了研究；17名受试者（30%）因疗效不佳而停药。检测到PANSS总分（末次观察结转，LOCF；p < 0.0001；效应大小 = 0.92）以及次要疗效指标有显著降低。总体而言，34.6%达到了PANSS反应标准，这与第1周内PANSS总分变化程度相关。嗜睡（21.4%）和疲劳（17.9%）是最常见的不良事件。检测到显著的平均体重增加（6.2千克）以及总血清甲状腺素平均下降（2.
