Findling Robert L, McKenna Kathleen, Earley Willie R, Stankowski Jill, Pathak Sanjeev
Division of Child & Adolescent Psychiatry, University Hospitals Case Medical Center, Cleveland, Ohio, USA.
J Child Adolesc Psychopharmacol. 2012 Oct;22(5):327-42. doi: 10.1089/cap.2011.0092.
The purpose of this study was to evaluate the efficacy and safety of acute quetiapine monotherapy in adolescents with schizophrenia.
Patients ages 13-17 years with an American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR) diagnosis of schizophrenia and a Positive and Negative Syndrome Scale (PANSS) total score ≥60 were randomized to 6 weeks of quetiapine (400 or 800 mg/day) or placebo treatment. The primary efficacy measure was change in PANSS total score from baseline to day 42. Safety endpoints included adverse events and assessments of clinical chemistry values, suicidality, and extrapyramidal symptoms.
The intent-to-treat population included 220 patients. Least-squares mean change in PANSS total score from baseline to endpoint was -27.31 with quetiapine 400 mg/day, -28.44 with quetiapine 800 mg/day, and -19.15 with placebo (p=0.043 and 0.009 for quetiapine 400 and 800 mg/day, respectively, vs. placebo; mixed-model, repeated-measures analysis). Several secondary efficacy outcomes, including Clinical Global Impressions-Improvement score, supported the primary outcome measure in demonstrating significantly greater improvement in quetiapine groups than in the placebo group. Mean changes in body weight at day 42 were 2.2 kg and 1.8 kg for quetiapine 400 and 800 mg/day, respectively, and -0.4 kg for placebo. Mean changes in certain clinical chemistry parameters, including total cholesterol and triglycerides, were numerically greater in the quetiapine groups than in the placebo group. Adverse events associated with quetiapine were mostly mild to moderate in intensity and were consistent with its known profile in adults with schizophrenia.
In this 6-week study of adolescent patients, quetiapine at doses of 400 and 800 mg/day provided significant improvements in symptoms associated with schizophrenia in adolescent patients, including the primary efficacy measure of PANSS total score change. Quetiapine was generally well tolerated with a profile broadly similar to that reported in adult and adolescent populations.
Quetiapine Fumarate (SEROQUEL(™)) Compared to Placebo in the Treatment of Adolescent Patients With Schizophrenia (ANCHOR 112). Available at: http://www.clinicaltrials.gov/ct2/show/NCT00090324?term=quetiapine+112&rank=1.
本研究旨在评估急性单药使用喹硫平治疗青少年精神分裂症的疗效和安全性。
年龄在13 - 17岁、符合美国精神病学协会《精神疾病诊断与统计手册》第4版修订版（DSM - IV - TR）精神分裂症诊断标准且阳性和阴性症状量表（PANSS）总分≥60的患者，被随机分为接受6周喹硫平（400或800毫克/天）或安慰剂治疗。主要疗效指标是从基线到第42天PANSS总分的变化。安全终点包括不良事件以及临床化学指标、自杀倾向和锥体外系症状的评估。
意向性治疗人群包括220名患者。从基线到终点，每天服用400毫克喹硫平的患者PANSS总分的最小二乘均值变化为 - 27.31，每天服用800毫克喹硫平的患者为 - 28.44，服用安慰剂的患者为 - 19.15（每天服用400毫克和800毫克喹硫平的患者与安慰剂组相比，p值分别为0.043和0.009；混合模型重复测量分析）。包括临床总体印象改善评分在内的几个次要疗效指标，支持了主要疗效指标，表明喹硫平组的改善明显大于安慰剂组。第42天时，每天服用400毫克和800毫克喹硫平的患者体重平均变化分别为2.2千克和1.8千克，服用安慰剂的患者体重平均变化为 - 0.4千克。包括总胆固醇和甘油三酯在内的某些临床化学参数的平均变化，喹硫平组在数值上大于安慰剂组。与喹硫平相关的不良事件大多为轻度至中度，与已知的成人精神分裂症患者情况相符。
在这项针对青少年患者的6周研究中，每天服用400毫克和800毫克喹硫平可使青少年精神分裂症患者与疾病相关的症状得到显著改善，包括PANSS总分变化这一主要疗效指标。喹硫平总体耐受性良好，其情况与成人和青少年人群中报告的大致相似。
富马酸喹硫平（思瑞康（™））与安慰剂治疗青少年精神分裂症患者的比较（ANCHOR 112）。可在：http://www.clinicaltrials.gov/ct2/show/NCT00090324?term=quetiapine+112&rank=1查询。
