Munizza C, Olivieri L, Di Loreto G, Dionisio P
Fourth Local Health Unit, Mental Health Department, Turin, Italy.
Curr Med Res Opin. 2006 Sep;22(9):1703-13. doi: 10.1185/030079906X121039.
To evaluate the efficacy and safety of trazodone prolonged-release compared with sertraline in the treatment of patients with major depression.
A total of 122 patients aged 19-64 years were enrolled in this multicenter, double-blind, double-dummy, randomized, comparator-controlled study. Patients received 7 days of single-blind placebo treatment followed by 6 weeks of double-blind treatment with trazodone prolonged-release 150-450 mg/day (n = 62) or sertraline 50-100 mg/day (n = 60).
Efficacy was evaluated by mean changes from baseline in the Hamilton Depression Rating scale (HAM-D), Montgomery Asberg Depression Rating Scale, Hamilton Anxiety Rating scale, and the Clinical Global Impression-Global Improvement/Severity scores; and by the rates of patients responding to treatment and considered to be in remission. Time to onset of efficacy and safety were assessed.
Trazodone and sertraline were equally effective in reducing depressive symptoms and promoting remission, and had similar onset times. In the Intent-to-Treat population, there were no significant differences in favor of trazodone at study endpoint in all efficacy measures, while a statistically significant difference was detected in the Per-Protocol population on HAM-D and in the percentage of responders. Analysis of HAM-D factors (anxiety/somatization, cognitive disturbance, retardation, and sleep disturbance) indicated that sleep disturbances were significantly less evident for patients taking trazodone at study endpoint. Adverse drug reactions, mostly of mild intensity, were reported in 42% of trazodone-treated patients (mainly of the nervous system) and 43% of sertraline-treated patients (mainly gastrointestinal). One event was considered to be serious: a patient treated with trazodone 450 mg/day showed moderate anxiety/tremor/insomnia and was hospitalized. Treatment was discontinued; the patient made a full recovery.
This study showed that after 6 weeks, trazodone and sertraline were not different in reducing symptoms of depression and in producing disease remission. Tolerability profiles reflected the differing pharmacological properties of these antidepressants. Trazodone may be a therapeutic option in the treatment of patients with major depression showing prevalent sleep disturbances.
评估曲唑酮缓释剂与舍曲林相比治疗重度抑郁症患者的疗效和安全性。
本多中心、双盲、双模拟、随机、对照研究共纳入122例年龄在19至64岁之间的患者。患者先接受7天的单盲安慰剂治疗，随后接受6周的双盲治疗，其中曲唑酮缓释剂150 - 450毫克/天（n = 62）或舍曲林50 - 100毫克/天（n = 60）。
疗效通过汉密尔顿抑郁量表（HAM - D）、蒙哥马利 - 阿斯伯格抑郁量表、汉密尔顿焦虑量表以及临床总体印象 - 总体改善/严重程度评分从基线的平均变化来评估；并通过治疗反应率和达到缓解的患者比例来评估。评估疗效和安全性的起效时间。
曲唑酮和舍曲林在减轻抑郁症状和促进缓解方面同样有效，且起效时间相似。在意向性分析人群中，在研究终点时所有疗效指标上均未发现曲唑酮有显著优势，而在符合方案人群中，在HAM - D及反应者百分比方面检测到有统计学意义的差异。对HAM - D因子（焦虑/躯体化、认知障碍、迟缓及睡眠障碍）的分析表明，在研究终点时服用曲唑酮的患者睡眠障碍明显减轻。42%服用曲唑酮的患者（主要为神经系统不良反应）和43%服用舍曲林的患者（主要为胃肠道不良反应）报告了药物不良反应，大多为轻度。有1例事件被认为严重：1例接受450毫克/天曲唑酮治疗的患者出现中度焦虑/震颤/失眠并住院。治疗中断；患者完全康复。
本研究表明，6周后，曲唑酮和舍曲林在减轻抑郁症状和实现疾病缓解方面无差异。耐受性特征反映了这些抗抑郁药不同的药理学特性。曲唑酮可能是治疗以睡眠障碍为主的重度抑郁症患者的一种治疗选择。
