Blacker R, Shanks N J, Chapman N, Davey A
St. Bartholomew's Hospital, London, UK.
Psychopharmacology (Berl). 1988;95 Suppl:S18-24. doi: 10.1007/BF00172625.
This 6-week, double-blind, randomised, multicentre study was performed to assess the efficacy and tolerability of evening administration of 150 mg trazodone as an initial and maintenance therapy and to compare this regimen with recommended dosages of mianserin, dothiepin and amitriptyline in the treatment of depressed, adult, general practice patients. A total of 227 eligible depressed patients were recruited into the study by a panel of general practitioners. One hundred and twelve patients were randomised to receive trazodone therapy, 36 received mianserin, 35 received dothiepin and 44 received amitriptyline. Trazodone was administered as a single daily dose of 150 mg. Mianserin was given at a dose of 30 mg for the first 7 days followed by 60 mg daily for the remaining 5 weeks. Dothiepin and amitriptyline were both given at a dosage of 75 mg daily for the 1st week; this was then increased to 150 mg and 100 mg, respectively, for the final 5 weeks of the study. Efficacy of the four treatments was assessed using the modified Hamilton depression rating scale scores and by the Investigator's judgment of both the global severity and improvement of the condition. No significant differences were shown, using any measure of efficacy, between trazodone and any of the three comparator drugs. All treatments resulted in significant improvement in both Ham-D scores and global measures over the period of the study. Using a total side-effect score to assess the incidence and severity of adverse events and adjusting for baseline differences, the four treatments were found to differ.(ABSTRACT TRUNCATED AT 250 WORDS)
这项为期6周的双盲、随机、多中心研究旨在评估每晚服用150毫克曲唑酮作为初始和维持治疗的疗效及耐受性,并将该治疗方案与米安色林、多塞平及阿米替林的推荐剂量在成年普通门诊抑郁症患者治疗中的效果进行比较。共有227名符合条件的抑郁症患者由一组全科医生招募入该研究。112名患者被随机分配接受曲唑酮治疗,36名接受米安色林治疗,35名接受多塞平治疗,44名接受阿米替林治疗。曲唑酮每日单次给药150毫克。米安色林在开始的7天内剂量为30毫克,之后5周每日剂量为60毫克。多塞平和阿米替林在研究的第1周均每日给药75毫克,然后在研究的最后5周分别增至150毫克和100毫克。使用改良的汉密尔顿抑郁量表评分以及研究者对病情总体严重程度和改善情况的判断来评估四种治疗方法的疗效。在任何疗效指标上,曲唑酮与三种对照药物中的任何一种相比均未显示出显著差异。在研究期间,所有治疗方法均使汉密尔顿抑郁量表评分和总体指标有显著改善。使用总副作用评分评估不良事件的发生率和严重程度,并对基线差异进行调整后,发现四种治疗方法存在差异。(摘要截断于250字)