Rüther E, Degner D, Munzel U, Brunner E, Lenhard G, Biehl J, Vögtle-Junkert U
Department of Psychiatry, University of Göttingen, Germany.
Pharmacopsychiatry. 1999 Jul;32(4):127-35. doi: 10.1055/s-2007-979218.
The purpose of this multicenter, randomized, double-blind, placebo-controlled parallel-group comparative study was to prove the efficacy and tolerance of sulpiride (150-300 mg) against placebo in mild to moderate depressive syndrome. The primary criterion of efficacy was the course of the HAMD total score from day 1 to day 42, compared between the two treatment groups. The duration of the treatment was six weeks, preceded by a one-week placebo run-in phase. The HAMD, CGI and KUSTA scores were determined, the tolerance assessed, and the laboratory parameters and serum prolactin levels determined before, during and at the end of the trial. 177 outpatients aged from 18 to 70 years with mild to moderate depressive syndrome (ICD-10: F32.0, F32.1, F33.0, F33.1) and a score of 18-27 points on the 21-item HAMD scale were randomized, 171 of whom (sulpiride: n=83; placebo: n=88) were included in the intention-to-treat analysis. All the baseline data recorded for the two groups displayed comparable values. The decrease of the HAMD score between day 1 and day 42 yielded a difference of 2.5 points in favour of the sulpiride group. This difference is statistically significant (p = 0.0007). The evaluations of the cases treated for at least 14 days or for 42 days (per protocol) showed consistent values. The analysis of the CGI values showed similarly distinct and clinically relevant differences for sulpiride in comparison with placebo. The evaluation of the KUSTA scores yielded mostly comparable values for the two groups. Adverse events occurred with about the same type and frequency in both groups, with severe adverse events occurring only in two placebo patients. The laboratory parameters revealed no significant differences between the treatment groups, with the exception of prolactin which moderately exceeded the range of normal in 50% of the patients treated with sulpiride. This trial proved that sulpiride is effective and well-tolerated when given in a mean dose of 181 mg per day for mild and moderate depression.
这项多中心、随机、双盲、安慰剂对照平行组比较研究的目的是证明舒必利（150 - 300毫克）治疗轻度至中度抑郁综合征相对于安慰剂的疗效和耐受性。疗效的主要标准是比较两个治疗组从第1天到第42天的汉密尔顿抑郁量表（HAMD）总分变化过程。治疗持续时间为六周，之前有一周的安慰剂导入期。在试验前、试验期间和试验结束时测定HAMD、临床总体印象量表（CGI）和库斯塔量表（KUSTA）评分，评估耐受性，并测定实验室参数和血清催乳素水平。177名年龄在18至70岁之间、患有轻度至中度抑郁综合征（国际疾病分类第10版：F32.0、F32.1、F33.0、F33.1）且在21项HAMD量表上得分为18 - 27分的门诊患者被随机分组，其中171名患者（舒必利组：n = 83；安慰剂组：n = 88）纳入意向性分析。两组记录的所有基线数据显示出可比的值。在第1天到第42天之间，HAMD评分的下降使舒必利组比安慰剂组多2.5分。这种差异具有统计学意义（p = 0.0007）。对至少治疗14天或42天（符合方案）的病例的评估显示出一致的值。CGI值的分析表明，与安慰剂相比，舒必利也有类似明显且具有临床意义的差异。KUSTA评分的评估显示两组的值大多具有可比性。两组不良事件的类型和频率大致相同，严重不良事件仅发生在两名安慰剂组患者中。实验室参数显示治疗组之间无显著差异，但舒必利治疗的患者中有50%的催乳素中度超过正常范围。该试验证明，对于轻度和中度抑郁症患者，每天平均剂量为181毫克的舒必利有效且耐受性良好。
