Souche A, Duclaud L, Zekri J R, Yzombard G, Masquin L, Vallée D, Leibovici G, Magnan M, Rouzier G, Dufour H
D.U.P.A., Hôpital de Cery, Prilly-Lausanne, Suisse.
Encephale. 1990 May-Jun;16(3):181-7.
Tianeptine is a new antidepressant with a tricyclic molecular structure. Its main neurochemical effect consists in an increase in serotonine re-uptake. Its efficacy as antidepressant and its good clinical safety have been confirmed in controlled trials against reference drugs. 1,231 patients with a DSM III diagnosis of major depression or dysthymic disorder were included in a long-term trial with tianeptine. 510 patients completed the one-year treatment period. The results of a subgroup of 100 patients treated in one of the centres of south-east France will be presented. 47 of these patients completed the trial. This study allowed to evaluate the therapeutic efficacy as well as the clinical safety of tianeptine during long-term prescription. Patients were treated in an open design after a 4-7 day placebo washout period. Therapeutic effects were assessed by the C.G.I. items (1 and 2), MADRS, HARS and HSCL. For the evaluation of clinical and paraclinical safety, spontaneous complaints of the patients and CGI-3 were documented; body weight, blood pressure and blood chemistry were also measured. Homogeneity between completers and non-completers was tested before statistical analysis of the clinical effects. Results of completers were analyzed using a two-way ANOVA (time x subjects); Newman-Keuls tests were performed in the case of a significant time effect. End-point analysis was used to test the results of the total sample. Patients completing the trial had a mean MADRS baseline score of 32.8. Given high this score, the patients have to be considered genuinely depressed at inclusion.(ABSTRACT TRUNCATED AT 250 WORDS)
噻奈普汀是一种具有三环分子结构的新型抗抑郁药。其主要神经化学作用在于增加血清素的再摄取。在与参比药物对照的临床试验中，已证实其作为抗抑郁药的疗效及良好的临床安全性。1231例诊断为DSM-III重度抑郁或心境恶劣障碍的患者纳入了一项噻奈普汀的长期试验。510例患者完成了为期一年的治疗期。将呈现法国东南部一个中心治疗的100例患者亚组的结果。其中47例患者完成了试验。本研究得以评估噻奈普汀长期处方时的治疗疗效及临床安全性。在4 - 7天的安慰剂洗脱期后，患者采用开放设计进行治疗。通过临床总体印象量表（C.G.I.）项目（1和2）、蒙哥马利抑郁评定量表（MADRS）、汉密尔顿焦虑量表（HARS）和症状自评量表（HSCL）评估治疗效果。为评估临床和副临床安全性，记录患者的自发主诉及C.G.I.-3；还测量了体重、血压和血液生化指标。在对临床效果进行统计分析前，检验完成者与未完成者之间的同质性。使用双向方差分析（时间×受试者）分析完成者的结果；在时间效应显著的情况下进行纽曼-基尔斯检验。采用终点分析检验总样本的结果。完成试验的患者蒙哥马利抑郁评定量表基线平均得分为32.8。鉴于该分数较高，这些患者在纳入时必须被视为真正抑郁。（摘要截短于250字）
