Lôo H, Ganry H, Marey C, Briole G, Castelnau D, Charbonnier J F, Dachary J M, Danion J M, Darcourt G, Capdeville C
Service Hospitalo-Universitaire de Santé Mentale et de Thérapeutique, Hôpital Sainte-Anne, Paris.
Encephale. 1990 Nov-Dec;16(6):445-52.
Tianeptine, a new antidepressant, has a tricyclic molecular structure. Its main biochemical activity consists of an increase in the reuptake of 5 HT both in men and animals, after acute and chronic administration. Tianeptine demonstrated its antidepressive clinical efficacy in several double-blind versus reference drug trials. A multicentre open trial, including depressed patients enabled us to evaluate the safety of tianeptine and to control the maintenance of the therapeutic efficacy in the course of its long-term prescription. Depressed patients included showed a major depressive episode, single (296.22) or recurrent (296.32) without melancholia or psychotic features, or a dysthymic disorder (300.40), according to DSM III criteria. A minimum MADRS score of a least 25, and the informed consent of the patients were required. The dose of tianeptine was 3 tablets per day (12.5 mg/tablet) with the possibility of increasing to 4 or decreasing to 2 tablets per day, depending on the symptomatology. Therapeutic efficacy was evaluated by item 1 and 2 of the Global Clinical Impression (CGI), the Montgomery and Asberg Depression Rating Scale (MADRS), the Hamilton Anxiety Rating Scale (HARS) and the Hopkins Symptom Check-List (HSCL). Clinical and paraclinical safety were evaluated by CGI item 3, standardized ratings of patients' complaints (CHESS 84), interruption for side effects, evaluation of blood pressure, weight, biological parameters, EKGs. This intermediate evaluation concerns the first 170 depressed patients treated over a one-year period as well as the total group of patients included (n = 447).(ABSTRACT TRUNCATED AT 250 WORDS)
噻奈普汀是一种新型抗抑郁药，具有三环分子结构。急性和慢性给药后，其主要生化活性包括增加人和动物体内5-羟色胺（5-HT）的再摄取。在多项与参比药物的双盲试验中，噻奈普汀显示出了抗抑郁的临床疗效。一项多中心开放性试验纳入了抑郁症患者，使我们能够评估噻奈普汀的安全性，并在其长期处方过程中控制治疗效果的维持情况。根据《精神疾病诊断与统计手册》第三版（DSM III）标准，纳入的抑郁症患者表现为单次（296.22）或复发性（296.32）重度抑郁发作，无抑郁或精神病性特征，或为恶劣心境障碍（300.40）。患者的蒙哥马利-阿斯伯格抑郁评定量表（MADRS）最低得分至少为25分，并需获得患者的知情同意。噻奈普汀的剂量为每日3片（每片12.5毫克），可根据症状增加至每日4片或减少至每日2片。通过整体临床印象（CGI）的第1项和第2项、蒙哥马利-阿斯伯格抑郁评定量表（MADRS）、汉密尔顿焦虑评定量表（HARS）和霍普金斯症状清单（HSCL）评估治疗效果。通过CGI第3项、患者投诉的标准化评分（CHESS 84）评估临床和副临床安全性，包括因副作用导致的治疗中断、血压、体重、生物学参数、心电图评估。这项中期评估涉及在一年期间接受治疗的前170名抑郁症患者以及纳入的患者总数（n = 447）。（摘要截选至250字）
