Olié J P, Guelfi J D, Malka R, Dulcire C, Kamoun A, Lôo H
Hôpital Sainte-Anne, Paris.
Encephale. 1988 Sep-Oct;14(5):379-84.
Numerous authors insist on the need for prolonged prescription of antidepressant drugs. Legislation develops and now requires long-term controls for psychotropic drugs. In order to assess long-term efficacy and safety of tianeptine, a clinical trial was undertaken with the objective of 100 patients completing one year of treatment. This multicentered study involves 157 psychiatrists all over France, under the responsibility of a national coordinator and 19 regional coordinators. The methodology is explained, as well as the various means that have been planned to set up the protocol, to follow the case reports and to analyse the results. The use of a central computer assisted monitoring and the organization of national and regional meetings with the investigators seem to take an important part in the management of the study. Preliminary results after 6 months of treatment for 478 patients are discussed. They confirm the prolonged efficacy and the safety of tianeptine. The effective contribution made by the logistic support should allow the study to reach its objectives. When completed, it should be a pilot study for further long-term studies with antidepressants.
众多作者坚持认为需要延长抗抑郁药物的处方时间。立法不断发展，现在要求对精神药物进行长期管控。为了评估噻奈普汀的长期疗效和安全性，开展了一项临床试验，目标是100名患者完成一年的治疗。这项多中心研究涉及法国各地的157名精神科医生，由一名国家协调员和19名地区协调员负责。文中解释了研究方法，以及为制定方案、跟踪病例报告和分析结果而计划采用的各种方法。使用中央计算机辅助监测以及与研究人员组织全国性和地区性会议似乎在研究管理中发挥着重要作用。文中讨论了478名患者治疗6个月后的初步结果。这些结果证实了噻奈普汀的长期疗效和安全性。后勤支持所做出的有效贡献应能使该研究实现其目标。完成后，它应为进一步的抗抑郁药物长期研究提供一个试点研究。
