[Long-term treatment using antidepressants. Tianeptine: methodology of a long-term study and preliminary results].
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.