[Patients treated for one year with tianeptine. Results at one of the centers of South-Eastern France].
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)
Souche
A
A
D.U.P.A., Hôpital de Cery, Prilly-Lausanne, Suisse.
Duclaud
L
L
Zekri
J R
JR
Yzombard
G
G
Masquin
L
L
Vallée
D
D
Leibovici
G
G
Magnan
M
M
Rouzier
G
G
Dufour
H
H
D000328:Adult; D000368:Aged; D000929:Antidepressive Agents, Tricyclic / Q000627:therapeutic use*; D003866:Depressive Disorder / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D005602:France; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D012008:Recurrence; D013841:Thiazepines / Q000627:therapeutic use*; D013997:Time Factors
D000929:Antidepressive Agents, Tricyclic; D013841:Thiazepines; C050504:tianeptine
Patients traités un an par la tianeptine. Présentation des résultats obtenus par l'un des Centres du Sud-Est de la France.