Efficacy and safety of tianeptine in the treatment of depressive disorders in comparison with fluoxetine.
BACKGROUND
Depression is treated by a great variety of antidepressant treatments. SSRIs (such as fluoxetine) are well known: it is, however, sure that further progress is needed and the search for antidepressants with other mechanisms of action (such as tianeptine) or different efficacy is still of interest.


METHODS
A multinational study compared tianeptine with fluoxetine in 387 patients with Depressive Episode, or Recurrent Depressive Disorder, or Bipolar Affective Disorder (ICD-10), in a double-blind parallel group design. They were treated for six weeks.


RESULTS
At inclusion, no significant difference between groups was shown. Final MADRS scores were 15.7 and 15.8 with tianeptine and fluoxetine, respectively (ITT population) (p = 0.944). MADRS responders were 58% and 56% with tianeptine and fluoxetine, respectively (p = 0.710). No statistical difference was observed for the other efficacy parameters. Thirty-six withdrawals occurred in each group, without any difference for the reasons of discontinuation. There was no major difference between groups for the other safety parameters.


CONCLUSIONS
In this study, both tianeptine and fluoxetine exhibited a good efficacy and safety.
Lôo
H
H
Service Hospitalo Universitaire de Santé Mentale et de Therapeutique, Sainte-Anne Hospital, Paris, France.
Saiz-Ruiz
J
J
Costa e Silva JACE
Ansseau
M
M
Herrington
R
R
Vaz-Serra
A
A
Dilling
H
H
de Risio
S
S
D000293:Adolescent; D000328:Adult; D000368:Aged; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D000929:Antidepressive Agents, Tricyclic / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D003866:Depressive Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013841:Thiazepines / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
D018687:Antidepressive Agents, Second-Generation; D000929:Antidepressive Agents, Tricyclic; D013841:Thiazepines; D005473:Fluoxetine; C050504:tianeptine