Efficacy and safety of tianeptine in major depression: evidence from a 3-month controlled clinical trial versus paroxetine.
OBJECTIVE
This study was performed to compare the efficacy and safety of tianeptine and paroxetine in the treatment of major depression. Anxiolytic drug use was systematically reported to provide an indirect evaluation of the anxiolytic activity of both treatments. Zopiclone use was assessed to provide an indirect evaluation of the possible hypnotic activity of both treatments.


METHODS
This was a 3-month controlled, randomised, double-blind clinical trial which involved 82 centres in France.


METHODS
277 outpatients who met DSM-IV criteria for major depression.


METHODS
Patients were treated with either tianeptine (12.5mg three times daily) or paroxetine (20mg once daily plus two placebo capsules). The drug dosages could be doubled after 3 weeks if required by the patient's medical state.


RESULTS
There was a significant decrease in the Montgomery-Asberg Depression Rating Scale score in both groups (from 28.9 at baseline to 11 at endpoint in the tianeptine group, and from 29.6 to 11.6 in the paroxetine group) after 3 months of treatment. No significant difference was evident between the groups. Secondary criteria confirmed the antidepressant efficacy of both medications, with no difference between tianeptine and paroxetine (Hamilton Depression Rating Scale global score at endpoint, Clinical Global Impression final scores, number of responders, delay-to-response, rate of dosage doubling at day 21). The anxiolytic and hypnotic consumption rates decreased in both groups, with no significant difference between the groups. There was no significant difference in clinical safety parameters.


CONCLUSIONS
Tianeptine appears to be as effective and as safe as paroxetine for the ambulatory treatment of major depression.
Waintraub
Lionel
L
Service de Psychiatrie du Pr. J.D. Guelfi, Centre Hospitalier Paul Brousse, Villejuif, France. lionel.waintraub@pbr.ap-hop-paris.fr
Septien
Lucia
L
Azoulay
Paul
P
D000293:Adolescent; D000328:Adult; D014151:Anti-Anxiety Agents / Q000627:therapeutic use; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D000929:Antidepressive Agents, Tricyclic / Q000009:adverse effects / Q000627:therapeutic use*; D053961:Azabicyclo Compounds; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D017374:Paroxetine / Q000009:adverse effects / Q000627:therapeutic use*; D010349:Patient Compliance; D010879:Piperazines / Q000627:therapeutic use; D011569:Psychiatric Status Rating Scales; D012893:Sleep Wake Disorders / Q000188:drug therapy; D013841:Thiazepines / Q000009:adverse effects / Q000627:therapeutic use*
D014151:Anti-Anxiety Agents; D018687:Antidepressive Agents, Second-Generation; D000929:Antidepressive Agents, Tricyclic; D053961:Azabicyclo Compounds; D006993:Hypnotics and Sedatives; D010879:Piperazines; D013841:Thiazepines; C515050:zopiclone; C050504:tianeptine; D017374:Paroxetine