Methods |
Six‐week randomised, double‐blind, multicentre study |
Participants |
In‐ and outpatients fulfilling ICD‐10 criteria for depressive episode, recurrent depressive disorder, or bipolar affective disorder (depressive), with a score of at least 25 on the Montgomery and Asberg Scale for Depression (MADRS), requiring an antidepressant treatment.
Age range: 18‐65 years
Exclusion criteria: severe risk of suicide, acute or chronic psychosis, failure to respond to 2 antidepressants for the current depressive episode, previous history of drug abuse or dependence, severe somatic diseases in evolution, current treatment with barbiturate, buspirone, anti‐epileptic drugs, use of diazepam, lorazepam and alprazolam. |
Interventions |
Fluoxetine: 196 participants
Tianeptine: 191 participants
Fluoxetine dose: 20 mg/day
Tianeptine dose: 37.5 mg/day |
Outcomes |
Primary outcome: MADRS global score
Secondary outcomes: decrease of at least 50% in MADRS global score (responder patients) and Clinical Global Impression (CGI) scores |
Notes |
Funding: unclear |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Randomised, no further information |
Allocation concealment (selection bias) |
Unclear risk |
No information provided |
Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Double blind, no further information |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Double blind, no further information |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Double blind, no further information |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Number and reasons for discontinuation reported, but withdrawal was not included in the analysis |
Selective reporting (reporting bias) |
Unclear risk |
Only serious adverse events reported. End point mean scores reported with standard deviations |
Other bias |
Unclear risk |
Funding: unclear |