Methods |
Twelve‐week double‐blind study |
Participants |
Outpatients suffering from a major depressive episode, recurrent depression or disthymia according to DSM‐III‐R, with a score of at least 25 on the HARD Humeur, Agoisse, Ralentissement, Danger (HARD), Ferreri anxiety rating diagram (FARD), Hopkins Symptom check‐list (HSCL).
Age range: 25‐65 years
Exclusion criteria: not reported |
Interventions |
Fluoxetine: 104 participants
Tianeptine: 102 participants
Fluoxetine dose: 20 mg/day
Tianeptine dose: 37.5 mg/day
Benzodiazepines allowed for severe anxiety or sleep disorders |
Outcomes |
HARD and on the FARD scales |
Notes |
Funding: by industry |
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 |
Low risk |
Dropout rate reported with reasons. Scores at endpoint are reported with denominator |
Selective reporting (reporting bias) |
Unclear risk |
Full side effects reported. Other outcomes not clearly stated |
Other bias |
High risk |
Last author's affiliation was IRIS and this company produces tianeptine |