Lepine 2001.

Methods	Multicentre, randomised, double‐blind study.
Participants	Male of female, in‐ or outpatients fulfilling DSM‐IV criteria for Major Depressive Disorder (MDD) single episode or recurrent, severity moderate to severe, without psychotic features, with or without melancholic features and, for recurrent disorders, with or without seasonal pattern and inter‐episode recovery), were eligible for the study. To be selected, patients had to present at D7 a minimum severity score of 25 on the Montgomery and Asberg Depression Rating Scale (MADRS) and of 9 on the Hamilton rating scale for depression (HDRS) (items 1,2,7,8,10 and 13). These severity criteria also had to be present at inclusion, and those patients with a decrease of 30% or more on MADRS or HDRS global scores were excluded. Patients fulfilling DSM‐IV criteria for other Major Depressive Disorders: Bipilar I or II Disorders, dysthymic disorder, cyclothymic disorder, mixed anxio‐depressive disorder, recurrent brief depressive disorder, schizophrenia or any other acute or chronic psychosis and patients whose present disorder was due to a general medical condition or to a substance were not eligible for the study.
Interventions	Paroxetine: 165 participants. Tianeptine: 162 participants. Paroxetine dose: 20 mg/day. Tianeptine dose: 37,5 mg/day. Treatment with a benzodiazepine during the last 2 weeks, or for more then 1 month during the last 6 months, or at daily dose equal to or greater the an equivalent of 15mg of diazepam on a lifetime period, were also non‐inclusion criteria.
Outcomes	MADRS, CPRS, HDRS, Hamilton rating scale for anxiety (HAM‐A), Clinical Global Impression (CGI), Severity of Depression Questionnaire (QSD), Hospital Anxiety and Depression (HAD), Mood and Anxiety Symptom Questionnaire (MASQ), Visual Analogue Scale (VAS). Total dropout, dropout due to side effects, dropout due to inefficacy. Number of patients experiencing at least one side effect, side‐effect profile.
Notes	This study was independent from pharmaceutical industry.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "randomized". No further details.
Allocation concealment (selection bias)	Unclear risk	No information provided.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "double blind". No further details.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "double blind". No further details.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "analysis of the efficacy data was performed both on the Intention‐to‐treat (ITT) population (ITT: all patients with at least one evaluation under treatment) and on the Per Protocol (PP) population (PP: all completed patients without major deviation, according to the study protocol). The analysis was done at the endpoint for the ITT population and visit by visit for the PP population. The analysis of safety used all patients who had taken at least one dose of randomized treatment". Less than 20% of participants in both arms withdrew from the study prematurely.
Selective reporting (reporting bias)	Low risk	Outcomes data were reported.
Other bias	Low risk	This study was independent from pharmaceutical industry.