| Methods |
Six‐week double‐blind, randomised multicentre study |
| Participants |
Outpatients fulfilling DSM‐III‐R criteria for major depressive episode, with a score of at least 25 on Montgomery and Asberg Scale for Depression (MADRS) and of at least 4 on Clinical Global Impression Scale (CGI).
Age range: 19‐68 years
Exclusion criteria: serious or uncontrolled medical illness, major anxiety, agitation, suicide risk, resistance during the current episode to at least two antidepressants, substance abuse or dependence, concomitant therapy with lithium, MAOIs, long‐acting neuroleptic. |
| Interventions |
Fluoxetine: 93 participants
Milnacipram: 97 participants
Fluoxetine dose: 20 mg/day
Milnacipram dose: 100 mg/day |
| Outcomes |
Hamilton Rating Scale for Depression‐24 item (HDRS‐24), MADRS, CGI |
| Notes |
Funding: by industry |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "randomly assigned". No further information |
| Allocation concealment (selection bias) |
Unclear risk |
No information provided |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Quote: "double blind", no further information |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Quote: "double blind", no further information |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Quote: "double blind", no further information |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Number and reasons for drop‐out reported. Rating scale scores reported without denominator |
| Selective reporting (reporting bias) |
High risk |
Endpoint scores reported only in figures. Side effects reported |
| Other bias |
High risk |
Last author's affiliation was Laboratories Pierre Fabre Medicament, and this company produces milnacipran |
