| Methods |
Six‐week double‐blind, randomised study |
| Participants |
Outpatients fulfilling DSM‐IV criteria for major depressive episode (lasting between 1 week and 1 year), with a score of at least 15 on the Hamilton Rating Scale for Depression‐17 item (HDRS‐17).
Age range: 18‐75 years
Exclusion criteria: pregnancy, lactation, actual suicide risk, history of current diagnosis of bipolar disorder, schizophrenia, psychotic symptoms, organic mental disorder, current diagnosis on DSM‐IV of anxiety or eating disorder, epilepsy, alcohol or substance abuse in the previous 6 months, serious medical diseases. |
| Interventions |
Fluoxetine: 66 participants
Mirtazapine: 66 participants
Fluoxetine dose range: 20‐40 mg/day
Mirtazapine dose range: 30‐45 mg/day |
| Outcomes |
HDRS‐17, Clinical Global Impression (CGI) |
| 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 other information |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Double blind, no other information |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Double blind, no other information |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Rating scale scores reported without denominator. Mean scores reported without standard deviations |
| Selective reporting (reporting bias) |
Unclear risk |
Only main reasons for premature discontinuation reported. Adverse events reported for more than 5% of the subjects |
| Other bias |
Unclear risk |
Funding: unclear |
