Methods |
Twenty four‐week randomised, double‐blind study |
Participants |
Patients with a diagnosis of Major Depressive Disorder (MDD), who responded to the drugs in 8 weeks.
Age range: 15‐60 years
Exclusion criteria: patients received any antidepressant drug previously, had criteria for grief, adjustment disorder, MDD with psychotic features, concomitant axis II or III disorder, bipolar disorder or schizophrenia, pregnancy or breastfeeding. |
Interventions |
Fluoxetine: 49 participants
Nortriptyline: 48 participants
Fluoxetine dose range: 20‐60 mg/day
Nortriptyline dose range: 50‐150 mg/day |
Outcomes |
Primary outcome: change in the total score of Beck Depression Inventory (BDI) |
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 |
Quote: "both patients and the evaluating team were unaware of treatment allocation", no further information |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Quote: "both patients and the evaluating team were unaware of treatment allocation", no further information |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Quote: "both patients and the evaluating team were unaware of treatment allocation", no further information |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Rating scale scores reported with standard deviations, but without denominators |
Selective reporting (reporting bias) |
Unclear risk |
Adverse drug reactions reported. Number of withdrawal reported only in the total sample and without specify reasons for discontinuation |
Other bias |
Unclear risk |
Funding: unclear |