Methods |
Five‐week randomised, double‐blind, multicentre study |
Participants |
Outpatients fulfilling DSM‐III‐R criteria for major depression (single episode or recurrent).
Age range: 18‐65 years
Exclusion criteria: concurrent diagnosis of bipolar disorder or schizophrenia, hyperactivity or agitation, presence of hyper thyroidism or a clinically unstable medical condition, history of narrow angle glaucoma, urinary retention, seizures or substance abuse, MAOI use within 14 days of baseline, pregnancy, lactation, potential childbearing, history of allergy to the study drugs. |
Interventions |
Fluoxetine: 103 participants
Nortriptyline: 102 participants
Fluoxetine dose range: 20‐40 mg/day
Nortriptyline dose range: 50‐100 mg/day |
Outcomes |
Hamilton Rating Scale for Depression (HDRS), Zung Depression Scale, 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 further information |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Quote: "patients received two bottles of identical capsules". No further information |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Unclear if blinding was successful |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Number and reasons for withdrawal reported. No endpoint scores (CGI, Zung Depression Scale) reported |
Selective reporting (reporting bias) |
Unclear risk |
Scores reported without standard deviations. Only most common adverse events were reported |
Other bias |
Unclear risk |
Funding: unclear |