Methods |
Six‐week double‐blind, randomised study |
Participants |
Outpatients (general practice) fulfilling Research Diagnostic Criteria (RDC) criteria for primary unipolar major depressive disorder, with a score of at least 17 on the Hamilton Rating Scale for Depression (HDRS‐17).
Age range: 18‐70 years
Exclusion criteria: physical illness, use of other antidepressant medication, pregnancy, potential childbearing, lactation |
Interventions |
Fluoxetine: 49 participants
Dothiepin: 51 participants
Fluoxetine dose range: 20‐60 mg/day
Dothiepine dose range: 50‐100 mg/day |
Outcomes |
HDRS‐17 score |
Notes |
Funding: by industry |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Randomly assigned, 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 |
Quote: "a double dummy technique was employed", no further information |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Double blind, no other information |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Scores reported without denominator. Effect side reported. Number of patients randomised and number lost during follow‐up not clear |
Selective reporting (reporting bias) |
High risk |
Means and standard deviations reported only in figures |
Other bias |
High risk |
Second author had affiliation in Eli Lilly, this company produces fluoxetine |