Methods |
Six‐week randomised, double‐blind, four‐centre study |
Participants |
Inpatients fulfilling DSM‐III‐R criteria for non‐psychotic major depression, with a score of at least 18 on the Hamilton Rating Scale for Depression‐17 item (HDRS‐17).
Age range: 18‐65 years
Exclusion criteria: history of any psychoactive disorder, bipolar mood disorder, substance abuse disorder, somatic disorder, glaucoma, urinary retention and/or prostatic disease and known allergy to maprotiline, pregnancy, absence of contraception, use of MAOI within 2 weeks and depot neuroleptics within 4 weeks of study entry, concomitant psychotropic active medication, with the exception of midazolam, max 15 mg, or medazepam, max 5 mg, for insomnia. |
Interventions |
Fluoxetine: 59 participants
Maprotiline : 46 participants
Fluoxetine dose: 20 mg/day
Maprotiline dose range: 100‐200 mg/day |
Outcomes |
HDRS‐17, Clinical Global Impression‐Severity (CGI) |
Notes |
Funding: by industry |
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: "to maintain the blind, all patients took three capsules of study medication every day", no further information |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Double blind, no further information |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Number and reasons for discontinuation were not reported. Scores reported without denominator |
Selective reporting (reporting bias) |
Unclear risk |
Endpoint scores reported with standard deviation. Side effects not reported |
Other bias |
High risk |
Quote: "this work was sponsored by Eli Lilly and Company". This company produces fluoxetine |