Methods |
Four‐week randomised, double‐blind, two‐centre study |
Participants |
Inpatients fulfilling DSM‐III‐R criteria for 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: serious allergies, drug and alcohol abuse, resistance to a previous treatment with an antidepressant prescribed at an effective dosage during at least 3 weeks, and therapy with MAOI in the last 14 days, or with fluoxetine in the last 5 weeks. |
Interventions |
Fluoxetine: 34 participants
Moclobemide: 36 participants
Fluoxetine dose range: 20‐40 mg/day
Moclobemide dose range: 300‐600 mg/day
Chloral hydrate and low dose of diazepam as hypnotic or/and anxiolytic were allowed |
Outcomes |
HDRS‐17, Clinical Global Impression (CGI) |
Notes |
Response: decrease of at least 50% in the HDRS‐17 total
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 dummy, 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 |
High risk |
Scores reported without denominators. Response rate was based on patients completed the trials and not on randomised patients |
Selective reporting (reporting bias) |
Unclear risk |
Number and reasons for dropouts reported. Endpoint scores at CGI not reported. Side effects reported |
Other bias |
Unclear risk |
Funding: unclear |