Methods |
Six‐week randomised, double‐blind study |
Participants |
In‐ and outpatients fulfilling DSM‐III‐R criteria for major depression without psychotic features, with a score of at least 17 on the Hamilton Rating Scale for Depression‐17 item (HDRS‐17).
Age range: 18‐70 years
Exclusion criteria: suicidal intent, any other psychiatric illness, severe organic disease, alcoholism and drug abuse, use of MAOI in the preceding 2 week, use of an antidepressant drug in the previous 4 days, or any investigational drug in the preceding 4 weeks, patients who ever received fluoxetine or moclobemide. |
Interventions |
Fluoxetine: 25 participants
Moclobemide: 24 participants
Fluoxetine dose range: 20‐40 mg/day
Moclobemide dose range: 300‐600 mg/day
Only lithium and bromazepam were allowed |
Outcomes |
Final score of less than 10 or a decrease of at least 50% from baseline on the HDRS‐17, Clinical Global Impression (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:"patients received capsules of identical appearance and taste", 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 |
End‐point scores reported without denominators. Analysis of HDRS scores were based on completers, instead of on randomised patients |
Selective reporting (reporting bias) |
Unclear risk |
Number and reasons of withdrawals reported. Adverse effects reported |
Other bias |
High risk |
Last author's affiliation was Roche Industry and this company produces moclobemide |