Methods |
Six‐week randomised, double‐blind study |
Participants |
In‐ and outpatients fulfilling DSM‐III‐R criteria for major depressive disorder, with a score of at least 16 on the Hamilton Rating Scale for Depression‐17 item (HDRS‐17).
Mean age: 47 years
Exclusion criteria: suicide risk, any other psychiatric illness, severe organic disease, alcoholism and drug abuse, use of MAOI in the previous 2 weeks and antidepressants in the previous 4 days or any investigational drugs in the previous 4 weeks, use in the past of fluoxetine or moclobemide. |
Interventions |
Fluoxetine: 50 participants
Moclobemide: 51 participants
Fluoxetine dose range: 20‐40 mg/day
Moclobemide dose range: 300‐600 mg/day
Lithium and one benzodiazepine were permitted |
Outcomes |
Primary outcomes: HDRS‐17, Clinical Global Impression (CGI) |
Notes |
Response: decrease of at least 50% in the total score or a score of maximum 10 on the HDRS‐17
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 |
Double blind, 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 dropout were reported. Denominator reported for responders was different from the number of randomised patients |
Selective reporting (reporting bias) |
Unclear risk |
Secondary outcomes not reported. Side effects and vital signs not clearly reported |
Other bias |
High risk |
Last author's affiliation is Roche S. A., Brussels, Belgium and this company produces moclobemide |