| Methods |
Eight‐week double‐blind, randomised study |
| Participants |
Outpatients fulfilling DSM‐III and Bech‐Rafaelsen Melancholia Scale criteria for major depressive disorder, with a score of at least 18 on the Hamilton Rating Scale for Depression (HDRS‐21).
Age range: 18‐70 years
Exclusion criteria: suicide risk, history of schizophrenia or organic brain dysfunction, history of severe allergies or serious physical illness, recent period of alcohol or alcohol abuse, pregnancy. |
| Interventions |
Fluoxetine: 29 participants
Imipramine: 30 participants
Fluoxetine dose: 20 mg/day
Imipramine dose range: 75‐150 mg/day |
| Outcomes |
HDRS‐21, Bech‐Rafaelsen Melancholia Scale (MES), Clinical Global Impression (CGI), Patient Global Impression (PGI) |
| 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 |
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 |
Unclear risk |
Reasons and numbers of dropouts reported. Scores reported without denominator |
| Selective reporting (reporting bias) |
Unclear risk |
Only most frequent side effects reported. End point scores and standard deviation not clearly reported |
| Other bias |
High risk |
One of the authors' affiliation was Eli Lilly, Denmark. This company produces fluoxetine |
