| 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 18 on the Hamilton Rating Scale for Depression‐21 item (HDRS‐21) and 20 on the Mini Mental State Examination (MMSE).
Age range: 60‐80 years
Exclusion criteria: history of serious allergies or alcohol and drug abuse in the last year, diagnosis of schizophrenia, dementia, glaucoma, prostatic hypertrophia, recent stroke, serious internal disease, and/or surgical conditions that could interfere with study drugs. |
| Interventions |
Fluoxetine: 20 participants
Mianserin: 20 participants
Fluoxetine dose: 20 mg/day
Mianserin dose: 40 mg/day |
| Outcomes |
HDRS‐21, Geriatric Depression Scale (GDS), Geriatric Rating Scale (GRS) |
| Notes |
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 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 |
Quote: "the statistical evaluation was conducted on the patients who completed the trial". The analysis was not conducted on ITT basis |
| Selective reporting (reporting bias) |
Unclear risk |
Number and reasons of adverse events reported. Endpoint scores reported without standard deviations |
| Other bias |
Unclear risk |
Funding: unclear |
