| Methods |
Six‐week randomised, double‐blind study |
| Participants |
Outpatients fulfilling DSM‐III criteria for unipolar major depression (single or recurrent episode), with a score of at least 20 on the Hamilton Rating Scale for Depression (HDRS) and Raskin Depression Scale (RDS) score of at least 8 and equal or greater to the Covi Anxiety Scale (CAS) score.
Age: over 64 years
Exclusion criteria: history of, or current conditions that might put them at risk or that precluded evaluation of the results |
| Interventions |
Fluoxetine: 78 participants
Doxepine: 79 participants
Fluoxetine dose range: 20‐80 mg/day
Doxepine dose range: 50‐250 mg/day |
| Outcomes |
HDRS, Clinical Global Impression (CGI) Severity, RDS, CAS scores |
| 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 |
Quote: "the study drugs and placebo were supplied in identical capsules", 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 |
Scores reported without denominators. Reasons and number of early termination not clear |
| Selective reporting (reporting bias) |
High risk |
Adverse effects were described only when reported by more than 10% of the sample. Mean scores reported without standard deviations |
| Other bias |
Unclear risk |
Funding: unclear |
