Methods |
Five‐week randomised, double‐blind study |
Participants |
In‐ and outpatients fulfilling RDC (Research Diagnostic Criteria) for unipolar major depressive disorder with a score of at least 17 on the first 17 items of the Hamilton Rating Scale for Depression (HDRS) and a score of at least 8 and equal to or higher than the Covi Anxiety Scale (CAS) score. Age mean: 40.7 (fluoxetine); 42.7 (doxepin). Exclusion criteria: history of drug abuse, concurrent administration of other psychotropic drugs including lithium. |
Interventions |
Fluoxetine: 26 participants
Doxepine: 25 participants
Fluoxetine dose range: 40‐80 mg/day
Doxepine dose range: 50‐150 mg/day
Chloral hydrate and oxazepam were allowed |
Outcomes |
HDRS, Clinical Global Impression (CGI), Raskin Depression Scale (RDS), CAS |
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 |
Unclear risk |
Number and reasons for dropout reported, but not included in the analysis |
Selective reporting (reporting bias) |
Unclear risk |
Endpoint mean scores reported without standard deviations. Only most common side effects reported |
Other bias |
Unclear risk |
Funding: unclear |