Methods |
Six‐week randomised, double‐blind study |
Participants |
Outpatients fulfilling DSM‐III‐R criteria for major depressive illness, with a score of at least 20 on the Hamilton Rating Scale for Depression‐17 item (HDRS‐17), a score of at least 8 on the Raskin Depression Scale (RDS) and greater than the Covi Anxiety Scale (CAS) score.
Mean age: 51 years in both groups
Exclusion criteria: not stated |
Interventions |
Fluoxetine: 20 participants
Amitriptyline: 21 participants
Fluoxetine dose range: 40‐80 mg/day
Amitriptyline dose range: 150‐300 mg/day |
Outcomes |
HDRS‐17, RDS , CAS, Clinical Global Impression (CGI) Improvement and Severity, 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 |
Quote: "capsules that looked identical were supplied to all patients in two bottles marked 'morning dose' and 'bedtime dose'", 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 early termination reported. Scores reported without denominator |
Selective reporting (reporting bias) |
Unclear risk |
Adverse events reported. End point scores reported without standard deviation |
Other bias |
High risk |
Quote: "supported by a grant from Eli Lilly & Company", this company produces fluoxetine |