Methods |
Six‐week randomised, double‐blind study |
Participants |
Outpatients fulfilling DSM‐III criteria for major depression (lasting more than 1 month), with a score of at least 20 on the Hamilton Rating Scale for Depression (HDRS).
Age: over 18 years
Exclusion criteria: pregnancy, lactation, absence of contraception, contraindication to amitriptyline, medical illness, history of seizures, glaucoma, severe allergies, multiple adverse drug reaction, known allergy to study medication, use of MAOI within 2 weeks, use of other investigational drugs in past 2 weeks, suicidal risk, DSM‐III diagnosis such as substance abuse in the past year, schizophrenia, schizoaffective disorder, bipolar or paranoid disorder. |
Interventions |
Fluoxetine: 30 participants
Amitriptyline: 31 participants
Fluoxetine dose range: 20‐60 mg/day
Amitriptyline dose range: 50‐200 mg/day
Only chloral hydrate was allowed for sleep |
Outcomes |
HDRS, Clinical Global Impression (CGI) |
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: "fluoxetine, amitriptyline and placebo were identical in appearance", 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 |
Adverse events not reported. Endpoint scores reported with mean and standard deviation |
Other bias |
High risk |
Quote: "this work was supported in part by Eli Lilly and Company" and this company produces fluoxetine |