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. 2013 Jul 17;2013(7):CD004185. doi: 10.1002/14651858.CD004185.pub3

Preskorn 1991.

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