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. 2014 Apr 3;2014(4):CD006531. doi: 10.1002/14651858.CD006531.pub2

PAR MDUK 032.

Methods Six‐week, randomised, double‐blind, double‐dummy, parallel‐group comparative study.
Participants Male and female patients, aged 18 to 75 years, suffering from reactive or endogenous unipolar depression according to the DSM‐III criteria, considered suitable for treatment with anti‐depressant drugs, and also having a minimum score of 17 on the first 17 items of the Hamilton rating scale for depression (HDRS‐21), were eligible for the inclusion in the study.
Interventions Paroxetine: 29 participants.
 Amitriptyline: 30 participants.
Paroxetine dose range: 20‐30 mg/day.
 Amitriptyline dose range: 100‐150 mg/day.
Outcomes HDRS‐21, Physician's Global Assessment of Severity of Illness (PGAS). Total dropout, dropout due to side‐effects, dropout due to inefficacy. Number of patients experiencing at least one side effect, side‐effect profile.
Notes Funding: paroxetine manufacturer.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomized". No further details.
Allocation concealment (selection bias) Unclear risk No information provided.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "double blind". No further details.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "double blind". No further details.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Quote: "the main analyses were carried out on the Inten‐to‐treat (ITT) population using the extender dataset ‐ a dataset that has missing values imputed by Last Observation Carried Forward (LOCF)".
Selective reporting (reporting bias) High risk Continuous outcomes data reported without Standard deviations.
Other bias Unclear risk Sponsorship bias cannot be ruled out.