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. |