29060/356.
| Methods | Eight‐week, double‐blind, multicentre, randomised, comparative study. | |
| Participants | Moderate to moderately severe depression with a diagnosis of Major Depressive Disorder (MDD) (DSM‐III‐R), male or female at least 18 years old, inpatients or outpatients with a Hamilton rating scale for depression (HDRS‐17) total score 18 or more, HAMD‐10 of 1 or more. | |
| Interventions | Fluoxetine: 68 participants. Paroxetine: 70 participants. Fluoxetine dose: 20 mg/day. Paroxetine dose: 20 mg/day. | |
| Outcomes | HDRS, Hamilton rating scale for anxiety (HAM‐A), Clinical Global Impression (CGI). 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 | High risk | Quote: "Intention‐to‐treat (ITT) population consisted of all subjects randomized to active treatment and for whom one valid post‐randomization evaluation was available. Per Protocol (PP) population consisted of all subjects who had no major protocol violation with regard to inclusion/exclusion criteria, duration of treatment was at least 42 days, and no major protocol violation occurred during the first 2 weeks of active treatment. Safety population consisted of all subjects who were randomized to treatment. Primary efficacy analysis was based on both ITT and PP population". More than 20% of participants abandoned the study prematurely. |
| Selective reporting (reporting bias) | Low risk | Outcomes data were reported. |
| Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |