Feighner 1989.
Methods | Six‐week double‐blind, randomised, parallel group, single‐centre, placebo‐controlled study. | |
Participants | Outpatients meeting DSM‐III criteria for major depression with a minimum score of 18 on Hamilton rating scale for depression (HDRS‐17). Age: older than 18 years. | |
Interventions | Paroxetine: 40 participants. Imipramine: 40 participants. Placebo: 40 participants. Paroxetine dose range: 10‐50 mg/day. Imipramine dose range: 65‐275 mg/day. |
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Outcomes | HDRS‐21, Clinical Global Impression (CGI) Improvement, Severity, Montgomery and Asberg Depression Rating Scale (MADRS), Patient Global Experience (PGE). Total dropout, dropout due to side effect, dropout due to lack of efficacy. 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 | Study endpoint: 19/40 missing from paroxetine group, 26/40 missing from control group. |
Selective reporting (reporting bias) | High risk | Dichotomous outcome not reported. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |