Gilmor 2002.
Methods | Seven‐week randomised, open‐label, parallel‐group, forced‐titration multicentre study. | |
Participants | Outpatients fulfilling DSM‐IV criteria for major depressive disorder, with a score of at least > or = 20 on the Montgomery and Asberg Depression Rating Scale (MADRS). Age range: 18‐57 years. | |
Interventions | Paroxetine: 38 participants. Desipramine: 14 participants. Paroxetine dose range: 10‐60 mg/day. Desipramine dose range: 50‐300 mg/day. |
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Outcomes | MADRS, Clinical Global Impression (CGI). Total dropout. |
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Notes | Funding: paroxetine manufacturer. This study was conducted in order to evaluate inhibition of norepinephrine uptake in patient with major depression, so it is not a study of efficacy or tolerability. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomly assigned to paroxetine or desipramine in a 3‐to‐1 ratio respectively". |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "open‐label". No further details. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "open‐label". No further details. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Dichotomous outcome not reported. Adverse events were not reported. Incomplete reporting of dropout due to side effects, dropout due to inefficacy. |
Selective reporting (reporting bias) | High risk | Dichotomous outcome not reported. Adverse events were not reported. Incomplete reporting of dropout due to side effects, dropout due to inefficacy. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |