Cassano 2002a.
Methods | Eight‐week, double‐blind, randomised, multicentre study. | |
Participants | Outpatients meeting DSM‐IV criteria for major depression (no patients with bipolar disorder) with a minimum score of 18 on the Hamilton rating scale for depression (HDRS). Age range: 18‐75 years. |
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Interventions | Paroxetine: 139 participants. Amisulpride: 138 participants. Paroxetine dose range: 20 mg/day. Amisulpride dose range: 50 mg/day. Benzodiazepine or hypnotic given at a stable dose were permitted. |
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Outcomes | HDRS, Montgomery and Asberg Depression Rating Scale (MADRS), Clinical Global Impression (CGI). Total dropout, dropout due to inefficacy, dropout due to side effects, number of patients experiencing at least one side effect, side‐effect profile. |
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Notes | Funding: amisulpride 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 | Low risk | Less than 20% of the allocated patients to both of the intervention arms dropped out during the study. The primary efficacy analysis was performed on the Per Protocol (PP) population that included all randomized patients fully compliant with the protocol during the active treatment period and having at least one evaluation of the primary endpoint after baseline. Consistency of results was assessed in the Intention‐to‐treat (ITT) population. For patients not completing the trial the Last Observation Carried Forward (LOCF) was analysed. |
Selective reporting (reporting bias) | High risk | Side effects reported only if statistically significant. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |