0600B1‐367.
| Methods | Pooled analysis of data from 5 double‐blind, parallel group trials conducted in depressed patients in the USA, Canada and Europe. | |
| Participants | Participants were 18 years of age who met the criteria for moderate to severe depression. Patients were eligible if they reported symptoms of depression for at least 1 month before the beginning of the study and scored a minimum of 20 on the Hamilton rating scale for depression (HDRS‐21 or 26 items) on the Montgomery and Asberg Depression Rating Scale (MADRS). | |
| Interventions | Paroxetine: 81 participants. Venlafaxine XR: 165 participants. Paroxetine dose: 20 mg/day. Venlafaxine dose range: 75‐150 mg/day. |
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| Outcomes | HDRS‐21, MADRS, Clinical Global Impression (CGI) Severity. Total dropout, dropout due to side effects, dropout due to inefficacy. | |
| Notes | Exclusion criteria included significant cardiovascular, renal, hepatic or seizure disorders. In addition, patients were excluded if they had significant abnormalities on baseline physical examination, laboratory tests, ECG or a history of alcohol or drug abuse. Funding: venlafaxine manufacturer. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomized (...) patients were randomly assigned". No further details. |
| Allocation concealment (selection bias) | Unclear risk | No information provided. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "all study medications, including placebo, were given with food in the morning and were provided in identical capsules". |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "scores based on the HDRS‐17 were generated for all Intention‐to‐treat (ITT) patients and were calculated on a Last Observation Carried Forward (LOCF) basis, such that the last observation for a patient who withdrew prematurely from the study was carried forward into all subsequent periods, up to 8 weeks". |
| Selective reporting (reporting bias) | Unclear risk | Outcomes data not clearly reported. |
| Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |