Baldwin 2006.
Methods | Twenty‐seven‐week double‐blind, randomised, multicentre study. For efficacy data we consider only the first eight weeks. | |
Participants | Setting unclear, patients meeting DSM‐IV for major depressive episode, with a minimum baseline score of 22 on the Montgomery and Asberg Depression Rating Scale (MADRS). Age: older than 18 years. | |
Interventions | Paroxetine: 101 participants.
Escitalopram: 105 participants. Paroxetine dose range: 20‐40 mg/day. Escitalopram dose range: 10‐20 mg/day. For patients who had received benzodiazepines for at least 6 months prior to continue these agents, providing the dose remained unchanged throughout the study period. |
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Outcomes | MADRS, Arizona sexual experience scale (ASEX). 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: escitalopram manufacturer. Adverse events reported only if occurring in >= 5% of any treatment group. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patients were assigned to escitalopram or paroxetine treatment according to a computer‐generated randomization list". |
Allocation concealment (selection bias) | Low risk | Quote: "the details of the randomization series were unknown to any of the investigators and were unknown to any of the investigators and were contained in a set of opaque envelops". |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "all study personnel and participants were blinded to treatment assignment for the duration of the study". "Treatment was in the form of tablets of identical appearance, taste and smell". |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "all study personnel and participants were blinded to treatment assignment for the duration of the study". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Efficacy analyses were conducted for the modified Intention‐to‐treat (ITT) population which included all randomized patients who took at least one dose of double blind study medication and who had least one valid post baseline MADRS assessment. |
Selective reporting (reporting bias) | High risk | Standard deviations of change score for depression were not reported. Adverse events were reported only if occurring in >= 5% of any treatment group. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out |