Aoba 2004.
Methods | Six‐week, double‐blind, randomised study. | |
Participants | Inpatients and outpatients meeting DSM‐IV criteria for major depression (no patients with bipolar disorder). Age range: 18‐65 years. | |
Interventions | Paroxetine: 106 participants. Imipramine: 104 participants. Paroxetine dose: 20‐40 mg/day. Imipramine dose: 50‐150 mg/day. |
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Outcomes | Hamilton rating scale for depression (HDRS‐17), 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: 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 | Unclear risk | Study endpoint: 22/106 missing from paroxetine group; 31/104 missing from control group. All safety analyses were performed on safety population. Efficacy analyses were performed on FAS population and the Last Observation Carried Forward (LOCF) dataset was used. The FAS population consisted in all subjects who have entered the treatment phase with the exception of those who did not meet the major eligibility criteria, those who did not take any study medication during the treatment phase and those with no valid post baseline assessment. |
Selective reporting (reporting bias) | High risk | Mean change from baseline only reported as "rate of decrease from baseline at endpoint". |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |