Wijkstra 2010.
Study characteristics | ||
Methods | Randomised, double‐blind study | |
Participants |
DSM‐IV‐defined psychotic depression Inpatients |
|
Interventions | 7 weeks of treatment with imipramine (plasma levels 200 to 300 μg/L), venlafaxine (375 mg/d), venlafaxine + quetiapine (375 mg/d + 600 mg/d) | |
Outcomes | Dichotomous data: study author defined (response). Response is ≧ 50% decrease in HAM‐D 17 scores from baseline to study endpoint, and final HAM‐D score ≦ 14. Remission is HAMD ≦ 7 (not predefined) | |
Notes | No quetiapine arm. Inclusion did not reach planned number (122 i.s.o. 155) Relatively low dropout rate (22/122 = 18%) |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | As reported: "randomisation was executed centrally using a computer‐generated randomisation list: randomly permuted blocks of size six" |
Allocation concealment (selection bias) | Low risk | As reported: "randomisation was executed centrally" |
Blinding (performance bias and detection bias) of participants | Low risk | Study was double‐blind. Blood was collected from each participant (only imipramine blood level was assessed). Treatment guesses were analysed and indicated high preservation of blindness |
Blinding (performance bias and detection bias) of personnel | Low risk | Double‐blind study. Blood was collected from each participant (only imipramine blood level was assessed). Treatment guesses were analysed and indicated high preservation of blindness |
Blinding (performance bias and detection bias) of outcome assessors | Low risk | As reported: "blindness was checked and high. All dose adjustments were done centrally by an independent psychiatrist" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None |
Selective reporting (reporting bias) | Low risk | Protocol available. Generally accepted outcomes have been used |
Other bias | Unclear risk | 122 participants included i.s.o. with the planned 155 resulting in loss of power Post hoc remission as secondary outcome measure |