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. 2021 Dec 7;2021(12):CD004044. doi: 10.1002/14651858.CD004044.pub5

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