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

Zanardi 2000.

Study characteristics
Methods Randomised, double‐blind comparison
Participants Unclear diagnosing procedure
DSM‐IV criteria; psychotic depressive episode
No HRSD criteria described at inclusion
Inpatients
No data about prior treatment for current episode
Interventions Venlafaxine vs fluvoxamine
Dose: 300 mg vs 300 mg from day 8
Blood levels: unknown
Additional medication: flurazepam < 30 mg
1 week medication free (single‐blind placebo period)
Treatment period: 5 weeks
Outcomes Dichotomous data: study author defined: response is HRSD‐21 < 9 + DDERS (Dimensions of Delusional Experience RS) = 0. Remission data not specified
Continuous data: symptom reduction: no ITT data; global response: no ITT data; QOL: no data
Overall dropout rate: yes
Dropout due to adverse effects: same as overall dropout rate
Mortality rate: 0
Notes We used additional data from the study author to exclude bipolar participants from analysis
Included 22 participants with major depressive disorder (MDD) with psychotic features. Responders in venlafaxine group 6/11 MDD. Responders fluvoxamine group 9/11 MDD. No dropouts in fluvoxamine group. 2 dropouts in venlafaxine group
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk As reported: "randomization was performed by a computer‐generated schedule"
Allocation concealment (selection bias) Unclear risk Randomisation method not described
Blinding not explicitly described. No data
Blinding (performance bias and detection bias)
of participants Unclear risk As reported: "patients were randomly assigned"
"Double‐blind controlled study"
Blinding (performance bias and detection bias)
of personnel Unclear risk "Double‐blind controlled study", but unclear whether double‐blind includes personnel
Blinding (performance bias and detection bias)
of outcome assessors Low risk As reported: "raters were blind to treatment"
Incomplete outcome data (attrition bias)
All outcomes Low risk None
Selective reporting (reporting bias) Unclear risk No protocol available. Generally accepted outcomes have been used
Other bias Unclear risk We re‐analysed the data by excluding bipolar participants with additional data from study author

DSM: Diagnostic and Statistical Manual of Mental Disorders.

HRSD/HAM‐D: Hamilton Rating Scale for Depression.

ITT: intention‐to‐treat.

LOCF: last observation carried forward.

MDD: major depressive disorder.

mg: milligram.

mL: millilitre.

ng: nanogram.

QOL: quality of life.