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.