Zanardi 1996.
| Study characteristics | ||
| Methods | Randomised, double‐blind comparison | |
| Participants | The SCID patient version was used for some participants but not for all (reply of study author to letter to editor) DSM‐III‐R criteria; psychotic depressive episode No HRSD criteria described at inclusion Inpatients No data about prior treatment for current episode | |
| Interventions | Sertraline vs paroxetine Dose: 150 mg vs 50 mg from day 8 Blood levels: unknown Additional medication: flurazepam < 30 mg (bipolar participants additional medication lithium; bipolar participants are excluded from our data) 1 week medication free (single‐blind placebo period) Treatment period: 5 weeks | |
| Outcomes | Dichotomous data: study author defined: Response is HRSD‐21 < 8 + DDERS (Dimensions of Delusional Experience RS) = 0. Remission data not specified Continuous data: symptom reduction: no data; global response: no data; QOL: no data Overall dropout rate: yes Dropout due to adverse effects: same as overall dropout Mortality rate: 0 | |
| Notes | 5/14 dropouts in paroxetine group and 0/18 in sertraline group Bipolar participants could be excluded from our analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | As reported: "patients were randomly assigned to two therapy groups" |
| Allocation concealment (selection bias) | Unclear risk | No data |
| Blinding (performance bias and detection bias) of participants | Unclear risk | As reported: "patients were randomly assigned". In title and abstract: "double‐blind controlled trial. No information about methods of blinding" |
| Blinding (performance bias and detection bias) of personnel | Unclear risk | As reported: "double‐blind controlled trial" |
| Blinding (performance bias and detection bias) of outcome assessors | Unclear risk | No data |
| 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 Difference in dropout is high: 5/14 vs 0/18 |