Anton 1990.
Study characteristics | ||
Methods | Randomised, double‐blind comparison | |
Participants | No explicit use of structured interview DSM‐III criteria; psychotic depressive episode HRSD‐17 > 18 Inpatients No data about prior treatment of current episode | |
Interventions | Amoxapine vs amitriptyline + perphenazine 300 to 500 mg vs 150 to 250 mg + 24 to 40 mg No blood levels 5 days' placebo period. Additional medication in these 5 days: lorazepam or oxazepam in 'low dose' Treatment period: 4 weeks. Additional medication is not mentioned in these 4 weeks | |
Outcomes | Dichotomous data: study author defined: response is reduction in HRSD‐17 > 50%. No remission data Continuous data: symptom reduction: no ITT data; global response: no ITT data; QOL: no data Overall dropout rate: yes Dropout due to adverse effects: yes (2 in ami + per) Mortality rate: 0 | |
Notes | 56 participants provided informed consent. 10 dropped out in washout before receiving active medication (4 refused and six improved substantially); 46 participants were randomly assigned 46 participants: 4 dropouts in both groups (total 8). Unclear how many bipolar participants among these 8 dropouts; 38 participants were analysed, including 6 bipolar participants 6/38 bipolar = 15.8% ITT responders: amoxapine 12/21 and ami + per 17/25 (instead of 12/17 and 17/21) Dropouts after random assignment: 9/21 and 7/25 Study author had no additional data available See also 1993 J Aff Disorders 28:125‐131 (same data set) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | As reported: "patients were randomly assigned in a double blind fashion" |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding (performance bias and detection bias) of participants | Low risk | As reported: "double blind treatment with identical capsules" |
Blinding (performance bias and detection bias) of personnel | Low risk | As reported: "double blind treatment with identical capsules" |
Blinding (performance bias and detection bias) of outcome assessors | Unclear risk | Probably yes. No explicit data |
Incomplete outcome data (attrition bias) All outcomes | High risk | 46 participants were randomly assigned. In the publication, only those participants who completed at least 2 weeks of active medication were analysed. 4 dropouts in both groups (total 8) |
Selective reporting (reporting bias) | Unclear risk | No protocol available. Generally accepted outcomes have been used |
Other bias | High risk | Unclear how many bipolar participants were present among these 8 dropouts; 38 participants were analysed, including 6 bipolar participants. 6/38 bipolar = 15.8%. No additional data available to exclude bipolar participants from re‐analysis We re‐analysed the data with ITT responders (intention‐to‐treat; dropouts included): amoxapine 12/21 and ami + per 17/25 (instead of 12/17 and 17/21). ITT dropouts after random assignment: 9/21 and 7/25 |