Skip to main content
. 2021 Dec 7;2021(12):CD004044. doi: 10.1002/14651858.CD004044.pub5

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)
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