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. 2020 May 11;2020(5):CD003689. doi: 10.1002/14651858.CD003689.pub4

Reding 1986.

Study characteristics
Methods Study design: parallel design
Number of arms: 2
Experimental arm: trazodone‐HCl (serotonin modulator)
Control arm: matched placebo
Participants Geographical location: USA
Setting: inpatient
Stroke criteria: all subtypes
Method of stroke diagnosis: via clinical signs and CT (100%)
Time since stroke: on average 45 +/‐ 5 days (treatment group) and 48 +/‐ 13 days (control group) prior to randomisation
Inclusion criteria: not reported
Exclusion criteria: 1) myocardial infarction within previous month; 2) antiarrhythmic medication
Total number randomised in this study: 27
Number randomised to treatment group: unclear
Number randomised to control group: unclear
Total number included in final analysis: 5
Number included in treatment group for final analysis: 3 (66% men, mean age 67 years, SE 6)
Number included in control group for final analysis: 2 (50% men, mean age 73 years, SE 16)
Interventions Treatment: trazodone‐HCl (serotonin modulator) 50 mg daily; dose escalation every 3 days to target dose of 200 mg
Control: matched placebo
Treatment duration: treatment continued for 32 +/‐ 6 days (treatment group) and 24 +/‐ 4 days (control group)
Follow‐up: not reported
Outcomes Primary outcomes
  • Depression measured via clinical diagnosis of depression


Secondary outcomes
  • Activities of daily living measured using the BI

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients were assigned to either treatment or placebo groups according to a table of random numbers." pp. 763
Allocation concealment (selection bias) Unclear risk Comments: method of allocation concealment not reported
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "Trazodone hydrochloride (50 mg) or placebo in an identical capsule was administered orally by the nursing staff ..." pp. 763
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "... attending physician, unaware of treatment group assignment, noted signs or symptoms possibly due to trazodone ..." pp. 764
Incomplete outcome data (attrition bias)
All outcomes High risk Comments: only 5/27 patients completed the study at target dose. The study was discontinued due to perceived side effects in both groups. The analysis is presented in subgroups with only numbers of improved not total numbers analysed
Selective reporting (reporting bias) Unclear risk Comments: no trial protocol available to compare with the publication
Other bias Low risk Comments: there was no statistically significant difference between the treatment and control group in baseline demographic characteristics