Cao 2020.
Study characteristics | ||
Methods | RCT Study type: interventional (clinical trial) Primary purpose: prevention |
|
Participants | 100 participants January 2013 to April 2016 Country: China Setting: inpatient At randomisation number allocated: N = 99: escitalopram (n = 52); usual care (n = 47) % male: escitalopram (%); usual care (%) Inclusion criteria
Exclusion criteria
|
|
Interventions | Experimental: prophylactic escitalopram in addition to the basic therapies. Started with 5 mg and gradually titrated to 10 mg/d, oral administration in the morning for 90 days Comparator: usual care. Secondary prevention of cerebral infarction, brain protection therapy and rehabilitation, without any antidepressants. People with difficulty sleeping could receive Zolpidem or benzodiazepines for a short period of time |
|
Outcomes | Primary and secondary outcome measures not stated
|
|
Funding source | ||
Notes | No trial registration information Dates study conducted: All patients were hospitalised patients treated for acute ischaemic stroke from January 2013 to April 2016 Declarations of Interest: none reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number table |
Allocation concealment (selection bias) | Unclear risk | Insufficient information available to permit a judgement of ‘low risk’ or ‘high risk’. This is usually the case if the method of concealment is not described or not described in sufficient detail to allow a definite judgement |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Control group did not receive a placebo |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Treatment evaluation conducted by a physician blind to patient’s clinical data, but it does not state whether the physician was blind to treatment allocation. So the judgement was that the risk of bias was unclear |
Incomplete outcome data (attrition bias) All outcomes | High risk | There are two publications‐the numbers initially included in the two papers do not match; also two patients out of 49 randomised to escitalopram dropped out. Given the inconsistency in the numbers reported, we judge that there is the potential for high risk of bias |
Selective reporting (reporting bias) | Unclear risk | No protocol is available |
Other bias | Unclear risk | The authors did not reply to questions and so we have graded this as unclear |