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. 2021 Nov 15;2021(11):CD009286. doi: 10.1002/14651858.CD009286.pub4

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
  • First ever acute anterior circulation cerebral infarction

  • Met the American Heart Association/American Stroke Association diagnostic criteria for stroke

  • Hospitalised within 1 week of stroke onset

  • Stroke confirmed cranial MRI


Exclusion criteria
  • Recurrent stroke, haemorrhagic stroke and posterior circulation stroke

  • Pre‐stroke depression, history of depression, or receiving mood stabilisers, antipsychotics, or any antidepressant before enrolment

  • Depression caused by other organic brain diseases, or depression caused by psychoactive substances and non‐addictive substances

  • Consciousness disorder, aphasia, and dementia

  • HAMD of ≥ 17

  • NIHSS score of ≥ 20

  • History of cancer and psychosis

  • Chronic obstructive pulmonary disease, heart failure, pulmonary, hepatic, or renal failure, or other severe chronic diseases

  • Serious suicidal tendencies

  • Laboratory and accessory examinations revealing coagulation dysfunction

  • Patients who refuse to participate or cooperate

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
  • 17‐item HAMD

  • NIHSS

  • MMSE

  • BI

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