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

Asadollahi 2018.

Study characteristics
Methods RCT
Study type: interventional (clinical trial)
Allocation: randomised
Intervention model: parallel assignment
Masking: double (participant, outcomes assessor)
Primary purpose: treatment
Participants 90 participants
Country: Iran
Setting: inpatient
At randomisation number allocated: N = 90: citalopram (n = 30); fluoxetine (n = 30); placebo (n = 30)
% male: citalopram (60%) fluoxetine (50%); placebo (56.6%)
Age: mean age: citalopram = 61.7 ± 9.6; fluoxetine = 60.2 ± 8.52; placebo = 58.7 ± 8.56
Inclusion criteria
  • > 18 years of age

  • suffering from hemiparesis or hemiplegia as a result of a first‐time acute Ischaemic stroke within the past 24 hours

  • an initial Fugl‐Meyer Motor Scale score of under 55


Exclusion criteria
  • NIHSS score < 5

  • Prior disabilities including aphasia, cognitive disorders and motor disorders due to stroke, or any other neurodegenerative disease

  • Pregnancy or breastfeeding

  • Currently taking antidepressants

  • Contraindications of therapy, including renal insufficiency (glomerular filtration rate < 30mL/min), abnormal liver function tests, hyponatremia, and a long QT interval on an electrocardiogram

  • Any significant adverse effects (agitation, hypertension, or other signs of serotonin syndrome) after initiation of treatment

Interventions Participants were randomly allocated to 1 of 3 groups: Group A received 20 mg orally of fluoxetine daily, Group B received 20 mg orally of citalopram daily, and Group C received a placebo orally. The duration of the therapy was 90 days. In addition to the medications, all of the participants received physiotherapy
Outcomes FMMS
Funding source No financial support received
Notes IRCT20141116019971N3. Recruitment January 2015 to January 2016. Authors declared no conflicts of interest
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "A computer‐generated schedule was used by investigators to assign the patients into one of three groups by block randomization: Group A—20mg P.O. daily of citalopram, Group B—20mg P.O. daily of fluoxetine, and Group C—a placebo (microcrystalline cellulose)."
Allocation concealment (selection bias) Low risk Computer‐generated schedule confirmed with authors
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "All of the drugs for each group of subjects were over‐encapsulated by a pharmacist."
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "Three evaluators were used in our study, namely, neurology residents who were blind to the interventions."
Incomplete outcome data (attrition bias)
All outcomes Low risk 5/90 discontinued medication due to moving away‐but this would not have introduced because the reasons for missing data are unlikely to be related to the true outcome (Quote: "The main reason for participants leaving the study was noncompliance in terms of taking their drugs regularly (10 subjects stopped taking the treatment but completed their follow‐up), while five participants intentionally failed to attend follow‐up after two months because they were resident in other cities distant from the location of the study.")
Selective reporting (reporting bias) Low risk There was just one outcome measure planned (see reference on Iranian clinical trials register) and this was reported
Other bias Low risk The study appears to be free of other sources of bias