IRCT201112228490N1.

Study name	Effect of fluoxetine on functional recovery of patients with cerebrovascular accident following middle cerebral artery trunk obstruction: a randomised clinical trial
Methods	Study type: interventional (clinical trial) Estimated enrolment: 60 participants Allocation: randomised Intervention model: parallel assignment Masking: unclear Primary purpose: treatment
Participants	Iran (Islamic Republic of Iran) Inclusion criteria Age 55 to 85 years Informed consent Unilateral occlusion of middle cerebral artery trunk Resident in Rasht Admission NIHSS < 20 No history of alcohol abuse No history of insomnia No epilepsy "No history of cerebral haemorrhage and heart of cerebral stroke" [sic] No history of systemic diseases of other organs, including liver failure and kidney No cardiac pace maker, severe neuropathy, systemic vascular disease or major affective disorders No concomitant stroke in an area other than the stroke of the middle cerebral artery Exclusion criteria Dissatisfaction of patient during the study Occurrence of serious adverse drug affects at any time during drug administration Alcohol abuse during the study period Occurrence of post‐stroke depression, concomitant use of the MAOIs or serotonergic drugs such as tricyclic antidepressants and SSRI
Interventions	Intervention: fluoxetine, 15 mg oral pill for the first month and 20 mg for the next 2 months Comparator: placebo, 15 mg oral pill for the first month and 20 mg for the next 2 months
Outcomes	Primary outcomes collected at discharge, 1 and 3 months Disability (mRS) Activities of Daily Living (BI) Functional recovery (NIHSS) Depression (BDI questionnaire) Secondary outcomes collected at discharge Cerebral blood flow changes of middle cerebral artery (TCD)
Starting date	5 April 2012
Contact information	Dr Babak Bakhshayesh Eghbali Poorsina hospital, Guilan University of Medical Sciences bakhshayesh@gums.ac.ir
Notes	IRCT201112228490N1 Contacted 7 February 2019