IRCT201112228490N1.
| Methods | Study design: parallel design Number of arms: 2 Treatment arm: fluoxetine (SSRI) Control arm: matched placebo |
| Participants | Geographical location: Iran Setting: unclear Stroke criteria: cerebral ischaemic stroke Method of stroke diagnosis: unclear Time since stroke: unclear Inclusion criteria: 1) informed consent; 2) unilateral occlusion of MCA trunk; 3) resident in Rasht; 4) admission NIHSS < 20; 5) no history of alcohol abuse; 6) no history of insomnia, epilepsy; 7) no previous history of cerebral haemorrhage and heart of cerebral stroke; 8) no previous history of systemic diseases of other organs, including liver failure and kidney; 9) absence of cardiac pace maker, severe neuropathy, systemic vascular disease or major affective disorders; 10) absence of concomitant stroke in an area other than the stroke of the MCA Exclusion criteria: 1) dissatisfaction of patient during the study; 2) occurrence of serious adverse drug affects at any time during drug administration; 3) alcohol abuse during the study period; 4) occurrence of post stroke depression concomitant use of the mono amine oxidase inhibitors or serotonergic drugs such as tricyclic antidepressants and SSRI Depression criteria: none Total number randomised in this trial: unclear Number randomised in treatment group: unclear Number randomised to control group: unclear Total number included in final analysis: unclear Number included in treatment group for final analysis: unclear Number included in control group for final analysis: unclear |
| Interventions | Treatment: fluoxetine (SSRI) 15 mg for the first month and 20 mg for the next 2 months Control: matched placebo 15 mg for the first month and 20 mg for the next 2 months Treatment duration: 3 months Follow‐up: unclear |
| Outcomes | Primary outcomes
Secondary outcomes
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| Notes |