Effect of fluoxetine on the functional recovery of patients with cerebrovascular accident

Effect of fluoxetine on functional recovery of patients with cerebrovascular accident following middle cerebral artery trunk obstruction: a randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201112228490N1

Enrollment

Registered

2012-01-25

Start date

2012-04-05

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral ischemic stroke. Cerebral infarction due to thrombosis of cerebral arteries

Interventions

Intervention 1: Fluoxetine, 15 milligram oral pill for the first month and 20 milligram for the next two months in control group. Intervention 2: Placebo, 15 milligram oral pill for the first month an

Treatment - Drugs

Placebo

Fluoxetine, 15 milligram oral pill for the first month and 20 milligram for the next two months in control group

Placebo, 15 milligram oral pill for the first month and 20 milligram for the next two months in control group

Eligibility

Sex/Gender

All

Age

55 Years to 85 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: informed consent; unilateral occlusion of middle cerebral artery trunk; resident in Rasht; Admission NIHSS< 20; No history of alcohol abuse; No history of insomnia, epilepsy; No previous history of cerebral hemorrhage and heart of cerebral stroke; No previous history of systemic diseases of other organs, including liver failure and kidney; Absence of cardiac pace maker, severe neuropathy, systemic vascular disease or major affective disorders; Absence of 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 (PSD) concomitant use of the mono amine oxidase inhibitors or serotonergic drugs such as tricyclic antidepressants and SSRI.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Disability. Timepoint: On admission day, on discharge day, 1 and 3 month later. Method of measurement: modified Rankin Scale (mRS).;Performance in basic Activities of Daily Living. Timepoint: On admission day, on discharge day, 1 and 3 month later. Method of measurement: Barthel Index.;Functional recovery. Timepoint: On admission day, on discharge day, 1 and 3 month later. Method of measurement: National Institutes of Health Stroke Scale (NIHSS).;Depression. Timepoint: On admission day, on discharge day, 1 and 3 month later. Method of measurement: Beck Depression Inventory (BDI) questionnaire.	—

Measure

Time frame

Disability. Timepoint: On admission day, on discharge day, 1 and 3 month later. Method of measurement: modified Rankin Scale (mRS).;Performance in basic Activities of Daily Living. Timepoint: On admission day, on discharge day, 1 and 3 month later. Method of measurement: Barthel Index.;Functional recovery. Timepoint: On admission day, on discharge day, 1 and 3 month later. Method of measurement: National Institutes of Health Stroke Scale (NIHSS).;Depression. Timepoint: On admission day, on discharge day, 1 and 3 month later. Method of measurement: Beck Depression Inventory (BDI) questionnaire.

—

Secondary

Measure	Time frame
Cerebral blood flow changes of middle cerebral artery. Timepoint: On admission day, on discharge day. Method of measurement: Transcranial Doppler (TCD).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Mohammad Seyed Saadat

Guilan University of Medical Sciences

sm_seyedsaadat@gums.ac.ir+98 13 1322 2444

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026