Investigate the effect of fluoxetine and Citalopram on motor performance after stroke in acute stroke patients

Determining the effect of citalopram and fluoxetine on motor performance after stroke in acute cerebral stroke patients

Randomized double-arm, double-blind, placebo-controlled

acute cerebral stroke patients

inclusion: age>18 Fugl-Meyer score<55 motor or sensory paralysis of half of the body after the first episode of acute stroke exclusion : Age over 70 years 2. National Institute of Health stroke score above 15 3. Previous disabilities including lack of speech, cognitive, and movement disorders caused by stroke or any disease of the cerebral cortex. 4. Pregnancy or breastfeeding 5. Current use of anti-depressant drugs 6. Kidney failure (glomerular filtration rate below 30 ml per minute) 7. Abnormal liver function tests 8. Hyponatremia and long TQ distance in the heart strip 9. Restlessness, increased pressure, or other manifestations of serotonin syndrome (after starting treatment)

group A: The participants will receive a capsule containing 20 mg of fluoxetine orally once a day for 90 days, along with one hour of physiotherapy sessions a day, five days a week, for 21 weeks. Intervention group B: The participants will receive a capsule containing 20 mg of citalopram orally once a day for 90 days, along with physiotherapy for one hour a day, five days a week, for 21 weeks. Control group: Participants will receive a capsule containing microcrystalline cellulose as a placebo once a day for 90 days and physiotherapy for one hour a day, five days a week, for 21 weeks.

in the upper limb (shoulder flexion 90 to 180 degrees - grasping - pronation and supination of the hand - wrist flexion and extension, elbow extension - shoulder raising) in the lower limb (standing on one leg - knee flexion while standingوsitting - dorsiflexion of the leg-plantar flexion of the leg - hip flexion)

The method of randomization will be as follows: using the block randomization method (permuted block randomization) in such a way that first all 4 combinations of letters A and B are written (6 blocks) and numbers 1 to 6 for each block. considered and by randomly choosing numbers 1 to 6 from the table of random numbers; Its corresponding blocks will be written. This process of selection continues until the number of letters A and B reaches the required number of samples. After entering the study and completing the written consent form, the patient will receive a numerical code from 1 to 100 and from the table Prepared, which is available to the project manager, corresponding to the numerical code assigned to one of the drugs A or B. A and B groups will be randomly assigned to either fluoxetine or citalopram. It should be noted that regarding the variables of primary disability severity and other factors affecting the functional score, given that this study will be a clinical trial, randomization can largely control known or unknown confounding factors. (Due to the large sample size) statistical modeling also controls the effect of these factors on the outcome of the disease.

To blind, both drugs are in the form of capsules and will be filled and coded by the neurology resident in bottles that are identical in appearance; these codes will be entered into a table and will be decoded only after the end of the study, so the patient and The doctor will not know the type of medicine received and the treatment group.

There is no further information.