Role of fluoxetine in pharmacological enhancement of motor functions in stroke patients: A randomized, placebo-controlled, single-blind trial
Background: Stroke is the primary cause of disability worldwide, the second most common cause of dementia and the third leading cause of death. Only few studies were conducted to study the role of fluoxetine in motor recovery in either ischemic or hemorrhagic stroke patients with probably less sever...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2021-09-01
|
| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865421001010 |
| _version_ | 1829492803909976064 |
|---|---|
| author | Karthickeyan Krishnan Muthuraj K Nandhini K Yalamanchili Dharma Teja Vikrama Simha Reddy Neethu Sara Raju Kiran Kumar Rathinam |
| author_facet | Karthickeyan Krishnan Muthuraj K Nandhini K Yalamanchili Dharma Teja Vikrama Simha Reddy Neethu Sara Raju Kiran Kumar Rathinam |
| author_sort | Karthickeyan Krishnan |
| collection | DOAJ |
| description | Background: Stroke is the primary cause of disability worldwide, the second most common cause of dementia and the third leading cause of death. Only few studies were conducted to study the role of fluoxetine in motor recovery in either ischemic or hemorrhagic stroke patients with probably less severe paresis. However, the current study evaluates both the effectiveness and safety of fluoxetine in the stroke population with a more severe motor deficit. Methods: Patients who had acute or subacute stroke with hemiparesis and aged between 18 and 80 years with medical research council (MRC) scale score <4 were included in this randomized, Single-blind, placebo-controlled trial in 1:1 ratio to placebo or fluoxetine 20 mg/day orally for 90 days. The primary outcome measures were changes in barthel index, time taken to complete nine hole peg test and number of hand tapping movements in 30 s by the affected limb between baseline, 45th day and 90th day. The secondary outcome measure was evaluation of the drug tolerability. Results: A total of 168 patients were assigned to fluoxetine (n = 84) or placebo (n = 84) group. Mean BI score significantly improved at 90th day in fluoxetine group (70.42 ± 10.56) than in placebo group (44.23 ± 8.52). Mean dexterity value decreased significantly at 90th day (2.61 ± 0.81) compared to baseline (3.98 ± 0.53) in fluoxetine group. However higher rate of decrease of mean dexterity value was seen in fluoxetine group when compared to placebo group. Mean number of hands tapping movements in 30 s increased significantly at 90th day (16.33 ± 3.58) compared to baseline (9.83 ± 2.92) in fluoxetine group. Few ADR reported during this study were dizziness, drowsiness and insomnia. Conclusion: The present study indicates that early prescription of fluoxetine is safe and may enhance motor function in patients presenting with severe motor impairments after stroke. However, the findings of the study should be confirmed in future controlled studies with large sample size. |
| first_indexed | 2024-12-16T06:21:42Z |
| format | Article |
| id | doaj.art-0e45c3bc197344e48359850e140456f1 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-12-16T06:21:42Z |
| publishDate | 2021-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-0e45c3bc197344e48359850e140456f12022-12-21T22:41:06ZengElsevierContemporary Clinical Trials Communications2451-86542021-09-0123100800Role of fluoxetine in pharmacological enhancement of motor functions in stroke patients: A randomized, placebo-controlled, single-blind trialKarthickeyan Krishnan0Muthuraj K1Nandhini K2Yalamanchili Dharma Teja3Vikrama Simha Reddy4Neethu Sara Raju5Kiran Kumar Rathinam6Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, 603 203, Tamil Nadu, India; Corresponding author. Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, SRM Nagar, Kattankulathur, 603 203, India.Department of Neurology, SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology, Kattankulathur, 603 203, Tamil Nadu, IndiaDepartment of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, 603 203, Tamil Nadu, IndiaDepartment of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, 603 203, Tamil Nadu, IndiaDepartment of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, 603 203, Tamil Nadu, IndiaDepartment of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, 603 203, Tamil Nadu, IndiaDepartment of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, 603 203, Tamil Nadu, IndiaBackground: Stroke is the primary cause of disability worldwide, the second most common cause of dementia and the third leading cause of death. Only few studies were conducted to study the role of fluoxetine in motor recovery in either ischemic or hemorrhagic stroke patients with probably less severe paresis. However, the current study evaluates both the effectiveness and safety of fluoxetine in the stroke population with a more severe motor deficit. Methods: Patients who had acute or subacute stroke with hemiparesis and aged between 18 and 80 years with medical research council (MRC) scale score <4 were included in this randomized, Single-blind, placebo-controlled trial in 1:1 ratio to placebo or fluoxetine 20 mg/day orally for 90 days. The primary outcome measures were changes in barthel index, time taken to complete nine hole peg test and number of hand tapping movements in 30 s by the affected limb between baseline, 45th day and 90th day. The secondary outcome measure was evaluation of the drug tolerability. Results: A total of 168 patients were assigned to fluoxetine (n = 84) or placebo (n = 84) group. Mean BI score significantly improved at 90th day in fluoxetine group (70.42 ± 10.56) than in placebo group (44.23 ± 8.52). Mean dexterity value decreased significantly at 90th day (2.61 ± 0.81) compared to baseline (3.98 ± 0.53) in fluoxetine group. However higher rate of decrease of mean dexterity value was seen in fluoxetine group when compared to placebo group. Mean number of hands tapping movements in 30 s increased significantly at 90th day (16.33 ± 3.58) compared to baseline (9.83 ± 2.92) in fluoxetine group. Few ADR reported during this study were dizziness, drowsiness and insomnia. Conclusion: The present study indicates that early prescription of fluoxetine is safe and may enhance motor function in patients presenting with severe motor impairments after stroke. However, the findings of the study should be confirmed in future controlled studies with large sample size.http://www.sciencedirect.com/science/article/pii/S2451865421001010StrokeFluoxetineNeurologyMotor functionDexterityRehabilitation |
| spellingShingle | Karthickeyan Krishnan Muthuraj K Nandhini K Yalamanchili Dharma Teja Vikrama Simha Reddy Neethu Sara Raju Kiran Kumar Rathinam Role of fluoxetine in pharmacological enhancement of motor functions in stroke patients: A randomized, placebo-controlled, single-blind trial Contemporary Clinical Trials Communications Stroke Fluoxetine Neurology Motor function Dexterity Rehabilitation |
| title | Role of fluoxetine in pharmacological enhancement of motor functions in stroke patients: A randomized, placebo-controlled, single-blind trial |
| title_full | Role of fluoxetine in pharmacological enhancement of motor functions in stroke patients: A randomized, placebo-controlled, single-blind trial |
| title_fullStr | Role of fluoxetine in pharmacological enhancement of motor functions in stroke patients: A randomized, placebo-controlled, single-blind trial |
| title_full_unstemmed | Role of fluoxetine in pharmacological enhancement of motor functions in stroke patients: A randomized, placebo-controlled, single-blind trial |
| title_short | Role of fluoxetine in pharmacological enhancement of motor functions in stroke patients: A randomized, placebo-controlled, single-blind trial |
| title_sort | role of fluoxetine in pharmacological enhancement of motor functions in stroke patients a randomized placebo controlled single blind trial |
| topic | Stroke Fluoxetine Neurology Motor function Dexterity Rehabilitation |
| url | http://www.sciencedirect.com/science/article/pii/S2451865421001010 |
| work_keys_str_mv | AT karthickeyankrishnan roleoffluoxetineinpharmacologicalenhancementofmotorfunctionsinstrokepatientsarandomizedplacebocontrolledsingleblindtrial AT muthurajk roleoffluoxetineinpharmacologicalenhancementofmotorfunctionsinstrokepatientsarandomizedplacebocontrolledsingleblindtrial AT nandhinik roleoffluoxetineinpharmacologicalenhancementofmotorfunctionsinstrokepatientsarandomizedplacebocontrolledsingleblindtrial AT yalamanchilidharmateja roleoffluoxetineinpharmacologicalenhancementofmotorfunctionsinstrokepatientsarandomizedplacebocontrolledsingleblindtrial AT vikramasimhareddy roleoffluoxetineinpharmacologicalenhancementofmotorfunctionsinstrokepatientsarandomizedplacebocontrolledsingleblindtrial AT neethusararaju roleoffluoxetineinpharmacologicalenhancementofmotorfunctionsinstrokepatientsarandomizedplacebocontrolledsingleblindtrial AT kirankumarrathinam roleoffluoxetineinpharmacologicalenhancementofmotorfunctionsinstrokepatientsarandomizedplacebocontrolledsingleblindtrial |