Evaluation of the effect of Modafinil in the improvement of the level of consciousness in patients with COVID‐19 encephalopathy: A randomized controlled trial

Abstract Aim COVID‐19 can lead to encephalopathy and loss of consciousness. This double‐blinded randomized clinical trial conducted in Tehran, Iran, aimed to assess the potential effectiveness of modafinil in patients with COVID‐19‐related encephalopathy. Methods Nineteen non‐intubated COVID‐19 pati...

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Main Authors: Fatemeh Talebi Kiasari, Mobin Naghshbandi, Maziar Emamikhah, Omid Moradi Moghaddam, Mohammad Niakan Lahiji, Mohammad Rohani, Narges Yazdi, Hamidreza Movahedi, Alireza Amanollahi, Pardis Irandoost, Roya Ghafoury
Format: Article
Language:English
Published: Wiley 2024-09-01
Series:Neuropsychopharmacology Reports
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Online Access:https://doi.org/10.1002/npr2.12447
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author Fatemeh Talebi Kiasari
Mobin Naghshbandi
Maziar Emamikhah
Omid Moradi Moghaddam
Mohammad Niakan Lahiji
Mohammad Rohani
Narges Yazdi
Hamidreza Movahedi
Alireza Amanollahi
Pardis Irandoost
Roya Ghafoury
author_facet Fatemeh Talebi Kiasari
Mobin Naghshbandi
Maziar Emamikhah
Omid Moradi Moghaddam
Mohammad Niakan Lahiji
Mohammad Rohani
Narges Yazdi
Hamidreza Movahedi
Alireza Amanollahi
Pardis Irandoost
Roya Ghafoury
author_sort Fatemeh Talebi Kiasari
collection DOAJ
description Abstract Aim COVID‐19 can lead to encephalopathy and loss of consciousness. This double‐blinded randomized clinical trial conducted in Tehran, Iran, aimed to assess the potential effectiveness of modafinil in patients with COVID‐19‐related encephalopathy. Methods Nineteen non‐intubated COVID‐19 patients with encephalopathy were randomized into two groups: a treatment group receiving crushed modafinil tablets and a placebo group receiving starch powder. Modafinil was administered at a dose of 100 mg every 2 h, reaching a peak dosage of 400 mg. The level of consciousness was assessed using the Glasgow Coma Score (GCS) at multiple time points on the day of medication administration. The trial was registered under IRCT20170903036041N3 on 23/5/2021. Results The average age in the modafinil and placebo groups was 75.33 and 70 years, respectively. No significant differences were observed between the two groups in terms of chronic conditions, clinical symptoms, or laboratory data. GCS scores were similar between the groups at baseline (p‐value = 0.699). After four doses of modafinil, GCS scores were slightly higher in the treatment group, but this difference was not statistically significant (p‐value = 0.581). GCS scores after each round of drug administration didn't significantly differ between the treatment and placebo groups (p‐value = 0.908). Conclusion Modafinil exhibited a slight improvement in the level of consciousness among COVID‐19 patients with encephalopathy, although this improvement did not reach statistical significance when compared to the control group. Further research with larger sample sizes and longer treatment durations is recommended to explore modafinil's potential benefits in managing altered consciousness in COVID‐19 patients.
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spelling doaj-art-a97bd78261f642b1bc98a91bcbcd81a92025-08-20T02:13:03ZengWileyNeuropsychopharmacology Reports2574-173X2024-09-0144349050110.1002/npr2.12447Evaluation of the effect of Modafinil in the improvement of the level of consciousness in patients with COVID‐19 encephalopathy: A randomized controlled trialFatemeh Talebi Kiasari0Mobin Naghshbandi1Maziar Emamikhah2Omid Moradi Moghaddam3Mohammad Niakan Lahiji4Mohammad Rohani5Narges Yazdi6Hamidreza Movahedi7Alireza Amanollahi8Pardis Irandoost9Roya Ghafoury10Department of Neurology, Hazrat‐e Rasool General Hospital, School of Medicine Iran University of Medical Sciences Tehran IranSchool of Medicine Iran University of Medical Sciences Tehran IranDepartment of Neurology, Hazrat‐e Rasool General Hospital, School of Medicine Iran University of Medical Sciences Tehran IranTrauma and Injury Research Center, Critical Care Department, School of Medicine Iran University of Medical Sciences Tehran IranTrauma and Injury Research Center, Critical Care Department, School of Medicine Iran University of Medical Sciences Tehran IranDepartment of Neurology, Hazrat‐e Rasool General Hospital, School of Medicine Iran University of Medical Sciences Tehran IranDepartment of Neurology, Hazrat‐e Rasool General Hospital, School of Medicine Iran University of Medical Sciences Tehran IranSchool of Medicine Iran University of Medical Sciences Tehran IranTrauma and Injury Research Center, Critical Care Department, School of Medicine Iran University of Medical Sciences Tehran IranDepartment of Nutrition, School of Public Health Iran University of Medical Sciences Tehran IranSchool of Medicine Iran University of Medical Sciences Tehran IranAbstract Aim COVID‐19 can lead to encephalopathy and loss of consciousness. This double‐blinded randomized clinical trial conducted in Tehran, Iran, aimed to assess the potential effectiveness of modafinil in patients with COVID‐19‐related encephalopathy. Methods Nineteen non‐intubated COVID‐19 patients with encephalopathy were randomized into two groups: a treatment group receiving crushed modafinil tablets and a placebo group receiving starch powder. Modafinil was administered at a dose of 100 mg every 2 h, reaching a peak dosage of 400 mg. The level of consciousness was assessed using the Glasgow Coma Score (GCS) at multiple time points on the day of medication administration. The trial was registered under IRCT20170903036041N3 on 23/5/2021. Results The average age in the modafinil and placebo groups was 75.33 and 70 years, respectively. No significant differences were observed between the two groups in terms of chronic conditions, clinical symptoms, or laboratory data. GCS scores were similar between the groups at baseline (p‐value = 0.699). After four doses of modafinil, GCS scores were slightly higher in the treatment group, but this difference was not statistically significant (p‐value = 0.581). GCS scores after each round of drug administration didn't significantly differ between the treatment and placebo groups (p‐value = 0.908). Conclusion Modafinil exhibited a slight improvement in the level of consciousness among COVID‐19 patients with encephalopathy, although this improvement did not reach statistical significance when compared to the control group. Further research with larger sample sizes and longer treatment durations is recommended to explore modafinil's potential benefits in managing altered consciousness in COVID‐19 patients.https://doi.org/10.1002/npr2.12447COVID‐19encephalopathyloss of consciousnessModafinil
spellingShingle Fatemeh Talebi Kiasari
Mobin Naghshbandi
Maziar Emamikhah
Omid Moradi Moghaddam
Mohammad Niakan Lahiji
Mohammad Rohani
Narges Yazdi
Hamidreza Movahedi
Alireza Amanollahi
Pardis Irandoost
Roya Ghafoury
Evaluation of the effect of Modafinil in the improvement of the level of consciousness in patients with COVID‐19 encephalopathy: A randomized controlled trial
Neuropsychopharmacology Reports
COVID‐19
encephalopathy
loss of consciousness
Modafinil
title Evaluation of the effect of Modafinil in the improvement of the level of consciousness in patients with COVID‐19 encephalopathy: A randomized controlled trial
title_full Evaluation of the effect of Modafinil in the improvement of the level of consciousness in patients with COVID‐19 encephalopathy: A randomized controlled trial
title_fullStr Evaluation of the effect of Modafinil in the improvement of the level of consciousness in patients with COVID‐19 encephalopathy: A randomized controlled trial
title_full_unstemmed Evaluation of the effect of Modafinil in the improvement of the level of consciousness in patients with COVID‐19 encephalopathy: A randomized controlled trial
title_short Evaluation of the effect of Modafinil in the improvement of the level of consciousness in patients with COVID‐19 encephalopathy: A randomized controlled trial
title_sort evaluation of the effect of modafinil in the improvement of the level of consciousness in patients with covid 19 encephalopathy a randomized controlled trial
topic COVID‐19
encephalopathy
loss of consciousness
Modafinil
url https://doi.org/10.1002/npr2.12447
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