sElective Serotonin reuPtake inhibitoRs In posT-covid: ESPRIT

Conditions

post COVID

Brief summary

Fatigue severity (Checklist Individual Strength (CIS-20R) fatigue score) at week 13

Detailed description

Fatigue severity (PROMIS fatigue 8), Cognitive functioning (PROMIS) cognitive function 8a, CIS-20R concentration score), Post Exertional Malaise (PEM) (DePaul Symptom Questionnaire (DSQ-PEM), Postural Orthostatic Tachycardia Syndrome (POTS) National Aeronautics and Space Administration (NASA) lean test and DSQ-POTS), Health-related quality of life (HRQL) (PROMIS-29, Bell disability scale)), Side effects, (Antidepressant Side Effect Checklist-21 (ASEC-21) and Frequency, Intensity, Burden of Side Effects Rating scale (FIBSER scale), withdrawal symptoms (Discontinuation- Emergent Signs and Symptoms (DESS) Scale), Biomarkers ((neuro) inflammation makers, glucocorticoid receptor (GR) activity, cortisol, serotonin, IDO-2 -kynurenine pathway (KP) metabolites)., Neuro-imaging substudy: Perfusion (Arterial Spin Labeling MRI), Neuro-imaging substudy: brain functioning and connectivity during resting-state and cognitive effort (challenging N-back (3-back vs. 0-back) with functional Magnetic Resonance Imaging (fMRI), Neuro-imaging substudy: brain metabolites and neuroinflammation (Magnetic Resonance Spectroscopy)

Related papers

No related papers found yet.

Interventions

DRUGFluvoxamine 50 mg film-coated tablets

DRUGPlacebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Fatigue severity (Checklist Individual Strength (CIS-20R) fatigue score) at week 13	—

Secondary

Measure	Time frame
Fatigue severity (PROMIS fatigue 8), Cognitive functioning (PROMIS) cognitive function 8a, CIS-20R concentration score), Post Exertional Malaise (PEM) (DePaul Symptom Questionnaire (DSQ-PEM), Postural Orthostatic Tachycardia Syndrome (POTS) National Aeronautics and Space Administration (NASA) lean test and DSQ-POTS), Health-related quality of life (HRQL) (PROMIS-29, Bell disability scale)), Side effects, (Antidepressant Side Effect Checklist-21 (ASEC-21) and Frequency, Intensity, Burden of Side Effects Rating scale (FIBSER scale), withdrawal symptoms (Discontinuation- Emergent Signs and Symptoms (DESS) Scale), Biomarkers ((neuro) inflammation makers, glucocorticoid receptor (GR) activity, cortisol, serotonin, IDO-2 -kynurenine pathway (KP) metabolites)., Neuro-imaging substudy: Perfusion (Arterial Spin Labeling MRI), Neuro-imaging substudy: brain functioning and connectivity during resting-state and cognitive effort (challenging N-back (3-back vs. 0-back) with functional Magnetic Reson	—

Measure

Time frame

Fatigue severity (PROMIS fatigue 8), Cognitive functioning (PROMIS) cognitive function 8a, CIS-20R concentration score), Post Exertional Malaise (PEM) (DePaul Symptom Questionnaire (DSQ-PEM), Postural Orthostatic Tachycardia Syndrome (POTS) National Aeronautics and Space Administration (NASA) lean test and DSQ-POTS), Health-related quality of life (HRQL) (PROMIS-29, Bell disability scale)), Side effects, (Antidepressant Side Effect Checklist-21 (ASEC-21) and Frequency, Intensity, Burden of Side Effects Rating scale (FIBSER scale), withdrawal symptoms (Discontinuation- Emergent Signs and Symptoms (DESS) Scale), Biomarkers ((neuro) inflammation makers, glucocorticoid receptor (GR) activity, cortisol, serotonin, IDO-2 -kynurenine pathway (KP) metabolites)., Neuro-imaging substudy: Perfusion (Arterial Spin Labeling MRI), Neuro-imaging substudy: brain functioning and connectivity during resting-state and cognitive effort (challenging N-back (3-back vs. 0-back) with functional Magnetic Reson

—

Countries

Netherlands

Outcome results

None listed