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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06108297
Other study ID # STUDY00007796
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 12, 2023
Est. completion date May 1, 2024

Study information

Verified date June 2024
Source State University of New York at Buffalo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This open-label study will assess if lithium dosages of 30-45mg/day are associated with greater symptomatic benefit than dosages of 10-15mg/day previously assessed among 50 patients with long COVID.


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Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Lithium
Elemental lithium as lithium aspartate.

Locations

Country Name City State
United States UBMD Neurology Williamsville New York

Sponsors (1)

Lead Sponsor Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fatigue Severity Scale (FSS) 7-item scale. Score range 1-49 with higher values signifying worse outcome Baseline to end-of-titration (up to 11 weeks)
Primary Brain Fog Severity Scale (BFSS) 7-item scale. Score range 1-49 with higher values signifying worse outcome Baseline to end-of-titration (up to 11 weeks)
Secondary Well Being Scale Single-item question. Score range 0-10 with higher values signifying better outcome. Baseline to end-of-titration (up to 11 weeks)
Secondary Short Form-12 Health Survey 12-item quality of life scale. Score range 0-100 for both the Physical Component Score and the Mental Component Score with higher values signifying better outcomes. Baseline to end-of-titration (up to 11 weeks)
Secondary FSS scores in those with FSS score =28 at baseline 7-item scale. Score range 1-49 with higher values signifying worse outcome Baseline to end-of-titration (up to 11 weeks)
Secondary BFSS scores in those with FSS score =28 at baseline 7-item scale. Score range 1-49 with higher values signifying worse outcome Baseline to end-of-titration (up to 11 weeks)
Secondary Modified Fatigue Impact Scale 21-item scale. Score range 0-84 with higher values signifying worse outcome Baseline to end-of-titration (up to 11 weeks)
Secondary Perceived Deficits Questionnaire, 5-Item Version 5-item scale. Score range 1-20 with higher values signifying worse outcome Baseline to end-of-titration (up to 11 weeks)
Secondary Beck Depression Inventory-II 21-item scale. Score range 0-63 with higher values signifying worse outcome Baseline to end-of-titration (up to 11 weeks)
Secondary Generalized Anxiety Disorder Scale-2 2-item scale. Score range 0-6 with higher values signifying worse outcome Baseline to end-of-titration (up to 11 weeks)
Secondary Headache and Body Pain Bother Scale 2-item scale. Score range 2-10 with higher values signifying worse outcome Baseline to end-of-titration (up to 11 weeks)
Secondary Insomnia Severity Index 7-item scale. Score range 0-28 with higher values signifying worse outcome Baseline to end-of-titration (up to 11 weeks)
Secondary Patient Global Impression of Change Single-item scale. Score range 1-7 with higher values signifying better outcome End-of-titration (up to 11 weeks)
Secondary Desire to Continue Therapy Scale Single-item scale. Score range 1-2 with higher value signifying better outcome End-of-titration (up to 11 weeks)
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