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Patients with post-COVID-19 symptoms of fatigue and cognitive dysfunction do not experience significant improvement with lithium aspartate, according to study findings published in JAMA Network Open.
To examine anecdotal findings that lithium aspartate, 5 to 15 m/d, reduced post-COVID-19 condition fatigue and cognitive dysfunction symptoms, researchers conducted a randomized, double-blind, placebo-controlled trial.
The researchers recruited patients from the University at Buffalo Western New York Community-Based Long COVID Registry, through local newspaper advertisements, and primary care offices. The trial was conducted from November 28, 2022, to June 29, 2023. Eligible patients had a positive COVID-19 test with new and bothersome fatigue following infection, no history of lithium use or conditions associated with chronic fatigue, and no tobacco or tetrahydrocannabinol use for more than 6 months prior to the study period. Patients also needed a Fatigue Severity Scale 7-item version (FSS-7) score or Brain Fog Severity Scale (BFSS) score of 28 or higher and a Beck Depression Inventory-II (BDI-II) score lower than 29.
Patients were randomly assigned to receive blinded capsules of lithium aspartate, 5 mg, or identical placebo capsules of microcrystalline cellulose. Patients were directed to take 2 capsules daily for the first 10 days, with the option to increase to 3 capsules per day for the last 11 days if symptoms did not improve.
In the next phase of the study, researchers asked all patients to take 2 capsules daily for 7 days, then increase to 3 capsules for the following 7 days if symptoms persisted. The researchers conducted a dose-finding study after the conclusion of the randomized control trial to assess the efficacy of lithium aspartate dosages of 40 to 45 mg/d.
A total of 50 patients completed the double-blind phase and entered the open-label phase. A total of 24 (mean age, 62.3) were assigned to the lithium aspartate treatment and 26 (mean age, 55.0) to the placebo group.
The sum of scores from the FSS-7 and the BFSS showed no significant differences between the treatment group and placebo group (3.6; 95% CI, -16.6 to 9.5; P =.59). Patient scores in additional questionnaires assessing body pain, generalized anxiety, well-being, insomnia, and other conditions also showed no significant differences from placebo.
Of the patients from the initial trial invited to participate in the dose-finding study, 3 completed the dose-finding study. Compared to the lower dose of 15 mg/d, patients using 40 to 45 mg/d reported significantly reduced scores in assessments for fatigue and cognitive dysfunction.
“[R]esults from 3 patients who completed the dose-finding study…and the anecdotal patient suggest that serum lithium levels between 0.18 and 0.49 mEq/L may offer meaningful improvements in PCC fatigue and/or cognitive dysfunction.”
Limitations of these findings include the small sample size and selection bias present in the dose-finding study and the absence of biomarker assessments due to the high cost of PET exams used to identify biomarkers.
One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
This article originally appeared on Psychiatry Advisor
