Trace-dosage of lithium for prevention of cognitive declining in mood illnesses: a randomized double-blind, placebo-controlled, study protocol
No Thumbnail Available
Date
2025-06
Journal Title
Journal ISSN
Volume Title
Publisher
Medip Academy
Abstract
Background: Mood disorders [bipolar disorder (BD) and recurrent unipolar depression] are among the most common mental health conditions worldwide, and are recognized as significant risk factor for development of mild cognitive impairment (MCI) and dementia. Lithium, the gold standard treatment for these mood disorders, has also been suggested as a potential neuroprotective agent, even at trace doses. This study aims to evaluate the effect of trace doses of lithium in preventing cognitive decline in individuals with mood disorders. Methods: This is randomized, double-blind, placebo-controlled trial involving 250 participants aged 55 to 75 years, all of whom have mood disorders and are not currently receiving lithium therapy. Participants will be randomized into either trace dose lithium (50 mg oral tablets daily) or placebo group, with 125 subjects in each group. All participants will continue their usual clinical treatment and will be followed every six month for five years. The primary outcome measure will be the incidence of MCI or worsening of pre-existing MCI, defined as change from baseline clinical dementia rating scale (CDR) score of 0 to 0.5 (MCI). Conclusions: If this research demonstrates that trace doses of lithium can prevent the onset or progression of MCI or dementia in patients with mood disorders, it could offer a new therapeutic approach for addressing cognitive decline in this high-risk population, with significant public health implications.
Description
Keywords
Lithium trace doses, Mood disorders, Cognitive declining prevention, Dementia prevention
Citation
Vöhringer PA, Palma BA, Provoste Álvaro A, Carrasco MI, Rojas MG, Ghaemi SN.. Trace-dosage of lithium for prevention of cognitive declining in mood illnesses: a randomized double-blind, placebo-controlled, study protocol . International Journal of Clinical Trials. 2025 Jun; 12(2): 121-126