Trace-dosage of lithium for prevention of cognitive declining in mood illnesses: a randomized double-blind, placebo-controlled, study protocol

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dc.contributor.authorVöhringer, PAen_US
dc.contributor.authorPalma, BAen_US
dc.contributor.authorProvoste, Álvaro, Aen_US
dc.contributor.authorCarrasco, MIen_US
dc.contributor.authorRojas, MGen_US
dc.contributor.authorGhaemi, SN.en_US
dc.date.accessioned2025-08-13T11:21:19Z
dc.date.available2025-08-13T11:21:19Z
dc.date.issued2025-06
dc.description.abstractBackground: 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.en_US
dc.identifier.affiliationsClínica Psiquiátrica Universitaria, Hospital Clínico Universidad de Chile, Santiago, Chile; Department of Psychiatry, Tufts University School of Medicine, Boston, MA, USA; Millennium Institute for Depression and Personality Research. MIDAP, Santiago, Chileen_US
dc.identifier.affiliationsClínica Psiquiátrica Universitaria, Hospital Clínico Universidad de Chile, Santiago, Chileen_US
dc.identifier.affiliationsClínica Psiquiátrica Universitaria, Hospital Clínico Universidad de Chile, Santiago, Chileen_US
dc.identifier.affiliationsClínica Psiquiátrica Universitaria, Hospital Clínico Universidad de Chile, Santiago, Chileen_US
dc.identifier.affiliationsClínica Psiquiátrica Universitaria, Hospital Clínico Universidad de Chile, Santiago, Chile; Millennium Institute for Depression and Personality Research. MIDAP, Santiago, Chileen_US
dc.identifier.affiliationsDepartment of Psychiatry, Tufts University School of Medicine, Boston, MA, USA ; Harvard Medical School, Boston, MA, USAen_US
dc.identifier.citationVöhringer 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): 121-126en_US
dc.identifier.issn2349-3240
dc.identifier.issn2349-3259
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/253748
dc.languageenen_US
dc.publisherMedip Academyen_US
dc.relation.issuenumber2en_US
dc.relation.volume12en_US
dc.source.urihttps://dx.doi.org/10.18203/2349-3259.ijct20251207en_US
dc.subjectLithium trace dosesen_US
dc.subjectMood disordersen_US
dc.subjectCognitive declining preventionen_US
dc.subjectDementia preventionen_US
dc.titleTrace-dosage of lithium for prevention of cognitive declining in mood illnesses: a randomized double-blind, placebo-controlled, study protocolen_US
dc.typeJournal Articleen_US
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