NCT06662526 · Phase 4 · NOT YET RECRUITING
Lithium for Prevention of Cognitive Declining in Mood Illnesses
This trial is testing whether a very low daily dose of lithium (50 mg, far below standard psychiatric doses) can slow or prevent the development of mild cognitive impairment in people who already have a mood disorder like depression or bipolar disorder. It is a Phase 4 trial, meaning lithium is already approved for other uses, but researchers are studying this specific low-dose, neuroprotective application in a new population.
You may qualify if
- Age 55-70.
- DSM-5 diagnosis of major depressive disorder or bipolar disorder (types I or II), current or lifetime.
- Prior to participation in this study, each subject must sign an informed consent.
You're excluded if
- Current mood treatment with lithium.
- Alcohol dependency within the past month.
- Current serious unstable medical conditions or history of medical illness that would contraindicate a trial of lithium.
- Current or past severe kidney disease or baseline creatinine > 1.5 mg/dl.
- Active suicidal ideation with plan and intent (Columbia Suicide Severity Rating Scale Screen Version (C-SSRS Screen) > 3 points).
- Current or past severe thyroid disease or baseline TSH >5.0 uUI/dl.
- Current diagnosis of dementia of any kind.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-10-30