Study of Lumateperone Added to Antidepressants for Treating Depression in Adults Aged 60 and Older

What this Trial Is About

This research study focuses on older adults aged 60 years and above who have treatment-resistant depression, specifically unipolar, non-psychotic major depressive disorder. The study aims to evaluate how well lumateperone Caplyta, a medication approved by the U.S. Food and Drug Administration for adults with major depressive disorder taking another antidepressant, works compared to a placebo. The trial is a 10-week, randomized, double-blind, placebo-controlled study involving approximately 100 participants. Participants will continue their current antidepressant medication at a stable dose and will be randomly assigned to receive either lumateperone or a matching placebo. The dosing usually starts at 21 mg per day for the first week, with adjustments based on specific medication interactions and liver function, increasing to 42 mg per day by Week 2 and maintained until Week 10. Those taking certain inhibitors or with moderate to severe liver impairment may have adjusted doses. The study includes screening, baseline assessment, treatment, and endpoint visits. Participants will undergo several visits including screening, baseline, and follow-ups at Weeks 1, 2, 4, 6, and 8 to monitor depression symptoms, medication changes, and side effects. The endpoint visit at Week 10 will assess mood, cognitive function, physical health including blood tests and ECG, and side effects. Additional visits may be scheduled if needed. The primary outcome measured is the change in depression severity from baseline to the end of treatment using the Montgomery-Asberg Depression Rating Scale MADRS.

Lumateperone for Late-Life Depression