RecruitingPhase 3NCT07623135

Lumateperone for Late-Life Depression

Sponsor

Eric Lenze

Enrollment

100 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

Depression - Major Depressive Disorder Late Life Depression (LLD)Treatment Resistant Depression (TRD)

Summary

The purpose of this research study is to examine how well a medication called lumateperone (Caplyta) works to relieve depression in older adults with treatment-resistant depression. Lumateperone (Caplyta) is approved by the U.S. Food and Drug Administration to treat Major Depressive Disorder in adults who are also taking another antidepressant medication. This study will compare lumateperone (Caplyta) to placebo (a sugar pill without medication).

Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Lumateperone and a drug called Placebo for people with depression - major depressive disorder, late life depression (lld), and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 60 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLumateperone

Participants will be randomized to take either lumateperone or placebo along with their existing antidepressant for 10 weeks. Dose will range from 10.5mg-42mg over the course of the study.

DRUGPlacebo

Participants will be randomized to take either lumateperone or placebo along with their existing antidepressant for 10 weeks. Dose will range from 10.5mg-42mg over the course of the study.