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NOT YET RECRUITING
NCT07623135
PHASE3

Lumateperone for Late-Life Depression

Sponsor: Eric Lenze

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-06

Completion Date

2028-06

Last Updated

2026-07-30

Healthy Volunteers

No

Interventions

DRUG

Lumateperone

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.

DRUG

Placebo

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.

Locations (2)

University of Arizona

Tucson, Arizona, United States

Washington University School of Medicine

St Louis, Missouri, United States