Clinical Trial

Lumateperone for Late-Life Depression

Study acronym: IRL Grey-C
Recruiting Phase 3
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).
Protocol Amendment History 1 change
critical Recruitment opened 2026-08-07
Trial Details
NCT Number NCT07623135
Lead Sponsor Eric Lenze
Collaborators: Intra-Cellular Therapies, Inc., Washington University School of Medicine
Conditions Treatment Resistant Depression (TRD), Late Life Depression (LLD), Depression / Major Depressive Disorder
Enrollment 100 participants
Start Date 2026-08
Primary Completion 2028-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-06