drugset / Trial / NCT07623135

Lumateperone for Late-Life Depression

NCT07623135

Phase 3 Not yet recruiting 100 enrolled Eric Lenze Intra-Cellular Therapies, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2026-06
Primary completion
2028-06
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Lumateperone Small molecule 10.5 mg
Subject Lumateperone Small molecule 21 mg
Subject Lumateperone Small molecule 42 mg