Lumateperone for Late-Life Depression
Eric Lenze
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).
Description
This study is a 10-week, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of adjunctive lumateperone in older adults with treatment-resistant depression (TRD). Approximately 100 participants aged ≥60 years with unipolar, non-psychotic major depressive disorder will be enrolled across two study sites. Participants will continue their existing antidepressant medication at a stable dose throughout the study and will be randomized to receive either lumateperone or matching placebo administered adjunctively during the treatment phase. * Scree…
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age \>=60 * Current unipolar non-psychotic major depression determined by SCID-5 * MADRS score \>=20 at screening and \>=18 at baseline * Treatment-resistance defined as documented history of non-response to at least two oral medications of adequate dose and duration in this episode or previous episode, OR clinician determination that treatment augmentation is appropriate * Currently taking oral antidepressant prescribed at least minimum therapeutic dose and for at least six weeks duration * MMSE score of \>/=24 Exclusion Criteria: * Dementia * High risk for suicide, d…
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.
Locations (2)
- University of ArizonaTucson, Arizona
- Washington University School of MedicineSt Louis, Missouri