Lumateperone for Late-Life Depression
Sponsored by Eric Lenze
About this study
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).
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. * Screening: Participants who sign consent will go through a screening process. This will involve answering questions about medical history, medications, demographics, mood and emotions as well as completing…
Where this study is enrolling
- I'm interested
University of Arizona
Tucson, Arizona
Who can participate
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, defined as a 4 or 5 on C-SSRS (indicating active suicidal ideation with current or recent intent or plan), and unable to be managed safely in the clinical trial. Urgent psychiatric referral will be made in these cases.
- ✕High risk alcohol use: defined as a score of 6 or more on the AUDIT-C
- ✕Medically inappropriate for participation as determined by PIs.
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.