Lumateperone for Late-Life Depression
Recruiting · NCT07623135 · Interventional (participants receive a specific treatment) · Lead sponsor: Eric Lenze
View the official record on ClinicalTrials.gov →Interventions studied
LumateperonePlacebo
What this trial is about
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).
Who can take part
Age range
60 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
2 locations listed across 2 US states.
- University of Arizona - Tucson, Arizona, United States
- Washington University School of Medicine - St Louis, Missouri, United States