Lumateperone for Late-Life Depression
- NCT ID
- NCT07623135
- Registry status
- Recruiting
- Study type
- Not specified in the registry data
- Phase
- Phase 3
- Sponsor
- Eric Lenze
Overview
ClinicalTrials.gov lists this study as Recruiting.
Enrollment: 100 participants (Estimated).
What is being studied
No interventions are listed in the registry data.
Who may be eligible
- Ages
- Not specified in the registry data
- Sex
- Not specified in the registry data
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following eligibility criteria.
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.
Study locations
2 study locations are listed.
Site recruitment status is not specified in the registry data for these locations.
Countries: United States
- Arizona, United States: 1
- Missouri, United States: 1
Sample of listed locations
- University of Arizona — Tucson, Arizona, 85713, United States — Site recruitment status not specified in the registry data
- Washington University School of Medicine — St Louis, Missouri, 63110, United States — Site recruitment status not specified in the registry data
Study details
- Start date
- September 1, 2026
- Primary completion date
- June 1, 2028
- First posted
- June 3, 2026
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT07623135
- Registry last updated
- September 16, 2026
- QualifiedStudies registry data refreshed
- September 21, 2026
View NCT07623135 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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