NCT07623135RecruitingPhase 3
Lumateperone for Late-Life Depression
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 28 May 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Eric Lenze
- Diseases
- Depression
- NCT number
- NCT07623135
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 100
- From 1 Sept 2026 to the primary completion date, 30 Jun 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- High risk alcohol use: defined as a score of 6 or more on the AUDIT-C
- Medically inappropriate for participation as determined by PIs.
Who the study is looking for
- 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
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| University of Arizona Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.