NCT07623135 Lumateperone for Late-Life Depression
| NCT ID | NCT07623135 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Eric Lenze |
| Condition | Treatment Resistant Depression (TRD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-09-01 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 100 participants in total. It began in 2026-09-01 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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.
Contact & Investigator
Eric J Lenze, MD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT07623135 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Treatment Resistant Depression (TRD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07623135 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 100 participants.
Is NCT07623135 currently recruiting?
Yes, NCT07623135 is actively recruiting participants. Contact the research team at stevens.a@wustl.edu for enrollment information.
Where is the NCT07623135 trial being conducted?
This trial is being conducted at Tucson, United States, St Louis, United States.
Who is sponsoring the NCT07623135 clinical trial?
NCT07623135 is sponsored by Eric Lenze. The principal investigator is Eric J Lenze, MD at Washington University School of Medicine. The trial plans to enroll 100 participants.
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