Lumateperone for Late-Life Depression (NCT07623135) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Lumateperone for Late-Life Depression
United States100 participantsStarted 2026-06
Plain-language 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).
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is Phase 3 and testing lumateperone specifically for late-life treatment-resistant depression, can you help me understand what 'treatment resistant' means in this context — and whether my history of not responding to previous antidepressants would actually fit what this study is looking for?
2The trial is measuring symptom change using a scale called the MADRS — what score range would count as meaningful improvement, and how does that compare to the kinds of changes I might expect from standard treatments I haven't tried yet?
3Because this trial is listed as 'not yet recruiting,' do you know roughly when it might open, and is it worth waiting for it versus starting or adjusting my current treatment now?
4Lumateperone is already approved for other psychiatric conditions, so how does the existing safety data on this drug apply to older adults specifically, and are there any age-related risks or drug interactions I should be aware of given my current medications?
5Are there other approved or emerging options for late-life treatment-resistant depression that I should compare this trial against before deciding whether it's worth discussing with you further?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score
Timeframe: From baseline to the end of treatment at week 10.