NCT07623135 Lumateperone Tosylate Depressive Disorder, Major Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07623135 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 22 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07623135 is a hot trial to watch
Depressive Disorder, Major is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07623135 is notable because it evaluates Lumateperone Tosylate in a Phase 3 design sponsored by Washington University School of Medicine. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07623135 |
| Official title | Lumateperone for Late-Life Depression (IRL Grey-C) |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | Lumateperone Tosylate |
| Sponsor | Washington University School of Medicine |
| Geography | United States |
| Enrollment | [object Object] |
| Primary endpoint | Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score |
| Endpoint time frame | From baseline to the end of treatment at week 10. |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
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).
Allocation is Randomized, masking is Quadruple, and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across United States shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score (From baseline to the end of treatment at week 10.) — To evaluate whether adjunctive lumateperone reduces depressive symptoms compared with placebo.
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Lumateperone Tosylate is indexed as Small molecule drug, with target 5-HT2A receptor x D2 receptor, mechanism 5-HT2A receptor antagonists, D2 receptor antagonists, and global highest development status Approved.
Company & Deal Intelligence MCP profile: Washington University School of Medicine is resolved to a normalized organization record in United States. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07623135 provides a focused lens on Depressive Disorder, Major development. Its value will be determined by whether Lumateperone Tosylate can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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