NCT07610369 Psilocybin Depressive Disorder Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07610369 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: 23 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07610369 is a hot trial to watch
Depressive Disorder is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07610369 is notable because it evaluates Psilocybin in a Phase 2 design sponsored by Yale University. 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 | NCT07610369 |
| Official title | The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease (PSI-PD) |
| Phase / status | Phase 2 / Recruiting |
| Intervention | Psilocybin |
| Sponsor | Yale University |
| Geography | United States |
| Enrollment | [object Object] |
| Primary endpoint | Change in depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) |
| Endpoint time frame | Baseline to 30 days after first drug dose |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.
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 depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) (Baseline to 30 days after first drug dose) — MADRS is a 10-item clinician-administered scale used to measure the severity of depressive symptoms. Total scores range from 0 to 60 with higher scores indicating more severe depression.
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: Psilocybin is indexed as Small molecule drug, with target 5-HT1A receptor x 5-HT2A receptor x 5-HT2C receptor x 5-HT6 receptor, mechanism 5-HT1A receptor antagonists, 5-HT2A receptor agonists, 5-HT2C receptor agonists, and global highest development status Approved.
Company & Deal Intelligence MCP profile: Yale University is resolved to a normalized organization record in NEW HAVEN COUNTY, 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
NCT07610369 provides a focused lens on Depressive Disorder development. Its value will be determined by whether Psilocybin can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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