NCT07610473 DT-101 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 NCT07610473 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 NCT07610473 is a hot trial to watch
Depressive Disorder, Major is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07610473 is notable because it evaluates DT-101 in a Phase 2 design sponsored by Draig Therapeutics Ltd.. 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 | NCT07610473 |
| Official title | A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depression (AERON-1) |
| Phase / status | Phase 2 / Recruiting |
| Intervention | DT-101 |
| Sponsor | Draig Therapeutics Ltd. |
| Geography | United States |
| Enrollment | [object Object] |
| Primary endpoint | Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 56 |
| Endpoint time frame | from enrolment to day 56 |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
In this study, researchers will learn more about a study drug called DT-101 in participants with Major Depressive Disorder (MDD), a form of depression. The goal of this clinical trial is to learn if DT-101 can treat depression in adults. The effect of DT-101 will be compared to placebo. A placebo looks the drug but contains no medicine. Subjects will attend the clinic for complete general health checks and to complete questionnaires.
Allocation is Randomized, masking is Triple, 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 from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 56 (from enrolment to day 56)
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: DT-101 is indexed as Unknown, with target AMPA receptor, mechanism AMPA receptor positive allosteric modulator, and global highest development status Phase 2.
Company & Deal Intelligence MCP profile: Draig Therapeutics Ltd. is resolved to a normalized organization record in United Kingdom. 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
NCT07610473 provides a focused lens on Depressive Disorder, Major development. Its value will be determined by whether DT-101 can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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