NCT07592689 Lysergic acid diethylamide 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 NCT07592689 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 NCT07592689 is a hot trial to watch
Depressive Disorder, Major is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07592689 is notable because it evaluates Lysergic acid diethylamide in a Phase 3 design sponsored by Definium Therapeutics US, Inc.. 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 | NCT07592689 |
| Official title | A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend) |
| Phase / status | Phase 3 / Recruiting |
| Intervention | Lysergic acid diethylamide |
| Sponsor | Definium Therapeutics US, Inc. |
| Geography | United States |
| Enrollment | [object Object] |
| Primary endpoint | Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 |
| Endpoint time frame | Baseline to Week 6 |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating DT120 Compared to Placebo in Major Depressive Disorder - Ascend
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 the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 (Baseline to Week 6) — The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more
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: Lysergic acid diethylamide is indexed as Small molecule drug, with target 5-HT2A receptor, mechanism 5-HT2A receptor agonists, and global highest development status Phase 3.
Company & Deal Intelligence MCP profile: Definium Therapeutics US, Inc. did not return an exact normalized organization match in this snapshot. 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
NCT07592689 provides a focused lens on Depressive Disorder, Major development. Its value will be determined by whether Lysergic acid diethylamide can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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