NCT07562191 Dimethyltryptamine Suicidal Ideation Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07562191 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: 24 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.

Why NCT07562191 is a hot trial to watch

Suicidal Ideation is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07562191 is notable because it evaluates Dimethyltryptamine in a Phase 2 design sponsored by Universidade Federal do Rio Grande do Norte. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.

Trial landscape snapshot

Protocol design and endpoint interpretation

This Phase 2b, randomized, double-blind, active-controlled clinical trial will evaluate the efficacy and safety of inhaled N,N-dimethyltryptamine (DMT) in adults with Major Depressive Disorder (MDD). The study will test whether inhaled DMT can rapidly reduce depressive symptoms and suicide risk compared with a low-dose active comparator. A total of 140 participants will be randomized 1:1 to receive either 15 mg followed 1 hour later by 60 mg of inhaled DMT, or 1 mg followed 1 hour later by 4 mg of inhaled DMT. Participants who do not achieve remission at Day 7 will enter an open-label extension and receive a high-dose DMT session on Day 14 (±3 days). All participants will be followed for up to 12 months to evaluate the durability of response, safety, functioning, and quality of life.

Allocation is Randomized, masking is Quadruple, and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across Brazil 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 (Antidepressant efficacy) (Baseline and Day 7 (D7) after the dosing session) — The MADRS is a clinician-rated scale used to evaluate the severity of depressive symptoms. It consists of 10 items, each rated from 0 to 6. The total score ranges from 0 to 60. Higher scores indicate greater severity of depression (worse outcome).

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: Dimethyltryptamine is indexed as Small molecule drug, with target 5-HT receptor, mechanism 5-HT receptor modulators, Neurons modulators, and global highest development status Phase 2.

Company & Deal Intelligence MCP profile: Universidade Federal do Rio Grande do Norte 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

NCT07562191 provides a focused lens on Suicidal Ideation development. Its value will be determined by whether Dimethyltryptamine can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.

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