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WithdrawnPhase 2

Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies

NCT07484906 · PRE-EMPT · University of New Mexico

Closed to entry
Status
Not accepting participants
Phase 2
Phase
Target enrolment
Study sites

What it is testing

Summary

PRE-EMPT will assemble a study group of 150 civilian and Veteran participants from three populations (low risk, intermediate risk, and high risk for self-harm). The investigators will obtain clinical assessments, MRI, and blood levels for circular RNA (circRNA). The teams will then administer three interventions (neurofeedback, transcranial magnetic stimulation, and psilocybin assisted therapy), and repeat the tests above. A team with expertise in artificial intelligence will then use our data to try to find patterns that identify who is at high risk versus low risk with a high degree of accuracy.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Scale of Suicidal Ideation

    Measured over Baseline (Day 1) to Post-Treatment Visit (Month 6)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 69 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. 18-69 years old 2. Have been on a stable psychiatric medication regimen for at least four weeks prior to study participation. Exclusion Criteria: 1. A prior history of other central nervous system disease or any history of seizures; 2. history of psychotic disorders (e.g., schizophrenia, schizoaffective disorder, bipolar disorder type I); 3. history of current or recent (within two years) substance/alcohol use disorder, with the exception of tobacco use disorder; 4. meet criteria for Very High risk of suicide, or require inpatient hospital-level care for psychiatric reasons at time of consent, to reduce exacerbation of risk of harm to self during study; 5. presence of any implanted metal or electrical device (e.g. pacemaker); 6. recent medical hospitalization (within three weeks); 7. any condition that would prevent the participant from completing the protocol, such as significant agitation; 8. appointment of a legal representative or treatment guardian; 9. any ongoing litigation related to a health condition; 10. any other contraindication to exposure to strong magnetic fields or MRI, such as severe claustrophobia; 11. pregnancy or lactation; 12. a family history of schizophrenia or schizoaffective disorder (first or second degree relatives), or bipolar disorder type 1 (first degree relatives), to reduce risk of exacerbation of an undiagnosed psychotic condition; 13. other medical conditions that would preclude safe participation in the trial (e.g., decompensated heart failure); 14. starting or planning to start psychotherapy or changing the frequency or intensity of existing psychotherapy during the trial (current psychotherapy can be continued provided the frequency and intensity has been stable for ≥2 months prior to screening); 15. membership in a vulnerable population (minors, prisoners); 16. any contraindication for blood draws.

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07484906 on ClinicalTrials.gov →

Last updated in the registry 2026-03-20. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits