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

NCT07484906 | Withdrawn Phase 2 DMC FDA Drug FDA Device

• 2 other identifiers: HRRC# 25-535HT9425-25-1-0954
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Suicidal Ideation

Keywords

depression; posttraumatic stress disorder; suicidal ideation; psilocybin; transcranial magnetic stimulation; neurofeedback; predictive modeling; artificial intelligence

Outcome Measures

Primary Outcomes (1)

• Scale of Suicidal Ideation

  The SSI is a 19-item, interviewer-administered rating scale that measures the current intensity of specific attitudes, behaviors, and plans to commit suicide.

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

Secondary Outcomes (6)

• Beck Depression Inventory-II

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

• PTSD Checklist-for DSM 5

  Baseline (Day 1) to Post Treatment Visit (Month 6)

• Columbia Suicide Severity Rating Scale

  Baseline (Day 1) to Post Treatment Visit (Month 6)

• Generalized Anxiety Disorder-7

  Baseline (Day 1) to Post Treatment Visit (Month 6)

• WHODAS 2.0

  Baseline (Day 1) to Post Treatment Visit (Month 6)

Other Outcomes (1)

• BOLD Signal Change

  Baseline (Day 1) to Post Treatment Visit (Month 6)

Study Arms (3)

fMRI Neurofeedback

EXPERIMENTAL

Participants undergo two sessions of fMRI neurofeedback, during which they attempt to modulate a visual display of amygdala activity during fMRI.

Behavioral: fMRI Neurofeedback

Accelerated theta burst stimulation

EXPERIMENTAL

Participants undergo 50 sessions of theta burst stimulation, delivered to the dorsolateral prefrontal cortex.

Device: Accelerated theta burst stimulation

Psilocybin assisted therapy

EXPERIMENTAL

Participants undergo three sessions of preparation, two psilocybin administration sessions, and two integration sessions.

Drug: Psilocybin assisted therapy

Interventions

fMRI Neurofeedback BEHAVIORAL

Participants undergo two sessions of fMRI neurofeedback, during which they attempt to modulate a visual display of amygdala activity during fMRI.

fMRI Neurofeedback

Accelerated theta burst stimulation DEVICE

Participants undergo 50 sessions of theta burst stimulation, delivered to the dorsolateral prefrontal cortex.

Accelerated theta burst stimulation

Psilocybin assisted therapy DRUG

Participants undergo three sessions of preparation, two psilocybin administration sessions, and two integration sessions.

Psilocybin assisted therapy

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Have been on a stable psychiatric medication regimen for at least four weeks prior to study participation.

You may not qualify if:

• A prior history of other central nervous system disease or any history of seizures;
• history of psychotic disorders (e.g., schizophrenia, schizoaffective disorder, bipolar disorder type I);
• history of current or recent (within two years) substance/alcohol use disorder, with the exception of tobacco use disorder;
• 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;
• presence of any implanted metal or electrical device (e.g. pacemaker);
• recent medical hospitalization (within three weeks);
• any condition that would prevent the participant from completing the protocol, such as significant agitation;
• appointment of a legal representative or treatment guardian;
• any ongoing litigation related to a health condition;
• any other contraindication to exposure to strong magnetic fields or MRI, such as severe claustrophobia;
• pregnancy or lactation;
• 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;
• other medical conditions that would preclude safe participation in the trial (e.g., decompensated heart failure);
• 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);
• membership in a vulnerable population (minors, prisoners);

Sponsors & Collaborators

• University of New Mexico: lead
• The Mind Research Network: collaborator
• New Mexico VA Healthcare System: collaborator
• Washington University School of Medicine: collaborator
• Georgia State University: collaborator

MeSH Terms

Conditions

Suicidal Ideation; Depression; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PRE-EMPT is a prospective, multi-arm, clinical trial investigating three different neuroplasticity-enhancing interventions and assessing their capability to improve CC and ER as well as clinical outcomes.

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: March 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: 2 years after conclusion of study (8/31/2031) for as long as NDA remains available (end date).
• Access Criteria: Users of NIMH Data Archive will be able to access the de-identified IPD through the NDA website.