Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies

Starting soon · Phase 2 · Has a placebo group

Conditions studied: PTSD, PTSD - Post Traumatic Stress Disorder, Major Depression, Suicidality

In brief

PRE-EMPT will assemble a cohort of 150 participants from three populations (low risk, intermediate risk, and high risk for self-harm). We will obtain clinical assessments, structural and functional MRI utilizing tasks pioneered by our team to assess cognitive control (CC) and emotion regulation (ER), and peripheral circular RNA (circRNA) levels to characterize the molecular brain states associated with behavioral risk. The clinical, imaging, and transcriptomic data will be fused and jointly analyzed to increase the accuracy of our risk prediction models. PRE-EMPT in three separate Aims will then prospectively assess three promising and innovative interventions for their potential to reduce suicidal ideation and alter activity in key neural networks: 1) neurofeedback (NF) using real-time fMRI with simultaneous electroencephalography (EEG), 2) a form of transcranial magnetic stimulation (TMS) called accelerated intermittent theta burst stimulation (aiTBS) with dose optimization through electric field modeling; and 3) psilocybin assisted therapy (PSI), with flexible dosing plan to maximize the depth of psychedelic experience. These therapies were chosen based on our team's prior work in all three interventions demonstrating rapid action and large effects.

Key facts

Study ID

NCT07745569

Run by

University of New Mexico

People needed

150

Starts

2026-08-31

Expected to finish

2030-06-30

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-69 years old
• Have been on a stable psychiatric medication regimen for at least four weeks prior to study participation.
• Formal diagnosis of major depressive disorder or post-traumatic stress disorder by a mental health professional.
• Must be under the care of a medical provider (ex: primary care, therapist, psychiatrist, psychiatric nurse practitioner) for mental health treatment who can provide contact information and written confirmation that they will be willing and able to care for participant during their entire involvement in the study.

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 one year) 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);
• any contraindication for blood draws.
• Arm 1:
• Inclusion:
• PRE-EMPT Risk Level Low or Intermediate (recent suicidal ideation, but no intent/plan; C-SSRS level low; mild-to-moderate depression (QIDS score 6-15) or PTSD (PCL-5 score 20-32))
• Right-handed.
• Arm 2:
• Inclusion:
• PRE-EMPT Risk Level Intermediate or High (recent suicidal ideation, but no intent or plan; C-SSRS level low to moderate; moderate to severe depression (QIDS score >16) or PTSD (PCL-5 score greater than or equal to 33))
• Arm 3:
• Inclusion:

Full record on ClinicalTrials.gov

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