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Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 30, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT07745569). This is a study registration, not published results. Lead sponsor: University of New Mexico. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 150 participants (ESTIMATED). Conditions: PTSD, PTSD - Post Traumatic Stress Disorder, Major Depression, Suicidality. Interventions: DEVICE: Transcranial Magnetic Stimulation; DRUG: Psilocybin (drug); BEHAVIORAL: Neurofeedback. Primary outcome measures: Neurofeedback , From enrollment through post-treatment visit about 6-8 weeks.. Brief summary: 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.