Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-69
SponsorUniversity of New Mexico
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Transcranial Magnetic Stimulation
- Psilocybin (drug)
- Neurofeedback
Treatment groups
150 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
University of New Mexico
Lead sponsor
United States Department of Defense
Collaborator
The Mind Research Network
Collaborator
Source ClinicalTrials.gov