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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Transcranial Magnetic Stimulation
DeviceThis intervention will deliver open-label aiTBS, an efficient FDA-cleared form of rTMS for major depressive disorder to patients with intermediate/high risk (i.e., significant depression and anxiety; chronic suicidal ideation). The study team will conduct modeling of the electric field intensity and distribution for each participant, and provide proof of concept for an electric-field informed dosing strategy that engages brain networks.
Psilocybin (drug)
DrugIn this intervention, open-label flexible-dosing of psilocybin assisted therapy in intermediate and high-risk patients will be delivered to reduce suicidal ideation and identify mediators of response. The study team will deliver two separate psilocybin sessions accompanied by preparation and integration therapy. Factors such as dose, depression severity, serotonergic use, and depth of mystical experiences will be correlated with suicidality reduction.
Neurofeedback
BehavioralThis intervention will deliver active or sham real-time fMRI neurofeedback occurring across two visits to a low-to-intermediate risk population, i.e., low-to-severe levels of depression or anxiety/PTSD identified by clinical scales, with suicidal ideation present but no intent or plan.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Arm 1: NeurofeedbackSham comparator 1 intervention
Group B: Arm 2: TMSActive comparator 1 intervention
Group C: Arm 3: PsilocybinActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Neurofeedback
Aim 1 will recruit a low risk to intermediate risk populations, i.e., low-to-moderate levels of depression or anxiety/PTSD with occasional suicidal ideation, up to significant depression and anxiety with chronic suicidal ideation). Following baseline assessment with the universal assessment battery, participants will be randomized to active or sham group and undergo real-time fMRI neurofeedback studies occurring across two visits.
Time frame
From enrollment through post-treatment visit about 6-8 weeks.Secondary outcomes
1
TMS
Aim 2 will recruit an intermediate to high risk population (i.e., significant depression and anxiety; chronic suicidal ideation) to receive aiTBS, an efficient FDA-cleared form of rTMS for major depressive disorder
Time frame
From enrollment through post-treatment visit about 6-8 weeks.Other outcomes
1
Psilocybin
Aim 3 will administer psilocybin assisted therapy in intermediate and high risk patients to reduce suicidal ideation and identify mediators of response. Participants will receive two separate psilocybin sessions accompanied by preparation and integration therapy. Factors such as dose, depression severity, serotonergic use, and depth of mystical experiences will be correlated with suicidality reduction.
Time frame
From enrollment through post-treatment visit about 6-8 weeks.2
Predictive model
Aim 4 will combine clinical, imaging, and circular RNA data gathered across Aims 1, 2, and 3 at baseline into a predictive model for behavioral risk and suicidal ideation. Co-I Plis will use joint information, dynamic connectivity, and deep learning to enhance prediction of behavioral risk. Circular RNA data from Co-I Cruchaga will be fused with the imaging and clinical data.
Time frame
From enrollment through post-treatment visit about 6-8 weeks.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of New Mexico
Lead sponsor
United States Department of Defense
Collaborator
The Mind Research Network
Collaborator
Source ClinicalTrials.gov
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