PTSDPhase 2PRE-EMPTNCT07745569
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
A Phase 2 study testing Transcranial Magnetic Stimulation, Psilocybin (drug) and Neurofeedback in people with PTSD and PTSD - Post Traumatic Stress Disorder, run by University of New Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- PTSD, PTSD - Post Traumatic Stress Disorder, Major Depression
- What is being tested?
- Transcranial Magnetic Stimulation, Psilocybin (drug) and Neurofeedback
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2026to 30 Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
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- Arm 2:
- 1) 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:
- 1) 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))
- Exclusions:
- Other additional medical conditions that would preclude safe participation in this arm of the trial:
- significantly impaired liver function,
- severe coronary artery disease,
- heart failure,
- uncontrolled hypertension (above 140/90 mmHg upon screening) ,
- If blood pressure is consistently elevated > 140/90 mmHg across 3 attempts, subjects may be referred to their primary care provider for management of hypertension. Upon management of blood pressure, subjects will have an opportunity to return once within the 30 day screening window to make 3 additional attempts at a blood pressure reading ≤ 140/90 mmHg. Subjects will be considered eligible upon registering 1 blood pressure reading ≤ 140/90 mmHg during the screening period. Blood pressure will be reassessed on Day 0 prior to dosing, and must be less than or equal to 140 systolic, 90 diastolic, with resting pulse ≤ 100 (ascertained within 20 minutes of IP administration in order for the participant to receive study medication.) e. history of cerebrovascular accident, f. severe obesity (BMI ≥ 35), g. untreated asthma, h. untreated hyperthyroidism, i. narrow-angle glaucoma, j. stenosing peptic ulcer, k. pyloroduodenal obstruction, l. symptomatic prostatichypertrophy, or m. bladder-neck obstruction, n. history of valvular heart disease or any heart condition that affects the valves
- serious ECG abnormalities (e.g., evidence of ischemia, myocardial infarction, QT interval corrected for heart rate [QTc] prolongation (QTc > 0.45 seconds), arrhythmia, or conduction abnormalities that increase the risk of arrhythmia);
- allergy or hypersensitivity to psilocybin or chocolate
Who cannot join
- 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);
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- 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:
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
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.
- Being tested
- Transcranial Magnetic Stimulation, Psilocybin (drug), Neurofeedback
- Keywords
- TMS, Transcranial magnetic stimulation, neuromodulation, psilocybin, neurofeedback
- Medical subject headings
- Stress Disorders, Post-Traumatic, Combat Disorders, Depressive Disorder, Major, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Also called TMS
This 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)Drug
In 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.
NeurofeedbackBehavioural
This 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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Neurofeedback | Sham comparator | You will undergo 2 sessions of neurofeedback treatment, with an interval of 1-2 weeks between sessions up to a month maximum. Neurofeedback training and treatment in this study is performed inside an MRI scanner while wearing a cap to measure brain waves (EEG). You will be lying comfortably inside an MRI machine for 1 hour while your brain activity is being scanned. You will see a screen with a thermometer-style red bar, which will represent activity of a specific region of your brain (the amygdala), involved in emotion experience in the active condition. For those assigned to the sham condition, the red bar will not represent brain activity and will move randomly. By controlling the height of the red bar in real time, you will be able to try to regulate activity of that brain region. By controlling the neurofeedback signal, you may learn to enhance your brain activity associated with happy future thoughts. Receives: Behavioral: Neurofeedback |
| Arm 2: TMS | Active comparator | The day before you begin the rTMS treatments, you will be asked to come in for a short visit to determine the level of stimulation that is right for you. You will then receive up to 100 rTMS treatments, given five days a week for 10 days. For the first 50 treatments, you will receive real stimulation to the left side of your brain. After 50 treatments to the left side, depending on how it affects you, you may qualify to receive 50 more treatments to the right side of your brain.
You might feel a slight twitch in your hand. A camera will track your head movements during the procedure. Most people experience tapping or twitching on their scalp during rTMS. The stimulation will last 10 minutes, followed by 30 minutes of rest before another session. Receives: Device: Transcranial Magnetic Stimulation |
| Arm 3: Psilocybin | Active comparator | You may receive 2 psilocybin assisted therapy treatments, given once a week, for 2 weeks.
Preparation Sessions: Before the first psilocybin session, you will meet with the study therapist and physician for 1-2 preparation meetings, to answer questions and make sure you understand the sequence of events during the intervention.
Psilocybin Session: You will lie on a comfortable couch, receive the medication and be guided through the psychedelic experience with the two trained study staff, while being medically monitored, for approximately 8 hours. If needed, you may receive medications to treat side effects like high blood pressure, or anxiety. You will need to have a trusted person to take you home and stay with you for the night after each psilocybin session.
Integration Session: The next day after each psilocybin session, you will meet with the therapist again and talk about your experience. Depending on what you experienced in the first week, the dose may be increased. Receives: Drug: Psilocybin (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From enrollment through post-treatment visit about 6-8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start31 Dec 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, The Mind Research Network
- Responsible party
- Sponsor
- Investigators
- Davin Quinn, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745569
- Sponsor's protocol ID
- 25-535
- Other IDs
- HT9425-25-1-0954
- Acronym
- PRE-EMPT
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
- ClinicalTrials.gov ID
- NCT07745569
- Acronym / sponsor ID
- PRE-EMPT / 25-535
- Keywords
- TMS, Transcranial magnetic stimulation, neuromodulation, psilocybin, neurofeedback
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- United States Department of Defense, The Mind Research Network
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Neurofeedback | Sham comparator | Behavioral: NeurofeedbackYou will undergo 2 sessions of neurofeedback treatment, with an interval of 1-2 weeks between sessions up to a month maximum. Neurofeedback training and treatment in this study is performed inside an MRI scanner while wearing a cap to measure brain waves (EEG). You will be lying comfortably inside an MRI machine for 1 hour while your brain activity is being scanned. You will see a screen with a thermometer-style red bar, which will represent activity of a specific region of your brain (the amygdala), involved in emotion experience in the active condition. For those assigned to the sham condition, the red bar will not represent brain activity and will move randomly. By controlling the height of the red bar in real time, you will be able to try to regulate activity of that brain region. By controlling the neurofeedback signal, you may learn to enhance your brain activity associated with happy future thoughts. |
| Arm 2: TMS | Active comparator | Device: Transcranial Magnetic StimulationThe day before you begin the rTMS treatments, you will be asked to come in for a short visit to determine the level of stimulation that is right for you. You will then receive up to 100 rTMS treatments, given five days a week for 10 days. For the first 50 treatments, you will receive real stimulation to the left side of your brain. After 50 treatments to the left side, depending on how it affects you, you may qualify to receive 50 more treatments to the right side of your brain. You might feel a slight twitch in your hand. A camera will track your head movements during the procedure. Most people experience tapping or twitching on their scalp during rTMS. The stimulation will last 10 minutes, followed by 30 minutes of rest before another session. |
| Arm 3: Psilocybin | Active comparator | Drug: Psilocybin (drug)You may receive 2 psilocybin assisted therapy treatments, given once a week, for 2 weeks. Preparation Sessions: Before the first psilocybin session, you will meet with the study therapist and physician for 1-2 preparation meetings, to answer questions and make sure you understand the sequence of events during the intervention. Psilocybin Session: You will lie on a comfortable couch, receive the medication and be guided through the psychedelic experience with the two trained study staff, while being medically monitored, for approximately 8 hours. If needed, you may receive medications to treat side effects like high blood pressure, or anxiety. You will need to have a trusted person to take you home and stay with you for the night after each psilocybin session. Integration Session: The next day after each psilocybin session, you will meet with the therapist again and talk about your experience. Depending on what you experienced in the first week, the dose may be increased. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
- 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))
Key exclusion criteria (17 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationAlso: TMSThis 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. | Device | Arm 2: TMS |
| Psilocybin (drug)In 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. | Drug | Arm 3: Psilocybin |
| NeurofeedbackThis 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. | Behavioural | Arm 1: Neurofeedback |
Primary outcome
Neurofeedback
Time frame: From enrollment through post-treatment visit about 6-8 weeks.
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.
1 secondary outcome
TMS
Time frame: From enrollment through post-treatment visit about 6-8 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Davin Quinn, MD principal investigator
University of New Mexico
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transcranial Magnetic Stimulation, Psilocybin (drug) and Neurofeedback in people with PTSD and PTSD - Post Traumatic Stress Disorder, run by University of New Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Crystal A Garcia (505-272-9552, crabaca@salud.unm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurofeedback (time frame: From enrollment through post-treatment visit about 6-8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.