A Phase 2 interventional study of Transcranial Magnetic Stimulation and Psilocybin (drug) in PTSD, PTSD - Post Traumatic Stress Disorder and Major Depression, sponsored by University of New Mexico. Not yet recruiting. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by University of New Mexico · Phase 2, Interventional, and Treatment
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.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 150 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →University of New Mexico is the lead sponsor of 313 studies on the registry; 29 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Arm 1:
Inclusion:
Arm 2:
Inclusion:
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:
Inclusion:
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:
i. 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 ( ≥ 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Neurofeedback
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.
Device: Transcranial Magnetic Stimulation
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.
Drug: Psilocybin (drug)
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.
Also known as: TMS
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.
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.
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.
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.
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.
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.
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Psilocybin
Stress Disorders, Post-Traumatic →