Suicidal IdeationPhase 2PRE-EMPTNCT07484906
Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
A Phase 2 study testing fMRI Neurofeedback, Accelerated theta burst stimulation and Psilocybin assisted therapy in people with Suicidal Ideation, run by University of New Mexico.
Trial summary
PRE-EMPT will assemble a study group of 150 civilian and Veteran participants from three populations (low risk, intermediate risk, and high risk for self-harm). The investigators will obtain clinical assessments, MRI, and blood levels for circular RNA (circRNA). Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- fMRI Neurofeedback, Accelerated theta burst stimulation and Psilocybin assisted therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Aug 2029
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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.
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 two years) 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.
About this study
PRE-EMPT will assemble a study group of 150 civilian and Veteran participants from three populations (low risk, intermediate risk, and high risk for self-harm). The investigators will obtain clinical assessments, MRI, and blood levels for circular RNA (circRNA). The teams will then administer three interventions (neurofeedback, transcranial magnetic stimulation, and psilocybin assisted therapy), and repeat the tests above. A team with expertise in artificial intelligence will then use our data to try to find patterns that identify who is at high risk versus low risk with a high degree of accuracy.
Read the detailed description
For U.S. Service Members, deployment and combat exposure can result in significant mental strain, with high rates of disability and suicide. Unfortunately our ability to predict and treat those at high risk of intentional self-harm is limited. PRE-EMPT (Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies) seeks to transform the assessment and treatment of the spectrum of depression, posttraumatic stress, and self-harm. PRE-EMPT will utilize multimodal neuroimaging, blood-based biomarkers, and predictive analytics to devise highly accurate models of behavioral risk, and to characterize response to three neuroplasticity-enhancing interventions.
Background: Rates of suicide have increased 37% since the year 2000 despite concerted governmental and institutional programs to address root causes such as stigma and lack of access. Suicide was the number one cause of active-duty fatality from 2014 to 2019, highlighting the vulnerability of Service Members and Veterans. Suicide is a highly multifactorial event and may be conceptualized as a state in which individuals cannot come up with any other option to endure difficult circumstances or intense feelings, representing failures of cognitive control (CC) and emotion regulation (ER). Similarly, the heritability of suicide risk is well known, and transcriptomics, or the study of transcript molecules such as RNA that regulate gene expression, has potential to reveal mechanisms of risk not fully explained by DNA analysis. Better methods of classifying suicide risk according to objective and measurable factors are needed to proactively identify persons at risk and provide interventions tailored to risk.
Research Plan: PRE-EMPT will assemble a cohort of 150 civilian and Veteran participants from three populations (low risk, intermediate risk, and high risk for self-harm). The investigators will obtain baseline 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. In parallel, investigators will mine publicly available databases to identify network nodes and use deep learning techniques on multivariate patterns of brain activation, structural topography, and functional connectivity. The clinical, imaging, and transcriptomic data will be fused and jointly analyzed to increase the accuracy of risk prediction models. PRE-EMPT in three separate arms 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) 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. Assessments will be repeated at post-treatment and at 1, 3, and 6 months after intervention. These therapies were chosen based on our team's prior work in all three interventions demonstrating rapid action and large effects. Each clinical arm will contribute independent insights into mediators of efficacy for the specific interventions and risk groups, while pooling data to identify predictors across the risk spectrum.
Specific Aim 1: To construct a neurobehavioral model from structural and functional MRI, clinical, and transcriptomic data that accurately predicts behavioral risk.
Specific Aim 2: To test three potential rapid-acting therapies for suicidal ideation and identify mechanistic mediators of response.
- Conditions
- Suicidal Ideation
- Being tested
- fMRI Neurofeedback, Accelerated theta burst stimulation, Psilocybin assisted therapy
- Keywords
- depression, posttraumatic stress disorder, suicidal ideation, psilocybin, transcranial magnetic stimulation, neurofeedback, predictive modeling, artificial intelligence
- Medical subject headings
- Suicidal Ideation, Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI NeurofeedbackBehavioural
Participants undergo two sessions of fMRI neurofeedback, during which they attempt to modulate a visual display of amygdala activity during fMRI.
Accelerated theta burst stimulationDevice
Participants undergo 50 sessions of theta burst stimulation, delivered to the dorsolateral prefrontal cortex.
Psilocybin assisted therapyDrug
Participants undergo three sessions of preparation, two psilocybin administration sessions, and two integration sessions.
| Study group | Role | What they receive |
|---|---|---|
| fMRI Neurofeedback | Experimental | Participants undergo two sessions of fMRI neurofeedback, during which they attempt to modulate a visual display of amygdala activity during fMRI. Receives: Behavioral: fMRI Neurofeedback |
| Accelerated theta burst stimulation | Experimental | Participants undergo 50 sessions of theta burst stimulation, delivered to the dorsolateral prefrontal cortex. Receives: Device: Accelerated theta burst stimulation |
| Psilocybin assisted therapy | Experimental | Participants undergo three sessions of preparation, two psilocybin administration sessions, and two integration sessions. Receives: Drug: Psilocybin assisted therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale of Suicidal Ideation
The SSI is a 19-item, interviewer-administered rating scale that measures the current intensity of specific attitudes, behaviors, and plans to commit suicide.
Measured: Baseline (Day 1) to Post-Treatment Visit (Month 6)
Secondary outcomes (6)
Beck Depression Inventory-II
The Beck Depression Inventory-II (BDI-II) is a 21-item self-report questionnaire widely used by mental health professionals to measure the severity of depression in adults and adolescents aged 13 and older.
Measured: Baseline (Day 1) to Post-Treatment Visit (Month 6)
PTSD Checklist-for DSM 5
The PCL-5 is the Posttraumatic Stress Disorder (PTSD) Checklist for DSM-5, a 20-item self-report measure used by healthcare professionals to screen for, monitor, and provisionally diagnose PTSD symptoms in adults.
Measured: Baseline (Day 1) to Post Treatment Visit (Month 6)
Columbia Suicide Severity Rating Scale
The Columbia Suicide Severity Rating Scale (C-SSRS) is a comprehensive clinical interview tool designed to assess the full history and current severity of suicidal ideation and behavior.
Measured: Baseline (Day 1) to Post Treatment Visit (Month 6)
Generalized Anxiety Disorder-7
The GAD-7 (Generalized Anxiety Disorder 7-item scale) is a self-administered screening tool designed to measure the severity of generalized anxiety disorder (GAD).
Measured: Baseline (Day 1) to Post Treatment Visit (Month 6)
WHODAS 2.0
The World Health Organization Disability Assessment Schedule 2.0 is a self-report tool for measuring general health and disability across various conditions, including mental and neurological disorders.
Measured: Baseline (Day 1) to Post Treatment Visit (Month 6)
Patient Global Impression of Change
The Patient Global Impression of Change (PGIC) is a 7-point self-report scale to measure a patient's subjective assessment of their improvement following treatment.
Measured: Baseline (Day 1) to Post Treatment Visit (Month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Why it stopped: This is temporary withdrawal as the record was started too soon. It will be reactivated in near future.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies 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
- Model description
- PRE-EMPT is a prospective, multi-arm, clinical trial investigating three different neuroplasticity-enhancing interventions and assessing their capability to improve CC and ER as well as clinical outcomes.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- The Mind Research Network, Georgia State University, New Mexico VA Healthcare System, Washington University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484906
- Sponsor's protocol ID
- HRRC# 25-535
- Other IDs
- HT9425-25-1-0954
- Acronym
- PRE-EMPT
- Status last verified
- Mar 2026
- First submitted
- 12 Feb 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Behavioral (primary and secondary outcome measures) and imaging data will be shared via the NIMH Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 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
- NCT07484906
- Acronym / sponsor ID
- PRE-EMPT / HRRC# 25-535
- Conditions
- Suicidal Ideation
- Keywords
- depression, posttraumatic stress disorder, suicidal ideation, psilocybin, transcranial magnetic stimulation, neurofeedback, predictive modeling, artificial intelligence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This is temporary withdrawal as the record was started too soon. It will be reactivated in near future.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- The Mind Research Network, Georgia State University, New Mexico VA Healthcare System, Washington University School of Medicine
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 20 Mar 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 study group of 150 civilian and Veteran participants from three populations (low risk, intermediate risk, and high risk for self-harm). The investigators will obtain clinical assessments, MRI, and blood levels for circular RNA (circRNA). The teams will then administer three interventions (neurofeedback, transcranial magnetic stimulation, and psilocybin assisted therapy), and repeat the tests above. A team with expertise in artificial intelligence will then use our data to try to find patterns that identify who is at high risk versus low risk with a high degree of accuracy.
Detailed description
For U.S. Service Members, deployment and combat exposure can result in significant mental strain, with high rates of disability and suicide. Unfortunately our ability to predict and treat those at high risk of intentional self-harm is limited. PRE-EMPT (Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies) seeks to transform the assessment and treatment of the spectrum of depression, posttraumatic stress, and self-harm. PRE-EMPT will utilize multimodal neuroimaging, blood-based biomarkers, and predictive analytics to devise highly accurate models of behavioral risk, and to characterize response to three neuroplasticity-enhancing interventions.
Background: Rates of suicide have increased 37% since the year 2000 despite concerted governmental and institutional programs to address root causes such as stigma and lack of access. Suicide was the number one cause of active-duty fatality from 2014 to 2019, highlighting the vulnerability of Service Members and Veterans. Suicide is a highly multifactorial event and may be conceptualized as a state in which individuals cannot come up with any other option to endure difficult circumstances or intense feelings, representing failures of cognitive control (CC) and emotion regulation (ER). Similarly, the heritability of suicide risk is well known, and transcriptomics, or the study of transcript molecules such as RNA that regulate gene expression, has potential to reveal mechanisms of risk not fully explained by DNA analysis. Better methods of classifying suicide risk according to objective and measurable factors are needed to proactively identify persons at risk and provide interventions tailored to risk.
Research Plan: PRE-EMPT will assemble a cohort of 150 civilian and Veteran participants from three populations (low risk, intermediate risk, and high risk for self-harm). The investigators will obtain baseline 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. In parallel, investigators will mine publicly available databases to identify network nodes and use deep learning techniques on multivariate patterns of brain activation, structural topography, and functional connectivity. The clinical, imaging, and transcriptomic data will be fused and jointly analyzed to increase the accuracy of risk prediction models. PRE-EMPT in three separate arms 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) 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. Assessments will be repeated at post-treatment and at 1, 3, and 6 months after intervention. These therapies were chosen based on our team's prior work in all three interventions demonstrating rapid action and large effects. Each clinical arm will contribute independent insights into mediators of efficacy for the specific interventions and risk groups, while pooling data to identify predictors across the risk spectrum.
Specific Aim 1: To construct a neurobehavioral model from structural and functional MRI, clinical, and transcriptomic data that accurately predicts behavioral risk.
Specific Aim 2: To test three potential rapid-acting therapies for suicidal ideation and identify mechanistic mediators of response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- PRE-EMPT is a prospective, multi-arm, clinical trial investigating three different neuroplasticity-enhancing interventions and assessing their capability to improve CC and ER as well as clinical outcomes.
| Arm | Type | Receives |
|---|---|---|
| fMRI Neurofeedback | Experimental | Behavioral: fMRI NeurofeedbackParticipants undergo two sessions of fMRI neurofeedback, during which they attempt to modulate a visual display of amygdala activity during fMRI. |
| Accelerated theta burst stimulation | Experimental | Device: Accelerated theta burst stimulationParticipants undergo 50 sessions of theta burst stimulation, delivered to the dorsolateral prefrontal cortex. |
| Psilocybin assisted therapy | Experimental | Drug: Psilocybin assisted therapyParticipants undergo three sessions of preparation, two psilocybin administration sessions, and two integration sessions. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-69 years old
- Have been on a stable psychiatric medication regimen for at least four weeks prior to study participation.
Key exclusion criteria (16 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 two years) 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 |
|---|---|---|
| fMRI NeurofeedbackParticipants undergo two sessions of fMRI neurofeedback, during which they attempt to modulate a visual display of amygdala activity during fMRI. | Behavioural | fMRI Neurofeedback |
| Accelerated theta burst stimulationParticipants undergo 50 sessions of theta burst stimulation, delivered to the dorsolateral prefrontal cortex. | Device | Accelerated theta burst stimulation |
| Psilocybin assisted therapyParticipants undergo three sessions of preparation, two psilocybin administration sessions, and two integration sessions. | Drug | Psilocybin assisted therapy |
Primary outcome
Scale of Suicidal Ideation
Time frame: Baseline (Day 1) to Post-Treatment Visit (Month 6)
The SSI is a 19-item, interviewer-administered rating scale that measures the current intensity of specific attitudes, behaviors, and plans to commit suicide.
6 secondary outcomes
Beck Depression Inventory-II
Time frame: Baseline (Day 1) to Post-Treatment Visit (Month 6)
PTSD Checklist-for DSM 5
Time frame: Baseline (Day 1) to Post Treatment Visit (Month 6)
Columbia Suicide Severity Rating Scale
Time frame: Baseline (Day 1) to Post Treatment Visit (Month 6)
Generalized Anxiety Disorder-7
Time frame: Baseline (Day 1) to Post Treatment Visit (Month 6)
WHODAS 2.0
Time frame: Baseline (Day 1) to Post Treatment Visit (Month 6)
Patient Global Impression of Change
Time frame: Baseline (Day 1) to Post Treatment Visit (Month 6)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Yes. Behavioral (primary and secondary outcome measures) and imaging data will be shared via the NIMH Data Archive
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fMRI Neurofeedback, Accelerated theta burst stimulation and Psilocybin assisted therapy in people with Suicidal Ideation, 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 2 inclusion and 16 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: withdrawn, as of the sponsor's last update on 20 Mar 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale of Suicidal Ideation (time frame: Baseline (Day 1) to Post-Treatment Visit (Month 6)). 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 20 Mar 2026.