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Clinical TrialSuicidalityDepressive DisordersPTSDPlaceboPlaceboPsilocybinWithdrawn

Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies

This Phase II, non-randomised, open-label, parallel-group trial (n=150) will study response to three neuroplasticity-enhancing interventions in civilian and Veteran adults (aged 18–69) at low, intermediate or high risk for self-harm. The study will evaluate clinical change in suicidal ideation (Scale of Suicidal Ideation from baseline to the post‑treatment visit at Month 6) and aim to characterise neurobiological and blood-based markers associated with risk and treatment response. Participants are allocated to one of three experimental arms: two sessions of fMRI neurofeedback targeting amygdala activity, an accelerated theta burst stimulation programme of 50 sessions delivered to the dorsolateral prefrontal cortex, or psilocybin‑assisted therapy comprising three preparation sessions, two psilocybin administration sessions and two integration sessions. Baseline and post‑treatment assessments include clinical measures, structural and functional MRI and blood sampling for circular RNA (circRNA); an artificial intelligence analytic team will use these multimodal data to develop predictive models of behavioural risk and treatment response.

Target Enrollment
Not specified
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

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.

Study Arms & Interventions

fMRI Neurofeedback

experimental

Participants undergo two sessions of fMRI neurofeedback, during which they attempt to modulate a visual display of amygdala activity during fMRI.

Interventions

  • Placebo

    Unmatched intervention: fMRI Neurofeedback

Accelerated theta burst stimulation

experimental

Participants undergo 50 sessions of theta burst stimulation, delivered to the dorsolateral prefrontal cortex.

Interventions

  • Placebo

    Unmatched intervention: Accelerated theta burst stimulation

Psilocybin assisted therapy

experimental

Participants undergo three sessions of preparation, two psilocybin administration sessions, and two integration sessions.

Interventions

  • Psilocybin

Participants

Ages
18 – 69
Sexes
Male & Female

Inclusion Criteria

  • 1. 18-69 years old
  • 2. Have been on a stable psychiatric medication regimen for at least four weeks prior to study participation.

Exclusion Criteria

  • 1. A prior history of other central nervous system disease or any history of seizures;
  • 2. history of psychotic disorders (e.g., schizophrenia, schizoaffective disorder, bipolar disorder type I);
  • 3. history of current or recent (within two years) substance/alcohol use disorder, with the exception of tobacco use disorder;
  • 4. 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;
  • 5. presence of any implanted metal or electrical device (e.g. pacemaker);
  • 6. recent medical hospitalization (within three weeks);
  • 7. any condition that would prevent the participant from completing the protocol, such as significant agitation;
  • 8. appointment of a legal representative or treatment guardian;
  • 9. any ongoing litigation related to a health condition;
  • 10. any other contraindication to exposure to strong magnetic fields or MRI, such as severe claustrophobia;
  • 11. pregnancy or lactation;
  • 12. 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;
  • 13. other medical conditions that would preclude safe participation in the trial (e.g., decompensated heart failure);
  • 14. 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);
  • 15. membership in a vulnerable population (minors, prisoners);
  • 16. any contraindication for blood draws.

Study Details

Study Team

Locations

United States

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