Brain scans may guide psychedelics and magnetic pulses to quell suicidal thoughts
NCT ID NCT07745569
First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time
Summary
This trial explores whether personalized brain imaging can predict who responds best to three rapid-acting treatments for suicidal ideation in people with depression or PTSD. Participants receive either real-time brain feedback (neurofeedback), a form of magnetic brain stimulation called TMS, or psilocybin-assisted therapy. The goal is to see if these therapies can reduce suicidal thoughts and change activity in key brain networks, potentially leading to more precise, effective treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Transcranial magnetic stimulation (TMS), neurofeedback, and psilocybin-assisted therapy
- What this could lead to
- If successful, this could lead to personalized, brain-guided treatments that rapidly reduce suicidal thoughts in people with depression and PTSD.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not apply broadly. The therapies carry risks, including psychological distress and side effects, and may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 69 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. 3. Formal diagnosis of major depressive disorder or post-traumatic stress disorder by a mental health professional. 4. 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. 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 one year) 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. Arm 1: Inclusion: 1. 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)) 2. Right-handed. 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: 1. Other additional medical conditions that would preclude safe participation in this arm of the trial: 1. significantly impaired liver function, 2. severe coronary artery disease, 3. heart failure, 4. uncontrolled hypertension (above 140/90 mmHg upon screening) , 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 (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 2. 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); 3. allergy or hypersensitivity to psilocybin or chocolate
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a sedative plus ear stimulation stop PTSD before it starts?
- Can a therapist on a screen ease both trauma and pain?
- Zapping two brain regions may restore pleasure in depression
- What can patients who tried both brain-stimulation treatments teach us?