Study of Psilocybin Under Anesthesia Controlled by EEG (NCT07479550) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study of Psilocybin Under Anesthesia Controlled by EEG
United States10 participantsStarted 2026-07
Plain-language summary
Major depressive disorder (MDD) affects millions of Americans and remains difficult to treat. Psilocybin, a psychedelic compound, has shown promise for reducing depression symptoms, but a key challenge in psychedelic research is that participants can usually tell whether they received the active drug - making it hard to conduct fully blinded studies.
This study (Studying Psilocybin with Anesthesia Controlled by EEG \[SPACE\]) tests a new approach: administering psilocybin while participants are under general anesthesia, so that the noticeable psychological effects of psilocybin are masked. This allows both participants and outcome assessors to remain unaware of whether psilocybin or placebo was given, improving the scientific rigor of the research.
Participants with MDD will be randomly assigned to receive either psilocybin or placebo across four dosing sessions conducted under general anesthesia. The study will assess whether this approach is safe and feasible, and will collect early data on whether it may reduce depression symptoms.
Who can participate
Age range
25 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. People 25 to 65 years of age at screening;
. Able to read, understand, and provide dated, informed consent, either in writing or electronically, prior to screening. Patients will be deemed likely to comply with study protocol and communicate with study staff about adverse events and other clinically important information;
. Fluent in English;
. Able to commit to attend all study visits and participate in all remote data collection procedures;
. Be stable in background psychotherapy for at least 4 weeks prior to enrollment outside of the study and able to access mental healthcare for the duration of the study;
. Body mass index between 17-35 kg/m2.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Blinding Success - Correct Identification of Psilocybin at Final Dosing Session
Timeframe: 1 day after the final dosing session (Visit 21, Week 4)
2
Blinding Success - Accuracy of Guessed Psilocybin Dose at Final Dosing Session
Timeframe: 1 day after the final dosing session (Visit 21, Week 4)
. Participant has a current diagnosis of MDD during a current Major Depressive Episode (MDE) (single or recurrent episode as defined by DSM-5-TR \[if single episode, duration of ≥4 weeks\] and verified after evaluation by a qualified member of the investigative team using the QuickSCID-5 (Quick Structured Clinical Interview for DSM-5 Disorders).
. Able to physically tolerate general anesthesia, as determined by American Society of Anesthesiologists (ASA) Physical Status Class I or II. ASA Class III participants whose functional impairment is directly related to a psychiatric diagnosis (depression) will be included.
Exclusion criteria
. Has any ongoing legal or disability claim such as Worker's Compensation
. Is taking a medication belonging to any of the following classes:
. Is taking benzodiazepine medication such that patient cannot tolerate withholding doses 8 hours before through 6 hours after planned study intervention
. Is taking agents that may interact with psilocybin metabolism effects such that the patient cannot tolerate withholding doses 8 hours before through 6 hours after planned study intervention.
. For individuals who can become pregnant:
. Participation in a clinical trial within 30 days of entry into this trial, or during the trial, or treatment with another investigational drug or other intervention within 30 days or 5 half-lives, whichever is longer, that may interfere with psilocybin metabolism/effects.
. Currently receiving electroconvulsive therapy (ECT). Previous treatment with ECT is permitted; last treatment must be at least 30 days prior to entry into this trial.
. History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms, mania, or bipolar affective disorder