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 range25 Years – 65 Years

SexALL

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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.
✓. 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.

What they're measuring

Blinding Success - Correct Identification of Psilocybin at Final Dosing Session

Timeframe: 1 day after the final dosing session (Visit 21, Week 4)

Blinding Success - Accuracy of Guessed Psilocybin Dose at Final Dosing Session

Timeframe: 1 day after the final dosing session (Visit 21, Week 4)

Trial details

NCT IDNCT07479550

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07

Contact for this trial

Dr. Boris Heifets, MD, PhD

4157161585 bheifets@stanford.edu

View on ClinicalTrials.gov More Major Depression trials

Plain-language summary

Who can participate

Age range25 Years – 65 Years

SexALL

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.
✓. 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.

Study of Psilocybin Under Anesthesia Controlled by EEG

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Study of Psilocybin Under Anesthesia Controlled by EEG

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Exclusion criteria