Study of Psilocybin Under Anesthesia Controlled by EEG

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT07479550
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Major Depression

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin (Usona Institute) — DRUG
    Oral psilocybin capsules administered at doses not disclosed to participants to preserve blinding. Each dose is administered approximately 30 minutes prior to induction of general anesthesia with propofol. Participants receive psilocybin or placebo across four weekly dosing sessions.
  • Propofol — DRUG
    Intravenous propofol administered by a board-certified anesthesiologist to induce and maintain general anesthesia during each of the four dosing sessions. Propofol is co-administered with psilocybin or placebo to mask the psychoactive effects of psilocybin and enable participant blinding.
  • Placebo — DRUG
    Oral placebo capsule identical in appearance to the psilocybin capsules, administered prior to induction of general anesthesia with propofol during one of the four dosing sessions.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Sequence A
    Participants are randomized 1:1 to one of two dosing sequences. All participants receive all four dosing conditions across weekly sessions: placebo (0 mg), psilocybin 10 mg, and psilocybin 25 mg administered in two separate sessions. Sequences differ only in the order of the first two sessions. Specific sequence assignments are not disclosed to preserve blinding.
  • Experimental: Sequence B
    Participants are randomized 1:1 to one of two dosing sequences. All participants receive all four dosing conditions across weekly sessions: placebo (0 mg), psilocybin 10 mg, and psilocybin 25 mg administered in two separate sessions. Sequences differ only in the order of the first two sessions. Specific sequence assignments are not disclosed to preserve blinding.

Primary Outcome Measure

Blinding Success - Correct Identification of Psilocybin at Final Dosing Session [ Time Frame: 1 day after the final dosing session (Visit 21, Week 4) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94304
Dr. Pilleriin Sikka, PhD
[email protected]
6506808801
Dr. Boris Heifets, MD, PhD
[email protected]
Dr. Boris Heifets, MD, PhD (PRINCIPAL_INVESTIGATOR)
Dr. Pilleriin Sikka, PhD (SUB_INVESTIGATOR)

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