A Phase 2 Randomized Study Examining the Safety, Feasibility, and Effectiveness of Masking Psilocybin Therapy With General Anesthesia in Major Depressive Disorder
Stanford University
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.
Description
Participants will receive four dosing sessions spaced one week apart. Each session involves taking an oral capsule containing either psilocybin (10 mg or 25 mg) or placebo, followed by general anesthesia with propofol. All sessions take place at Stanford Hospital under the supervision of a board-certified anesthesiologist. Between and after sessions, participants complete questionnaires about mood, sleep, wellbeing, and anxiety. Participants may also wear a consumer-grade EEG headband at home to track sleep patterns. The total study duration per participant is approximately 7 weeks, across a…
Eligibility
- Age range
- 25–65 years
- Sex
- All
- Healthy volunteers
- No
INCLUSION CRITERIA: A participant will be eligible for inclusion when all of the following criteria are met: 1. People 25 to 65 years of age at screening; 2. 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; 3. Fluent in English; 4. Able to commit to attend all study visits and participate in all remote data collection procedures; 5. Be stable in background psychothe…
Interventions
- DrugPsilocybin (Usona Institute)
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.
- DrugPropofol
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.
- DrugPlacebo
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.
Location
- Stanford UniversityStanford, California