PSIL301: Psilocybin for Major Depressive Disorder

RECRUITMENT FOR STUDY

Sunstone is recruiting participants for a phase 3, randomized, double-blind, multicenter study to evaluate the efficacy, safety, and tolerability of psilocybin in adults with Major Depressive Disorder (MDD).

Introduction and Rationale for Study

Depression (major depressive disorder) is a common and serious medical illness that negatively affects how you feel, the way you think, and how you act. Depression is a leading contributor to the global burden of disease.

Psilocybin is an alternative treatment to traditional antidepressant medications. Research to date has demonstrated a significant and sustained improvement in depression outcomes after the administration of psilocybin with the psychological support of a trained therapist. This research seeks to continue exploring the therapeutic value of this type of therapy.

Purpose and Description

The purpose of this study is to evaluate the efficacy, safety, and tolerability of psilocybin in adults with Major Depressive Disorder. In particular, there is an emphasis on the follow-up period of the study to evaluate the long-term efficacy.


The study involves 6 weeks of double-blinded protocol and 52 weeks of follow-up with total participation for 60-64 weeks:

  • Preparation Sessions
  • 1 Dosing Session
  • 3 Integration Sessions
  • Option for open label 25 mg psilocybin*
  • Psychoeducation and peer support sessions during 1 year follow-up

*Pending eligibility after day 43

Important Considerations

  • The study’s procedures and study drug are at no cost to the participant.
  • Eligible participants will be randomized to receive a single dose of either 25 mg psilocybin, 5 mg psilocybin, or an inactive placebo. Participants, research staff, and therapists are all blinded.
  • All in person visits take place at The Bill Richards Center for Healing, Aquilino Cancer Center, 9905 Medical Center Drive, Rockville, MD.
  • Psilocybin or placebo will be administered in a safe setting with constant support from trained and experienced therapists. The support includes careful preparation before the experience and processing after the experience. Psychedelic effects are typically temporary, and safety is continually monitored.
  • Eligible participants will taper off of, or discontinue from, all antidepressants as part of their participation in the study. This plan is created with study physician approval and participant safety is monitored. Participants MUST NOT discontinue ANY medication without the physician’s approval. Participants requiring an antidepressant taper must have an identified clinician to assume care in the event the antidepressant taper is not tolerated.
  • Participants should not be pregnant, nursing or planning a pregnancy, and must agree to use a highly effective method of birth control during the entire course of the clinical trial.
  • Risks to participation will be reviewed extensively during the screening and informed consent process.

Potential benefit of participation

There may not be any benefit to participants; but you are contributing to the scientific knowledge which may lead to the expansion of treatment options for people with PTSD. Participation is also completely voluntary and you may leave the study at any time.

To inquire about participation in the USONA PSIL301 Study, apply below:

Apply For The Study

For more information about the study: https://clinicaltrials.gov/study/NCT06308653?term=USONA&rank=2