Psilocybin Assisted Therapy for Major Depression – COMP 104

Sunstone Therapies is currently recruiting participants for a Phase 2, randomized, double-blind, controlled study to investigate the safety, tolerability, pharmacokinetics, and efficacy of psilocybin in participants with Major Depressive Disorder.

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 the fourth leading contributor to the global burden of disease, with between 11%-15% of the population estimated to be affected.

Psilocybin-assisted therapy is an alternative treatment to both traditional antidepressant medications and other forms of therapy. 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 COMP 104 is to investigate the safety, tolerability, pharmacokinetics, and efficacy of a single dose of psilocybin with psychological support in participants 18 years or older with major depressive disorder, with up to four prior treatment failures for the current episode of depression.

The study involves the following in-person activities between a 9 – 16 week period:

  • 1 screening visit
  • 3 or more preparation visits
  • Drug administration
  • 2 Integration sessions
  • 2 additional follow up visits
  • A variety of medical and psychiatric assessments are performed throughout the study, including blood draws at nearly every visit.

Important Considerations

  • The study’s procedures and therapy are at no cost to the participant. Eligible participants are compensated with a stipend at every visit. Reasonable travel expenses may be reimbursed.
  • Eligible participants will be randomized in a 1:1:1 ratio to receive 1mg, 10mg, or 25mg of psilocybin. Participants, research staff, and therapists are all blinded.
  • All visits take place in person at The Bill Richards Center for Healing, Aquilino Cancer Center, 9905 Medical Center Drive, Rockville, MD.
  • Psilocybin 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. If necessary, the study physician will consult with patients’ providers.
  • 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

Psilocybin-assisted therapy has the potential to provide a rapid and long-lasting antidepressant effect after a single administration.

To inquire about participation in the COMP 104 Study, apply below:

For more information about the study: