At a Glance
Trial Details
- Condition(s)
Major Depressive Disorder - Investigational Treatment Under Study
Psilocybin
Trial Details
CONDITION(s)
Major Depressive Disorder (MDD)
Purpose
The purpose of this research is to study the medical and safety effects of a single dose of an investigational drug called psilocybin compared to a placebo in participants with depression. Each participant will be randomized to receive either a one-time dose of psilocybin or a placebo.
Approximate Enrollment Dates
Fall 2019 ‑ Fall 2021
Participants Required
100 people
needed to enroll
Phase
Phase 2
Phase 2 clinical trials are the second step in a typical four-step drug approval process. During this process, the safety and usefulness of the investigational treatment is tested in larger groups of people as the drug moves through the phases. Phase 2 studies can involve up to several hundred volunteers.
Research Groups
50% Psilocybin
Chance of receiving investigational treatment under study.
50% Placebo (niacin)
Chance of receiving active placebo.
What's Involved
Visit Overview
Each appointment is a little different and visit lengths vary, but most appointments last about 2 hours. At these visits, the following activities may occur:
- Physical exams with a medical professional
- Psychological evaluations and answering questions about your depression
- Blood draws and urine samples
Visit lengths are approximate and events are summarized. You can learn about the exact timing and events after you indicate an interest in the clinical trial.
Who Qualifies
You may qualify for this study if you meet the criteria listed below. You can learn if you qualify after you indicate an interest in the clinical trial.
- Gender(s)
All - Ages
21-65 Years
Additional Entry Criteria
Locations
Researchers in 9 planned locations across the U.S. are looking for volunteers for this clinical trial. New locations may be added in the future. You can learn more about the study locations after you indicate an interest in the clinical trial.
Because of the number of visits required, and for safety reasons, participants should live within approximately 2 hours of the study site.
- Now Recruiting
7 - Soon Recruiting
2
| Research Site | Location | Status | Next Steps |
|---|---|---|---|
| Great Lakes Clinical Trials | Chicago, IL | Now Recruiting | Pre-Qualify Now |
| Johns Hopkins University | Baltimore, MD | Now Recruiting | Pre-Qualify Now |
| New York University | New York, NY | Now Recruiting | Pre-Qualify Now |
| Segal Trials | Lauderhill, FL | Now Recruiting | Pre-Qualify Now |
| University of California, San Francisco (UCSF) | San Francisco, CA | Now Recruiting | Pre-Qualify Now |
| University of Wisconsin - Madison | Madison, WI | Now Recruiting | Pre-Qualify Now |
| Yale University | New Haven, CT | Now Recruiting | Pre-Qualify Now |
| Pacific Treatment in Research and Psychedelics/Pacific Neuroscience Institute (PTRP/PNI) | Santa Monica, CA | Soon Recruiting | Get Notified |
| Hassman Research Institute (HRI) | Berlin, NJ | Soon Recruiting | Get Notified |