Frontlight ResearchEarly access
Taking people in United StatesPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
Key facts
- Who runs it
- COMPASS Pathways
- Where
- Boston, Carrollton, Chicago, Eden Prairie, Irvine, Las Vegas, Lincoln, Los Angeles, Miami, Moorpark, New York, North Canton, Orem, Orlando, San Jose, The Bronx, and Tucson, United StatesSee the 17 sitesAlso in 1 other country, 3 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 300 people, planned
- Started
- 14 Sept 2026
- Expected to end
- Sept 2029
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- COMP360 psilocybin
- Record updated
- 12 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 3 criteriaShow less
Who can take part
- 18 years or older
- Diagnosed with PTSD at least 6 months ago
Who cannot take part
- Diagnosed with certain psychiatric conditions such as bipolar disorder, schizophrenia, OCD, anorexia, or other conditions
Where in United States
Also in 1 other country, 3 sites
- MABoston, United StatesTaking people
- TXCarrollton, United StatesTaking people
- ILChicago, United StatesTaking people
- MNEden Prairie, United StatesTaking people
- CAIrvine, United StatesTaking people
- NVLas Vegas, United StatesTaking people
- NELincoln, United StatesTaking people
- CALos Angeles, United StatesTaking people
- FLMiami, United StatesTaking people
- CAMoorpark, United StatesTaking people
- NYNew York, United StatesTaking people
- OHNorth Canton, United StatesTaking people
- UTOrem, United StatesTaking people
- FLOrlando, United StatesTaking people
- CASan Jose, United StatesTaking people
- NYThe Bronx, United StatesTaking people
- AZTucson, United StatesTaking people
About the trial
What the trial wants to find out
The Redefine Study (COMP202) is testing COMP360 to see if it may reduce post-traumatic stress disorder (PTSD) symptoms when administered alongside monitoring and support from a trained study team. COMP360 is a lab-made form of the naturally occurring chemical compound psilocybin.
The 3 groups in the trial
- 1 mg COMP360 psilocybinExisting treatment, for comparison
Treatment: COMP360 psilocybin
- 10 mg COMP360 psilocybinTreatment being tested
Treatment: COMP360 psilocybin
- 25 mg COMP360 psilocybinTreatment being tested
Treatment: COMP360 psilocybin
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 2b/3, Multicentre, Randomised, Double-blind, Controlled Trial, With an Open Label Extension, to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
- Record updated
- 12 November 2026