Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07570654 | Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder | PHASE2 | NOT YET_RECRUITING | 300 | — | — | Sep 1, 2026 | Sep 1, 2029 | May 12, 2026 | - | — |
The CAPS-5 (Clinician-Administered PTSD Scale for DSM-5) is a 30-item structured interview that yields a total severity score (0-80) reflecting PTSD symptoms. A higher CAPS-5 score indicates more severe, intense, and frequent PTSD symptoms.
| Arm | Type | Description |
|---|---|---|
| 1 mg COMP360 psilocybin | ACTIVE_COMPARATOR | - |
| 10 mg COMP360 psilocybin | EXPERIMENTAL | - |
| 25 mg COMP360 psilocybin | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| COMP360 psilocybin | DRUG | COMP360 psilocybin administered with monitoring and support |
Inclusion Criteria: * 18 years or older * Diagnosed with PTSD at least 6 months ago Exclusion Criteria: \- Diagnosed with certain psychiatric conditions such as bipolar disorder, schizophrenia, OCD, anorexia, or other conditions