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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 mg COMP360 psilocybin | Active Comparator |
| |
| 10 mg COMP360 psilocybin | Experimental |
| |
| 25 mg COMP360 psilocybin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COMP360 psilocybin | Drug | COMP360 psilocybin administered with monitoring and support |
|
| Measure | Description | Time Frame |
|---|---|---|
| COMP360 25 mg versus COMP360 1 mg change from Baseline to Week 8 in CAPS-5 total severity score | 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. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
- Diagnosed with certain psychiatric conditions such as bipolar disorder, schizophrenia, OCD, anorexia, or other conditions
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| ID | Term |
|---|---|
| D003130 | Combat Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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