Mindfulness-based Psilocybin Therapy for PTSD
The goal of this study is to learn how psilocybin delivered with mindfulness-based therapy may help symptoms of posttraumatic stress disorder (PTSD). This is an assessor-blinded, randomized, controlled study in participants with PTSD. The study will investigate the changes in brain activity, connectivity, and microstru
| Condition(s) | Post Traumatic Stress Disorder, Depression - Major Depressive Disorder |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The goal of this study is to learn how psilocybin delivered with mindfulness-based therapy may help symptoms of posttraumatic stress disorder (PTSD). This is an assessor-blinded, randomized, controlled study in participants with PTSD. The study will investigate the changes in brain activity, connectivity, and microstructural neuroplasticity assessed using EEG/EMG and multimodal MRI measures after administration of one oral dose of psilocybin, accompanied either with standard "psychological support" only; or with standard support plus Mindfulness-based Cognitive Therapy (MBCT). |
| Who can participate | Inclusion Criteria: 1. Participant is assigned female or male at birth. 2. Participant is aged between 21 to 65 years, inclusive, at Screening. 3. Participant has a BMI of 18 to 35 kg/m2, inclusive, at Screening. 4. Participant is ≥60 kg. 5. Participant has a diagnosis of PTSD (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition \[DSM-5\] established through a clinician interview that includes the Mini-International Neuropsychiatric Interview \[MINI\]) and CAPS-5. 6. PTSD severity moderate to severe based on CAPS score ≥24. 7. Depression severity moderate to severe based on MADRS score ≥21. 9\. Participant has been on a stable dose (no more than 50% change) of antidepressant medication (SSRI) in the last month prior to Screening. 10\. Participants capable o |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Lead sponsor | Anthony P King |
| Locations | Columbus, Ohio, United States |
| Start date | 2026-07-01 |
| NCT ID | NCT07104916 |
| Official listing | https://clinicaltrials.gov/study/NCT07104916 |