Mindfulness-based Psilocybin Therapy for PTSD (NCT07104916) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Mindfulness-based Psilocybin Therapy for PTSD
30 participantsStarted 2026-05
Plain-language 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
Age range21 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Participant is assigned female or male at birth.
✓. Participant is aged between 21 to 65 years, inclusive, at Screening.
✓. Participant has a BMI of 18 to 35 kg/m2, inclusive, at Screening.
✓. Participant is ≥60 kg.
✓. 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.
✓. PTSD severity moderate to severe based on CAPS score ≥24.
✓. Depression severity moderate to severe based on MADRS score ≥21.
Exclusion criteria
✕. Taking the medications buspirone or venlafaxine in past month
✕. Current or previously diagnosed schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder or brief psychotic disorder; current or previous history of bipolar disorder, or current personality disorder (as determined by MINI at Screening).
✕. Clinically significant risk of suicidality, as determined through a comprehensive psychiatric interview that incorporates the Columbia Suicide Severity Rating Scale (CSSRS); a score of 4 or higher on the suicidal ideation subscale of C-SSRS (past 6 months) or any suicidal behaviour (lifetime), would be exclusionary.
What they're measuring
1
Changes in parameter estimate of regional brain activity measured by fMRI after one dose of psilocybin in participants with PTSD
Timeframe: Between Baseline and Time point 24 hours and 28 days post-Investigational Product
2
Changes in region-to-region connectivity measured by fMRI after PAT with one dose of psilocybin in patients with PTSD
Timeframe: Between Baseline and Time point 24 hours and 28 days post-Investigational Product
3
Changes in event related potentials (ERP) after PAT with one dose of psilocybin in participants with PTSD
Timeframe: Between Baseline and Time point 24 hours and 28 days post-Investigational Product.
4
Changes in acoustic startle electromyographic (EMG) response after PAT with one dose of psilocybin in patients with PTSD
Timeframe: Between Baseline and Time point 24 hours and 28 days post-Investigational Product
. History of substance use disorder within the 12 months, as assessed by a structured clinical interview (Mini International Neuropsychiatric Interview \[MINI\], Version 7.0.2) or determined by self-report, or intake of \>21 units of alcohol weekly, and the inability to refrain from alcohol use from 48 hours before Screening and each scheduled visit until discharge from the study site. One unit is equivalent to a 285 mL glass of full-strength beer or 1 (30 mL) measure of spirits or 1 glass (100 mL) of wine.
✕. Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressant, other non-SSRI or non-SNRI antidepressants (e.g. bupropion, mirtazapine, etc), an antipsychotic or a mood stabilizer.
✕. Exposure to psilocybin, or any other psychedelics, such as ayahuasca, mescaline, LSD or peyote more than 10 times in the last 10 years, or any psychedelic use within 6 months prior to Screening.
✕. Use of psychotropic medicine/supplement (or medicine/supplement that would interact with psilocybin) during the 28 days before dosing. Participants may take a stable chronic dose of antidepressant medication(s) and/or sedatives/hypnotics. The Investigator and study team may review medication on a case-by-case basis to determine if its use would compromise participant safety or interfere with study procedures or data interpretation.
✕. Family history of schizophrenia or schizoaffective disorder (first degree relatives), or bipolar disorder type 1 (first degree relatives).