Mindfulness-based Psilocybin Therapy for PTSD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-65
SponsorAnthony P King
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant is assigned female or male at birth.
Participant is aged between 21 to 65 years, inclusive, at Screening. This is to reduce variability in brain function and connectivity in this small pilot study that may be related to age / developmental factors in persons under 21 and over 65.
Participant has a BMI of 18 to 30 kg/m2, inclusive, at Screening.
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 the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).
Disqualifiers
Cardiovascular disease, including coronary artery disease (CAD) and congestive heart failure (CHF). This is an FDA requirement.
Current or previously diagnosis of 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). This is an FDA requirement.
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.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Psilocybin + MBCT therapy
Combination productThe experimental arm has psilocybin with support and MBCT sessions.
Active Comparator: Psilocybin with Support Only
Combination productThe active comparator has psilocybin with support only.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Psilocybin with support + MBCTExperimental treatment 1 intervention
Group B: Psilocybin with support onlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in parameter estimate of regional brain activity measured by fMRI after one dose of psilocybin in participants with PTSD
Change in Blood oxygenation level dependent (BOLD) fMRI signal after task comparing PAT with MBCT group vs PAT with support only group
Time frame
Between Baseline and Time point 24 hours and 28 days post-Investigational Product2
Changes in region-to-region connectivity measured by fMRI after PAT with one dose of psilocybin in patients with PTSD
Changes in resting state activity of brain areas comparing PAT with MBCT group vs PAT with support only group
Time frame
Between Baseline and Time point 24 hours and 28 days post-Investigational Product3
Changes in event related potentials (ERP) after PAT with one dose of psilocybin in participants with PTSD
Change in ERP as assessed by Electroencephalography (EEG) after task comparing PAT+MBCT group and PAT with support only group
Time frame
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
Changes in acoustic startle magnitude measured by EMG after task comparing PAT + MBCT group and PAT with support only group
Time frame
Between Baseline and Time point 24 hours and 28 days post-Investigational ProductSecondary outcomes
1
Changes in clinician-assessed PTSD Symptoms after PAT with one dose of psilocybin in patients with PTSD
Comparison of Clinician Administered PTSD Scale for DSM-5 (CAPS-5 ) score changes from Baseline to 28 days post IP between PAT + MBCT group vs the PAT with support only group. CAPS-5 scores are minimum 0 and maximum 80, higher scores mean a worse outcome
Time frame
Baseline to 24 h and 28 days post IP2
Changes in clinician-assessed Depression Symptoms after PAT with one dose of psilocybin in patients with PTSD
Comparison of Montgomery Ashberg Depression Rating Scale (MADRS) score changes from Baseline to 24 hrs and 28 days post IP between PAT + MBCT group vs the PAT with support only group. MADRS scores are minimum 0 and maximum 60, higher scores mean a worse outcome
Time frame
Baseline to 24 hours and 28 days post-Investigational Product (IP)3
Changes in Self-report PTSD Symptoms after PAT with one dose of psilocybin in patients with PTSD
Comparison of PTSD Checklist for DSM-5 (PCL-5) score changes from Baseline to 28 days post IP between PAT + MBCT group vs the PAT with support only group. PCL-5 scores are minimum 0 and maximum 80, higher scores mean a worse outcome
Time frame
Baseline to 24 hrs and 28 days post IP4
Changes in Self-report Depression Symptoms after PAT with one dose of psilocybin in patients with PTSD
Comparison of Beck Depression Inventory - II (BDI-II) score changes from Baseline to 28 days post IP between PAT + MBCT group vs the PAT with support only group. BDI-II scores are minimum 0 and maximum 63, higher scores mean a worse outcome
Time frame
Baseline to 24 hrs and 28 days post IPOther outcomes
1
Changes in Brain Microstructural Neuroplasticity after PAT with one dose of psilocybin in patients with PTSD
To assess the role of psychedelic experience on the changes in brain function and/or microstructural neuroplasticity. Correlation between levels of psychedelic experience assessed by self-report questionnaires and the changes in diffusion-weight imagine (DWI) MRI (Neurite Orientation Diffusion and Density)
Time frame
Baseline 24 hours and 28 days post-Investigational Product (IP)2
Proteins and Biomarkers
Correlation between CAPS-5 and MADRS score change and ratio of Gsα, activated to basal adenylyl cyclase (Gsα-AC biomarker score) from Baseline to 24hrs and 21 days post IP between psilocybin with support group vs the psilocybin with active PTSD therapy
Time frame
24 hours and 28 days post-Investigational Product (IP)Sponsors and contacts
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Source ClinicalTrials.gov