Post Traumatic Stress DisorderPhase 2NCT07104916
Mindfulness-based Psilocybin Therapy for PTSD
A Phase 2 study testing Psilocybin + MBCT therapy and Active Comparator: Psilocybin with Support Only in people with Post Traumatic Stress Disorder and Depression - Major Depressive Disorder, run by Anthony P King at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Post Traumatic Stress Disorder, Depression - Major Depressive Disorder
- What is being tested?
- Psilocybin + MBCT therapy and Active Comparator: Psilocybin with Support Only
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants meeting the following criteria will be included in the study:
- 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).
- PTSD severity moderate to severe based on CAPS-5 score ≥25, and with moderate depression MADRS ≥20.
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- Participants capable of producing sperm must use a condom during the trial and for 3 months after their dose of trial medication, if their partner is a person of childbearing potential. In addition, their partner of childbearing potential must also use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) from dosing until 3 months following dosing. Condoms alone and abstinence are not considered highly effective methods of contraception.
- Participants of childbearing potential must agree to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) in combination with use of a condom by a partner who is capable of producing sperm, during the trial and for 3 months after dosing. Condoms alone and abstinence are not considered highly effective methods of contraception. Such participants must have a negative pregnancy test at Screening and Day 1.
- Participants of non-childbearing potential who are or were capable of producing eggs (ova) must be postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy or bilateral oophorectomy. Postmenopausal is defined as spontaneous amenorrhea for at least 12 months, and a serum follicle stimulating hormone (FSH) level in the menopausal range, unless the participant is taking hormone replacement therapy or is using hormonal contraception.
- Provision of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- If appropriate, describe why certain populations may be excluded (e.g., non-English speaking individuals for studies involving informed consent).
Who cannot join
- Participants with the following will be excluded from study participation:
- 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.
- 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.
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- 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) including buspirone and venlafaxine, during the 28 days before dosing. Participants may take a stable chronic dose of other SSRI 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).
- Clinically relevant history of abnormal physical health interfering with the study as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including [but not limited to], neurological, endocrine, cardiovascular, respiratory, gastrointestinal (including dyspepsia or gastroesophageal reflux disease), hepatic, or renal disorder).
- Participant has a presence or relevant history of any of the following medical conditions: organic brain disorders (e.g., epilepsy, seizure, intracranial hypertension, intracranial bleed and aneurysmal disease, brain tumor or other medical conditions associated with seizures or convulsions).
- Diagnosis of hypertension or arrhythmia.
- Clinically relevant abnormal heart rate (resting supine heart rate >100 bpm) or blood pressure (resting supine systolic blood pressure (SBP) above 140 mmHg or diastolic blood pressure (DBP) above 90 mmHg) at screening. Screening supine SBP, DBP and heart rate for evaluation will be the average of 3 readings obtained after at least 5 minutes rest. Participants with abnormal vital signs which are out of range and deemed clinically significant by the Investigator at Day 1, following triplicate readings.
- Presence of clinically significant ECG abnormalities at the Screening visit, as defined by medical judgement.
- QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 msec at Screening, following triplicate ECG readings.
- Hypothyroidism and/or current abnormal thyroid function tests. In case of uncertain or questionable screening thyroid function test results, the TSH test may be repeated once during screening. The TSH test must be reviewed to ensure that it is within normal limits before randomizing a participant into the study.
- Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs, or physical findings at Screening. In case of uncertain or questionable results, tests performed during Screening may be repeated once to confirm eligibility or judged to be clinically irrelevant.
- Other eligibility considerations (i.e., participant personal circumstances, behavior, and/or any current problem that might interfere with participation or that is incompatible with establishment of rapport or safe exposure to psilocin), as judged by the Investigator.
- History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion (ADME) of the study drug.
- Any other concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study as outlined in this Protocol, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study.
- Participant is not fluent in English. Participants must be fluent in English because the consent form as well as all assessments are written and will be administered/communicated in English.
- Aspartate aminotransferase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT) or total bilirubin levels ≥1.5 x the upper limit of normal (ULN) at Screening. These laboratory evaluations may be repeated once at the discretion of the Investigator. If the repeat test is within the reference range, the participant may be included if the Investigator considers that the previous finding will not introduce additional risk factors.
- Positive urine test for drugs of abuse or alcohol breath test at Screening or Day 1. A positive test for cannabinoids (e.g., marijuana) at Screening may not exclude a participant if after discussion with and evaluation by the Investigator, the participant agrees not to use any marijuana or other cannabinoid products during the study, and if allowed to participate, the participant must test negative for cannabinoids on Day 1.
- Participant who consumes excessive amounts of caffeine (e.g., coffee, tea, caffeinated sodas) or (methyl) xanthines (e.g., chocolate) based on the Investigator's determination and discretion.
- The participant has participated in a clinical study and has received a medication or a new chemical entity within 3 months prior to dosing of current study medication.
- Known sensitivity to psilocybin, psilocin and/or any excipients present in the formulation.
- Participant is taking or has taken any drugs known to inhibit monoamine oxidase within 28 days prior to study drug administration.
- Participant is taking or has taken OTC doses of 5-hydroxytryptophan or St John's Wort within 28 days prior to study drug administration.
- Strenuous exercise within 48 hours prior to each visit, and while at the study site.
- Participants capable of producing sperm who will not abstain from sperm donation between first dosing and 3 months after final dosing.
- Participants of childbearing potential who are pregnant, breastfeeding or planning to conceive. This is an FDA requirement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Medical Center
Columbus, Ohio, 43210
Anthony King, PhD, 7347094744, anthony.king@osumc.edu
Wenfei Yu, BS, 614 688 9537, wenfei.yu@osumc.edu
About this study
Official title: A Pilot Mechanistic RCT of Psilocybin With Mindfulness-based Therapy vs Support for Posttraumatic Stress Disorder (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 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).
Read the detailed description
Many patients with PTSD do not respond or have an incomplete response to treatment with currently available medications that are FDA-approved for PTSD, and/or do not respond to psychotherapies for PTSD. The use of psychedelics (e.g. psilocybin) is being investigated as a new approach to improve symptoms in patients with PTSD and depression, however their mechanism of action is still not well understood. Furthermore, while psychedelics are usually administered in the context of psychological support ("psychedelic assisted therapy", PAT) the kinds of support therapy used and possible interactions with drug with therapy effects is not well understood.
This study will investigate the changes in brain activity, connectivity, and microstructural neuroplasticity, assessed using electroencephalography (EEG) / electromyography (EMG) and functional magnetic resonance imaging (fMRI) /diffusion-weighted magnetic resonance imaging (DWI), after administration of one oral dose of 25 mg synthetic Psilocybin delivered in the context of either non-directive psychological support only (the most common approach for PAT) or in combination with psychological support plus an active form of psychotherapy called Mindfulness-based Cognitive Therapy (MBCT).
Up to 30 participants will be enrolled altogether.
The initial phase of this study will be an open label administration of 25 mg synthetic Psilocybin combined with standard "PAT psychological support" plus MBCT in ten participants with PTSD, to allow us to pilot this new intervention package.
In the next phase of the study, we will randomly assign twenty participants with PTSD into two groups: one group receiving 25 mg of synthetic Psilocybin (open label) combined with standard "PAT support" only, and one group receiving 25 mg of synthetic Psilocybin (open label) combined with standard "support" plus active form MBCT psychotherapy. In both groups, psychological support will be provided before, during and after the administration session. The MBCT group will also receive bi-weekly individual MBCT sessions and will be invited to complete daily homework, as per the MBCT protocol.
Assessments performed at Baseline and on Day 2 and Day 28 after administration will include EEG/EMG, MRI, clinician-administered scales (CAPS-5, MADRS, C-SSRS) and self-report questionnaires to assess PTSD, depression and anxiety symptoms, cognitive testing, self-report questionnaires to evaluate the psychedelic effects of synthetic Psilocybin administration, and blood collection for the Gsα-AC biomarker assay.
- Being tested
- Psilocybin + MBCT therapy, Active Comparator: Psilocybin with Support Only
- Keywords
- Psychedelic, functional MRI, Mindfulness-based Cognitive Therapy, Psilocybin, microstructural neuroplasticity
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin + MBCT therapyCombination product
The experimental arm has psilocybin with support and MBCT sessions.
Active Comparator: Psilocybin with Support OnlyCombination product
The active comparator has psilocybin with support only.
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin with support + MBCT | Experimental | Participants will receive one oral dose of psilocybin (capsule), with PAT psychological support and MBCT sessions before, during, and after the psilocybin administration Receives: Combination Product: Psilocybin + MBCT therapy |
| Psilocybin with support only | Active comparator | Participants will receive one oral dose of psilocybin (capsule), with PAT psychological support only sessions before, during, and after the psilocybin administration Receives: Combination Product: Active Comparator: Psilocybin with Support Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Between Baseline and Time point 24 hours and 28 days post-Investigational Product
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
Measured: Between Baseline and Time point 24 hours and 28 days post-Investigational Product
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
Measured: Between Baseline and Time point 24 hours and 28 days post-Investigational Product.
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
Measured: Between Baseline and Time point 24 hours and 28 days post-Investigational Product
Secondary outcomes (4)
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
Measured: Baseline to 24 h and 28 days post IP
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
Measured: Baseline to 24 hours and 28 days post-Investigational Product (IP)
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
Measured: Baseline to 24 hrs and 28 days post IP
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
Measured: Baseline to 24 hrs and 28 days post IP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Sep 2026
- Primary completionSep 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Phase II, randomized, assessor-blind study in participants with PTSD. The study will investigate the changes in brain activity, connectivity, and microstructural neuroplasticity assessed using EEG/EMG and fMRI / DWI measures after administration of one oral dose of psilocybin, accompanied either with standard "psychological support" or with active therapy called MBCT.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anthony P King
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Sponsor-investigator, Anthony P King, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104916
- Sponsor's protocol ID
- STUDY20250273
- Status last verified
- Oct 2026
- First submitted
- 28 Jul 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are considering sharing individual participant data sets including all collected IPD, vs all IPD that underlie results in a publication, for the purpose of furthering scientific knowledge
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Mechanistic RCT of Psilocybin With Mindfulness-based Therapy vs Support for Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT07104916
- Acronym / sponsor ID
- STUDY20250273
- Keywords
- Psychedelic, functional MRI, Mindfulness-based Cognitive Therapy, Psilocybin, microstructural neuroplasticity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Anthony P KingUniversity, hospital or other
- Collaborators
- Ohio State University
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Many patients with PTSD do not respond or have an incomplete response to treatment with currently available medications that are FDA-approved for PTSD, and/or do not respond to psychotherapies for PTSD. The use of psychedelics (e.g. psilocybin) is being investigated as a new approach to improve symptoms in patients with PTSD and depression, however their mechanism of action is still not well understood. Furthermore, while psychedelics are usually administered in the context of psychological support ("psychedelic assisted therapy", PAT) the kinds of support therapy used and possible interactions with drug with therapy effects is not well understood.
This study will investigate the changes in brain activity, connectivity, and microstructural neuroplasticity, assessed using electroencephalography (EEG) / electromyography (EMG) and functional magnetic resonance imaging (fMRI) /diffusion-weighted magnetic resonance imaging (DWI), after administration of one oral dose of 25 mg synthetic Psilocybin delivered in the context of either non-directive psychological support only (the most common approach for PAT) or in combination with psychological support plus an active form of psychotherapy called Mindfulness-based Cognitive Therapy (MBCT).
Up to 30 participants will be enrolled altogether.
The initial phase of this study will be an open label administration of 25 mg synthetic Psilocybin combined with standard "PAT psychological support" plus MBCT in ten participants with PTSD, to allow us to pilot this new intervention package.
In the next phase of the study, we will randomly assign twenty participants with PTSD into two groups: one group receiving 25 mg of synthetic Psilocybin (open label) combined with standard "PAT support" only, and one group receiving 25 mg of synthetic Psilocybin (open label) combined with standard "support" plus active form MBCT psychotherapy. In both groups, psychological support will be provided before, during and after the administration session. The MBCT group will also receive bi-weekly individual MBCT sessions and will be invited to complete daily homework, as per the MBCT protocol.
Assessments performed at Baseline and on Day 2 and Day 28 after administration will include EEG/EMG, MRI, clinician-administered scales (CAPS-5, MADRS, C-SSRS) and self-report questionnaires to assess PTSD, depression and anxiety symptoms, cognitive testing, self-report questionnaires to evaluate the psychedelic effects of synthetic Psilocybin administration, and blood collection for the Gsα-AC biomarker assay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a Phase II, randomized, assessor-blind study in participants with PTSD. The study will investigate the changes in brain activity, connectivity, and microstructural neuroplasticity assessed using EEG/EMG and fMRI / DWI measures after administration of one oral dose of psilocybin, accompanied either with standard "psychological support" or with active therapy called MBCT.
| Arm | Type | Receives |
|---|---|---|
| Psilocybin with support + MBCT | Experimental | Combination Product: Psilocybin + MBCT therapyParticipants will receive one oral dose of psilocybin (capsule), with PAT psychological support and MBCT sessions before, during, and after the psilocybin administration |
| Psilocybin with support only | Active comparator | Combination Product: Active Comparator: Psilocybin with Support OnlyParticipants will receive one oral dose of psilocybin (capsule), with PAT psychological support only sessions before, during, and after the psilocybin administration |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
- PTSD severity moderate to severe based on CAPS-5 score ≥25, and with moderate depression MADRS ≥20.
Key exclusion criteria (31 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin + MBCT therapyThe experimental arm has psilocybin with support and MBCT sessions. | Combination product | Psilocybin with support + MBCT |
| Active Comparator: Psilocybin with Support OnlyThe active comparator has psilocybin with support only. | Combination product | Psilocybin with support only |
Primary outcome
Changes in parameter estimate of regional brain activity measured by fMRI after one dose of psilocybin in participants with PTSD
Time frame: Between Baseline and Time point 24 hours and 28 days post-Investigational Product
Change in Blood oxygenation level dependent (BOLD) fMRI signal after task comparing PAT with MBCT group vs PAT with support only group
Changes in region-to-region connectivity measured by fMRI after PAT with one dose of psilocybin in patients with PTSD
Time frame: Between Baseline and Time point 24 hours and 28 days post-Investigational Product
Changes in resting state activity of brain areas comparing PAT with MBCT group vs PAT with support only group
Changes in event related potentials (ERP) after PAT with one dose of psilocybin in participants with PTSD
Time frame: Between Baseline and Time point 24 hours and 28 days post-Investigational Product.
Change in ERP as assessed by Electroencephalography (EEG) after task comparing PAT+MBCT group and PAT with support only group
Changes in acoustic startle electromyographic (EMG) response after PAT with one dose of psilocybin in patients with PTSD
Time frame: Between Baseline and Time point 24 hours and 28 days post-Investigational Product
Changes in acoustic startle magnitude measured by EMG after task comparing PAT + MBCT group and PAT with support only group
4 secondary outcomes
Changes in clinician-assessed PTSD Symptoms after PAT with one dose of psilocybin in patients with PTSD
Time frame: Baseline to 24 h and 28 days post IP
Changes in clinician-assessed Depression Symptoms after PAT with one dose of psilocybin in patients with PTSD
Time frame: Baseline to 24 hours and 28 days post-Investigational Product (IP)
Changes in Self-report PTSD Symptoms after PAT with one dose of psilocybin in patients with PTSD
Time frame: Baseline to 24 hrs and 28 days post IP
Changes in Self-report Depression Symptoms after PAT with one dose of psilocybin in patients with PTSD
Time frame: Baseline to 24 hrs and 28 days post IP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Undecided. We are considering sharing individual participant data sets including all collected IPD, vs all IPD that underlie results in a publication, for the purpose of furthering scientific knowledge
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin + MBCT therapy and Active Comparator: Psilocybin with Support Only in people with Post Traumatic Stress Disorder and Depression - Major Depressive Disorder, run by Anthony P King at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony King, PhD (614 688-9537, anthony.king@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in parameter estimate of regional brain activity measured by fMRI after one dose of psilocybin in participants with PTSD (time frame: Between Baseline and Time point 24 hours and 28 days post-Investigational Product). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.