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Home/Research/Psilocybin/PTSD

Psilocybin for PTSD

81 papers and 25 clinical trials exploring psilocybin as a treatment for ptsd.

CompoundClassic Psychedelic

Psilocybin

Psilocybin is a naturally occurring tryptamine psychedelic that acts as a prodrug to psilocin, a potent 5-HT2A receptor agonist. It is the furthest advanced psychedelic in clinical development, with two positive Phase III trials in treatment-resistant depression and expanding regulated access in Australia, Germany, and US states.

Full Psilocybin profile
Indication354 million people suffering from PTSD globally.

PTSD

Posttraumatic stress disorder (PTSD) is a significant mental health challenge affecting over 354 million individuals globally. Psychedelics, particularly MDMA and psilocybin, are emerging as promising therapeutic options, offering new avenues for treatment through innovative psychotherapeutic interventions.

Full PTSD profile

Academic Research

81 papers
Paywallindividual

Changes in anxiety, quality of life, and functioning following psilocybin-assisted therapy in veterans with treatment-resistant depression

This secondary analysis of an open-label trial (n=15) examined a single 25 mg dose of psilocybin with psychological support in veterans with treatment-resistant depression, focusing on anxiety, quality of life, functioning, and PTSD symptoms. Improvements were observed across these measures, but most were no longer significant after accounting for concurrent improvements in depression.

Published
June 4, 2026
Journal
Journal of Affective Disorders
Authors
Kelly, C. M., Fradet, M., Bostian, C. M., Donnelly, A., Ellis, S., Ostacher, M., Aaronson, S., Suppes, T.
Open Accessindividual

Psychedelic-assisted therapy: a survey on the clinical methods of Swiss physicians

This survey study (n=41) examined how Swiss physicians provide psychedelic-assisted therapy under legal exemptions, mainly for depression, anxiety, PTSD and chronic pain. It found wide variation in practice, with psilocybin, MDMA and LSD commonly used, music often played during sessions, and adverse effects usually including disorientation, feeling cold, anxiety and nausea.

Published
May 20, 2026
Journal
Therapeutic Advances in Psychopharmacology
Authors
Beichmann, K., Catzeflis, P., Aicher, H. D., Seragnoli, F., Calder, A., Amrani, A., Hasler, G.
Paywallindividual

From trials to clinics: investigators' perspectives on translating psychedelic research into clinical care

This qualitative study (n=21) interviewed US psychedelic clinical investigators about how treatments such as MDMA and psilocybin might move from trials into routine care. They saw major challenges in the role of psychotherapy, treatment cost and scalability, and the effects of hype and stigma on uptake.

Published
May 19, 2026
Authors
Mitchell, J., Neitzke-Spruill, L., Mathai, D. S., Robinson, J. O., Kavan, Z., Averil, L. A., McGuire, A. L.
Open Accessmeta

Psychedelic medicine: mechanisms, evidence, and translation to practice

This review (2026) summarises the rapidly growing evidence for psychedelic-assisted therapies, finding the strongest support for psilocybin in treatment-resistant depression (TRD) and MDMA in post-traumatic stress disorder (PTSD). It also highlights that while these treatments are generally well tolerated in controlled settings, major challenges remain around unclear mechanisms, trial limitations, scalability, and translation into routine practice.

Published
February 23, 2026
Journal
BMJ
Authors
Jacobs, E., Zahid, Z., Hinkle, J., Nayak, S., Yaden, D. B.
Open Accessindividual

Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD A Randomized Clinical Trial

In a multicentre, double‑blind, placebo‑controlled phase 2 trial of 65 adults with chronic PTSD, once‑weekly oral TSND‑201 produced significantly greater reductions in clinician‑rated PTSD severity (CAPS‑5; LS mean difference 9.64, P = .01) and improvements in self‑reported symptoms, functioning and depression versus placebo. TSND‑201 was generally well tolerated — common adverse events included headache, decreased appetite, nausea, dizziness and transient blood‑pressure increases — supporting its potential as a rapid‑acting, durable treatment for PTSD.

Published
February 18, 2026
Journal
JAMA Psychiatry
Authors
Jones, A., Warner-Schmidt, J., Kwak, H., Stogniew, M., Mandell, B., Ching, T. H., Stein, M. B., Kelmendi, B.
Open Accessindividual

Investigational psilocybin treatment for post-traumatic stress disorder: a qualitative study of participant experience, trauma engagement, and differences from standard treatment

This qualitative sub-study (n=21) nested within a Phase II trial found that psilocybin treatment enabled participants with PTSD to engage with trauma-related material both directly and indirectly through affective, somatic, and self-transcendent experiences, contrasting with standard treatments that require direct confrontation with trauma memories.

Published
December 1, 2025
Journal
EClinicalMedicine
Authors
Modlin, N. L., Williamson, V., Goodwin, G. M., Malievskaia, E., Atli, M., Elek, Z., Gaillard, A., Koelpin, D., Cleare, A., Agrawal, M., Yehuda, R., Kirlic, N., Rucker, J.

Clinical Trials

25 trials
Not yet recruitingPhase II/III

Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder

This Phase II/III, multicentre, randomised, double-blind, controlled trial (n=300) will evaluate the efficacy, safety and tolerability of COMP360 psilocybin in adults with post-traumatic stress disorder (PTSD). The study will compare 25 mg COMP360 with 1 mg COMP360, with 10 mg COMP360 also included, and will assess whether COMP360 can reduce PTSD symptoms when given alongside monitoring and support from a trained study team. Participants are adults aged 18 years and over who have had a PTSD diagnosis for at least 6 months. COMP360 psilocybin will be administered with monitoring and support, and the primary endpoint is the change from baseline to Week 8 in CAPS-5 total severity score for 25 mg versus 1 mg. The trial also includes an open-label extension.

Started
September 1, 2026
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT07570654
Not yet recruitingPhase III

Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression

This Phase III, randomised, quadruple‑masked, parallel trial (n=240) will evaluate the efficacy and risks of psilocybin for treatment‑resistant depression in U.S. military veterans with and without concurrent post‑traumatic stress disorder, with the primary outcome being change in the Montgomery‑Åsberg Depression Rating Scale (MADRS) at 2 weeks. This multi‑site study randomises participants to either a psilocybin intervention dose or a psilocybin comparator dose under blinded conditions. Consenting veterans will receive two psilocybin dosing sessions with psychological preparation, administration and integration support from a facilitator; participants are randomised at the first administration to one of the two doses and one month later all participants receive a 25 mg dose at the second session. Outcomes are measured by an independent evaluator masked to treatment at 2 and 4 weeks after each dosing session, with longer‑term follow‑up over 6 months, and both expected and unanticipated adverse events collected. Key eligibility includes English‑speaking U.S. veterans aged 18–75 years with a current major depressive episode (MADRS ≥20) who have not responded to ≥2 adequate antidepressant treatments.

Started
June 1, 2026
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT07226232
WithdrawnPhase II

Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies

This Phase II, non-randomised, open-label, parallel-group trial (n=150) will study response to three neuroplasticity-enhancing interventions in civilian and Veteran adults (aged 18–69) at low, intermediate or high risk for self-harm. The study will evaluate clinical change in suicidal ideation (Scale of Suicidal Ideation from baseline to the post‑treatment visit at Month 6) and aim to characterise neurobiological and blood-based markers associated with risk and treatment response. Participants are allocated to one of three experimental arms: two sessions of fMRI neurofeedback targeting amygdala activity, an accelerated theta burst stimulation programme of 50 sessions delivered to the dorsolateral prefrontal cortex, or psilocybin‑assisted therapy comprising three preparation sessions, two psilocybin administration sessions and two integration sessions. Baseline and post‑treatment assessments include clinical measures, structural and functional MRI and blood sampling for circular RNA (circRNA); an artificial intelligence analytic team will use these multimodal data to develop predictive models of behavioural risk and treatment response.

Started
May 1, 2026
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT07484906
RecruitingPhase I

Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder

This Phase I, open-label, single-group trial (n=36) will evaluate group psilocybin-assisted therapy for adults with post-traumatic stress disorder (PTSD), including veterans or first responders, female survivors of sexual violence, and Indigenous people. The study will assess safety, feasibility, and preliminary effects on PTSD severity. Participants will receive two group-format psilocybin dosing sessions scheduled 4 weeks apart, held at the ISUBI Center at UNM or another site approved by the DEA for psilocybin storage. The main outcomes are study completion, adverse events and serious adverse events assessed using CTCAE v5.0, and change in PTSD symptom scores on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and PTSD Checklist for DSM-5 (PCL-5), measured from baseline to 18 weeks.

Started
May 1, 2026
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT07506395
Not yet recruitingPhase II

Psilocybin-Assisted Randomized Therapy

This Phase II, randomised, open-label, parallel trial (n=150) will evaluate the safety, tolerability, acceptability and preliminary efficacy of a single 25 mg dose of psilocybin administered with two different psychotherapy approaches in Georgia military service members, reservists, National Guard members or active-duty personnel seeking treatment for PTSD. The primary aims are to pilot tolerability and safety and to compare changes in PTSD symptoms between psilocybin plus supportive therapy and psilocybin plus massed prolonged exposure (PE) therapy. Participants will be randomised to receive a single 25 mg psilocybin dosing session paired either with supportive (non-directive) therapy—comprising preparatory work and two integrative support sessions one week apart with online surveys between sessions—or with massed PE consisting of 10 manualised PE sessions delivered over 10 days with imaginal and in vivo exposure homework and interim online surveys. Safety and tolerability will be assessed using the Swiss Psychedelic Side Effects Inventory (SPSI), Psychedelic-assisted Therapy After Effects (PATAE) and the Accessibility Questionnaire (AQ); other outcomes include Subjective Units of Distress (SUDS) during imaginal exposure, fear extinction and recall assessed by fear potentiated startle, and symptom measures (CAPS-5-R change baseline to 1 month, PCL-5 at baseline, 1, 6 and 12 months, and PHQ-9 at baseline, 1, 6 and 12 months). The study is planned to run from March 2026 to March 2027.

Started
March 1, 2026
Type
interventional
Blinding
none
Randomized
Yes
Registry ID
NCT07332143
RecruitingPhase I

Safety and Preliminary Efficacy of Organic Whole Psilocybin-Containing Mushrooms to Treat Patients Suffering From PTSD

This Phase I, open-label, single-group trial (n=24) will study the safety, pharmacokinetic profile and preliminary efficacy of organic whole psilocybin-containing mushrooms (30mg psilocybin administered orally in a single dosing session) in adults with post‑traumatic stress disorder (PTSD), with primary emphasis on adverse events and mental/psychotic adverse events. Up to 24 participants aged ≥18 years who meet DSM‑5 criteria for current PTSD of ≥6 months (with at least one traumatic event on the LEC‑5 and a PCL‑5 score ≥33) will self-administer dried psilocybin mushrooms in a chocolate formulation during a single dosing session. The study is single‑arm and open‑label; outcomes include incidence of adverse events and serious adverse events graded by NCI CTCAE v5.0 and incidence of mental/psychotic adverse events from dosing through a 3‑month follow‑up, and the trial will also characterise pharmacokinetics and collect preliminary efficacy and patient‑reported measures.

Started
December 1, 2025
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT07275970

Explore further

Search all Psilocybin papers Search all PTSD trials Full Psilocybin profile Full PTSD profile