Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Psilocybin-Assisted Psychotherapy for Veterans With PTSD (PsiVet)

25 sierpnia 2026 zaktualizowane przez: ARQ National Psychotrauma Centre

Psilocybin-Assisted Psychotherapy for Posttraumatic Stress Disorder in Military Veterans: A Pilot Feasibility Study

This study will evaluate the feasibility, safety and preliminary efficacy of psilocybin-assisted psychotherapy in military veterans with treatment-refractory posttraumatic stress disorder (PTSD).

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Posttraumatic stress disorder (PTSD) is a severe and debilitating mental health condition that significantly impacts patients' lives, leading to functional impairments, strained relationships, and high healthcare costs. About half of the patients with PTSD do not benefit from current evidence-based psychotherapy and available pharmacological treatments offer only limited benefits. Therefore, there is a high need for novel therapeutic approaches in the treatment of PTSD.

Psilocybin-assisted psychotherapy is a promising approach combining the pharmacological effects of psilocybin, a serotonergic psychedelic, with psychotherapy. Psilocybin-assisted psychotherapy has shown promising effects in several phase 2 studies in the treatment of mental health conditions such as depression and end-of-life anxiety, with two phase 3 studies underway for treatment-resistant depression. Building on these initial promising results, psilocybin-assisted psychotherapy is increasingly being studied for other psychiatric indications, including PTSD.

Many of psilocybin's potential therapeutic mechanisms appear to be transdiagnostic in nature. For example, studies suggest that psilocybin can enhance introspection, emotional processing, and psychological flexibility, all of which could facilitate psychotherapeutic processes. Psilocybin has also been shown to reduce avoidance and promote neural plasticity and cognitive reappraisal, which could be particularly relevant for addressing core symptoms of PTSD, such as persistent avoidance and rigid negative thought patterns. Furthermore, its ability to foster a sense of connectedness aligns well with the therapeutic need of individuals with PTSD who face challenges related to social isolation.

Preliminary findings from an initial Phase 2 trial suggest that psilocybin-assisted psychotherapy may be safe and associated with clinically meaningful improvements in PTSD symptoms. However, this study differed from the present study in several important aspects. Participants were not required to have had previous unsuccessful evidence-based psychotherapies for PTSD, and psilocybin administration was not embedded within psychotherapeutic treatment. The current open-label pilot study will focus on veterans with treatment-refractory PTSD, a patient population that frequently shows partial or no response to standard evidence-based PTSD treatment. In addition, psilocybin administration will be part of an extensive psychotherapeutic treatment protocol. This study aims to collect data on the feasibility, preliminary efficacy and safety of psilocybin-assisted psychotherapy in this population, to inform a potential future randomized controlled trial.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

12

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Holandia
      • Oegstgeest, Holandia, 2342 EG
        • ARQ National Psychotrauma Centre / ARQ Centrum'45

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • Are between 18 and 70 years old.
  • Able to provide written informed consent.
  • Fluent in speaking and reading Dutch.
  • Is a veteran of the Dutch Armed Forces.
  • Able to swallow pills.
  • Have a body mass index (kg/m2) of >18.0.
  • Meet DSM-5 criteria for current PTSD.
  • Meet criteria for treatment-refractory PTSD.
  • Agree to have study visits audiovisually recorded.
  • Able to provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of the participant becoming unwell or unreachable.

Exclusion Criteria:

  • Has a history of any medical condition that could make receiving psilocybin harmful because of temporary increases in blood pressure and heart rate.
  • Has a medical or psychiatric condition that could interfere with study participation or pose a risk to the participant's safety or well-being.
  • Has uncontrolled hypertension.
  • Unable or unwilling to safely taper-off prohibited psychiatric medication.
  • Has been exposed to electroconvulsive therapy (ECT) within 12 weeks of enrollment.
  • Has any current problem which, in the opinion of the investigator, might interfere with study participation.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Psilocybin-assisted psychotherapy
Lek: Psilocybin-assisted Psychotherapy
Two psilocybin sessions (15 mg psilocybin in the first session; 25 mg psilocybin in the second session) embedded in a psychotherapeutic framework with three preparatory sessions and six integrative sessions.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
Ramy czasowe: From Baseline to 1 month after final integrative psychotherapy session
The last month CAPS-5-R is a semi-structured interview that assesses index history of DSM-5-defined traumatic event exposure, including the most distressing event and time since exposure, and rates intrusion symptoms (intrusive thoughts or memories), avoidance, cognitive and mood symptoms, arousal and reactivity symptoms, duration and degree of distress and dissociation. The CAPS-5-R will be administered by a study independent CAPS-5-R rater.
From Baseline to 1 month after final integrative psychotherapy session
Semi-structured interview
Ramy czasowe: One month after final integrative psychotherapy session
Comprehensive qualitative information about participants' evaluation of the feasibility, acceptability and efficacy of psilocybin-assisted psychotherapy for PTSD will be collected through a semi-structured interview.
One month after final integrative psychotherapy session
Treatment Acceptability/Adherence Scale Modified (TAAS-M)
Ramy czasowe: One month after final integrative psychotherapy session
A modified 10-item version of the Treatment Acceptability and Adherence Scale (TAAS-M) will be used to describe acceptability and adherence to psilocybin-assisted psychotherapy.
One month after final integrative psychotherapy session
Feasibility of participant screening and study retention
Ramy czasowe: From screening until one month after the final integrative psychotherapy session.
The feasibility of participant screening and study retention will be assessed by documenting the number and proportion of participants who fail screening, the number and proportion of enrolled participants who discontinue the intervention, and the reasons for screen failure and discontinuation. All measures will be summarized descriptively.
From screening until one month after the final integrative psychotherapy session.
Concomitant medication use
Ramy czasowe: From screening until one month after the final integrative psychotherapy session.
Concomitant medication use during study participation will be recorded.
From screening until one month after the final integrative psychotherapy session.
Columbia Suicide Severity Rating Scale (C-SSRS)
Ramy czasowe: Measured at several timepoints from screening to one month after the final integrative psychotherapy session.
The C-SSRS is a clinician-administered measure of suicidal behavior devised to detect potential suicidal thoughts or behaviors during a clinical trial.
Measured at several timepoints from screening to one month after the final integrative psychotherapy session.
Adverse events
Ramy czasowe: From screening until one month after the final integrative psychotherapy session.
Severity, incidence and frequency of AEs and serious adverse events (SAEs).
From screening until one month after the final integrative psychotherapy session.
Blood pressure
Ramy czasowe: At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
Systiloc and diastolic blood pressure (mmHg) will be monitored.
At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
Heart rate
Ramy czasowe: At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
Heart rate (beats per minute) will be monitored.
At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
Body temperature
Ramy czasowe: At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
Body temperature (°C) will be monitored.
At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Sheehan Disability Scale
Ramy czasowe: Change from Baseline to one month after final integrative psychotherapy session
The Sheehan Disability Scale is a 3-item assessment of functional impairment.
Change from Baseline to one month after final integrative psychotherapy session
Beck Depression Inventory-II (BDI-II)
Ramy czasowe: Change from baseline to one month after final integrative psychotherapy session
The BDI-II is a 21-item self-report measure for depression symptom severity.
Change from baseline to one month after final integrative psychotherapy session

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

ARQ National Psychotrauma Centre

Współpracownicy

Leiden University Medical Center
National Healthcare System for Veterans / Landelijk Zorgsysteem voor Veteranen (LZV)

Śledczy

  • Główny śledczy: Eric Vermetten, MD, PhD, Leiden University Medical Center

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 grudnia 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2028

Ukończenie studiów (Szacowany)

1 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

23 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

25 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

28 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

25 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2025-521488-11-00
  • 2025 (Grant/umowa NIH USA: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj