Clinical Trials in the Netherlands / NCT07792538
Starting soon
Phase 2
Psilocybin-Assisted Psychotherapy for Veterans With PTSD
NCT07792538 · tracked via the Priya Life Science Netherlands tracker
Condition(s) studied
Posttraumatic Stress Disorder (PTSD)
Investigational drug(s) / intervention(s)
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.
Study summary
This study will evaluate the feasibility, safety and preliminary efficacy of psilocybin-assisted psychotherapy in military veterans with treatment-refractory posttraumatic stress disorder (PTSD).
Eligibility
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.
Primary outcome measure(s)
- Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) — 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. - Semi-structured interview — 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. - Treatment Acceptability/Adherence Scale Modified (TAAS-M) — 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. - Feasibility of participant screening and study retention — 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. - Concomitant medication use — From screening until one month after the final integrative psychotherapy session.
Concomitant medication use during study participation will be recorded. - Columbia Suicide Severity Rating Scale (C-SSRS) — 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. - Adverse events — From screening until one month after the final integrative psychotherapy session.
Severity, incidence and frequency of AEs and serious adverse events (SAEs). - Blood pressure — 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. - Heart rate — 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. - Body temperature — At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
Body temperature (°C) will be monitored.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| ARQ National Psychotrauma Centre / ARQ Centrum'45 | Oegstgeest | Netherlands |
More ARQ National Psychotrauma Centre trials in the Netherlands
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07792538 on ClinicalTrials.gov ↗ ← All trials in the Netherlands