Psilocybin-Assisted Therapy for Intergenerational Trauma (NCT06899165) | Clinical Trial Compass
RecruitingPhase 2
Psilocybin-Assisted Therapy for Intergenerational Trauma
United States100 participantsStarted 2025-08-28
Plain-language summary
This is an open-label psilocybin-assisted therapy study that will examine the safety and tolerability of psilocybin-assisted therapy in the offspring of genocide survivors with mood and anxiety disorders.
The study will also investigate the efficacy of psilocybin-assisted therapy in reducing symptoms such as depression, anxiety and stress, as well as changes to the psychological effects of parental exposure to genocide, and changes to psychological resilience.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Age at least 18 years old at time of signing the informed consent
* Biological child of at least one parent who directly survived/escaped a genocide
* Meets diagnostic criteria for a depressive or anxiety disorder
* Capable of providing informed consent and complying with study procedures
* Currently using or agreeing to use adequate contraceptive methods.
* Fluent in speaking and reading English
* Able to swallow pills
* Agrees to have study visits recorded with audio and video
* Able to provide a contact person who can be reached by investigators in the event of the participant becoming unwell or unreachable
* Agrees to inform the investigators within 48 hours of any medical conditions and procedures
* Agrees to release of outside medical and psychiatric records
* Must not participate in any other interventional clinical trials for the duration of the study.
* Must commit to medication dosing, therapy, and all study procedures.
Exclusion Criteria:
* Not able to give adequate informed consent.
* Was directly exposed to or survived a genocide.
* Has a history of any medical condition, or any significant clinical finding on screening tests, that could make receiving psilocybin harmful.
* Has acute, severe or unstable medical illness.
* Has a history of stroke or Transient Ischemic Attack (TIA).
* Has a history of psychiatric hospitalization within the last 6 months.
* Current serious suicide risk.
* Unable or unwilling to safely taper off prohibited ps…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.