Psilocybin-assisted therapy for adults who are biological children of genocide survivors
Processing Intergenerational Trauma With Psilocybin-Assisted Therapy
This project will test whether two supervised 25 mg doses of psilocybin plus preparation and integration therapy help adults who are biological children of genocide survivors reduce depression, anxiety, and stress.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06899165 on ClinicalTrials.gov |
What this trial studies
This open-label Phase 2 trial gives all eligible participants two supervised 25 mg doses of psilocybin about 3–4 weeks apart with preparation and integration sessions led by two trained clinicians. The study enrolls adults who are biological children of genocide survivors and who meet diagnostic criteria for a depressive or anxiety disorder. Safety and tolerability will be monitored with clinical assessments and audio/video recordings, and symptom measures of depression, anxiety, stress, intergenerational trauma effects, and psychological resilience will be collected over follow-up. Because there is no placebo control, the focus is on safety, tolerability, feasibility, and signals of clinical benefit.
Who should consider this trial
Good fit: Adults (18+) who are biological children of at least one parent who survived or escaped a genocide, meet diagnostic criteria for a depressive or anxiety disorder, can provide informed consent, speak and read English, swallow pills, and commit to dosing and therapy procedures are ideal candidates.
Not a fit: People who are not biological children of genocide survivors, who do not have a depressive or anxiety disorder, or who cannot complete the required dosing, therapy, or recorded visits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce depression, anxiety, and stress symptoms and strengthen psychological resilience in offspring of genocide survivors.
How similar studies have performed: Psilocybin-assisted therapy has shown promising improvements for depression and anxiety in other clinical trials, but its use specifically for intergenerational trauma is a novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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 psychiatric medications. * Abusing alcohol or other substances. * Has used psychedelics within 3 months of enrollment. * Are pregnant or nursing or able to become pregnant and are not practicing an effective means of contraception.
Where this trial is running
New York, New York
- The Parsons Research Center for Psychedelic Healing — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Rachel Yehuda, PhD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Lauren Lepow, MD, PhD
- Email: lauren.lepow@mountsinai.org
- Phone: 646-438-5044
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.