RecruitingPhase 2NCT06899165

Psilocybin-Assisted Therapy for Intergenerational Trauma

Processing Intergenerational Trauma With Psilocybin-Assisted Therapy

Sponsor

Rachel Yehuda

Enrollment

100 participants

Start Date

Aug 28, 2025

Study Type

INTERVENTIONAL

Conditions

Depression Anxiety Psychological Stress

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria13

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 Criteria11

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.