Status:
RECRUITING
Psilocybin-Assisted Therapy for Intergenerational Trauma
Lead Sponsor:
Rachel Yehuda
Conditions:
Psychological Stress
Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 disord...
Detailed Description
This study is investigating whether Psilocybin-assisted therapy improves depression, anxiety and stress symptoms in the offspring (biological children) of genocide survivors. Intergenerational trauma ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 2 2030
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06899165
Start Date
August 28 2025
End Date
January 2 2030
Last Update
September 8 2025
Active Locations (1)
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1
The Parsons Research Center for Psychedelic Healing
New York, New York, United States, 10025