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Search / Trial NCT06899165

Psilocybin-Assisted Therapy for Intergenerational Trauma

Launched by RACHEL YEHUDA · Mar 21, 2025

Trial Information

Current as of July 23, 2025

Not yet recruiting

Keywords

Psilocybin Psilocybin Assisted Therapy Intergenerational Trauma Psychedelic Stress Genocide

ClinConnect Summary

This clinical trial is researching how psilocybin-assisted therapy can help people who are the children of genocide survivors and are dealing with depression, anxiety, or psychological stress. The goal is to see if this type of therapy can improve their mood and help them cope with the emotional effects of their parents' experiences, as well as boost their overall psychological resilience. The study is currently not recruiting participants, but it aims to provide valuable insights into how this therapy can support mental health in those affected by intergenerational trauma.

To participate, individuals must be at least 18 years old, be the biological child of a genocide survivor, and have a diagnosed mood or anxiety disorder. They should also be fluent in English and able to follow study procedures, like taking medication and attending therapy sessions. Participants will be asked to come in for visits, where they will receive therapy that includes psilocybin, a compound found in certain mushrooms. It's important to note that those with a history of severe mental health issues, certain medical conditions, or substance abuse will not be eligible for this study. This trial aims to understand the safety and effectiveness of this therapy, while ensuring that participants are well cared for throughout the process.

Gender

ALL

Eligibility 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.

About Rachel Yehuda

Dr. Rachel Yehuda is a renowned clinical trial sponsor and researcher specializing in the fields of trauma, stress, and PTSD. With a distinguished career in psychiatry and neuroscience, she leads innovative studies aimed at understanding the biological and psychological mechanisms underlying stress responses and their implications for mental health. Her work integrates cutting-edge methodologies and a commitment to advancing evidence-based treatments, making significant contributions to the field of psychosomatic medicine. Dr. Yehuda's leadership in clinical trials reflects her dedication to improving therapeutic outcomes for individuals affected by trauma and stress-related disorders.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Rachel Yehuda, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported