Psilocybin-Assisted Therapy for Intergenerational Trauma

Phase 2

Not yet recruiting

• Conditions: Psychological Stress; Depression; Anxiety
• Interventions: Drug: Psilocybin; Behavioral: Integration sessions

• Registration Number: NCT06899165
• Lead Sponsor: Rachel Yehuda

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 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.

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 is the concept that the effects of experiencing extreme stress can be perpetuated to future generations. A genocide here is defined by the extinction or threat of extinction of a racial, religious or ethnic group, by an oppressive regime. A genocide survivor here is defined by an individual who survived or escaped a genocide in their country of origin. Currently, there are no evidence-based treatments developed specifically for the syndrome associated with Intergenerational trauma. This study aims to assess the safety and tolerability of psilocybin-assisted therapy, and assess 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.

Participants will be asked to attend one or more screening visits to assess eligibility. If eligible, participants will be treated with two separate doses of the study medication, Psilocybin, 3-4 weeks apart. This is an open-label research study, meaning all participants will receive Psilocybin (25mg). Two trained clinical practitioners will work with participants across preparation, dosing, and integration processes. Participants will complete assessments throughout the study until their participation has ended. Safety measures are in place to check the overall health and well-being of participants

Participation will consist of:

* Screening Period (up to 4 weeks): Phone screen, informed consent, eligibility assessment.

* Tapering \& Enrollment Period (variable): Enrollment, supervised medical tapering where necessary as discussed with the study doctor, biomarker collection and psychometric baseline assessments.

* Preparatory \& Treatment Period (up to 14 weeks): Three preparatory sessions with study clinicians, assessments; two dosing days at least three weeks apart, three weekly integration sessions with study clinicians following each dose, a 72-hour check-in call after each dosing day, assessments.

* Follow-Up Period (up to 5 weeks): Follow-up one month after final integration session, assessments, clinical evaluation, biomarker collection

Study Timeline

• Study First Submitted: 2025-03-21
• Study First Submitted QC: 2025-03-21
• Study First Posted: 2025-03-27
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-24
• Last Update Posted: 2025-07-29
• Study Start: 2025-08-21
• Primary Completion: 2029-05-31
• Study Completion: 2030-01-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Psilocybin-Assisted Therapy	Psilocybin	Offspring of genocide survivors with mood and anxiety disorders will undergo weekly therapy sessions and will be given 2 doses of psilocybin at least 3 weeks apart.
Psilocybin-Assisted Therapy	Integration sessions	Offspring of genocide survivors with mood and anxiety disorders will undergo weekly therapy sessions and will be given 2 doses of psilocybin at least 3 weeks apart.

Primary Outcome Measures

Name	Time	Method
Columbia-Suicide Severity Rating Scale (C-SSRS)	up to 23 weeks	Suicide risk as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Full Scale: 0 - 6. Higher scores indicate increased risk of suicide.
Brief Psychiatric Rating Scale (BPRS-6)	up to 23 weeks	Brief Psychiatric Rating Scale (BPRS-6) - Full Scale: 0 - 36. Higher scores indicate the number and severity of psychiatric symptoms.

Secondary Outcome Measures

Name	Time	Method
Change in Depression, Anxiety, and Stress Symptoms Scale (DASS-21)	Baseline (V0), Weeks Week 4-10 (V7), Week 6-15 (V11), Week 23(V12)	Change in Depression, Anxiety, and Stress Symptoms Scale (DASS-21) score. Stress scale - Subscale: 0 - 42 Anxiety scale - Subscale: 0 - 42 Depression scale - Subscale: 0 - 42 Full scale: 0 - 126; Higher scores indicate higher severity of symptomology.
Change in Parental PTSD Questionnaire (PPQ)	Baseline (V0) and Week 23 (V12)	Change in Parental PTSD Questionnaire (PPQ) score. Full Scale: 11 - 55 Higher scores indicate more negatively affected by perception of parents' trauma
Change in Resilience Scale for Adults (RSA)	Baseline (V0) and at Week 23 (V12)	Change in Resilience Scale for Adults (RSA) score. Full Scale: 33- 231 Higher scores indicate higher resilience

Trial Locations

Locations (1)

The Parsons Research Center for Psychedelic Healing; 🇺🇸 New York, New York, United States