Psilocybin-Assisted Therapy for Intergenerational Trauma

NCT06899165 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY-24-01320
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Stress; Depression; Anxiety

Keywords

psilocybin; psilocybin-assisted therapy; intergenerational trauma; psychedelic; stress; genocide

Outcome Measures

Primary Outcomes (2)

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  Suicide risk as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Full Scale: 0 - 6. Higher scores indicate increased risk of suicide.

  up to 23 weeks

• Brief Psychiatric Rating Scale (BPRS-6)

  Brief Psychiatric Rating Scale (BPRS-6) - Full Scale: 0 - 36. Higher scores indicate the number and severity of psychiatric symptoms.

  up to 23 weeks

Secondary Outcomes (3)

• 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 Parental PTSD Questionnaire (PPQ)

  Baseline (V0) and Week 23 (V12)

• Change in Resilience Scale for Adults (RSA)

  Baseline (V0) and at Week 23 (V12)

Study Arms (1)

Psilocybin-Assisted Therapy

EXPERIMENTAL

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.

Drug: Psilocybin; Behavioral: Integration sessions

Interventions

Psilocybin DRUG

Psilocybin 25mg, capsules taken orally under the supervision of two trained study therapists

Also known as: Psilocybin-Assisted Therapy

Psilocybin-Assisted Therapy

Integration sessions BEHAVIORAL

weekly integration sessions (therapy) for 6 weeks

Psilocybin-Assisted Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rachel Yehuda: lead

Study Sites (1)

The Parsons Research Center for Psychedelic Healing

New York, New York, 10025, United States

RECRUITING

MeSH Terms

Conditions

Stress, Psychological; Depression; Anxiety Disorders; Historical Trauma

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Psychological Trauma; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Rachel Yehuda, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Lepow, MD, PhD

CONTACT

646-438-5044; lauren.lepow@mountsinai.org

Evelyn Alkin, MA

CONTACT

929-489-7440; IntergenStudy@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Parsons Research Center for Psychedelic Healing, Professor of Psychiatry at Mount Sinai

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 27, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): January 2, 2030
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)