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; Anxiety; Depression

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.
• Evidence of clinically significant intergenerational trauma-related symptoms, as determined by the modified Parental PTSD Questionnaire (mPPQ).
• Meet diagnostic criteria for a depressive, anxiety, trauma-, or stressor-related disorder on the Structured Clinical Interview for DSM-5 (SCID-5).
• BMI of ≥ 17.
• Capable of providing written informed consent and complying with study procedures.
• If of reproductive potential, willing to use a highly effective method of contraception throughout study participation. Participants who can father a child and have partners of reproductive potential must also agree to use effective contraception throughout study participation.
• Willing and medically appropriate to discontinue serotonergic medications before study treatment and remain off such medications throughout study participation, as determined by the study physician in consultation with the participant's treating healthcare provider.
• Fluent in speaking and reading English.
• Able to swallow pills.
• Agree to have all study visits (both in-person and remote) 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.
• Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
• Agree to release relevant medical and psychiatric records for eligibility determination and safety monitoring.
• Agree to comply with protocol-specified lifestyle restrictions and study requirements.

You may not qualify if:

• Individual was directly exposed to the genocide.
• Current or recent illicit drug or prescription drug substance use disorder (excluding cannabis and tobacco use disorders), as determined by DSM-5 criteria and clinical assessment.
• Current or recent alcohol or cannabis use disorder that, in the opinion of the investigator, may interfere with safe participation or study outcomes.
• Current psychiatric hospitalization or psychiatric hospitalization within the last 6 months.
• Recent use of psychedelic substances.
• Recent non-medical or illicit use of ketamine.
• Past or current psychotic disorder (including psychotic MDD), mania, or bipolar disorder.
• Current serious suicide risk, recent suicidal behavior, or clinician concern that the participant poses a risk to self or others.
• Acute, severe, or unstable medical illness, including clinical or laboratory evidence of severe renal and/or hepatic impairment.
• Any physical or intellectual disability adversely affecting ability to complete assessments.
• Current pregnancy or currently chest/breastfeeding.
• Any clinically meaningful abnormal laboratory test result, as determined by the investigator.
• Current treatment with medications contraindicated with study treatment that cannot be safely tapered, discontinued, or substituted in accordance with the protocol.
• History of clinically significant QT prolongation or other clinically significant cardiac conduction abnormality.
• Use of medications known to prolong the QT interval that cannot be safely discontinued.

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, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): January 2, 2030
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)