Psilocybin-Assisted Therapy for Intergenerational Trauma

August 11, 2026 updated by: Rachel Yehuda

Processing Intergenerational Trauma With Psilocybin-Assisted Therapy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10025
        • Recruiting
        • The Parsons Research Center for Psychedelic Healing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.
  • 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.

Safety note (not incl./excl. criteria): Note to Potential Participants: Individuals interested in this study should not stop, taper, or otherwise change prescribed medications before speaking with the study team. Any medication changes required for study participation will be evaluated by qualified study clinicians and, when appropriate, coordinated with the participant's treating healthcare provider.

Exclusion Criteria:

  • 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.
  • Any congenital prolongation of the QT interval or a family history of long QT syndrome.
  • A family history in a first-degree relative of psychosis/schizophrenia or related disorders as assessed by clinical interview with Study MD.
  • A first-degree family history of bipolar disorder as assessed by clinical interview with Study MD.
  • Current anorexia nervosa or bulimia nervosa as determined by DSM-V criteria using the SCID-V.
  • A clinically meaningful history of cardiac arrhythmias or who require treatment with an antiarrhythmic medication.
  • Preexisting clinically meaningful cardiovascular conditions, including cardiac valvulopathy, pulmonary hypertension that may be worsened/exacerbated by elevated blood pressure or heart rate.
  • Neurological conditions including stroke, transient ischemic attack (TIA), epilepsy, neurodegenerative disease, brain tumor, or other neurological disorders that would impact participation in the trial.
  • Insulin-dependent diabetes.
  • Vital sign abnormalities at screening that exceed protocol-defined safety thresholds.
  • Hypersensitivity to psilocybin.
  • Psychiatric or other condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin.
  • Positive toxicology findings not adequately explained by prescribed medications or approved treatment regimens.
  • Clinically meaningful abnormalities on screening electrocardiogram (ECG).
  • Fall risk if not mitigated by assistance from study staff.
  • Can't identify a support person who will be able to accompany them home and stay the night with them post experimental session.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Psilocybin-Assisted Therapy
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
Psilocybin 25mg, capsules taken orally under the supervision of two trained study therapists
Other Names:
  • Psilocybin-Assisted Therapy
Behavioral: Integration sessions
weekly integration sessions (therapy) for 6 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: 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.
up to 23 weeks
Brief Psychiatric Rating Scale (BPRS-6)
Time Frame: up to 23 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Depression, Anxiety, and Stress Symptoms Scale (DASS-21)
Time Frame: 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.
Baseline (V0), Weeks Week 4-10 (V7), Week 6-15 (V11), Week 23(V12)
Change in Parental PTSD Questionnaire (PPQ)
Time Frame: 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
Baseline (V0) and Week 23 (V12)
Change in Resilience Scale for Adults (RSA)
Time Frame: Baseline (V0) and at Week 23 (V12)
Change in Resilience Scale for Adults (RSA) score. Full Scale: 33- 231 Higher scores indicate higher resilience
Baseline (V0) and at Week 23 (V12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rachel Yehuda

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rachel Yehuda, PhD, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 2, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY-24-01320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plans to at this time

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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