Psychological StressPhase 2NCT06899165
Psilocybin-Assisted Therapy for Intergenerational Trauma
A Phase 2 study testing Psilocybin and Integration sessions in people with Psychological Stress and Depression, run by Rachel Yehuda at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Stress, Depression, Anxiety
- What is being tested?
- Psilocybin and Integration sessions
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2026to 2 Jan 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Parsons Research Center for Psychedelic Healing
New York, New York, 10025
About this study
Official title: 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.
Read the 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
- Conditions
- Psychological Stress, Depression, Anxiety
- Being tested
- Psilocybin, Integration sessions
- Keywords
- psilocybin, psilocybin-assisted therapy, intergenerational trauma, psychedelic, stress, genocide
- Medical subject headings
- Stress, Psychological, Depression, Anxiety Disorders, Historical Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Also called Psilocybin-Assisted Therapy
Psilocybin 25mg, capsules taken orally under the supervision of two trained study therapists
Integration sessionsBehavioural
weekly integration sessions (therapy) for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Psilocybin; Behavioral: Integration sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 23 weeks
Secondary outcomes (3)
Change in Depression, Anxiety, and Stress Symptoms Scale (DASS-21)
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.
Measured: Baseline (V0), Weeks Week 4-10 (V7), Week 6-15 (V11), Week 23(V12)
Change in Parental PTSD Questionnaire (PPQ)
Change in Parental PTSD Questionnaire (PPQ) score. Full Scale: 11 - 55 Higher scores indicate more negatively affected by perception of parents' trauma
Measured: Baseline (V0) and Week 23 (V12)
Change in Resilience Scale for Adults (RSA)
Change in Resilience Scale for Adults (RSA) score. Full Scale: 33- 231 Higher scores indicate higher resilience
Measured: Baseline (V0) and at Week 23 (V12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start28 Aug 2026 (estimated)
- Primary completion31 May 2029 (estimated)
- Study completion2 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rachel Yehuda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rachel Yehuda, Icahn School of Medicine at Mount Sinai
- Investigators
- Rachel Yehuda, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899165
- Sponsor's protocol ID
- STUDY-24-01320
- Status last verified
- Aug 2026
- First submitted
- 21 Mar 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to at this time
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Processing Intergenerational Trauma With Psilocybin-Assisted Therapy
- ClinicalTrials.gov ID
- NCT06899165
- Acronym / sponsor ID
- STUDY-24-01320
- Conditions
- Psychological Stress, Depression, Anxiety
- Keywords
- psilocybin, psilocybin-assisted therapy, intergenerational trauma, psychedelic, stress, genocide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rachel YehudaUniversity, hospital or other
- Study start
- 28 Aug 2026 (estimated)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 2 Jan 2030 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psilocybin-Assisted Therapy | Experimental | Drug: Psilocybin, Behavioral: Integration sessionsOffspring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinAlso: Psilocybin-Assisted TherapyPsilocybin 25mg, capsules taken orally under the supervision of two trained study therapists | Drug | Psilocybin-Assisted Therapy |
| Integration sessionsweekly integration sessions (therapy) for 6 weeks | Behavioural | Psilocybin-Assisted Therapy |
Primary outcome
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.
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.
3 secondary outcomes
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 Parental PTSD Questionnaire (PPQ)
Time frame: Baseline (V0) and Week 23 (V12)
Change in Resilience Scale for Adults (RSA)
Time frame: Baseline (V0) and at Week 23 (V12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No. No plans to at this time
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Yehuda, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin and Integration sessions in people with Psychological Stress and Depression, run by Rachel Yehuda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Lepow, MD, PhD (646-438-5044, lauren.lepow@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Columbia-Suicide Severity Rating Scale (C-SSRS) (time frame: up to 23 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.