NCT06899165 · Rachel Yehuda
Psilocybin-Assisted Therapy for Intergenerational Trauma
What this study is about
This is an where both patients and doctors know the treatment given psilocybin-assisted therapy study that will examine the safety and how well patients handle the treatment of psilocybin-assisted therapy in the offspring of genocide survivors with mood and anxiety disorders.
View original scientific description
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.
Interventions
DRUG
Psilocybin
Psilocybin 25mg, capsules taken orally under the supervision of two trained study therapists
BEHAVIORAL
Integration sessions
weekly integration sessions (therapy) for 6 weeks
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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.
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.
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 8, 2025 · Source of record for eligibility and locations