Clinical trial NCT06899165: Psilocybin-Assisted Therapy for Intergenerational Trauma
Official title: Processing Intergenerational Trauma with Psilocybin-Assisted Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Psychological Stress
Depression
Anxiety
Keywords: psilocybin
psilocybin-assisted therapy
intergenerational trauma
psychedelic
stress
genocide
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: up to 23 weeks
measure: Brief Psychiatric Rating Scale (BPRS-6)
timeFrame: up to 23 weeks
Secondary outcomes:
measure: Change in Depression, Anxiety, and Stress Symptoms Scale (DASS-21)
timeFrame: Baseline (V0), Weeks Week 4-10 (V7), Week 6-15 (V11), Week 23(V12)
measure: Change in Parental PTSD Questionnaire (PPQ)
timeFrame: Baseline (V0) and Week 23 (V12)
measure: Change in Resilience Scale for Adults (RSA)
timeFrame: Baseline (V0) and at Week 23 (V12)
Other outcomes:
Locations:
city: New York
country: United States
facility: The Parsons Research Center for Psychedelic Healing
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Rachel Yehuda, PhD
role: PRINCIPAL_INVESTIGATOR
References: