[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585192":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":32,"locations":42,"responsibleParty":56,"collaborators":27,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":27,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":27,"enrollmentInfo":69,"targetDuration":27,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":80,"overallStatus":45,"whyStopped":27,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14],"Drug: Psilocybin","Behavioral: Integration sessions",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Psilocybin","Psilocybin 25mg, capsules taken orally under the supervision of two trained study therapists",[9],[9],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BEHAVIORAL","Integration sessions","weekly integration sessions (therapy) for 6 weeks",[9],null,[29],{"name":30,"affiliation":5,"role":31},"Rachel Yehuda, PhD","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":27,"email":37},"Lauren Lepow, MD, PhD","CONTACT","646-438-5044","lauren.lepow@mountsinai.org",{"name":39,"role":35,"phone":40,"phoneExt":27,"email":41},"Evelyn Alkin, MA","929-489-7440","IntergenStudy@mssm.edu",[43],{"facility":44,"status":45,"city":46,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":27},"The Parsons Research Center for Psychedelic Healing","RECRUITING","New York","10025","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-74.00597,40.71427,{"lat":54,"lon":53},{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"SPONSOR_INVESTIGATOR","Rachel Yehuda","Director of the Parsons Research Center for Psychedelic Healing, Professor of Psychiatry at Mount Sinai","100585192","phase-2-psilocybin-assisted-therapy-for-intergenerational-trauma-100585192",false,"NCT06899165","Psilocybin-Assisted Therapy for Intergenerational Trauma","Processing Intergenerational Trauma With Psilocybin-Assisted Therapy","Inclusion criteria:\n\n* Age at least 18 years old at time of signing the informed consent\n* Biological child of at least one parent who directly survived\u002Fescaped a genocide\n* Meets diagnostic criteria for a depressive or anxiety disorder\n* Capable of providing informed consent and complying with study procedures\n* Currently using or agreeing to use adequate contraceptive methods.\n* Fluent in speaking and reading English\n* Able to swallow pills\n* Agrees to have study visits recorded with audio and video\n* Able to provide a contact person who can be reached by investigators in the event of the participant becoming unwell or unreachable\n* Agrees to inform the investigators within 48 hours of any medical conditions and procedures\n* Agrees to release of outside medical and psychiatric records\n* Must not participate in any other interventional clinical trials for the duration of the study.\n* Must commit to medication dosing, therapy, and all study procedures.\n\nExclusion Criteria:\n\n* Not able to give adequate informed consent.\n* Was directly exposed to or survived a genocide.\n* Has a history of any medical condition, or any significant clinical finding on screening tests, that could make receiving psilocybin harmful.\n* Has acute, severe or unstable medical illness.\n* Has a history of stroke or Transient Ischemic Attack (TIA).\n* Has a history of psychiatric hospitalization within the last 6 months.\n* Current serious suicide risk.\n* Unable or unwilling to safely taper off prohibited psychiatric medications.\n* Abusing alcohol or other substances.\n* Has used psychedelics within 3 months of enrollment.\n* Are pregnant or nursing or able to become pregnant and are not practicing an effective means of contraception.","ALL","18 Years",{"count":70,"type":71},100,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","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.\n\nThe 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.",[77,78,79],"Psychological Stress","Depression","Anxiety",[81,82,83,84,85,86],"psilocybin","psilocybin-assisted therapy","intergenerational trauma","psychedelic","stress","genocide","2025-09-02",{"date":89,"type":90},"2025-09-08","ACTUAL",{"date":92,"type":90},"2025-08-28",{"date":94,"type":71},"2030-01-02",{"name":58,"class":6},1]