Psychological Stress / Anxiety / Depression · Phase 2 Trial

Psilocybin-Assisted Therapy for Intergenerational Trauma

ClinicalTrials.gov · August 13, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 open-label trial registration examining psilocybin-assisted therapy combined with integration sessions in offspring of genocide survivors with mood and anxiety disorders. No results have been posted in the registry; the study is actively recruiting. The design—lacking blinding and a control arm—is typical of early-phase investigations but carries bias risk that limits inference until results are reported.

What was studied

Phase 2, Interventional, Single Group, Open label, Treatment purpose. Psychological Stress, Depression, Anxiety; age from 18 Years. Intervention: Psilocybin-Assisted Therapy. n = 100. 1 site: United States.

Key findings

Safety

This is a registry record only; no efficacy, safety, or tolerability results are reported

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

Phase 2 open-label trial with no results posted; early-stage study of psilocybin-assisted therapy still recruiting, examining safety and efficacy in a specialized population.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Columbia-Suicide Severity Rating Scale (C-SSRS) (assessed at up to 23 weeks); Brief Psychiatric Rating Scale (BPRS-6) (assessed at up to 23 weeks)

DesignPhase 2, Interventional, Single Group, Open label, Treatment purpose

PopulationPsychological Stress, Depression, Anxiety; age from 18 Years

Sample size100

InterventionPsilocybin-Assisted Therapy

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment100

Primary outcome measure 1Columbia-Suicide Severity Rating Scale (C-SSRS), up to 23 weeks

Primary outcome measure 2Brief Psychiatric Rating Scale (BPRS-6), up to 23 weeks

Study phasePhase 2

Caveats

This is a registry record only; no efficacy, safety, or tolerability results are reported
Open-label design without control arm limits causal inference
Study is still recruiting; enrollment and follow-up not complete
No sample size justification or power analysis provided in registry record

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Open-label Phase 2 design without control arm; no blinding

Directness

moderate

Directly addresses safety, tolerability, and efficacy in target population

Consistency

insufficient

No results reported; cannot assess consistency with prior work

Risk of bias

limited

Open-label design with no comparator introduces detection and selection bias

Sample adequacy

moderate

Estimated 100 participants planned; adequacy for Phase 2 cannot be confirmed pre-results

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06899165). This is a study registration, not published results. Lead sponsor: Rachel Yehuda. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Psychological Stress, Depression, Anxiety. Interventions: DRUG: Psilocybin; BEHAVIORAL: Integration sessions. Primary outcome measures: Columbia-Suicide Severity Rating Scale (C-SSRS) , up to 23 weeks; Brief Psychiatric Rating Scale (BPRS-6) , up to 23 weeks. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Psychological StressAnxietyNCT06899165DepressionIntegration sessionsRachel YehudaPsilocybin