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Psilocybin-Assisted Therapy for Intergenerational Trauma

ConditionsPsychological StressDepressionAnxiety
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRachel Yehuda

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Psilocybin

    Drug

    Psilocybin 25mg, capsules taken orally under the supervision of two trained study therapists

  • Integration sessions

    Behavioral

    weekly integration sessions (therapy) for 6 weeks

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Psilocybin-Assisted TherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
up to 23 weeks
2

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.

Time frame
up to 23 weeks

Secondary outcomes

1

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.

Time frame
Baseline (V0), Weeks Week 4-10 (V7), Week 6-15 (V11), Week 23(V12)
2

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

Time frame
Baseline (V0) and Week 23 (V12)
3

Change in Resilience Scale for Adults (RSA)

Change in Resilience Scale for Adults (RSA) score. Full Scale: 33- 231 Higher scores indicate higher resilience

Time frame
Baseline (V0) and at Week 23 (V12)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rachel Yehuda

Lead sponsor

Icahn School of Medicine at Mount Sinai

Sponsor institution

Source ClinicalTrials.gov
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