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Retrospective Observational Study of Intensity Effects in Psychedelic-assisted Treatment

NCT07164287 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 376

Last updated 2025-10-02

No results posted yet for this study

Summary

This retrospective observational study examines the effects of psychedelic-assisted psychotherapy (PAP) with lysergic acid diethylamide (LSD) or psilocybin in patients with treatment-resistant depressive, anxiety, or addictive disorders.

Data will be analyzed from patients treated at the University Hospitals of Geneva between June 2020 and April 2025 who obtained individual authorizations from the Swiss Federal Office of Public Health for use of LSD or psilocybin under compassionate use criteria.

The main objective is to assess the effects of psychedelic-assisted psychotherapy with LSD or psilocybin on changes in depressive symptoms, anxiety symptoms. Secondary objectives include evaluating the association between psychedelic session intensity and the administered dose of LSD or psilocybin, changes in depressive symptoms, anxiety symptoms, and problematic substance use, as well as their association with intensity effects. Additionally physiological effects during session will be assessed.

All data are retrospectively collected from clinical records with prior patient consent.

This study aims to generate evidence on the feasibility, safety, and therapeutic potential of PAP in real-world clinical practice.

Conditions

  • Major Depressive Disorder (MDD)
  • Anxiety Disorders
  • Substance Use Disorder (SUD)
  • PTSD - Post Traumatic Stress Disorder

Interventions

DRUG

Lysergic Acid Diethylamide (LSD) or psilocybin

Psychedelic-assisted psychotherapy with LSD or psilocybin as a part of a clinical routine in our department

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2025-04-30
Completion
2025-09-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07164287 on ClinicalTrials.gov