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ACTIVE NOT RECRUITING
NCT07164287

Retrospective Observational Study of Intensity Effects in Psychedelic-assisted Treatment

Sponsor: University Hospital, Geneva

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

376

Start Date

2020-06-01

Completion Date

2025-09-30

Last Updated

2025-10-02

Healthy Volunteers

No

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

Locations (1)

Geneva University Hospital

Geneva, Switzerland