Active, Not RecruitingN/Apsilocybin

Retrospective Observational Study of Intensity Effects in Psychedelic-assisted Treatment

Sponsored by University Hospital, Geneva

NCT ID
NCT07164287
Target Enrollment
376 participants
Start Date
2020-06-01
Est. Completion
2025-09-30

About This Study

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 Studied

Major Depressive Disorder (MDD)Anxiety DisordersSubstance Use Disorder (SUD)PTSD - Post Traumatic Stress Disorder

Interventions

  • Lysergic Acid Diethylamide (LSD) or psilocybin

Eligibility

Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* Patients treated in the compassionate PAP program at Geneva University Hospitals between June 2020 and April 2025.
* Diagnosis of depressive, anxiety, or addictive disorder resistant to standard treatments.
* General consent for use of routinely collected clinical data.
* Federal Office of Public Health authorization for PAP.

Exclusion Criteria:

* psychotic disorder
* bipolar disorder
* high suicidal risk
* severe cardiovascular disease
* severe liver disease
* neurological disease of the central nervous system
* pregnancy
* breastfeeding

Study Locations (1)

Geneva University Hospital
Geneva, Switzerland

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source

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