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Retrospective Observational Study of Intensity Effects in Psychedelic-assisted Treatment

NCT07164287 · University Hospital, Geneva

Closed to entry
Status
Not accepting participants
Not applicable
Phase
376
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Self-reported depressive symptoms (BDI-II)

    Measured over Baseline and 1 month after each psychedelic treatment session (sessions 1-3, up to 12 months)

  • Self-reported symptoms of anxiety (STAI)

    Measured over Baseline and 1 month after each psychedelic treatment session (sessions 1-3, up to 12 months)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
Geneva University HospitalGeneva—Switzerland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07164287 on ClinicalTrials.gov →

Last updated in the registry 2025-10-02. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance