Active — Not RecruitingNot Applicable

Retrospective Observational Study of Intensity Effects in Psychedelic-assisted Treatment

Switzerland376 participantsStarted 2020-06-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Self-reported depressive symptoms (BDI-II)

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

Self-reported symptoms of anxiety (STAI)

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

Trial details

NCT IDNCT07164287

SponsorUniversity Hospital, Geneva

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More Major Depressive Disorder (MDD) trials