An observational study in Major Depressive Disorder (MDD), Anxiety Disorders and Substance Use Disorder (SUD), sponsored by University Hospital, Geneva. Active, not recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by University Hospital, Geneva · Observational
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.
The overall project is a retrospective observational study evaluating the effects of psychedelic-assisted psychotherapy (PAP) with LSD or psilocybin in treatment-resistant depressive, anxiety, and addictive disorders. Data from 200 patients treated at Geneva University Hospitals will be included, with the primary aim of assessing relationships between psychedelic dose, subjective intensity of experience, and clinical outcomes.
Subset Analysis: Cardiovascular Outcomes In addition to the main objectives, a subset analysis will be conducted to evaluate cardiovascular effects of LSD and psilocybin. Routinely collected data from 30 patients with treatment-resistant depression or anxiety disorders will be included.
Population: 30 patients who underwent their first psychedelic session (LSD 100-200 µg or psilocybin 15-25 mg).
Measurements: Heart rate and self-rated anxiety (visual analogue scale) recorded at seven time points between 30 and 300 minutes post-administration on the treatment day.
A further subset analysis investigated the role of early maladaptive schemas (EMS) in psychedelic-assisted psychotherapy.
Populations: 192 patients who routinely completed the Young Schema Questionnaire - Rasch version (YSQ-R) before treatment were included; of these, 97 initiated PAP with LSD or psilocybin and 74 contributed longitudinal outcomes.
Measurements: Baseline EMS profiles (YSQ-R) measured at Baseline (screening or preparation visit, before first psychedelic session), immediately after each psychedelic session (sessions 1-3, up to 9 months) and 1 month after each psychedelic session (sessions 1-3, up to 12 months after baseline).
2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.
This study's planned enrollment of 376 is above the median of 140 across 357 observational studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →University Hospital, Geneva is the lead sponsor of 372 studies on the registry; 68 are open to participants now.
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Adults with treatment-resistant depressive, anxiety, or addictive disorders who received psychedelic-assisted psychotherapy under compassionate use authorization treated in the psychedelic-assisted psychotherapy program at Addiction Division, Department of Psychiatry, Geneva University Hospital, Switzerland.
Exclusion Criteria:
Psychedelic-assisted psychotherapy with LSD or psilocybin as a part of a clinical routine in our department
Self-reported depressive symptoms (BDI-II)
Beck Depression Inventory-II, total scores ranging from 0 to 63, higher scores indicating higher depressive symptoms
Time frame: Baseline and 1 month after each psychedelic treatment session (sessions 1-3, up to 12 months)
Self-reported symptoms of anxiety (STAI)
State-Trait Anxiety Inventory, total scores ranging from 20 to 80, higher scores indicating higher anxiety
Time frame: Baseline and 1 month after each psychedelic treatment session (sessions 1-3, up to 12 months)
Self-reported intensity of mystical experience
Assessed with the self-report Mystical experience Questionnaire (MEQ-30) with total man score ranging from 0 to 5, with higher scores indicating higher intensity of mystical experience
Time frame: the day of treatment administration
heart rate
beats per minute
Time frame: day of treatment administration
Self-rated anxiety
Self-rated anxiety using a 0-100 visual analogue scale (VAS), with higher scores indicating higher anxiety
Time frame: day of treatment administration
Young Schema Questionnaire - Rasch version
116-item self-report questionnaire assessing 20 early maladaptive schemas. Items are rated on a 6-point Likert scale (1 = completely untrue of me, 6 = describes me perfectly). Higher scores indicate greater schema intensity; schema-specific and overall mean scores can be derived.
Time frame: Baseline (screening or preparation visit, before first psychedelic session), immediately after each psychedelic session (sessions 1-3, up to 9 months) and 1 month after each psychedelic session (sessions 1-3, up to 12 months after baseline)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Geneva