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NCT07164287Active, not recruiting

Retrospective Observational Study of Intensity Effects in Psychedelic-assisted Treatment

Source: ClinicalTrials.gov · Last updated 2 Oct 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
376 (estimated)
First submitted
22 Aug 2025
Start date
1 Jun 2020
Primary completion date
30 Apr 2025
Lead sponsor
University Hospital, Geneva
Diseases
Depression
NCT number
NCT07164287

What you commit to

  • Study type: Observational
  • Planned participants: 376
  • From 1 Jun 2020 to the primary completion date, 30 Apr 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • psychotic disorder
  • bipolar disorder
  • severe cardiovascular disease
  • severe liver disease
  • neurological disease of the central nervous system

Other

  • high suicidal risk
  • pregnancy
  • breastfeeding

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Geneva University Hospital
Coordinator of this site? Confirm its status
GenevaSwitzerlandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.