Major Depressive Disorder (MDD)NCT07164287
Retrospective Observational Study of Intensity Effects in Psychedelic-assisted Treatment
An observational study of Major Depressive Disorder (MDD) and Anxiety Disorders, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder (MDD), Anxiety Disorders, Substance Use Disorder (SUD)
- What is being tested?
- Lysergic Acid Diethylamide (LSD) or psilocybin
- How many people
- 376 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2020to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- psychotic disorder
- bipolar disorder
- high suicidal risk
- severe cardiovascular disease
- severe liver disease
- neurological disease of the central nervous system
- pregnancy
- breastfeeding
Trial locations and contacts
1 site in 1 country.
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.
Read more
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.
Read the detailed description
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).
- Conditions
- Major Depressive Disorder (MDD), Anxiety Disorders, Substance Use Disorder (SUD), PTSD - Post Traumatic Stress Disorder
- Being tested
- Lysergic Acid Diethylamide (LSD) or psilocybin
- Keywords
- psychedelic, LSD, psilocybin
- Medical subject headings
- Depressive Disorder, Major, Anxiety Disorders, Substance-Related Disorders, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lysergic Acid Diethylamide (LSD) or psilocybinDrug
Psychedelic-assisted psychotherapy with LSD or psilocybin as a part of a clinical routine in our department
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported depressive symptoms (BDI-II)
Beck Depression Inventory-II, total scores ranging from 0 to 63, higher scores indicating higher depressive symptoms
Measured: 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
Measured: Baseline and 1 month after each psychedelic treatment session (sessions 1-3, up to 12 months)
Secondary outcomes (4)
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
Measured: the day of treatment administration
heart rate
beats per minute
Measured: day of treatment administration
Self-rated anxiety
Self-rated anxiety using a 0-100 visual analogue scale (VAS), with higher scores indicating higher anxiety
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Jun 2020
- Primary completion30 Apr 2025
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Penzenstadler, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164287
- Sponsor's protocol ID
- ID 2022-02015
- Status last verified
- Sep 2025
- First submitted
- 22 Aug 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Study of Intensity Effects in Psychedelic-assisted Treatment
- ClinicalTrials.gov ID
- NCT07164287
- Acronym / sponsor ID
- ID 2022-02015
- Conditions
- Major Depressive Disorder (MDD), Anxiety Disorders, Substance Use Disorder (SUD), PTSD - Post Traumatic Stress Disorder
- Keywords
- psychedelic, LSD, psilocybin
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- psychotic disorder
- bipolar disorder
- high suicidal risk
- severe cardiovascular disease
- severe liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lysergic Acid Diethylamide (LSD) or psilocybinPsychedelic-assisted psychotherapy with LSD or psilocybin as a part of a clinical routine in our department | Drug | – |
Primary outcome
Self-reported depressive symptoms (BDI-II)
Time frame: Baseline and 1 month after each psychedelic treatment session (sessions 1-3, up to 12 months)
Beck Depression Inventory-II, total scores ranging from 0 to 63, higher scores indicating higher depressive symptoms
Self-reported symptoms of anxiety (STAI)
Time frame: Baseline and 1 month after each psychedelic treatment session (sessions 1-3, up to 12 months)
State-Trait Anxiety Inventory, total scores ranging from 20 to 80, higher scores indicating higher anxiety
4 secondary outcomes
Self-reported intensity of mystical experience
Time frame: the day of treatment administration
heart rate
Time frame: day of treatment administration
Self-rated anxiety
Time frame: day of treatment administration
Young Schema Questionnaire - Rasch version
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder (MDD) and Anxiety Disorders, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported depressive symptoms (BDI-II) (time frame: Baseline and 1 month after each psychedelic treatment session (sessions 1-3, up to 12 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.