Major Depressive Disorder (MDD)PAPOXT_MDDNCT07345858
Salivary Oxytocin as a Biomarker of Psychedelic Treatment
An observational study of Major Depressive Disorder (MDD), run by University of Geneva, Switzerland at 1 site in Switzerland.
Trial summary
This study aims to investigate whether oxytocin reactivity during a psychedelic session for MDD treatment predicts treatment response, specifically by examining its relationship with changes in flexibility and depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder (MDD)
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Jan 2026to 30 Oct 2026
- How long will I take part?
- 1 Month
- 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: Participants will be invited to participate among consecutive patients with treatment-resistant MDD enrolled for psychedelic treatment in the Division of addictology-Department of Psychiatry of the Geneva University hospitals) after receiving approval from the Swiss Federal Office of Public health for compassionate treatment with LSD or psilocybin. Only those receiving LSD or psilocybin for the first time (first treatment cycle) will be included.
Who may be able to join
- Age >=18 years-old
- MDD defined by DSM-V criteria, and resistant to treatment
- Ongoing classical psychotherapeutic treatment
- Agreement to discontinue necessary psychotropic medications (some classes of anti-depressants are allowed with no need to taper off).
Who cannot join
- Psychotic or bipolar disorder
- High suicidal risk
- Severe cardiovascular, hepatic or neurological (affecting the central nervous system) disorders
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Salivary Oxytocin as a Biomarker of Psychedelic Assisted Psychotherapy in Patients With Major Depressive Disorder
This study aims to investigate whether oxytocin reactivity during a psychedelic session for MDD treatment predicts treatment response, specifically by examining its relationship with changes in flexibility and depressive symptoms.
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- oxytocin, psychedelics, lsd, psilocybin, Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Oxytocin
Measure taken during psychedelic treatment
Measured: One day
Secondary outcomes (5)
Beck Depression Inventory
Self-reported depressive symptoms
Measured: 3 months
Cognitive Flexibility Inventory
Self-reported flexibility questionnaire
Measured: 3 months
Trait anxiety inventory (STAI-T)
Self-reported anxiety symptoms
Measured: 3 months
Cognitive Emotion Regulation Questionnaire (CERQ)
Self-reported cognitive emotion regulation strategies
Measured: 3 months
Emotion Regulation Questionnaire
self-reported emotion regulation strategies
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start5 Jan 2026
- Primary completion31 Jul 2026 (estimated)
- Study completion30 Oct 2026 (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.
- 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
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatiana Aboulafia Brakha, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345858
- Sponsor's protocol ID
- BASEC ID 2025-02092
- Acronym
- PAPOXT_MDD
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 16 Jan 2026
- 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 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Oxytocin as a Biomarker of Psychedelic Assisted Psychotherapy in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07345858
- Acronym / sponsor ID
- PAPOXT_MDD / BASEC ID 2025-02092
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- oxytocin, psychedelics, lsd, psilocybin, Depression
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 16 Jan 2026 (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 study aims to investigate whether oxytocin reactivity during a psychedelic session for MDD treatment predicts treatment response, specifically by examining its relationship with changes in flexibility and depressive symptoms.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be invited to participate among consecutive patients with treatment-resistant MDD enrolled for psychedelic treatment in the Division of addictology-Department of Psychiatry of the Geneva University hospitals) after receiving approval from the Swiss Federal Office of Public health for compassionate treatment with LSD or psilocybin. Only those receiving LSD or psilocybin for the first time (first treatment cycle) will be included.
Key inclusion criteria (4 listed)
- Age >=18 years-old
- MDD defined by DSM-V criteria, and resistant to treatment
- Ongoing classical psychotherapeutic treatment
- Agreement to discontinue necessary psychotropic medications (some classes of anti-depressants are allowed with no need to taper off).
Key exclusion criteria (4 listed)
- Psychotic or bipolar disorder
- High suicidal risk
- Severe cardiovascular, hepatic or neurological (affecting the central nervous system) disorders
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Salivary Oxytocin
Time frame: One day
Measure taken during psychedelic treatment
5 secondary outcomes
Beck Depression Inventory
Time frame: 3 months
Cognitive Flexibility Inventory
Time frame: 3 months
Trait anxiety inventory (STAI-T)
Time frame: 3 months
Cognitive Emotion Regulation Questionnaire (CERQ)
Time frame: 3 months
Emotion Regulation Questionnaire
Time frame: 3 months
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 16 Jan 2026.
- 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.
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), run by University of Geneva, Switzerland 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 4 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: enrolling by invitation, as of the sponsor's last update on 16 Jan 2026. 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?
Salivary Oxytocin (time frame: One day). 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 16 Jan 2026.