Salivary Oxytocin as a Biomarker of Psychedelic Treatment (PAPOXT_MDD)

January 7, 2026 updated by: Tatiana Aboulafia Brakha, University of Geneva, Switzerland

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.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland
        • Geneva University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Psychotic or bipolar disorder
  • High suicidal risk
  • Severe cardiovascular, hepatic or neurological (affecting the central nervous system) disorders
  • Pregnancy or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary Oxytocin
Time Frame: One day
Measure taken during psychedelic treatment
One day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory
Time Frame: 3 months
Self-reported depressive symptoms
3 months
Cognitive Flexibility Inventory
Time Frame: 3 months
Self-reported flexibility questionnaire
3 months
Trait anxiety inventory (STAI-T)
Time Frame: 3 months
Self-reported anxiety symptoms
3 months
Cognitive Emotion Regulation Questionnaire (CERQ)
Time Frame: 3 months
Self-reported cognitive emotion regulation strategies
3 months
Emotion Regulation Questionnaire
Time Frame: 3 months
self-reported emotion regulation strategies
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Geneva, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEC ID 2025-02092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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