NCT07345858Enrolling By InvitationNot Applicable
Salivary Oxytocin as a Biomarker of Psychedelic Assisted Psychotherapy in Patients With Major Depressive Disorder
University of Geneva, Switzerland1 site in 1 country80 target enrollmentStarted: January 5, 2026Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Salivary Oxytocin
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Salivary Oxytocin
Time Frame: One day
Measure taken during psychedelic treatment
Secondary Outcomes
- Beck Depression Inventory(3 months)
- Cognitive Flexibility Inventory(3 months)
- Trait anxiety inventory (STAI-T)(3 months)
- Cognitive Emotion Regulation Questionnaire (CERQ)(3 months)
- Emotion Regulation Questionnaire(3 months)
Investigators
Tatiana Aboulafia Brakha
PhD
University of Geneva, Switzerland
Study Sites (1)
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