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Clinical Trials/NCT07345858
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:
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Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
Salivary Oxytocin
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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

Sponsor
University of Geneva, Switzerland
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tatiana Aboulafia Brakha

PhD

University of Geneva, Switzerland

Study Sites (1)

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