Salivary Oxytocin as a Biomarker in Psychedelic Assisted Psychotherapy

Completed

• Conditions: Depression, Anxiety

• Registration Number: NCT06557239
• Lead Sponsor: Tatiana Aboulafia Brakha

Brief Summary

The main objective of this pilot study is to obtain preliminary data on the reactivity of salivary oxytocin during a single LSD intake as part of PAP treatment for anxiety disorders or depression (treatment authorisations granted in advance by the Federal Officie of Public Health for compassionate use of the substance).

There will be no interference with the usual clinical routine in our Service. The protocol is only for taking additional saliva measurements to measure oxytocin levels on the day of treatment.

Participants will be asked to give 4 saliva samples the day of their LSD treatment .In addition they will fill-in self-report questionnaires which are part of the clinical routine

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-05
• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-15
• Study First Posted: 2024-08-16
• Primary Completion: 2024-12-11
• Study Completion: 2024-12-11
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• ongoing psychotherapy with a certified psychotherapist, anxiety disorder or depression resistant to usual treatments, agreement to stop necessary medication

Exclusion Criteria

• Exclusion: psychotic or bipolar disorder, high suicidal risk, severe cardiovascular disease, severe liver disease, neurological disease of the central nervous system, pregnancy and breastfeeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Salivary oxytocin	the day of treatment administration (one day)	oxytocin sampled in the saliva

Secondary Outcome Measures

Name	Time	Method
Self-reported symptoms of anxiety (STAI-T)	over 6 months	State-Trait Anxiety Inventory (trait), total scores ranging from 20 to 80, higher scores indicating higher anxiety
Self-reported depressive symptoms (BDI-II)	over 6 months	Beck Depresion Inventory-II, total scores ranging from 0 to 63, higher scores indicating higher depressive symptoms
Self-reported intensity of mystical experience	The 1 day of treatment administration	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
Self-reported intensity of Connectedness	The 1 day of treatment administration	Assessed with the self-report Watts Connectedness Scale,total mean score ranging from 0 to 100, with higher scores indicating higher connectedess

Trial Locations

Locations (1)

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland