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Salivary Oxytocin as a Biomarker in Psychedelic Assisted Psychotherapy

Salivary Oxytocin as a Biomarker in Psychedelic Assisted Psychotherapy for Anxiety and Depression: a Pilot Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06557239
Acronym
PAP_OXT
Enrollment
10
Registered
2024-08-16
Start date
2024-08-05
Completion date
2024-12-11
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Anxiety

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

Interventions

DRUGLysergic Acid Diethylamide (LSD)

one single dose of LSD in the context of psychedelic assisted psychotherapy as a part of a clinical routine in our department

Sponsors

Tatiana Aboulafia Brakha
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Salivary oxytocinthe day of treatment administration (one day)oxytocin sampled in the saliva

Secondary

MeasureTime frameDescription
Self-reported intensity of mystical experienceThe 1 day of treatment administrationAssessed 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 ConnectednessThe 1 day of treatment administrationAssessed with the self-report Watts Connectedness Scale,total mean score ranging from 0 to 100, with higher scores indicating higher connectedess
Self-reported symptoms of anxiety (STAI-T)over 6 monthsState-Trait Anxiety Inventory (trait), total scores ranging from 20 to 80, higher scores indicating higher anxiety
Self-reported depressive symptoms (BDI-II)over 6 monthsBeck Depresion Inventory-II, total scores ranging from 0 to 63, higher scores indicating higher depressive symptoms

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026