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Enrolling by Invitation

NCT Number: NCT07345858

Salivary Oxytocin as a Biomarker of Psychedelic Treatment

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.

Enrolling by Invitation

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Key information

Conditions

Major Depressive Disorder (MDD) Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Geneva University Hospitals

Geneva, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Salivary Oxytocin

    Time frame: One day

    Measure taken during psychedelic treatment

Secondary outcomes

  1. Beck Depression Inventory

    Time frame: 3 months

    Self-reported depressive symptoms

  2. Cognitive Flexibility Inventory

    Time frame: 3 months

    Self-reported flexibility questionnaire

  3. Trait anxiety inventory (STAI-T)

    Time frame: 3 months

    Self-reported anxiety symptoms

  4. Cognitive Emotion Regulation Questionnaire (CERQ)

    Time frame: 3 months

    Self-reported cognitive emotion regulation strategies

  5. Emotion Regulation Questionnaire

    Time frame: 3 months

    self-reported emotion regulation strategies

Sponsors and collaborators

Lead sponsor

University of Geneva, Switzerland

Other

Registry information

Official study title

Salivary Oxytocin as a Biomarker of Psychedelic Assisted Psychotherapy in Patients With Major Depressive Disorder

Acronym: PAPOXT_MDD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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