NCT07345858

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress41%
Jan 2026Oct 2026

Study Start

First participant enrolled

January 5, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

January 7, 2026

Last Update Submit

January 7, 2026

Conditions

Major Depressive Disorder (MDD)

Keywords

oxytocinpsychedelicslsdpsilocybinDepression

Outcome Measures

Primary Outcomes (1)

  • Salivary Oxytocin

    Measure taken during psychedelic treatment

    One day

Secondary Outcomes (5)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be invited to participate among consecutive patients with treatment-resistant MDD enrolled for psychedelic treatment in the Division of addictology-Department of Psychiatry of the Geneva University hospitals) after receiving approval from the Swiss Federal Office of Public health for compassionate treatment with LSD or psilocybin. Only those receiving LSD or psilocybin for the first time (first treatment cycle) will be included.

You may qualify if:

  • 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).

You may not qualify if:

  • Psychotic or bipolar disorder
  • High suicidal risk
  • Severe cardiovascular, hepatic or neurological (affecting the central nervous system) disorders
  • Pregnancy or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospitals

Geneva, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Salivary samples

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 16, 2026

Study Start

January 5, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Locations

CH(1)