RecruitingPhase 2NCT06676774

Effect of Intranasal Oxytocin on Emotion Recognition and Acute Psycho-Social Stress-induced Cortisol Increase in Patients With Central Diabetes Insipidus and Healthy Controls

Effect of Intranasal Oxytocin on Emotion Recognition and Acute Psycho-Social Stress-induced Cortisol Increase in Patients With Central Diabetes Insipidus (Arginine Vasopressin Deficiency) and Healthy Controls - the OxyMOTION-Study


Sponsor

University Hospital, Basel, Switzerland

Enrollment

42 participants

Start Date

May 16, 2025

Study Type

INTERVENTIONAL

Summary

This study aims to investigate the potential beneficial effects of intranasal oxytocin compared to placebo on emotion recognition and acute psychosocial stress in patients with arginine vasopressin deficiency compared to matched healthy controls.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Adult healthy volunteers
  • Matched for age, sex, BMI, and oestrogen replacement/menopause/hormonal contraceptives to patients.
  • No medication, except hormonal contraception
  • Adult patients with a confirmed diagnosis of AVP deficiency based on accepted criteria6
  • Stable hormone replacement therapy for at least three months with desmopressin and, in case of additional anterior pituitary deficiencies, with the respective substitution therapies.

Exclusion Criteria5

  • Participation in a trial with investigational drugs within 30 days
  • Active substance use disorder within the last six months
  • Consumption of alcoholic beverages >15 drinks/week
  • Current or previous psychotic disorder (e.g., schizophrenia spectrum disorder)
  • Pregnancy and breastfeeding within the last eight weeks

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Interventions

DRUGOxytocin nasal spray

Participants will be instructed on correctly applying the intranasal study medication and will self-administer a single dose of 24 IU oxytocin under the supervision of unblinded study personnel.

OTHERPlacebo

Participants will be instructed on correctly applying the intranasal study medication and will self-administer a single dose of placebo (0.9% normal saline) under the supervision of unblinded study personnel.


Locations(1)

University Hospital Basel

Basel, Switzerland

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NCT06676774