Actively Recruiting

Phase 2
Age: 18Years +
All Genders
Healthy Volunteers
ID06676774

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

Led by University Hospital, Basel, Switzerland · Updated on 2025-05-23

42

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

The trial investigates the effects of intranasal oxytocin compared to placebo on emotion recognition and acute psychosocial stress in patients with arginine vasopressin deficiency (central diabetes insipidus) compared to healthy controls. This condition involves a deficiency in a neuropeptide that affects water balance and is treated with desmopressin, but patients often experience psychological symptoms such as anxiety, impaired emotion recognition, and increased stress. Oxytocin, a related neuropeptide, may influence social-emotional functions and reduce stress, and this study explores whether oxytocin treatment can improve these psychological symptoms. Participants will self-administer a single dose of 24 IU intranasal oxytocin or placebo under supervision in a randomized, placebo-controlled, double-blind, crossover design. The study is divided into two parts: Part A assessing recognition of facial and body emotions with a two-week washout between visits, and Part B measuring cortisol response to acute psychosocial stress with an eight-week washout. The order of receiving oxytocin or placebo varies among four group assignments. Throughout the study, participants undergo tests measuring facial emotion and body expression recognition, cortisol response to stress, empathy, subjective emotional responses, heart rate, and blood pressure. The study lasts up to 10 weeks for stress response assessments and up to 4 weeks for emotion recognition. The research team monitors participants closely to evaluate the impact of oxytocin versus placebo on psychological and physiological responses.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult healthy volunteers matched for age, sex, BMI, and hormonal status
  • No medication except hormonal contraception for healthy controls
  • Adult patients with confirmed diagnosis of arginine vasopressin deficiency
  • Stable hormone replacement therapy including desmopressin for at least three months
Not Eligible

You will not qualify if you...

  • Participation in a trial with investigational drugs within 30 days
  • Active substance use disorder within the last six months
  • Consumption of more than 15 alcoholic drinks per week
  • Current or previous psychotic disorder
  • Pregnancy or breastfeeding within the last eight weeks

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 10 weeks depending on crossover parts with wash-out periods

Participants will self-administer a single dose of intranasal oxytocin or placebo under supervision in a randomized, placebo-controlled, double-blind, cross-over design to investigate effects on emotion recognition and acute stress response.

4 study visits with wash-out periods of 2 to 8 weeks between visits

Trial Site Locations

Total: 1 location

1

University Hospital Basel

Basel, Switzerland, 4031

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Research Team

M

Mirjam Christ-Crain, Prof. Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

4

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