Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Actively Recruiting
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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