Effects of intranasal oxytocin on emotion recognition and stress in diabetes insipidus patients
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
This study is testing if a nasal spray of oxytocin can help people with diabetes insipidus better recognize emotions and lower their stress levels compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT06676774 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of intranasal oxytocin on emotion recognition and cortisol levels in response to psychosocial stress in patients with arginine vasopressin deficiency, compared to healthy controls. The research aims to understand how oxytocin, a neuropeptide involved in social-emotional functioning, may alleviate psychological symptoms often reported by these patients despite treatment with desmopressin. Participants will receive either oxytocin nasal spray or a placebo, and their emotional responses and stress levels will be measured. The study seeks to provide insights into the potential anxiolytic and prosocial effects of oxytocin in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with arginine vasopressin deficiency who are stable on hormone replacement therapy.
Not a fit: Patients with active substance use disorders, psychotic disorders, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve emotional well-being and stress management in patients with arginine vasopressin deficiency.
How similar studies have performed: Other studies have shown promising results with oxytocin in enhancing emotional recognition and reducing stress, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria healthy controls 1. Adult healthy volunteers 2. Matched for age, sex, BMI, and oestrogen replacement/menopause/hormonal contraceptives to patients. 3. No medication, except hormonal contraception Inclusion criteria 1. Adult patients with a confirmed diagnosis of AVP deficiency based on accepted criteria6 2. 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 criteria 1. Participation in a trial with investigational drugs within 30 days 2. Active substance use disorder within the last six months 3. Consumption of alcoholic beverages \>15 drinks/week 4. Current or previous psychotic disorder (e.g., schizophrenia spectrum disorder) 5. Pregnancy and breastfeeding within the last eight weeks
Where this trial is running
Basel
- University Hospital Basel — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Mirjam Christ-Crain, Prof. Dr. — University Hospital, Basel, Switzerland
- Study coordinator: Mirjam Christ-Crain, Prof. Dr.
- Email: mirjam.christ-crain@ubs.ch
- Phone: +41 61 328 70 80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.