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
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
Switzerland
University Hospital Basel
RECRUITING
Basel
Contact Information
Primary
Mirjam Christ-Crain, Prof. Dr.
mirjam.christ-crain@ubs.ch
+41 61 328 70 80
Time Frame
Start Date: 2025-05-16
Estimated Completion Date: 2027-02
Participants
Target number of participants: 42
Treatments
Experimental: Part B oxytocin - Part A oxytocin - Part A Placebo - Part B Placebo
Part A will investigate the recognition of facial emotions \& body expressions in a cross-over design with a two-week wash-out period between both study visits. Part B will investigate the response of cortisol to acute psychosocial stress (TSST) with an eight-week wash-out period between both study visits. The order of group assignment is as follows: 1. Part B oxytocin, 2. Part A oxytocin, 3. Part A placebo, 4. Part B placebo
Experimental: Part B oxytocin - Part A Placebo - Part A oxytocin - Part B Placebo
Part A will investigate the recognition of facial emotions \& body expressions in a cross-over design with a two-week wash-out period between both study visits. Part B will investigate the response of cortisol to acute psychosocial stress (TSST) with an eight-week wash-out period between both study visits. The order of group assignment is as follows: 1. Part B oxytocin, 2. Part A placebo, 3. Part A oxytocin, 4. Part B placebo
Experimental: Part B Placebo - Part A Placebo - Part A oxytocin - Part B oxytocin
Part A will investigate the recognition of facial emotions \& body expressions in a cross-over design with a two-week wash-out period between both study visits. Part B will investigate the response of cortisol to acute psychosocial stress (TSST) with an eight-week wash-out period between both study visits. The order of group assignment is as follows: 1. Part B placebo, 2. Part A placebo, 3. Part A oxytocin, 4. Part B oxytocin
Experimental: Part B Placebo - Part A oxytocin - Part A Placebo - Part B oxytocin
Part A will investigate the recognition of facial emotions \& body expressions in a cross-over design with a two-week wash-out period between both study visits. Part B will investigate the response of cortisol to acute psychosocial stress (TSST) with an eight-week wash-out period between both study visits. The order of group assignment is as follows: 1. Part B placebo, 2. Part A oxytocin, 3. Part A placebo, 4. Part B oxytocin
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Basel, Switzerland