Effect of Oxytocin on Emotion Recognition and Acute Psychosocial Stress in Patients with Central Diabetes Insipidus (Vasopressin Deficiency) and Healthy Controls
Summary description of the study
Patients with central diabetes insipidus suffer from a deficiency of the anti-diuretic hormone vasopressin. Patients with such a vasopressin deficiency produce a large amount of urine and must compensate for this fluid loss with a high fluid intake. Desmopressin, a medication similar to vasopressin, can be used to treat this condition. Despite treatment with desmopressin, patients often report symptoms such as general anxiety, social withdrawal, depressed mood, and have a reduced quality of life. A recent study has shown that these patients not only lack the hormone vasopressin but also the hormone oxytocin. In the brain, oxytocin is produced in the same area as vasopressin and released from the pituitary gland. The hormone is involved in important positive psychosocial aspects such as building trust, closeness, and love, has anxiolytic effects, positively influences sensations such as relaxation, and increases empathy; thus, this hormone is also referred to as the love and cuddle hormone. The observed psychological changes in patients may therefore be partially explained by this additional deficiency of oxytocin. In this study, we investigate whether a single administration of the study drug oxytocin in patients leads to an improvement in emotion perception or reduced stress reaction to psychological stress.
(BASEC)
Intervention under investigation
This study is a so-called crossover study, meaning that all participants in the study receive a placebo on two study days and oxytocin as a nasal spray on two study days. After the preliminary examination, a total of four study days take place: • On two of these study days, a computer test for emotion perception is conducted – once with placebo and once with oxytocin as a nasal spray. • On the other two study days, a test of the stress reaction is conducted – once with placebo and once with oxytocin as a nasal spray.
(BASEC)
Disease under investigation
Patients with central diabetes insipidus (Arginine Vasopressin deficiency)
(BASEC)
Inclusion criteria for healthy controls 1. Healthy volunteers 2. Same age, gender, BMI, and estrogen replacement/menopause/hormonal contraceptives as the patients. 3. No medications, except hormonal contraception. Inclusion criteria for patients 1. Adult patients with a confirmed diagnosis of AVP deficiency based on recognized criteria. 2. Stable hormone replacement therapy for at least three months. (BASEC)
Exclusion criteria
Exclusion criteria 3. Participation in a study with investigational products within the last 30 days 4. Active substance use disorder within the last six months 5. Consumption of alcoholic beverages >15 drinks/week 6. Current or past psychotic disorder (e.g., schizophrenia spectrum disorder) 7. Pregnancy and breastfeeding within the last eight weeks (BASEC)
Trial sites
Basel
(BASEC)
Sponsor
Mirjam Christ-Crain
(BASEC)
Contact
Contact Person Switzerland
Mirjam Christ-Crain
061 265 25 25
mirjam.christ-crain@clutterusb.chUniversity Hospital Basel
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
03.09.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Effect of lntranasal Oxytocin on Emotion Recognition and Acute Psycho-Social Stress-induced Cortisol increase in Patients with Central Diabetes lnsipidus (Arginine Vasopressin Deficiency) and Healthy Controls (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
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Link to the results in the primary register
not available