Effect of Oxytocin on Emotion Recognition and Acute Psychosocial Stress in Patients with Central Diabetes Insipidus (Vasopressin Deficiency) and Healthy Controls
Résumé de l'étude
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 étudiée
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)
Maladie en cours d'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)
Critères d'exclusion
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)
Lieu de l’étude
Bâle
(BASEC)
Sponsor
Mirjam Christ-Crain
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Mirjam Christ-Crain
061 265 25 25
mirjam.christ-crain@clutterusb.chUniversity Hospital Basel
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
03.09.2024
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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