The OxyTUTION Trial
Type d'essai
Interventional clinical trial of medicinal product
(ICTRP)
Intervention étudiée
Product Name: , Product Code:SCP107200984, Pharmaceutical Form: , Other descriptive name: , Strength: , Product Name: The placebo nasal spray will be identical in volume, labelling but not
container system, and other features. The placebo will contain 0.9%
sodium chloride and no OXT., Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A
(ICTRP)
Maladie en cours d'investigation
central diabetes insipidusTherapeutic area: Phenomena and Processes [G] - Metabolism [G03]Therapeutic area: Diseases [C] - Hormonal diseases [C19]
(ICTRP)
Inclusion criteria: Adult patients with a confirmed diagnosis of central diabetes insipidus based on accepted criteria, Heightened anxiety levels (STAI Trait subscale = 39 score points) or alexithymia levels (im- paired ability to identify and describe feelings TAS-20 total = 52 score points), Stable hormone replacement therapy for at least three months with desmopressin and, in case of additional anterior pituitary deficiencies, with the respective substitution therapies, Adult patients aged over 18 years
(ICTRP)
Critères d'exclusion
Exclusion criteria: Participation in a trial with investigational drugs within 30 days, Pregnancy and breastfeeding within the last 8 weeks, Active substance use disorder within the last six months, Consumption of alcoholic beverages >15 drinks/week, Unwilling to use a medically acceptable form of contraception throughout the study period (female of childbearing potential only), Current or previous psychotic disorder (e.g., schizophrenia spectrum disorder), Prolonged QTc-time > 470 ms assessed with a 12-lead electrocardiogram., Hypersensitivity to the excipients substances methyl p-hydroxybenzoate (E218) and propyl p- hydroxybenzoate (E216)
(ICTRP)
Lieu de l’étude
Suisse, Pays-Bas, Allemagne
(ICTRP)
Titre académique
Oxytocin substitution therapy in patients with AVP deficiency (central diabetes insipidus): a double-blind randomised placebo-controlled trial - the OxyTUTION trial - OxyTUTION (ICTRP)
Plan de l'étude
Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Number of treatment arms in the trial:
(ICTRP)
Critères d'évaluation principaux et secondaires
Main Objective: Primary objective
To determine the effect of internasal OXT (24 IU twice daily) compared to placebo for 28 (+/- 2) days on:
? Change in anxiety levels assessed with the State-Trait Anxiety Inventory (Trait-Anxiety Scale, STAI-T)
? Change in correct recognition of facial & body expressions assessed upon the EmBody/EmFace Task
We hypothesize that the decrease in anxiety and/or increase in correct classification of facial & body expressions will be greater in the OXT group than in the placebo group.;Secondary Objective: Emotion recognition and empathy, Hormonal and subjective response to psychological stress, Amygdala and subjective response in the functional MRI scan, Other psychological measures, Metabolic parameters, Objective assessment of a third person, Safety measure;Primary end point(s): Trait anxiety level and correct classifications of facial & body expression after 28 (+/-2) days of treatment assessed with the STAI-T and the EmBody/EmFace Task. ? The STAI-T comprises 20 items scoring 1-4 points each. ? The EmBody/EmFace comprises 84 items scoring correct or incorrect each.
(ICTRP)
Secondary end point(s):Emotion recognition and empathy;Secondary end point(s):Hormonal and subjective response to psychological stress;Secondary end point(s):Amygdala and subjective response in the functional MRI scan;Secondary end point(s):Further psychological outcomes;Secondary end point(s):Metabolic outcomes;Secondary end point(s):Objective assessment of a close third person;Secondary end point(s):Safety outcome
(ICTRP)
Date d'enregistrement
11.09.2024 (ICTRP)
Inclusion du premier participant
06.03.2025 (ICTRP)
Sponsors secondaires
non disponible
Contacts supplémentaires
Cihan Atila, Cihan.Atila@usb.ch, +41613286833, Universitaetsspital Basel (ICTRP)
ID secondaires
NCT06036004 (ICTRP)
Résultats-Données individuelles des participants
No
(ICTRP)
Informations complémentaires sur l'essai
https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2024-516813-19-00 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible