The OxyTUTION Trial
Tipo di studio
Interventional clinical trial of medicinal product
(ICTRP)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
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)
Luogo dello studio
Svizzera, Paesi Bassi, Germania
(ICTRP)
Titolo accademico
Oxytocin substitution therapy in patients with AVP deficiency (central diabetes insipidus): a double-blind randomised placebo-controlled trial - the OxyTUTION trial - OxyTUTION (ICTRP)
Disegno dello studio
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)
Endpoint primari e secondari
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)
Data di registrazione
11.09.2024 (ICTRP)
Inclusione del primo partecipante
06.03.2025 (ICTRP)
Sponsor secondari
non disponibile
Contatti aggiuntivi
Cihan Atila, Cihan.Atila@usb.ch, +41613286833, Universitaetsspital Basel (ICTRP)
ID secondari
NCT06036004 (ICTRP)
Risultati-Dati individuali dei partecipanti
No
(ICTRP)
Ulteriori informazioni sullo studio
https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2024-516813-19-00 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile