The OxyTUTION Trial
Studientyp
Interventional clinical trial of medicinal product
(ICTRP)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Schweiz, Niederlande, Deutschland
(ICTRP)
Wissenschaftlicher Titel
Oxytocin substitution therapy in patients with AVP deficiency (central diabetes insipidus): a double-blind randomised placebo-controlled trial - the OxyTUTION trial - OxyTUTION (ICTRP)
Studiendesign
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)
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
11.09.2024 (ICTRP)
Einschluss des ersten Teilnehmers
06.03.2025 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Cihan Atila, Cihan.Atila@usb.ch, +41613286833, Universitaetsspital Basel (ICTRP)
Sekundäre IDs
NCT06036004 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
No
(ICTRP)
Weitere Informationen zur Studie
https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2024-516813-19-00 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar