The OxyTUTION Trial
Type of trial
Interventional clinical trial of medicinal product
(ICTRP)
Intervention under investigation
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)
Disease under 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)
Exclusion criteria
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)
Trial sites
Switzerland, Netherlands, Germany
(ICTRP)
Academic title
Oxytocin substitution therapy in patients with AVP deficiency (central diabetes insipidus): a double-blind randomised placebo-controlled trial - the OxyTUTION trial - OxyTUTION (ICTRP)
Trial design
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)
Primary and secondary end points
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)
Registration date
11.09.2024 (ICTRP)
Incorporation of the first participant
06.03.2025 (ICTRP)
Secondary sponsors
not available
Additional contacts
Cihan Atila, Cihan.Atila@usb.ch, +41613286833, Universitaetsspital Basel (ICTRP)
Secondary trial IDs
NCT06036004 (ICTRP)
Results-Individual Participant Data (IPD)
No
(ICTRP)
Further information on the trial
https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2024-516813-19-00 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available