Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus: a Double-blind Randomised Placebo-controlled Trial: the OxyTUTION Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This randomized, placebo-controlled, double-blind trial aims to investigate intranasal OXT as a novel therapeutical option in central diabetes insipidus (cDI) to improve psychological symptoms and socio-emotional functioning. Optionally, patients can present for additional assessments in sub-studies: * fMRI sub-study at day 14 (± 2 days) (one additional visit) * Social-stress sub-study at day 14 (± 2 days) (one additional visit)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 (impaired 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.

Locations
Other Locations
Netherlands
Erasmus University Medical Center Rotterdam
NOT_YET_RECRUITING
Rotterdam
Switzerland
University Hospital Basel, Department of Endocrinology, Diabetes & Metabolism
RECRUITING
Basel
Contact Information
Primary
Mirjam Christ-Crain, Prof. Dr. med.
mirjam.christ-crain@ubs.ch
+41 61 328 70 80
Time Frame
Start Date: 2024-01-08
Estimated Completion Date: 2026-10
Participants
Target number of participants: 112
Treatments
Active_comparator: Study Product Intervention: intranasal OXT
Intranasal OXT spray of 40 IU per ml (Syntocinon®).
Placebo_comparator: Control Intervention: placebo nasal spray
The placebo nasal spray will be identical in volume, labelling, container system, and other features.
Sponsors
Leads: University Hospital, Basel, Switzerland

This content was sourced from clinicaltrials.gov

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