Status:
RECRUITING
Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Central Diabetes Insipidus (cDI)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 soc...
Detailed Description
Arginine vasopressin (AVP) and oxytocin (OXT) are hormones released into circulation from the posterior pituitary. While AVP acts mainly in the kidneys and causes reuptake of free water, OXT is well-k...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Participation in a trial with investigational drugs within 30 days
- Active substance use disorder within the last six months
- Consumption of alcoholic beverages \>15 drinks/week
- Current or previous psychotic disorder (e.g., schizophrenia spectrum disorder)
- Pregnancy and breastfeeding within the last eight weeks
- Unwilling to use a medically acceptable form of contraception throughout the study period (female of childbearing potential only)
- Prolonged QTc-time \>470 ms assessed with a 12-lead electrocardiogram.
Key Trial Info
Start Date :
January 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT06036004
Start Date
January 8 2024
End Date
October 1 2026
Last Update
January 5 2026
Active Locations (2)
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1
Erasmus University Medical Center Rotterdam
Rotterdam, Netherlands, 3015
2
University Hospital Basel, Department of Endocrinology, Diabetes & Metabolism
Basel, Switzerland, 4031