Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus

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

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 (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 Criteria:

* 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.

Conditions2

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