Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus

• Status: Recruiting
• Trial end date: 2026-10-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland

Criteria

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.

• Regular use (> 3 times per week) of sympathomimetic drugs (e.g., bronchodilators)