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Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus

RecruitingPhase 2Ages 18 Years - anyAllUniversity Hospital, Basel, Switzerland
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In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Intranasal OXT
  • Placebo nasal spray
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Where

3 sites
Charité University Medical Center Berlin
Berlin, Germany
Erasmus University Medical Center Rotterdam
Rotterdam, Netherlands
University Hospital Basel, Department of Endocrinology, Diabetes & Metabolism
Basel, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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