Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus
Oxytocin Substitution Therapy in Patients With AVP Deficiency (Central Diabetes Insipidus)
University Hospital, Basel, Switzerland
112 participants
Jan 8, 2024
INTERVENTIONAL
Conditions
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 Criteria3
- 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 Criteria7
- 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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Interventions
Syntocinon® contains the synthesized peptide OXT in a solution formulated to promote absorption through the nasal mucosa. Additional ingredients are E216 (propyl-4-hydroxybenzoate), E218 (methyl-4-hydroxybenzoate), and chlorobutanol hemihydrate. One bottle contains 5 ml, i.e., 200 IU of OXT in total. Each 0.1 ml nasal insulation delivers 4 IU of oxytocin. OXT (24 IU twice daily) is given for 28 (± 2) days of treatment.
The placebo will contain no OXT but, otherwise, be identical to the intranasal OXT product with respect to the other ingredients. Placebo is given twice daily for 28 (± 2) days of treatment.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06036004