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Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus
Sponsor: University Hospital, Basel, Switzerland
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)
Official title: Oxytocin Substitution Therapy in Patients With AVP Deficiency (Central Diabetes Insipidus)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
112
Start Date
2024-01-08
Completion Date
2026-10
Last Updated
2026-01-05
Healthy Volunteers
No
Conditions
Interventions
Intranasal OXT
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.
Placebo nasal spray
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)
Erasmus University Medical Center Rotterdam
Rotterdam, Netherlands
University Hospital Basel, Department of Endocrinology, Diabetes & Metabolism
Basel, Switzerland