Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus
Recruiting
Phase 2
Interventional Study
Central Diabetes Insipidus (cDI)
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 112 (estimated)
- Sponsor
- University Hospital, Basel, Switzerland · Other
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About This Trial
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…
Trial Locations
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Eligibility 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)
*…
Contacts