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Oxytocin Substitution Therapy in Patients With AVP Deficiency (Central Diabetes Insipidus) (OxyTUTION)
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)
Details
| Lead sponsor | University Hospital, Basel, Switzerland |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 112 |
| Start date | 2024-01-08 |
| Completion | 2026-10 |
Conditions
- Central Diabetes Insipidus (cDI)
Interventions
- Intranasal OXT
- Placebo nasal spray
Primary outcomes
- Change in State-Trait Anxiety Inventory (STAI) questionnaire to assess general anxiety levels — Day 0, day 1, day 14, day 28
Questionnaire with scores ranging from 1 ("almost never") to 4 ("almost always"). The STAI has two sub-scales, the State-Anxiety Scale (STAI-S; 20 items) and the Trait-Anxiety Scale (STAI-T; 20 items). The STAI-S evaluates the current state of anxiety, asking how respondents feel "right now," using items that measure subjective feelings of apprehension, tension, nervousness, worry, and activation/arousal of the autonomic nervous system. The STAI-T evaluates relatively stable aspects of "anxiety proneness," including general states of calmness, confidence, and security. The total scores range from 20 to 80, with higher scores indicating more pronounced anxiety. A score above 39/80 indicates clinically significant anxiety symptoms. - Change in EmBody/EmFace to assess recognition of facial and body expressions — Day 0, day 1, day 28
The EmBody and EmFace subtasks comprise each of 42 stimuli showing body or facial expressions of angry, happy, or neutral affect. Stimuli last 1.5 seconds at 24 frames per second and are geometrically and optically standardised to prevent biases induced by ethnic cues. Each trial consists of one point-light display (PLD), followed by a response window during which participants are asked to indicate via mouse input which emotion they believe was portrayed in the PLD in a three-option forced-choice format (angry-neutral-happy). The total correct classification scores range from 0 to 42 (for each sub-task), with higher scores indicating more correct recognition of facial \& body expressions.
Countries
Germany, Netherlands, Switzerland