Oxytocin substitution therapy in patients with AVP deficiency (central diabetes insipidus): a double-blind randomised placebo-controlled trial - the OxyTUTION trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Trait anxiety level and correct classifications of facial & body expression after 28 (+/-2) days of treatment assessed with the STAI-T and the EmBody/EmFace Task. ▪ The STAI-T comprises 20 items scoring 1-4 points each. ▪ The EmBody/EmFace comprises 84 items scoring correct or incorrect each.
Study Overview
Brief Summary
Primary objective To determine the effect of internasal OXT (24 IU twice daily) compared to placebo for 28 (+/- 2) days on: ▪ Change in anxiety levels assessed with the State-Trait Anxiety Inventory (Trait-Anxiety Scale, STAI-T) ▪ Change in correct recognition of facial & body expressions assessed upon the EmBody/EmFace Task We hypothesize that the decrease in anxiety and/or increase in correct classification of facial & body expressions will be greater in the OXT group than in the placebo group.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients with a confirmed diagnosis of central diabetes insipidus based on accepted criteria
- •Heightened self-reported anxiety levels (STAI – Trait subscale ≥39 score points) or alexithymia levels (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
- •Pregnancy and breastfeeding within the last 8 weeks
- •Active substance use disorder within the last six months
- •Consumption of alcoholic beverages >15 drinks/week
- •Unwilling to use a medically acceptable form of contraception throughout the study period (female of childbearing potential only)
- •Current or previous psychotic disorder (e.g., schizophrenia spectrum disorder)
- •Prolonged QTc-time > 470 ms assessed with a 12-lead electrocardiogram.
Outcomes
Primary Outcomes
Trait anxiety level and correct classifications of facial & body expression after 28 (+/-2) days of treatment assessed with the STAI-T and the EmBody/EmFace Task. ▪ The STAI-T comprises 20 items scoring 1-4 points each. ▪ The EmBody/EmFace comprises 84 items scoring correct or incorrect each.
Trait anxiety level and correct classifications of facial & body expression after 28 (+/-2) days of treatment assessed with the STAI-T and the EmBody/EmFace Task. ▪ The STAI-T comprises 20 items scoring 1-4 points each. ▪ The EmBody/EmFace comprises 84 items scoring correct or incorrect each.
Secondary Outcomes
- Emotion recognition and empathy
- Hormonal and subjective response to psychological stress
- Amygdala and subjective response in the functional MRI scan
- Further psychological outcomes
- Metabolic outcomes
- Objective assessment of a close third person
- Safety outcome
Investigators
Cihan Atila
Scientific
Universitaetsspital Basel