The OxyTUTION Trial
EU CTIS ID: 2024-516813-19-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 (im- paired 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
- Adult patients aged over 18 years
You likely can't join if
- 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)
See the full eligibility 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 (im- paired 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
- Adult patients aged over 18 years
- 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.
- Hypersensitivity to the excipients substances methyl p-hydroxybenzoate (E218) and propyl p- hydroxybenzoate (E216)
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.