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New treatment option for Central Diabetes Insipidus (cDI)
Official title Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus
ClinicalTrials.gov ID: NCT06036004
What this study is testing
What is Intranasal OXT?
Intranasal OXT is an investigational medicine, given as an once-daily, being studied as a potential treatment for central diabetes insipidus (cdi).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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 (impaired ability to identify and describe feelings; TAS-20...
- Stable hormone replacement therapy for at least three months with desmopressin and, in case of additional anterior pituitary deficiencies, with the...
You likely can't join if
- Participation in a trial with investigational drugs within 30 days
- Active substance use disorder within the last six months
- Consumption of alcoholic beverages \>15 drinks/week
- Current or previous psychotic disorder (e.g., schizophrenia spectrum disorder)
- Pregnancy and breastfeeding within the last eight weeks
- Unwilling to use a medically acceptable form of contraception throughout the study period (female of childbearing potential only)
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 (impaired 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.
- Participation in a trial with investigational drugs within 30 days
- Active substance use disorder within the last six months
- Consumption of alcoholic beverages \>15 drinks/week
- Current or previous psychotic disorder (e.g., schizophrenia spectrum disorder)
- Pregnancy and breastfeeding within the last eight weeks
- Unwilling to use a medically acceptable form of contraception throughout the study period (female of childbearing potential only)
- Prolonged QTc-time \>470 ms assessed with a 12-lead electrocardiogram.
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
- Rotterdam, Netherlands
- Basel, 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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany; Rotterdam, Netherlands; Basel, 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 ClinicalTrials.gov; the study team decides eligibility.