Study on Oxytocin Nasal Spray for Patients with Central Diabetes Insipidus

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What is this study about?

The OxyTUTION Trial is a clinical study focused on patients with central diabetes insipidus, a condition where the body has trouble managing water balance due to a deficiency in a hormone called vasopressin. This study is exploring the effects of a treatment using a nasal spray containing oxytocin, a hormone that can influence social behaviors and emotions. The trial will compare the effects of oxytocin to a placebo nasal spray, which looks the same but does not contain the active hormone.

The purpose of the study is to see if oxytocin can help reduce anxiety and improve the ability to recognize facial and body expressions in people with central diabetes insipidus. Participants will use the nasal spray twice daily for about 28 days. During this time, researchers will assess changes in anxiety levels and the ability to correctly identify emotions through specific tasks. The study aims to determine if these improvements are greater in those receiving oxytocin compared to those using the placebo.

Throughout the study, additional outcomes will be monitored, such as emotion recognition, empathy, and responses to stress. Researchers will also look at how the brain responds using MRI scans, as well as other psychological and metabolic outcomes. Safety will be a key focus to ensure the well-being of all participants. The trial is expected to provide valuable insights into the potential benefits of oxytocin for individuals with central diabetes insipidus.

1 introduction to the trial

Upon joining the study, the patient will be informed about the trial’s purpose, which is to evaluate the effect of oxytocin nasal spray on anxiety and emotion recognition in individuals with central diabetes insipidus.

The patient will be briefed on the double-blind, randomized, placebo-controlled nature of the trial, meaning neither the patient nor the researchers will know whether the patient is receiving the active treatment or a placebo.

2 medication administration

The patient will receive a nasal spray containing either oxytocin or a placebo. The placebo will look identical to the oxytocin spray but will contain only 0.9% sodium chloride.

The nasal spray will be administered at a dosage of 24 international units (IU) twice daily for a period of 28 days, with a possible variation of plus or minus 2 days.

3 assessment of anxiety and emotion recognition

Throughout the trial, the patient will undergo assessments to measure changes in anxiety levels using the State-Trait Anxiety Inventory (STAI-T), which consists of 20 items scored from 1 to 4 points each.

The patient will also participate in tasks to evaluate the correct recognition of facial and body expressions, known as the EmBody/EmFace Task, which includes 84 items scored as correct or incorrect.

4 evaluation of primary and secondary outcomes

The primary outcomes will focus on changes in anxiety levels and the ability to correctly classify facial and body expressions after the treatment period.

Secondary outcomes will include assessments of emotion recognition, empathy, hormonal and subjective responses to stress, brain activity responses in functional MRI scans, and other psychological and metabolic outcomes.

5 completion of the trial

At the end of the treatment period, the patient will complete final assessments to evaluate the primary and secondary outcomes.

The trial is expected to conclude by September 30, 2026, with recruitment starting on November 1, 2024.

Who Can Join the Study?

Adults with a confirmed diagnosis of central diabetes insipidus. This is a condition where the body has trouble managing water balance, leading to frequent urination and thirst.
Individuals who report high levels of anxiety or difficulty identifying their own emotions. This is measured using specific questionnaires: the State-Trait Anxiety Inventory (STAI) with a score of 39 or higher, or the Toronto Alexithymia Scale (TAS-20) with a score of 52 or higher.
Participants must be on a stable hormone replacement therapy for at least three months. This includes taking desmopressin, a medication that helps control urine production, and any other necessary hormone treatments if they have other hormone deficiencies.
Both men and women are eligible to participate.

Who Cannot Join the Study?

Individuals with central diabetes insipidus cannot participate. This is a condition where the body has trouble balancing water levels, leading to excessive thirst and urination.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Ezahggj Utrhrjfnfrus Mtvjoyu Ccnycsl Rmvhnuffc (hnlozwj Msl	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.11.2024
The Netherlands	Recruiting	01.11.2024

Trial locations

Oxytocin: This medication is being tested as a substitution therapy for patients with a deficiency in vasopressin, a condition known as central diabetes insipidus. In this trial, oxytocin is administered through the nose twice daily. The study aims to see if oxytocin can help reduce anxiety levels and improve the ability to recognize facial and body expressions.

Investigated diseases:

Diabetes insipidus

Central Diabetes Insipidus – Central diabetes insipidus is a condition characterized by an imbalance in the body’s water regulation due to insufficient production of the hormone vasopressin. This hormone is responsible for controlling the kidneys’ ability to retain water. When vasopressin levels are low, the kidneys fail to concentrate urine, leading to excessive urination and thirst. Individuals with this condition often experience frequent urination, which can lead to dehydration if fluid intake does not match the loss. The condition can be caused by damage to the hypothalamus or pituitary gland, which are responsible for vasopressin production. It is important for individuals with central diabetes insipidus to maintain adequate hydration to manage symptoms effectively.

Trial ID:

2024-516813-19-00

Protocol code:

OxyTUTION

NCT ID:

NCT06036004

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Oxytocin Nasal Spray for Patients with Central Diabetes Insipidus

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