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Central Diabetes Insipidus (cDI)Phase 2OxyTUTIONNCT06036004

Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus

A Phase 2 study testing Intranasal OXT in people with Central Diabetes Insipidus (cDI), run by University Hospital, Basel, Switzerland at 3 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Central Diabetes Insipidus (cDI)
What is being tested?
Intranasal OXT
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
112 participants
Where
3 sitesin 3 countries
Study dates
8 Jan 2024to Oct 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Mirjam Christ-Crain, Prof. Dr. med. contact

+41 61 328 70 80

mirjam.christ-crain@ubs.ch

3 sites in 3 countries

Germany1 site, 1 recruiting

  • Charité University Medical Center Berlin

    Berlin, 10117

    Linus Haberbosch, Dr. med., +4930-450614425, linus.haberbosch@charite.de

    Recruiting

Other trials in Germany

Netherlands1 site, 1 recruiting

  • Erasmus University Medical Center Rotterdam

    Rotterdam, 3015

    Julie Refardt, MD PhD, +31627112079, j.refardt@erasmusmc.nl

    Julie Refardt, MD PhD

    Recruiting

Other trials in Netherlands

Switzerland1 site, 1 recruiting

  • University Hospital Basel, Department of Endocrinology, Diabetes & Metabolism

    Basel, 4031

    Mirjam Christ-Crain, Prof. Dr. med., +41 61 328 70 80, mirjam.christ-crain@ubs.ch

    Mirjam Christ-Crain, Prof. Dr. med.

    Recruiting

Other trials in Switzerland

About this study

Official title: Oxytocin Substitution Therapy in Patients With AVP Deficiency (Central Diabetes Insipidus)

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)
Read the detailed description

Arginine vasopressin (AVP) and oxytocin (OXT) are hormones released into circulation from the posterior pituitary. While AVP acts mainly in the kidneys and causes reuptake of free water, OXT is well-known for its key role in the regulation of complex social-emotional functioning including attachment and pair bonding, fear possessing, emotion recognition, and empathy.

Disruption of the hypothalamic-pituitary axis can cause AVP deficiency

  • known as central diabetes insipidus (cDI) - characterized by polyuria and polydipsia. Once diagnosed, desmopressin (an AVP receptor analogue) can be effectively used to treat diabetes insipidus. However, despite treatment with desmopressin, patients often report residual psychological symptoms, particularly heightened anxiety levels, depressed mood, impairment in social interactions, leading to an overall reduced quality of life.

Due to the anatomical proximity, local disruptions of the AVP system could also disturb the OXT system leading to an additional OXT deficiency. The additional OXT deficiency could explain (at least partially) the residual psychological deficits in patients with cDI. OXT replacement therapy to improve psychological symptoms would have great clinical implications. This randomized, placebo-controlled, double-blind trial aims to investigate intranasal OXT as a novel therapeutical option in cDI to improve psychological symptoms and socio-emotional functioning.

Optional fMRI sub-study: Participants will undergo a structural sequence to investigate grey and white matter anatomy (T1- weighted). Functional neuronal responses will be assessed through the surrogate of blood oxygenated level dependent (BOLD) signal, an indirect measure of neural activity. Three functional sequences (echo planar imaging, EPI) will investigate group differences in various aspects of brain activity: a resting state sequence and the EFMT.

Optional Social-stress sub-study: The three main components are an anticipation phase, a 5-minute interview, and a surprise mental arithmetic task. Acute stress is measured by cortisol increase.

Being tested
Intranasal OXT, Placebo nasal spray
Keywords
oxytocin (OXT), hypothalamic-pituitary axis, Arginine vasopressin (AVP), OXT deficiency, socio-emotional functioning, intranasal OXT
Medical subject headings
Diabetes Insipidus, Neurogenic, Diabetes Insipidus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intranasal OXTDrug

    Syntocinon® contains the synthesized peptide OXT in a solution formulated to promote absorption through the nasal mucosa. Additional ingredients are E216 (propyl-4-hydroxybenzoate), E218 (methyl-4-hydroxybenzoate), and chlorobutanol hemihydrate. One bottle contains 5 ml, i.e., 200 IU of OXT in total. Each 0.1 ml nasal insulation delivers 4 IU of oxytocin.

    OXT (24 IU twice daily) is given for 28 (± 2) days of treatment.

  • Placebo nasal sprayOther

    The placebo will contain no OXT but, otherwise, be identical to the intranasal OXT product with respect to the other ingredients.

    Placebo is given twice daily for 28 (± 2) days of treatment.

Study groups in NCT06036004
Study groupRoleWhat they receive
Study Product Intervention: intranasal OXTActive comparatorIntranasal OXT spray of 40 IU per ml (Syntocinon®).
Receives: Drug: Intranasal OXT
Control Intervention: placebo nasal sprayPlacebo comparatorThe placebo nasal spray will be identical in volume, labelling, container system, and other features.
Receives: Other: Placebo nasal spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in State-Trait Anxiety Inventory (STAI) questionnaire to assess general anxiety levels

    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.

    Measured: Day 0, day 1, day 14, day 28

  2. Change in EmBody/EmFace to assess recognition of facial and body expressions

    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.

    Measured: Day 0, day 1, day 28

Secondary outcomes (6)

  1. Change in Facial emotion recognition task (FERT) to assess emotion recognition and empathy

    The FERT assesses the recognition of basic emotions. The task includes ten neutral faces and 160 faces that express one of four basic emotions (i.e., happiness, sadness, anger, and fear), with pictures morphed between 0% (i.e., neutral) and 100% in 10% steps. Stimuli are shown in random order for 500 ms, followed by the rating screen, where participants have to indicate the correct emotion. The outcome measure is accuracy (proportion correct).

    Measured: Day 0, day 28

  2. Change in Multifaceted Empathy Test (MET) to assess the cognitive and emotional aspects of empathy

    The computer-assisted test consists of 40 photographs that showed people in emotionally charged situations. To assess cognitive empathy, the participants are required to infer the mental state of the subject in each scene and indicate the correct mental state from a list of four responses. Cognitive empathy is the percentage of correct responses in the total responses. To measure emotional empathy, the subjects are asked to rate how much they feel for an individual in each scene (i.e., explicit emotional empathy) and how much they are aroused by each scene (i.e., implicit emotional empathy) on a 1-9 point scale.

    Measured: Day 0, day 1, day 28

  3. Change in Hamilton Anxiety Rating Scale (HAM) to assess the severity of anxiety symptoms

    The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The physician/psychologist is instructed to assess the extent to which the patient displays the given criterion. Each item is independently scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56 (<17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe).

    Measured: Day 0, day 28

  4. Change in Toronto Alexithymia Scale 20 (TAS-20) to assess emotions experienced by oneself or others

    The TAS 20 has a three- factor structure: difficulty identifying and describing feelings and externally oriented thinking. It includes 20 items with scores ranging from 1 (strongly disagree) to 5 (strongly agree). The total scores range from 20 to 100, with higher scores indicating worse alexithymia. A score of ≥61 indicates alexithymia (difficulty understanding one's emotions), a score of 52 to 60 indicates possible alexithymia, and a ≤51 non-alexithymia.

    Measured: Day 0, day 28

  5. Change in Autism-Spectrum Quotient Test (AQ) to assess the expression of ASD traits in an individual by his or her subjective self-assessment

    The AQ consists of 50 items, with four choices for each item from "definitely agree" to "definitely disagree" and a total score from 0 to 50. A score above the proposed cut-off of 29 highlights significant traits of autism

    Measured: Day 0, day 28

  6. Change in Beck's Depression Inventory II (BDI-II) to assess depression

    It uses 21 items ranked from 0 (symptom absent) to 3 (severe symptoms) to measure the severity of depression. The minimum score is 0, and the maximum score is 63. In non-clinical populations, scores above 20 indicate depression. In those diagnosed with depression, the score ≤16, mild mood disturbance; 17 to 20, borderline clinical depression, 21 to 30, moderate depression, and score ≥31, severe depression.

    Measured: Day 0, day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study start8 Jan 2024
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
double-blind randomised placebo-controlled trial: participants will be randomly assigned 1:1 to receive either treatment with intranasal OXT or intranasal placebo
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06036004
Sponsor's protocol ID
2023-01010; kt22ChristCrain
Other IDs
2023
Acronym
OxyTUTION
Status last verified
May 2026
First submitted
6 Sep 2023
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data that underlie the results of this study will be made available upon reasonable request to the corresponding author, following publication of the primary results. Data will be shared with qualified researchers for purposes of academic, non-commercial research, subject to approval of a methodologically sound proposal and completion of a data-sharing agreement. Requests will be evaluated in accordance with applicable ethical approvals, data protection regulations, and institutional policies. Access will require approval and a signed data access agreement. The Department of Clinical Research (DKF), University of Basel, will act as an independent Data Access Committee and securely store the data at the time of publication. Requests for data reuse may be submitted via dkf.unibas.ch/contact.

Publications

  • Atila C, Leibnitz S, Nikaj A, Liechti ME, De Quervain D, Christ-Crain M; OxyTUTION Study Group. Oxytocin substitution therapy in patients with AVP deficiency (central diabetes insipidus): study protocol of a double-blind, randomised placebo-controlled trial. BMJ Open. 2026 May 4;16(5):e109940. doi: 10.1136/bmjopen-2025-109940.

    PubMed 42082227

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intranasal OXT in people with Central Diabetes Insipidus (cDI), run by University Hospital, Basel, Switzerland at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mirjam Christ-Crain, Prof. Dr. med. (+41 61 328 70 80, mirjam.christ-crain@ubs.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in State-Trait Anxiety Inventory (STAI) questionnaire to assess general anxiety levels (time frame: Day 0, day 1, day 14, day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06036004, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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