Arginine Vasopressin DeficiencyPhase 2OxyMOTIONNCT06676774
Effect of Intranasal Oxytocin on Emotion Recognition and Acute Psycho-Social Stress-induced Cortisol Increase in Patients With Central Diabetes Insipidus and Healthy Controls
A Phase 2 study testing Oxytocin nasal spray in people with Arginine Vasopressin Deficiency and Diabetes Insipidus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study aims to investigate the potential beneficial effects of intranasal oxytocin compared to placebo on emotion recognition and acute psychosocial stress in patients with arginine vasopressin deficiency compared to matched healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arginine Vasopressin Deficiency, Diabetes Insipidus
- What is being tested?
- Oxytocin nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 May 2025to Feb 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult healthy volunteers
- Matched for age, sex, BMI, and oestrogen replacement/menopause/hormonal contraceptives to patients.
- No medication, except hormonal contraception
- Adult patients with a confirmed diagnosis of AVP deficiency based on accepted criteria6
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Mirjam Christ-Crain, Prof. Dr., +41 61 328 70 80, mirjam.christ-crain@ubs.ch
Mirjam Christ-Crain, Prof. Dr.
About this study
Official title: Effect of Intranasal Oxytocin on Emotion Recognition and Acute Psycho-Social Stress-induced Cortisol Increase in Patients With Central Diabetes Insipidus (Arginine Vasopressin Deficiency) and Healthy Controls - the OxyMOTION-Study
This study aims to investigate the potential beneficial effects of intranasal oxytocin compared to placebo on emotion recognition and acute psychosocial stress in patients with arginine vasopressin deficiency compared to matched healthy controls.
Read the detailed description
Arginine vasopressin (AVP) and oxytocin are both nine-amino acid neuropeptides produced in the hypothalamus and are released into circulation from axon terminals projecting to the posterior pituitary. Disruption of the hypothalamic-pituitary axis due to inflammation, tumours, or head trauma may cause AVP deficiency, formerly known as central diabetes insipidus, a condition characterised by polyuria and polydipsia. Once diagnosed with AVP deficiency, desmopressin (AVP receptor 2 analogue) is prescribed to overcome polyuria and polydipsia symptoms. However, despite adequate treatment with desmopressin, patients often report residual psychological symptoms such as heightened anxiety, impairment in identifying and expressing emotions, lower levels of empathy, and increased stress-related behaviour. Oxytocin regulates complex socio-emotional functioning, including attachment and pair bonding, fear extinction, emotion recognition, and empathy. In line with this, oxytocin acts as a stress-buffering hormone as it reduces cortisol in response to stress and has anxiolytic effects. In addition to its release from axonal terminals, there is dendritic release of oxytocin into the brain, including key regions engaged in social-emotional behaviour such as the amygdala, hippocampus, insula. Specifically, it has been supposed that the prosocial effect of oxytocin might be secondary to an anxiolytic effect that involves modulation of amygdala responsivity and by improving emotion recognition. Due to the anatomical proximity, disruption of the AVP system leading to AVP deficiency could also disturb the oxytocin system leading to an additional oxytocin deficiency. Therefore, the psychopathological findings in patients may be caused by an additional oxytocin deficiency. Established pituitary provocation tests, however, failed to show a consistent increase in oxytocin levels. Several studies documented marked acute increases in circulating oxytocin levels in response to 3,4-methylenedioxymethamphetamine (MDMA, known as 'ecstasy') in healthy individuals explaining the empathic feelings and prosocial and anxiolytic effects of MDMA. Based on these results, the study team recently investigated MDMA as a novel provocation test for oxytocin deficiency in patients with AVP deficiency. The study team thereby demonstrated an additional oxytocin deficiency in patients with AVP deficiency using this novel stimulation test with MDMA. Results from this study demonstrate no or only minimal increase in oxytocin after MDMA intake in AVP deficiency while an almost 8-fold increase from baseline values in healthy controls. Acute oxytocin-induced effects under MDMA, such as increased trust, closeness, and openness to others, identification of facial emotions, and fear extinction, were significantly lower in patients compared to healthy controls. Based on this, the additional oxytocin deficiency could explain the psychopathology in patients. Given these data and evidence, oxytocin treatment to improve emotion recognition, decrease anxiety, and buffer effusive stress-induced cortisol increase would have great clinical implications. To date, the central effects of intranasal oxytocin in patients with AVP deficiency have not been addressed, and whether oxytocin administration in these patients can improve the psychological symptoms and provide a novel treatment option needs to be answered. Therefore, this case-control trial with randomized, placebo-controlled, double-blind, cross-over design aims to investigate the effects of a single dose of intranasal oxytocin compared to intranasal placebo on emotion recognition, and acute anxiety and cortisol in response to acute psychosocial stress in patients with AVP deficiency compared to healthy controls.
- Being tested
- Oxytocin nasal spray, Placebo
- Keywords
- intranasal oxytocin
- 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.
Oxytocin nasal sprayDrug
Participants will be instructed on correctly applying the intranasal study medication and will self-administer a single dose of 24 IU oxytocin under the supervision of unblinded study personnel.
PlaceboOther
Participants will be instructed on correctly applying the intranasal study medication and will self-administer a single dose of placebo (0.9% normal saline) under the supervision of unblinded study personnel.
| Study group | Role | What they receive |
|---|---|---|
| Part B oxytocin - Part A oxytocin - Part A Placebo - Part B Placebo | Experimental | Part A will investigate the recognition of facial emotions \& body expressions in a cross-over design with a two-week wash-out period between both study visits. Part B will investigate the response of cortisol to acute psychosocial stress (TSST) with an eight-week wash-out period between both study visits. The order of group assignment is as follows: 1. Part B oxytocin, 2. Part A oxytocin, 3. Part A placebo, 4. Part B placebo Receives: Drug: Oxytocin nasal spray; Other: Placebo |
| Part B oxytocin - Part A Placebo - Part A oxytocin - Part B Placebo | Experimental | Part A will investigate the recognition of facial emotions \& body expressions in a cross-over design with a two-week wash-out period between both study visits. Part B will investigate the response of cortisol to acute psychosocial stress (TSST) with an eight-week wash-out period between both study visits. The order of group assignment is as follows: 1. Part B oxytocin, 2. Part A placebo, 3. Part A oxytocin, 4. Part B placebo Receives: Drug: Oxytocin nasal spray; Other: Placebo |
| Part B Placebo - Part A Placebo - Part A oxytocin - Part B oxytocin | Experimental | Part A will investigate the recognition of facial emotions \& body expressions in a cross-over design with a two-week wash-out period between both study visits. Part B will investigate the response of cortisol to acute psychosocial stress (TSST) with an eight-week wash-out period between both study visits. The order of group assignment is as follows: 1. Part B placebo, 2. Part A placebo, 3. Part A oxytocin, 4. Part B oxytocin Receives: Drug: Oxytocin nasal spray; Other: Placebo |
| Part B Placebo - Part A oxytocin - Part A Placebo - Part B oxytocin | Experimental | Part A will investigate the recognition of facial emotions \& body expressions in a cross-over design with a two-week wash-out period between both study visits. Part B will investigate the response of cortisol to acute psychosocial stress (TSST) with an eight-week wash-out period between both study visits. The order of group assignment is as follows: 1. Part B placebo, 2. Part A oxytocin, 3. Part A placebo, 4. Part B oxytocin Receives: Drug: Oxytocin nasal spray; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of oxytocin compared to placebo in patients with AVP deficiency compared to healthy controls on recognition of facial emotions/body expression
Differences between the placebo and oxytocin session will be assessed for each participant in correct recognition of facial emotions \& body expressions assessed with the EmBody (emotion from body expressions) /EmFace (emotion from facial expressions) task of 3 or more score points (score range: 20-80) The EmBody and EmFace subtasks comprise each of 42 stimuli showing body or facial expressions of angry, happy, or neutral affect (14 clips per emotion, half in front view and half in half-profile side view from the left). Stimuli last 1.5 seconds at 24 frames per second and are geometrically and optically standardized to prevent biases induced by ethnic cues (e.g., hair or skin tone) or clothing. Item order is pseudorandom to prevent sequence effects and was determined using the following constraints: the same emotion is shown no more than twice in a row; the same view per emotion is not shown consecutively (i.e., no angry-front, angry-front).
Measured: up to 4 weeks
Effect of oxytocin compared to placebo in patients with AVP deficiency compared to healthy controls cortisol in response to acute stress
Differences between the placebo and oxytocin session will be assessed for each participant in cortisol levels in response to acute psychosocial stress induced upon the TSST (Trier Social Stress Test) by 15% or more in the area under the cortisol response curve.
Salivary cortisol will be measured (as a measure of unbound cortisol concentrations in plasma) before and upon the TSST. Blood cortisol will also be measured The TSST consists of an unprepared speech and mental arithmetic performed in front of an audience.
Previous studies indicated that this stress protocol reliably induces a significant HPA (Hypothalamic-pituitary-adrenal)-axis activation, with 2- to 3-fold increases in free cortisol and subjective responses indicative of moderate stress in healthy individuals.
Measured: up to 10 weeks
Secondary outcomes (5)
Emotion recognition
-Percentage of correct classifications per emotion in Facial Emotional Recognition Task (FERT). The FERT assesses the recognition of basic emotions.
The task includes 10 neutral faces and 160 faces that express one of four basic emotions 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.
Measured: up to 4 weeks
Empathy
-Level of direct, indirect, and cognitive empathy for positive and negative emotions in the Multifaceted Empathy Task (MET). MET is a computer-assisted test, which consists of 40 photographs that show people in emotionally charged situations. To measure emotional empathy subjects are asked to rate how much they feel for an individual in each scene and how much they are aroused by each scene on a 1-9-point scale. The 3 aspects are each tested with 20 stimuli with positive valence and 20 with negative valence, resulting in a total of 120 trials.
Measured: up to 4 weeks
Subjective emotional response to acute stress
Acute anxiety levels using the STAI-S (State-Trait Anxiety Inventory). This is a questionnaire to determine general anxiety levels. Based on responses to 40 items, with scores ranging from 1 ("almost never") to 4 ("almost always"), a total score is calculated. The STAI has two sub-scales, the State-Anxiety Scale (20 items) and the Trait-Anxiety Scale (20 items). The State-Anxiety Scale 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 Trait-Anxiety Scale 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.
Measured: up to 10 weeks
Heart rate (bpm)
Heart rate as an indicator for subjective autonomic response to acute stress
Measured: up to 10 weeks
blood pressure (mmHG)
Blood pressure as an idicator for subjective autonomic response to acute stress
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start16 May 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arginine Vasopressin DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Model description
- Case-control trial with randomized, placebo-controlled, double-blind, cross-over design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirjam Christ-Crain, Prof. Dr., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676774
- Sponsor's protocol ID
- 2024-01152; kt24christcrain7
- Acronym
- OxyMOTION
- Status last verified
- May 2025
- First submitted
- 1 Nov 2024
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intranasal Oxytocin on Emotion Recognition and Acute Psycho-Social Stress-induced Cortisol Increase in Patients With Central Diabetes Insipidus (Arginine Vasopressin Deficiency) and Healthy Controls - the OxyMOTION-Study
- ClinicalTrials.gov ID
- NCT06676774
- Acronym / sponsor ID
- OxyMOTION / 2024-01152; kt24christcrain7
- Keywords
- intranasal oxytocin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 16 May 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the potential beneficial effects of intranasal oxytocin compared to placebo on emotion recognition and acute psychosocial stress in patients with arginine vasopressin deficiency compared to matched healthy controls.
Detailed description
Arginine vasopressin (AVP) and oxytocin are both nine-amino acid neuropeptides produced in the hypothalamus and are released into circulation from axon terminals projecting to the posterior pituitary. Disruption of the hypothalamic-pituitary axis due to inflammation, tumours, or head trauma may cause AVP deficiency, formerly known as central diabetes insipidus, a condition characterised by polyuria and polydipsia. Once diagnosed with AVP deficiency, desmopressin (AVP receptor 2 analogue) is prescribed to overcome polyuria and polydipsia symptoms. However, despite adequate treatment with desmopressin, patients often report residual psychological symptoms such as heightened anxiety, impairment in identifying and expressing emotions, lower levels of empathy, and increased stress-related behaviour. Oxytocin regulates complex socio-emotional functioning, including attachment and pair bonding, fear extinction, emotion recognition, and empathy. In line with this, oxytocin acts as a stress-buffering hormone as it reduces cortisol in response to stress and has anxiolytic effects. In addition to its release from axonal terminals, there is dendritic release of oxytocin into the brain, including key regions engaged in social-emotional behaviour such as the amygdala, hippocampus, insula. Specifically, it has been supposed that the prosocial effect of oxytocin might be secondary to an anxiolytic effect that involves modulation of amygdala responsivity and by improving emotion recognition. Due to the anatomical proximity, disruption of the AVP system leading to AVP deficiency could also disturb the oxytocin system leading to an additional oxytocin deficiency. Therefore, the psychopathological findings in patients may be caused by an additional oxytocin deficiency. Established pituitary provocation tests, however, failed to show a consistent increase in oxytocin levels. Several studies documented marked acute increases in circulating oxytocin levels in response to 3,4-methylenedioxymethamphetamine (MDMA, known as 'ecstasy') in healthy individuals explaining the empathic feelings and prosocial and anxiolytic effects of MDMA. Based on these results, the study team recently investigated MDMA as a novel provocation test for oxytocin deficiency in patients with AVP deficiency. The study team thereby demonstrated an additional oxytocin deficiency in patients with AVP deficiency using this novel stimulation test with MDMA. Results from this study demonstrate no or only minimal increase in oxytocin after MDMA intake in AVP deficiency while an almost 8-fold increase from baseline values in healthy controls. Acute oxytocin-induced effects under MDMA, such as increased trust, closeness, and openness to others, identification of facial emotions, and fear extinction, were significantly lower in patients compared to healthy controls. Based on this, the additional oxytocin deficiency could explain the psychopathology in patients. Given these data and evidence, oxytocin treatment to improve emotion recognition, decrease anxiety, and buffer effusive stress-induced cortisol increase would have great clinical implications. To date, the central effects of intranasal oxytocin in patients with AVP deficiency have not been addressed, and whether oxytocin administration in these patients can improve the psychological symptoms and provide a novel treatment option needs to be answered. Therefore, this case-control trial with randomized, placebo-controlled, double-blind, cross-over design aims to investigate the effects of a single dose of intranasal oxytocin compared to intranasal placebo on emotion recognition, and acute anxiety and cortisol in response to acute psychosocial stress in patients with AVP deficiency compared to healthy controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Case-control trial with randomized, placebo-controlled, double-blind, cross-over design
| Arm | Type | Receives |
|---|---|---|
| Part B oxytocin - Part A oxytocin - Part A Placebo - Part B Placebo | Experimental | Drug: Oxytocin nasal spray, Other: PlaceboPart A will investigate the recognition of facial emotions \& body expressions in a cross-over design with a two-week wash-out period between both study visits. Part B will investigate the response of cortisol to acute psychosocial stress (TSST) with an eight-week wash-out period between both study visits. The order of group assignment is as follows: 1. Part B oxytocin, 2. Part A oxytocin, 3. Part A placebo, 4. Part B placebo |
| Part B oxytocin - Part A Placebo - Part A oxytocin - Part B Placebo | Experimental | Drug: Oxytocin nasal spray, Other: PlaceboPart A will investigate the recognition of facial emotions \& body expressions in a cross-over design with a two-week wash-out period between both study visits. Part B will investigate the response of cortisol to acute psychosocial stress (TSST) with an eight-week wash-out period between both study visits. The order of group assignment is as follows: 1. Part B oxytocin, 2. Part A placebo, 3. Part A oxytocin, 4. Part B placebo |
| Part B Placebo - Part A Placebo - Part A oxytocin - Part B oxytocin | Experimental | Drug: Oxytocin nasal spray, Other: PlaceboPart A will investigate the recognition of facial emotions \& body expressions in a cross-over design with a two-week wash-out period between both study visits. Part B will investigate the response of cortisol to acute psychosocial stress (TSST) with an eight-week wash-out period between both study visits. The order of group assignment is as follows: 1. Part B placebo, 2. Part A placebo, 3. Part A oxytocin, 4. Part B oxytocin |
| Part B Placebo - Part A oxytocin - Part A Placebo - Part B oxytocin | Experimental | Drug: Oxytocin nasal spray, Other: PlaceboPart A will investigate the recognition of facial emotions \& body expressions in a cross-over design with a two-week wash-out period between both study visits. Part B will investigate the response of cortisol to acute psychosocial stress (TSST) with an eight-week wash-out period between both study visits. The order of group assignment is as follows: 1. Part B placebo, 2. Part A oxytocin, 3. Part A placebo, 4. Part B oxytocin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult healthy volunteers
- Matched for age, sex, BMI, and oestrogen replacement/menopause/hormonal contraceptives to patients.
- No medication, except hormonal contraception
- Adult patients with a confirmed diagnosis of AVP deficiency based on accepted criteria6
- Stable hormone replacement therapy for at least three months with desmopressin and, in case of additional anterior pituitary deficiencies, with the respective substitution therapies.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin nasal sprayParticipants will be instructed on correctly applying the intranasal study medication and will self-administer a single dose of 24 IU oxytocin under the supervision of unblinded study personnel. | Drug | Part B Placebo - Part A Placebo - Part A oxytocin - Part B oxytocin, Part B Placebo - Part A oxytocin - Part A Placebo - Part B oxytocin, Part B oxytocin - Part A Placebo - Part A oxytocin - Part B Placebo, Part B oxytocin - Part A oxytocin - Part A Placebo - Part B Placebo |
| PlaceboParticipants will be instructed on correctly applying the intranasal study medication and will self-administer a single dose of placebo (0.9% normal saline) under the supervision of unblinded study personnel. | Other | Part B Placebo - Part A Placebo - Part A oxytocin - Part B oxytocin, Part B Placebo - Part A oxytocin - Part A Placebo - Part B oxytocin, Part B oxytocin - Part A Placebo - Part A oxytocin - Part B Placebo, Part B oxytocin - Part A oxytocin - Part A Placebo - Part B Placebo |
Primary outcome
Effect of oxytocin compared to placebo in patients with AVP deficiency compared to healthy controls on recognition of facial emotions/body expression
Time frame: up to 4 weeks
Differences between the placebo and oxytocin session will be assessed for each participant in correct recognition of facial emotions \& body expressions assessed with the EmBody (emotion from body expressions) /EmFace (emotion from facial expressions) task of 3 or more score points (score range: 20-80) The EmBody and EmFace subtasks comprise each of 42 stimuli showing body or facial expressions of angry, happy, or neutral affect (14 clips per emotion, half in front view and half in half-profile side view from the left). Stimuli last 1.5 seconds at 24 frames per second and are geometrically and optically standardized to prevent biases induced by ethnic cues (e.g., hair or skin tone) or clothing. Item order is pseudorandom to prevent sequence effects and was determined using the following constraints: the same emotion is shown no more than twice in a row; the same view per emotion is not shown consecutively (i.e., no angry-front, angry-front).
Effect of oxytocin compared to placebo in patients with AVP deficiency compared to healthy controls cortisol in response to acute stress
Time frame: up to 10 weeks
Differences between the placebo and oxytocin session will be assessed for each participant in cortisol levels in response to acute psychosocial stress induced upon the TSST (Trier Social Stress Test) by 15% or more in the area under the cortisol response curve. Salivary cortisol will be measured (as a measure of unbound cortisol concentrations in plasma) before and upon the TSST. Blood cortisol will also be measured The TSST consists of an unprepared speech and mental arithmetic performed in front of an audience. Previous studies indicated that this stress protocol reliably induces a significant HPA (Hypothalamic-pituitary-adrenal)-axis activation, with 2- to 3-fold increases in free cortisol and subjective responses indicative of moderate stress in healthy individuals.
5 secondary outcomes
Emotion recognition
Time frame: up to 4 weeks
Empathy
Time frame: up to 4 weeks
Subjective emotional response to acute stress
Time frame: up to 10 weeks
Heart rate (bpm)
Time frame: up to 10 weeks
blood pressure (mmHG)
Time frame: up to 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mirjam Christ-Crain, Prof. Dr. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin nasal spray in people with Arginine Vasopressin Deficiency and Diabetes Insipidus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 5 inclusion and 5 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 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. 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. (+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?
Effect of oxytocin compared to placebo in patients with AVP deficiency compared to healthy controls on recognition of facial emotions/body expression (time frame: up to 4 weeks). 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?
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 23 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.