Effect of Intranasal Oxytocin on Emotion Recognition and Acute Psycho-Social Stress-induced Cortisol Increase in Patients With Central Diabetes Insipidus and Healthy Controls

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

It had four arms (groups): Part B oxytocin - Part A oxytocin - Part A Placebo - Part B Placebo (experimental), Part B oxytocin - Part A Placebo - Part A oxytocin - Part B Placebo (experimental), Part B Placebo - Part A Placebo - Part A oxytocin - Part B oxytocin (experimental) and 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 oxytocin, 2. Part A oxytocin, 3. Part A placebo, 4. Part B placebo.

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.

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.

The registry classes the interventions as drug and other.

More on the Plan

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.

Oxytocin regulates complex socio-emotional functioning, including attachment and pair bonding, fear extinction, emotion recognition, and empathy.

Who Took Part

Enrollment: 42 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could 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.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2025-05-16 with completion listed for 2027-02.

It ran at 1 site in Switzerland.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Emotion recognition, Empathy, Subjective emotional response to acute stress, Heart rate (bpm) and blood pressure (mmHG).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 42 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.