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

NCT06676774 | Recruiting Phase 2

• 1 other identifier: 2024-01152; kt24christcrain7
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arginine Vasopressin Deficiency; Diabetes Insipidus

Keywords

intranasal oxytocin

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  up to 10 weeks

Secondary Outcomes (5)

• Emotion recognition

  up to 4 weeks

• Empathy

  up to 4 weeks

• Subjective emotional response to acute stress

  up to 10 weeks

• Heart rate (bpm)

  up to 10 weeks

• blood pressure (mmHG)

  up to 10 weeks

Study Arms (4)

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

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

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

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

Drug: Oxytocin nasal spray; Other: Placebo

Interventions

Oxytocin nasal spray DRUG

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.

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

Placebo OTHER

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Diabetes Insipidus, Neurogenic; Diabetes Insipidus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Mirjam Christ-Crain, Prof. Dr.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirjam Christ-Crain, Prof. Dr.

CONTACT

+41 61 328 70 80; mirjam.christ-crain@ubs.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Case-control trial with randomized, placebo-controlled, double-blind, cross-over design

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 6, 2024
• Study Start: May 16, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

CH (1)