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NCT Number: NCT04789148

Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency

This is a randomized, double-blind, placebo-controlled crossover pilot study of single-dose intranasal oxytocin (6 IU and 24 IU) vs. placebo in adult men and women (aged 18 years and above) with arginine-vasopressin deficiency to evaluate the effect of oxytocin on anxiety, depression, and socioemotional functioning (Part A), with an optional randomized, double-blind, placebo-controlled 2-week repeated dose substudy of intranasal oxytocin 6 IU or placebo (Part B).

Following a screening visit to determine eligibility, participants will return for three main study visits in Part A. During the main study visits, study participants will receive either oxytocin or placebo, followed by assessments of emotional behavior.

In Part A, thirty participants will be equally randomized to one of six possible groups:

1. 6 IU oxytocin - 24 IU oxytocin - placebo 2. 6 IU oxytocin - placebo - 24 IU oxytocin 3. 24 IU oxytocin - 6 IU oxytocin - placebo 4. 24 IU oxytocin - placebo - 6 IU oxytocin 5. placebo - 6 IU oxytocin - 24 IU oxytocin 6. placebo - 24 IU oxytocin - 6 IU oxytocin

Following completion of the Part A crossover portion of the study, in Part B participants may also choose to continue participation in an optional, randomized, double-blind, placebo-controlled substudy of intranasal oxytocin 6 IU or placebo three times a day for two weeks, followed by assessments of emotional behavior.

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Key information

Conditions

Vasopressin Deficiency Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Diabetes Insipidus Diabetes Insipidus, Neurogenic Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypopituitarism Hypothalamic Diseases Kidney Diseases Male Urogenital Diseases Mental Disorders Nervous System Diseases Pituitary Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 and above
  • Arginine-vasopressin deficiency
  • Normal FT4 or T4
  • Normal serum/plasma sodium
  • Stable hormone replacement

Exclusion criteria

  • Active substance use disorder within the last 6 months
  • History of psychosis
  • Suicidal behavior and/or active suicidal ideation with plan and/or intent, e.g., suicidal ideation of type 4 or type 5 as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS), in the last month
  • Medication changes within 4 weeks of enrollment or planned medication changes during the study
  • History of chronic nasal obstruction or local pathology in nostril pathway which, in the opinion of the investigator, would prevent appropriate nasal administration of the study drug.
  • History of cardiac disease, including arrhythmias, coronary heart disease, coronary artery spasms, valvular heart disease, hypertrophic cardiomyopathy (hypertension is not exclusionary)
  • History of chronic kidney disease stage III and above
  • History of liver cirrhosis
  • Pregnancy or breastfeeding within the last 8 weeks
  • Unwilling to use a medically acceptable form of contraception throughout the study period (female of child-bearing potential only)
  • Any significant illness, condition, drug or medical device that the Investigator determines could interfere with study participation, data collection, or safety

Treatment and study plan

Intranasal Oxytocin (IN-OXT)

Drug

6 IU single dose

Placebo

Drug

Intranasal placebo three times a day for 2 weeks

Primary outcomes

  1. Dot-probe task - anxious behavior between low dose oxytocin and placebo

    Time frame: 20 minutes following intervention at each main visit

    Difference in response times (in milliseconds) to dots appearing in the location of the previously shown negative versus the neutral face between 6 IU oxytocin vs placebo in the dot-probe task.

Secondary outcomes

  1. Dot-probe task - anxious behavior between all three interventions

    Time frame: 20 minutes following intervention

    Difference in response time (in milliseconds) to dots appearing in the location of the previously shown negative versus neutral face between 6 IU oxytocin, 24 IU oxytocin, and placebo in the dot-probe task.

  2. Depressive behavior - probabilistic reward task between all three interventions

    Time frame: 30 minutes following intervention at each main visit

    Response bias developed toward the more frequently reinforced alternative between 6 IU oxytocin, 24 IU oxytocin, and placebo in the probabilistic reward task.

  3. Socioemotional functioning - Emotion recognition task between all three interventions

    Time frame: 40 minutes following intervention at each main visit

    Accuracy in identifying correct emotion between 6 IU oxytocin, 24 IU oxytocin, and placebo in the emotion recognition task.

Study contacts

Contact information is provided by the study sponsor or research team.

Elisa Asanza, MSN, MPH

CONTACT

[email protected]

617-726-3870

Francesca Galbiati, MD

CONTACT

[email protected]

(617) 726-3870

Sponsors and collaborators

Lead sponsor

Elizabeth Austen Lawson

Other

Collaborators

  • Tonix Pharmaceuticals, Inc.

Registry information

Official study title

Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency - A Pilot Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 9, 2021
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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