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NCT04789148·Phase 1·INTERVENTIONAL

Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency

VasopressinOxytocinBrain healthRecruiting

Status

Recruiting

Phase

Phase 1

Enrollment

40

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Intranasal Oxytocin (IN-OXT)

6 IU single dose

DRUG

Intranasal Oxytocin (IN-OXT)

IN-OXT 6 IU three times a day for 2 weeks

DRUG

Placebo

Intranasal placebo three times a day for 2 weeks

DRUG

Intranasal Oxytocin (IN-OXT)

24 IU single dose

DRUG

Placebo

placebo single dose

Timeline

From registration to results.

  1. First posted

    Mar 9, 2021

  2. Study start

    Sep 10, 2025

  3. Primary completion

    Jun 2027

  4. Study completion

    Jun 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jul 23, 2026

Outcomes

What the study measures.

Primary outcomes

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

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.

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.

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Massachusetts General Hospital, Neuroendocrine Unit

Boston, Massachusetts, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Vasopressin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsVasopressin trial dashboard →DatabaseVasopressin database entry →ResearchVasopressin research guide →TrialsOxytocin trial dashboard →