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Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency

NCT04789148 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-16

No results posted yet for this study

Summary

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.

Conditions

  • Vasopressin Deficiency

Interventions

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

Sponsors & Collaborators

  • Tonix Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Elizabeth Austen Lawson

    lead OTHER

Principal Investigators

  • Elizabeth A Lawson, MD, MMSc · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04789148 on ClinicalTrials.gov