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RecruitingNCT04789148Updated Oct 26, 2026

Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency

A Phase 1 interventional study of Intranasal Oxytocin (IN-OXT) 6 IU single dose and Intranasal Oxytocin (IN-OXT) 6 IU repeat dose in Vasopressin Deficiency, sponsored by Elizabeth Austen Lawson. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Elizabeth Austen Lawson · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 2 months later.
Updated Oct 26, 2026Eligibility revisedInterventions changed+1 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Vasopressin Deficiency

Keywords

  • Hypopituitarism
  • posterior pituitary
  • oxytocin
  • psychopathology
  • anxiety
  • depressive symptoms
  • socioemotional functioning
03

In context

Diabetes Insipidus, Neurogenic

27 studies on the registry are indexed under Diabetes Insipidus, Neurogenic; 12 are open to participants now.

This study's planned enrollment of 40 is close to the median of 42 across 23 interventional studies indexed under Diabetes Insipidus, Neurogenic.

Browse Diabetes Insipidus, Neurogenic studies →

Lead sponsor

Elizabeth Austen Lawson is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 26, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 that could interfere with study procedures or endpoints per study physician discretion
  • 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 ventricular arrhythmias, coronary heart disease, and hypertrophic cardiomyopathy
  • 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 throughout the study period (female of only)
  • Any significant illness, condition, drug or medical device that the Investigator determines could interfere with study participation, data collection, or safety
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Part A Arm 1

    Part A Main visit 1: 6 IU intranasal oxytocin; Part A Main visit 2: 24 IU intranasal oxytocin; Part A Main visit 3: intranasal placebo

    Drug: Intranasal Oxytocin (IN-OXT) 6 IU single dose · Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose · Drug: Placebo repeat dose

  • Experimental
    Part A Arm 2

    Part A Main visit 1: 6 IU intranasal oxytocin; Part A Main visit 2: intranasal placebo; Part A Main visit 3: 24 IU intranasal oxytocin

    Drug: Intranasal Oxytocin (IN-OXT) 6 IU single dose · Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose · Drug: Placebo repeat dose

  • Experimental
    Part A Arm 3

    Part A Main visit 1: 24 IU intranasal oxytocin; Part A Main visit 2: 6 IU intranasal oxytocin; Part A Main visit 3: intranasal placebo

    Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose · Drug: Placebo repeat dose · Drug: Intranasal Oxytocin (IN-OXT) 24 IU single dose

  • Experimental
    Part A Arm 4

    Part A Main visit 1: 24 IU intranasal oxytocin; Part A Main visit 2: intranasal placebo; Part A Main visit 3: 6 IU intranasal oxytocin

    Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose · Drug: Placebo repeat dose · Drug: Intranasal Oxytocin (IN-OXT) 24 IU single dose

  • Experimental
    Part A Arm 5

    Part A Main visit 1: intranasal placebo; Part A Main visit 2: 6 IU intranasal oxytocin; Part A Main visit 3: 24 IU intranasal oxytocin

    Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose · Drug: Placebo repeat dose · Drug: Placebo single dose

  • Experimental
    Part A Arm 6

    Part A Main visit 1: intranasal placebo; Part A Main visit 2: 24 IU intranasal oxytocin; Part A Main visit 3: 6 IU intranasal oxytocin

    Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose · Drug: Placebo repeat dose · Drug: Placebo single dose

  • Active comparator
    Part B Arm 1

    Part B: Intranasal oxytocin 6 IU three times a day for 14 days

    Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose

  • Experimental
    Part B Arm 2

    Part B: Intranasal placebo three times a day for 14 days

    Drug: Placebo repeat dose

Interventions

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 20 minutes following intervention at each main visit

Secondary outcomes

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

    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.

    Time frame: 20 minutes following intervention

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

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

    Time frame: 30 minutes following intervention at each main visit

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

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

    Time frame: 40 minutes following intervention at each main visit

07

Study locations

1 of 1 sites recruiting
  • Massachusetts General Hospital, Neuroendocrine Unit
    Boston, Massachusetts 02114, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Eligibility
1 inclusion criterion edited; 2 exclusion criteria edited
What changed in the criteria
Inclusion criteria
  • EditedNormal FT4 or T4
Exclusion criteria
  • ChangedBefore Medication changes within 4 weeks of enrollment or planned medication changes during the studyNow Medication changes that could interfere with study procedures or endpoints per study physician discretion
  • ChangedBefore History of cardiac disease, including arrhythmias, coronary heart disease, coronary artery spasms, valvular heart disease, hypertrophic cardiomyopathy (hypertension is not exclusionary)Now History of clinically relevant ventricular arrhythmias, coronary heart disease, and hypertrophic cardiomyopathy
Oct 26, 2026
Interventions
Added Drug: Intranasal Oxytocin (IN-OXT) 6 IU single dose·Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose·Drug: Placebo repeat dose·Drug: Intranasal Oxytocin (IN-OXT) 24 IU single dose·Drug: Placebo single dose; removed Drug: Intranasal Oxytocin (IN-OXT)·Drug: Placebo
Oct 26, 2026
Contact
Study contact changed: F•••@bwh.harvard.edu · •••3870→e•••@mgh.harvard.edu · •••3870. See the current contact
Oct 26, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Massachusetts General Hospital, Neuroendocrine Unit · Boston, United StatesContact f•••@bwh.harvard.edu · •••3870→e•••@mgh.harvard.edu · •••3870Contact added (no phone or email listed)
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    Eligibility 1 inclusion criterion edited; 2 exclusion criteria edited
    What changed in the criteria
    Inclusion criteria
    • EditedNormal FT4 or T4
    Exclusion criteria
    • ChangedBefore Medication changes within 4 weeks of enrollment or planned medication changes during the studyNow Medication changes that could interfere with study procedures or endpoints per study physician discretion
    • ChangedBefore History of cardiac disease, including arrhythmias, coronary heart disease, coronary artery spasms, valvular heart disease, hypertrophic cardiomyopathy (hypertension is not exclusionary)Now History of clinically relevant ventricular arrhythmias, coronary heart disease, and hypertrophic cardiomyopathy
    Interventions Added Drug: Intranasal Oxytocin (IN-OXT) 6 IU single dose·Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose·Drug: Placebo repeat dose·Drug: Intranasal Oxytocin (IN-OXT) 24 IU single dose·Drug: Placebo single dose; removed Drug: Intranasal Oxytocin (IN-OXT)·Drug: Placebo
    Contact Study contact changed: F•••@bwh.harvard.edu · •••3870→e•••@mgh.harvard.edu · •••3870. See the current contact
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Massachusetts General Hospital, Neuroendocrine Unit · Boston, United StatesContact f•••@bwh.harvard.edu · •••3870→e•••@mgh.harvard.edu · •••3870Contact added (no phone or email listed)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04789148
Lead sponsor
Elizabeth Austen Lawson
Collaborators
Tonix Pharmaceuticals, Inc.
Responsible party
Elizabeth Austen Lawson (Associate Professor of Medicine, Harvard Medical School; Director, Interdisciplinary Oxytocin Research Program, Neuroendocrine Unit, Massachusetts General Hospital, Massachusetts General Hospital) — Sponsor-investigator
First posted
Mar 9, 2021
Start date
Sep 10, 2025
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Oct 26, 2026

Study contacts

Elizabeth A Lawson, MD, MMSc
Contact
ealawson@mgh.harvard.edu
(617) 726-3870
Elisa Asanza, MSN, MPH
Contact
easanza@mgh.harvard.edu
617-726-3870
Elizabeth A Lawson, MD, MMSc
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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