Vasopressin DeficiencyPhase 1NCT04789148
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
A Phase 1 study testing Intranasal Oxytocin (IN-OXT) in people with Vasopressin Deficiency, run by Elizabeth Austen Lawson at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasopressin Deficiency
- What is being tested?
- Intranasal Oxytocin (IN-OXT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2025to Jun 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and above
- Arginine-vasopressin deficiency
- Normal FT4 or T4
- Normal serum/plasma sodium
- Stable hormone replacement
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital, Neuroendocrine Unit
Boston, Massachusetts, 02114
Francesca Galbiati, MD, (617) 726-3870, fgalbiati@bwh.harvard.edu
Elisa Asanza, MSN, MPH, 617-726-3870, easanza@mgh.harvard.edu
About this study
Official title: Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency - A Pilot Study
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.
Read more
In Part A, thirty participants will be equally randomized to one of six possible groups:
- 6 IU oxytocin - 24 IU oxytocin - placebo
- 6 IU oxytocin - placebo - 24 IU oxytocin
- 24 IU oxytocin - 6 IU oxytocin - placebo
- 24 IU oxytocin - placebo - 6 IU oxytocin
- placebo - 6 IU oxytocin - 24 IU oxytocin
- 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
- Being tested
- Intranasal Oxytocin (IN-OXT), Placebo
- Keywords
- Hypopituitarism, posterior pituitary, oxytocin, psychopathology, anxiety, depressive symptoms, socioemotional functioning
- Medical subject headings
- Diabetes Insipidus, Neurogenic, Hypopituitarism, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal Oxytocin (IN-OXT)Drug
6 IU single dose
Intranasal Oxytocin (IN-OXT)Drug
IN-OXT 6 IU three times a day for 2 weeks
PlaceboDrug
Intranasal placebo three times a day for 2 weeks
Intranasal Oxytocin (IN-OXT)Drug
24 IU single dose
PlaceboDrug
placebo single dose
| Study group | Role | What they receive |
|---|---|---|
| Part A Arm 1 | Experimental | Main visit 1: 6 IU intranasal oxytocin; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: intranasal placebo Receives: Drug: Intranasal Oxytocin (IN-OXT); Drug: Placebo |
| Part A Arm 2 | Experimental | Main visit 1: 6 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 24 IU intranasal oxytocin Receives: Drug: Intranasal Oxytocin (IN-OXT); Drug: Placebo |
| Part A Arm 3 | Experimental | Main visit 1: 24 IU intranasal oxytocin; Main visit 2: 6 IU intranasal oxytocin; Main visit 3: intranasal placebo Receives: Drug: Intranasal Oxytocin (IN-OXT); Drug: Placebo |
| Part A Arm 4 | Experimental | Main visit 1: 24 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 6 IU intranasal oxytocin Receives: Drug: Intranasal Oxytocin (IN-OXT); Drug: Placebo |
| Part A Arm 5 | Experimental | Main visit 1: intranasal placebo; Main visit 2: 6 IU intranasal oxytocin; Main visit 3: 24 IU intranasal oxytocin Receives: Drug: Intranasal Oxytocin (IN-OXT); Drug: Placebo |
| Part A Arm 6 | Experimental | Main visit 1: intranasal placebo; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: 6 IU intranasal oxytocin Receives: Drug: Intranasal Oxytocin (IN-OXT); Drug: Placebo |
| Part B Arm 1 | Active comparator | Intranasal oxytocin 6 IU three times a day for 14 days Receives: Drug: Intranasal Oxytocin (IN-OXT) |
| Part B Arm 2 | Experimental | Intranasal placebo three times a day for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes following intervention at each main visit
Secondary outcomes (3)
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.
Measured: 20 minutes following intervention
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.
Measured: 30 minutes following intervention at each main visit
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.
Measured: 40 minutes following intervention at each main visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start10 Sep 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasopressin DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blind, placebo-controlled, single dose crossover study evaluating 2 different dose levels of intranasal oxytocin vs placebo (Part A), followed by Part B, an optional 2-week randomized, double-blind, placebo-controlled substudy investigating intranasal oxytocin 6 IU vs. placebo three times a day.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elizabeth Austen Lawson
- Sponsor type
- University, hospital or other
- Collaborators
- Tonix Pharmaceuticals, Inc.
- Responsible party
- Sponsor-investigator, Elizabeth Austen Lawson, Massachusetts General Hospital
- Investigators
- Elizabeth A Lawson, MD, MMSc, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789148
- Sponsor's protocol ID
- 2020P003071
- Status last verified
- Sep 2025
- First submitted
- 5 Mar 2021
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No