Vasopressin DeficiencyPhase 1NCT04789148
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
A Phase 1 study testing Intranasal Oxytocin (IN-OXT) 6 IU single dose, Intranasal Oxytocin (IN-OXT) 6 IU repeat dose and Intranasal Oxytocin (IN-OXT) 24 IU single dose 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) 6 IU single dose, Intranasal Oxytocin (IN-OXT) 6 IU repeat dose and Intranasal Oxytocin (IN-OXT) 24 IU single dose
- 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
- Are there results?
- Not yet: the study is under way
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
- 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 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 clinically relevant ventricular arrhythmias, coronary heart disease, and hypertrophic cardiomyopathy
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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
Elizabeth A Lawson, MD, MMSc, (617) 726-3870, ealawson@mgh.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) 6 IU single dose, Intranasal Oxytocin (IN-OXT) 6 IU repeat dose, Placebo repeat dose, Intranasal Oxytocin (IN-OXT) 24 IU single dose, Placebo single dose
- 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) 6 IU single doseDrug
Part A: 6 IU single dose
Intranasal Oxytocin (IN-OXT) 6 IU repeat doseDrug
Part B: IN-OXT 6 IU three times a day for 2 weeks
Placebo repeat doseDrug
Part B: Intranasal placebo three times a day for 2 weeks
Intranasal Oxytocin (IN-OXT) 24 IU single doseDrug
Part A: 24 IU single dose
Placebo single doseDrug
Part A: placebo single dose
| Study group | Role | What they receive |
|---|---|---|
| Part A Arm 1 | Experimental | 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 Receives: Drug: Intranasal Oxytocin (IN-OXT) 6 IU single dose; Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose; Drug: Placebo repeat dose |
| Part A Arm 2 | Experimental | 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 Receives: Drug: Intranasal Oxytocin (IN-OXT) 6 IU single dose; Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose; Drug: Placebo repeat dose |
| Part A Arm 3 | Experimental | 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 Receives: Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose; Drug: Placebo repeat dose; Drug: Intranasal Oxytocin (IN-OXT) 24 IU single dose |
| Part A Arm 4 | Experimental | 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 Receives: Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose; Drug: Placebo repeat dose; Drug: Intranasal Oxytocin (IN-OXT) 24 IU single dose |
| Part A Arm 5 | Experimental | 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 Receives: Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose; Drug: Placebo repeat dose; Drug: Placebo single dose |
| Part A Arm 6 | Experimental | 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 Receives: Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose; Drug: Placebo repeat dose; Drug: Placebo single dose |
| Part B Arm 1 | Active comparator | Part B: Intranasal oxytocin 6 IU three times a day for 14 days Receives: Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose |
| Part B Arm 2 | Experimental | Part B: Intranasal placebo three times a day for 14 days Receives: Drug: Placebo repeat dose |
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
- Oct 2026
- First submitted
- 5 Mar 2021
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency - A Pilot Study
- ClinicalTrials.gov ID
- NCT04789148
- Acronym / sponsor ID
- 2020P003071
- Conditions
- Vasopressin Deficiency
- Keywords
- Hypopituitarism, posterior pituitary, oxytocin, psychopathology, anxiety, depressive symptoms, socioemotional functioning
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Elizabeth Austen LawsonUniversity, hospital or other
- Collaborators
- Tonix Pharmaceuticals, Inc.
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- 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.
| Arm | Type | Receives |
|---|---|---|
| Part A Arm 1 | Experimental | Drug: Intranasal Oxytocin (IN-OXT) 6 IU single dose, Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose, Drug: Placebo repeat dosePart A Main visit 1: 6 IU intranasal oxytocin; Part A Main visit 2: 24 IU intranasal oxytocin; Part A Main visit 3: intranasal placebo |
| Part A Arm 2 | Experimental | Drug: Intranasal Oxytocin (IN-OXT) 6 IU single dose, Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose, Drug: Placebo repeat dosePart A Main visit 1: 6 IU intranasal oxytocin; Part A Main visit 2: intranasal placebo; Part A Main visit 3: 24 IU intranasal oxytocin |
| Part A Arm 3 | Experimental | Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose, Drug: Placebo repeat dose, Drug: Intranasal Oxytocin (IN-OXT) 24 IU single dosePart A Main visit 1: 24 IU intranasal oxytocin; Part A Main visit 2: 6 IU intranasal oxytocin; Part A Main visit 3: intranasal placebo |
| Part A Arm 4 | Experimental | Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose, Drug: Placebo repeat dose, Drug: Intranasal Oxytocin (IN-OXT) 24 IU single dosePart A Main visit 1: 24 IU intranasal oxytocin; Part A Main visit 2: intranasal placebo; Part A Main visit 3: 6 IU intranasal oxytocin |
| Part A Arm 5 | Experimental | Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose, Drug: Placebo repeat dose, Drug: Placebo single dosePart A Main visit 1: intranasal placebo; Part A Main visit 2: 6 IU intranasal oxytocin; Part A Main visit 3: 24 IU intranasal oxytocin |
| Part A Arm 6 | Experimental | Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dose, Drug: Placebo repeat dose, Drug: Placebo single dosePart A Main visit 1: intranasal placebo; Part A Main visit 2: 24 IU intranasal oxytocin; Part A Main visit 3: 6 IU intranasal oxytocin |
| Part B Arm 1 | Active comparator | Drug: Intranasal Oxytocin (IN-OXT) 6 IU repeat dosePart B: Intranasal oxytocin 6 IU three times a day for 14 days |
| Part B Arm 2 | Experimental | Drug: Placebo repeat dosePart B: Intranasal placebo three times a day for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 and above
- Arginine-vasopressin deficiency
- Normal FT4
- Normal serum/plasma sodium
- Stable hormone replacement
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal Oxytocin (IN-OXT) 6 IU single dosePart A: 6 IU single dose | Drug | Part A Arm 1, Part A Arm 2 |
| Intranasal Oxytocin (IN-OXT) 6 IU repeat dosePart B: IN-OXT 6 IU three times a day for 2 weeks | Drug | Part A Arm 1, Part A Arm 2, Part A Arm 3, Part A Arm 4, Part A Arm 5, Part A Arm 6, Part B Arm 1 |
| Placebo repeat dosePart B: Intranasal placebo three times a day for 2 weeks | Drug | Part A Arm 1, Part A Arm 2, Part A Arm 3, Part A Arm 4, Part A Arm 5, Part A Arm 6, Part B Arm 2 |
| Intranasal Oxytocin (IN-OXT) 24 IU single dosePart A: 24 IU single dose | Drug | Part A Arm 3, Part A Arm 4 |
| Placebo single dosePart A: placebo single dose | Drug | Part A Arm 5, Part A Arm 6 |
Primary outcome
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.
3 secondary outcomes
Dot-probe task - anxious behavior between all three interventions
Time frame: 20 minutes following intervention
Depressive behavior - probabilistic reward task between all three interventions
Time frame: 30 minutes following intervention at each main visit
Socioemotional functioning - Emotion recognition task between all three interventions
Time frame: 40 minutes following intervention at each main visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth A Lawson, MD, MMSc principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intranasal Oxytocin (IN-OXT) 6 IU single dose, Intranasal Oxytocin (IN-OXT) 6 IU repeat dose and Intranasal Oxytocin (IN-OXT) 24 IU single dose in people with Vasopressin Deficiency, run by Elizabeth Austen Lawson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth A Lawson, MD, MMSc ((617) 726-3870, ealawson@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dot-probe task - anxious behavior between low dose oxytocin and placebo (time frame: 20 minutes following intervention at each main visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.