Back to resultsEffects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus
Primary Purpose
Central Diabetes Insipidus
Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxytocin nasal spray
Sponsored by
About this trial
This is an interventional basic science trial for Central Diabetes Insipidus focused on measuring Hypopituitarism, posterior pituitary, oxytocin, psychopathology, anxiety, depressive symptoms, socioemotional functioning
Eligibility Criteria
Inclusion Criteria:
- Central diabetes insipidus (based on routine clinical practice, e.g., clinical symptoms, serum and urinary sodium and osmolality levels or the water deprivation test)
- Normal FT4 or T4
- Stable hormone replacement (no change in dose of hormone replacement in six weeks prior to baseline)
Exclusion Criteria:
- Active substance use disorder within the last 6 months
- History of psychosis
- Current suicidal ideation
- Medication changes within 4 weeks of enrollment or during the study
- History of cardiac disease, including arrhythmias, coronary heart disease, coronary artery spasms, valvular heart disease, hypertrophic cardiomyopathy (hypertension is not exclusionary)
- Hyponatremia
- Creatinine >1.5mg/dL.
- ALT or AST >2.5x upper limit of normal
- Hematocrit less than 2% below the norm
- 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)
- Received an investigational drug or medical device in the past 30 days or within 5 half-lives of main study visit or be concurrently enrolled in another investigational product clinical trial.
- Any significant illness or condition that the Investigator determines could interfere with study participation, data collection, or safety
Sites / Locations
- Massachusetts General Hospital, Neuroendocrine Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
4 IU oxytocin - 24 IU oxytocin - placebo
4 IU oxytocin - placebo - 24 IU oxytocin
24 IU oxytocin - 4 IU oxytocin - placebo
24 IU oxytocin - placebo - 4 IU oxytocin
Placebo - 4 IU oxytocin - 24 IU oxytocin
Placebo - 24 IU oxytocin - 4 IU oxytocin
Arm Description
Main visit 1: 4 IU intranasal oxytocin; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: intranasal placebo
Main visit 1: 4 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 24 IU intranasal oxytocin
Main visit 1: 24 IU intranasal oxytocin; Main visit 2: 4 IU intranasal oxytocin; Main visit 3: intranasal placebo
Main visit 1: 24 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 4 IU intranasal oxytocin
Main visit 1: intranasal placebo; Main visit 2: 4 IU intranasal oxytocin; Main visit 3: 24 IU intranasal oxytocin
Main visit 1: intranasal placebo; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: 4 IU intranasal oxytocin
Outcomes
Primary Outcome Measures
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 4 IU oxytocin vs placebo in the dot-probe task.
Secondary Outcome Measures
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 4 IU oxytocin, 24 IU oxytocin, and placebo in the dot-probe task.
Depressive behavior - probabilistic reward task between all three interventions
Response bias developed toward the more frequently reinforced alternative between 4 IU oxytocin, 24 IU oxytocin, and placebo in the probabilistic reward task.
Socioemotional functioning - Emotion recognition task between all three interventions
Accuracy in identifying correct emotion between 4 IU oxytocin, 24 IU oxytocin, and placebo in the emotion recognition task.
Full Information
NCT ID
NCT04789148
First Posted
March 5, 2021
Last Updated
November 30, 2022
Sponsor
Elizabeth Austen Lawson
1. Study Identification
Unique Protocol Identification Number
NCT04789148
Brief Title
Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus
Official Title
Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus - A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elizabeth Austen Lawson
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized, double-blind, placebo-controlled crossover pilot study of single-dose intranasal oxytocin (4 IU and 24 IU) in 18-60-year-old men and women with central diabetes insipidus to evaluate the effect of oxytocin on anxiety, depression and socioemotional functioning.
Following a screening visit to determine eligibility, participants will return for three main study visits. During the main study visits, study participants will receive either oxytocin or placebo, followed by assessments of emotional behavior.
Thirty participants will be equally randomized to one of six possible drug orders:
4 IU oxytocin - 24 IU oxytocin - placebo
4 IU oxytocin - placebo - 24 IU oxytocin
24 IU oxytocin - 4 IU oxytocin - placebo
24 IU oxytocin - placebo - 4 IU oxytocin
placebo - 4 IU oxytocin - 24 IU oxytocin
placebo - 24 IU oxytocin - 4 IU oxytocin
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Diabetes Insipidus
Keywords
Hypopituitarism, posterior pituitary, oxytocin, psychopathology, anxiety, depressive symptoms, socioemotional functioning
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
4 IU oxytocin - 24 IU oxytocin - placebo
Arm Type
Experimental
Arm Description
Main visit 1: 4 IU intranasal oxytocin; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: intranasal placebo
Arm Title
4 IU oxytocin - placebo - 24 IU oxytocin
Arm Type
Experimental
Arm Description
Main visit 1: 4 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 24 IU intranasal oxytocin
Arm Title
24 IU oxytocin - 4 IU oxytocin - placebo
Arm Type
Experimental
Arm Description
Main visit 1: 24 IU intranasal oxytocin; Main visit 2: 4 IU intranasal oxytocin; Main visit 3: intranasal placebo
Arm Title
24 IU oxytocin - placebo - 4 IU oxytocin
Arm Type
Experimental
Arm Description
Main visit 1: 24 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 4 IU intranasal oxytocin
Arm Title
Placebo - 4 IU oxytocin - 24 IU oxytocin
Arm Type
Experimental
Arm Description
Main visit 1: intranasal placebo; Main visit 2: 4 IU intranasal oxytocin; Main visit 3: 24 IU intranasal oxytocin
Arm Title
Placebo - 24 IU oxytocin - 4 IU oxytocin
Arm Type
Experimental
Arm Description
Main visit 1: intranasal placebo; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: 4 IU intranasal oxytocin
Intervention Type
Drug
Intervention Name(s)
Oxytocin nasal spray
Intervention Description
4 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo
Primary Outcome Measure Information:
Title
Dot-probe task - anxious behavior between low dose oxytocin and placebo
Description
Difference in response times (in milliseconds) to dots appearing in the location of the previously shown negative versus the neutral face between 4 IU oxytocin vs placebo in the dot-probe task.
Time Frame
20 minutes following intervention at each main visit
Secondary Outcome Measure Information:
Title
Dot-probe task - anxious behavior between all three interventions
Description
Difference in response time (in milliseconds) to dots appearing in the location of the previously shown negative versus neutral face between 4 IU oxytocin, 24 IU oxytocin, and placebo in the dot-probe task.
Time Frame
20 minutes following intervention
Title
Depressive behavior - probabilistic reward task between all three interventions
Description
Response bias developed toward the more frequently reinforced alternative between 4 IU oxytocin, 24 IU oxytocin, and placebo in the probabilistic reward task.
Time Frame
30 minutes following intervention at each main visit
Title
Socioemotional functioning - Emotion recognition task between all three interventions
Description
Accuracy in identifying correct emotion between 4 IU oxytocin, 24 IU oxytocin, and placebo in the emotion recognition task.
Time Frame
40 minutes following intervention at each main visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Central diabetes insipidus (based on routine clinical practice, e.g., clinical symptoms, serum and urinary sodium and osmolality levels or the water deprivation test)
Normal FT4 or T4
Stable hormone replacement (no change in dose of hormone replacement in six weeks prior to baseline)
Exclusion Criteria:
Active substance use disorder within the last 6 months
History of psychosis
Current suicidal ideation
Medication changes within 4 weeks of enrollment or during the study
History of cardiac disease, including arrhythmias, coronary heart disease, coronary artery spasms, valvular heart disease, hypertrophic cardiomyopathy (hypertension is not exclusionary)
Hyponatremia
Creatinine >1.5mg/dL.
ALT or AST >2.5x upper limit of normal
Hematocrit less than 2% below the norm
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)
Received an investigational drug or medical device in the past 30 days or within 5 half-lives of main study visit or be concurrently enrolled in another investigational product clinical trial.
Any significant illness or condition that the Investigator determines could interfere with study participation, data collection, or safety
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth A Lawson, MD, MMSc
Phone
(617) 726-3870
Email
ealawson@partners.org
First Name & Middle Initial & Last Name or Official Title & Degree
Clara O Sailer, MD, PhD
Phone
617-724-2510
Email
cosailer@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Lawson, MD, MMSc
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital, Neuroendocrine Unit
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Lawson, MD, MMSc
Phone
617-726-3870
Email
ealawson@partners.org
First Name & Middle Initial & Last Name & Degree
Clara O Sailer, MD, PhD
Phone
617-724-2510
Email
cosailer@mgh.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus
We'll reach out to this number within 24 hrs