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Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus

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ClinicalTrials.gov Identifier: NCT04789148
Recruitment Status : Not yet recruiting
First Posted : March 9, 2021
Last Update Posted : December 7, 2021
Sponsor:
Information provided by (Responsible Party):
Elizabeth Austen Lawson, Massachusetts General Hospital

Study Description
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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:

  1. 4 IU oxytocin - 24 IU oxytocin - placebo
  2. 4 IU oxytocin - placebo - 24 IU oxytocin
  3. 24 IU oxytocin - 4 IU oxytocin - placebo
  4. 24 IU oxytocin - placebo - 4 IU oxytocin
  5. placebo - 4 IU oxytocin - 24 IU oxytocin
  6. placebo - 24 IU oxytocin - 4 IU oxytocin

Condition or disease Intervention/treatment Phase
Central Diabetes Insipidus Drug: Oxytocin nasal spray Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus - A Pilot Study
Estimated Study Start Date : February 2022
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arms and Interventions
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Arm Intervention/treatment
Experimental: 4 IU oxytocin - 24 IU oxytocin - placebo
Main visit 1: 4 IU intranasal oxytocin; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: intranasal placebo
 Drug: Oxytocin nasal spray
4 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo
Experimental: 4 IU oxytocin - placebo - 24 IU oxytocin
Main visit 1: 4 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 24 IU intranasal oxytocin
 Drug: Oxytocin nasal spray
4 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo
Experimental: 24 IU oxytocin - 4 IU oxytocin - placebo
Main visit 1: 24 IU intranasal oxytocin; Main visit 2: 4 IU intranasal oxytocin; Main visit 3: intranasal placebo
 Drug: Oxytocin nasal spray
4 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo
Experimental: 24 IU oxytocin - placebo - 4 IU oxytocin
Main visit 1: 24 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 4 IU intranasal oxytocin
 Drug: Oxytocin nasal spray
4 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo
Experimental: Placebo - 4 IU oxytocin - 24 IU oxytocin
Main visit 1: intranasal placebo; Main visit 2: 4 IU intranasal oxytocin; Main visit 3: 24 IU intranasal oxytocin
 Drug: Oxytocin nasal spray
4 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo
Experimental: Placebo - 24 IU oxytocin - 4 IU oxytocin
Main visit 1: intranasal placebo; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: 4 IU intranasal oxytocin
 Drug: Oxytocin nasal spray
4 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 4 IU oxytocin vs placebo in the dot-probe task.


Secondary Outcome Measures :
  1. Dot-probe task - anxious behavior between all three interventions [ Time Frame: 20 minutes following intervention ]
    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.

  2. Depressive behavior - probabilistic reward task between all three interventions [ Time Frame: 30 minutes following intervention at each main visit ]
    Response bias developed toward the more frequently reinforced alternative between 4 IU oxytocin, 24 IU oxytocin, and placebo in the probabilistic reward task.

  3. Socioemotional functioning - Emotion recognition task between all three interventions [ Time Frame: 40 minutes following intervention at each main visit ]
    Accuracy in identifying correct emotion between 4 IU oxytocin, 24 IU oxytocin, and placebo in the emotion recognition task.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04789148


Contacts
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Contact: Elizabeth A Lawson, MD, MMSc (617) 726-3870 ealawson@partners.org
Contact: Clara O Sailer, MD, PhD 617-724-2510 cosailer@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital, Neuroendocrine Unit
Boston, Massachusetts, United States, 02114
Contact: Elizabeth A Lawson, MD, MMSc    617-726-3870    ealawson@partners.org   
Contact: Clara O Sailer, MD, PhD    617-724-2510    cosailer@mgh.harvard.edu   
Sponsors and Collaborators
Elizabeth Austen Lawson
Investigators
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Principal Investigator: Elizabeth A Lawson, MD, MMSc Massachusetts General Hospital
More Information
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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
ClinicalTrials.gov Identifier: NCT04789148    
Other Study ID Numbers: 2020P003071
First Posted: March 9, 2021    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elizabeth Austen Lawson, Massachusetts General Hospital:
Hypopituitarism
posterior pituitary
oxytocin
psychopathology
 anxiety
depressive symptoms
socioemotional functioning
Additional relevant MeSH terms:
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Diabetes Insipidus
Diabetes Insipidus, Neurogenic
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
 Urologic Diseases
Pituitary Diseases
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs