Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus

• Sponsor: Elizabeth Austen Lawson (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04789148
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 6
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 3.8

Study Details

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:

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

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Mar 31, 2023
• Anticipated Study Completion Date: Mar 31, 2023

Arms and Interventions

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

Primary Outcome Measures

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

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital, Neuroendocrine Unit	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Elizabeth Austen Lawson

Investigators

• Principal Investigator: Elizabeth A Lawson, MD, MMSc, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Mar 9, 2021
• Last Update Posted: May 2, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Elizabeth Austen Lawson, Associate Professor of Medicine, Harvard Medical School; Director, Interdisciplinary Oxytocin Research Program, Neuroendocrine Unit, Massachusetts General Hospital, Massachusetts General Hospital: Hypopituitarism; posterior pituitary; oxytocin; psychopathology; anxiety; depressive symptoms; socioemotional functioning
• Additional relevant MeSH terms: Diabetes Insipidus; Diabetes Insipidus, Neurogenic; Diabetes Mellitus; Oxytocin

Study Results

No Results Posted as of May 2, 2022