Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus

Central Diabetes Insipidus Clinical Trial

Official title:

Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus - A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04789148
• Other study ID #: 2020P003071
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2022
• Source: Massachusetts General Hospital
• Contact: Elizabeth A Lawson, MD, MMSc
• Phone: (617) 726-3870
• Email: ealawson[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Diabetes Insipidus
• Diabetes Insipidus
• Diabetes Mellitus

Intervention

Drug:
• Oxytocin nasal spray
4 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo

Locations

Country	Name	City	State
United States	Massachusetts General Hospital, Neuroendocrine Unit	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Elizabeth Austen Lawson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	20 minutes following intervention at each main visit
Secondary	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.	20 minutes following intervention
Secondary	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.	30 minutes following intervention at each main visit
Secondary	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.	40 minutes following intervention at each main visit