Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus

Study Overview
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Brief Summary
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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

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

Conditions
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Central Diabetes Insipidus

Intervention / Treatment
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* Drug: Oxytocin nasal spray


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4 IU oxytocin - 24 IU oxytocin - placebo<br>Main visit 1: 4 IU intranasal oxytocin; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: intranasal placebo | Drug: Oxytocin nasal spray<br>* 4 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo<br>|
| Experimental: 4 IU oxytocin - placebo - 24 IU oxytocin<br>Main visit 1: 4 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 24 IU intranasal oxytocin | Drug: Oxytocin nasal spray<br>* 4 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo<br>|
| Experimental: 24 IU oxytocin - 4 IU oxytocin - placebo<br>Main visit 1: 24 IU intranasal oxytocin; Main visit 2: 4 IU intranasal oxytocin; Main visit 3: intranasal placebo | Drug: Oxytocin nasal spray<br>* 4 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo<br>|
| Experimental: 24 IU oxytocin - placebo - 4 IU oxytocin<br>Main visit 1: 24 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 4 IU intranasal oxytocin | Drug: Oxytocin nasal spray<br>* 4 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo<br>|
| Experimental: Placebo - 4 IU oxytocin - 24 IU oxytocin<br>Main visit 1: intranasal placebo; Main visit 2: 4 IU intranasal oxytocin; Main visit 3: 24 IU intranasal oxytocin | Drug: Oxytocin nasal spray<br>* 4 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo<br>|
| Experimental: Placebo - 24 IU oxytocin - 4 IU oxytocin<br>Main visit 1: intranasal placebo; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: 4 IU intranasal oxytocin | Drug: Oxytocin nasal spray<br>* 4 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depressive symptoms, Hypopituitarism, posterior pituitary, oxytocin, psychopathology, anxiety, socioemotional functioning