Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus
Central Diabetes Insipidus
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
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
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
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