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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


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04789148
Study type Interventional
Source Massachusetts General Hospital
Contact Elizabeth A Lawson, MD, MMSc
Phone (617) 726-3870
Email ealawson@partners.org
Status Not yet recruiting
Phase Phase 1
Start date June 2023
Completion date June 30, 2025

See also
  Status Clinical Trial Phase
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Recruiting NCT03474601 - Seoul National University Pituitary Disease Cohort Study
Completed NCT04902235 - Identification and Clinical Relevance of an Oxytocin Deficient State (CRH Study) Phase 4
Completed NCT01280188 - A Study of Minirin Melt in Japanese Patients With Central Diabetes Insipidus (CDI). Phase 3
Completed NCT05319301 - Identification and Clinical Relevance of an Oxytocin Deficient State (Melatonin Study) N/A