Clinical Trial: Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus
Study Status: NOT_YET_RECRUITING
Recruit Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Official Title: Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus - A Pilot Study
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:
- 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
Detailed Summary:
Sponsor: Elizabeth Austen Lawson
Current Primary Outcome: 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.
Original Primary Outcome: 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.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Massachusetts General Hospital
Dates:
Date Received: March 05, 2021
Date Started: June 01, 2023
Date Completion: June 01, 2023
Last Updated: November 30, 2022
Last Verified: November 01, 2022
