Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04648137
Status:
COMPLETED
Last Update Posted:
2022-04-13
First Post:
2020-11-23
Brief Title:
Circulating Oxytocin Changes in Response to the Oxytocin System Stimulator MDMA in Patients With Diabetes Insipidus and Healthy Controls
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Circulating Oxytocin Changes in Response to the Oxytocin System Stimulator MDMA in Patients With Diabetes Insipidus and Healthy Controls
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OxyMA
Brief Summary:
This study is to evaluate oxytocin levels in response to MDMA administration as compared to placebo in patients with diabetes insipidus and healthy volunteers
Detailed Description:
Disruption of the hypothalamic-pituitary axis due to congenital abnormalities tumors or head trauma may cause anterior andor posterior pituitary deficiency also known as partial or panhypopituitarism Patients with hypopituitarism especially those with panhypopituitarism ie anterior and posterior insufficiency often report residual symptoms and lower quality of life despite adequate substitution treatment of deficient pituitary hormones A recent study identified a potential oxytocin deficient state in men with combined anterior and posterior deficiency Due to the close proximity of vasopressin and oxytocin disruption of the vasopressin system leading to diabetes insipidus could as well disturb the oxytocin system leading to low oxytocin levels It is therefore possible that the increased psychopathology and reduced quality of life as observed in patients with central diabetes insipidus is caused by an oxytocin deficiency Several studies documented marked acute increases in circulating oxytocin levels in response to 34-methylenedioxymethamphetamine MDMA administration as compared to placebo in healthy volunteers
MDMA could therefore be useful as a provocation test to detect an oxytocin deficiency in patients with central diabetes insipidus This study is to investigate if oxytocin provocation following a single dose administration of MDMA is reduced in patients with central diabetes insipidus as compared to healthy volunteers
MDMA could therefore be useful as a provocation test to detect an oxytocin deficiency in patients with central diabetes insipidus This study is to investigate if oxytocin provocation following a single dose administration of MDMA is reduced in patients with central diabetes insipidus as compared to healthy volunteers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None