Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06036004
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2023-09-06
Brief Title:
Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus a Double-blind Randomised Placebo-controlled Trial the OxyTUTION Trial
Status:
RECRUITING
Status Verified Date:
2024-01
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:
OxyTUTION
Brief Summary:
This randomized placebo-controlled double-blind trial aims to investigate intranasal OXT as a novel therapeutical option in central diabetes insipidus cDI to improve psychological symptoms and socio-emotional functioning
Optionally patients can present for additional assessments in sub-studies
fMRI sub-study at day 14 2 days one additional visit
Social-stress sub-study at day 14 2 days one additional visit
Optionally patients can present for additional assessments in sub-studies
fMRI sub-study at day 14 2 days one additional visit
Social-stress sub-study at day 14 2 days one additional visit
Detailed Description:
Arginine vasopressin AVP and oxytocin OXT are hormones released into circulation from the posterior pituitary While AVP acts mainly in the kidneys and causes reuptake of free water OXT is well-known for its key role in the regulation of complex social-emotional functioning including attachment and pair bonding fear possessing emotion recognition and empathy
Disruption of the hypothalamic-pituitary axis can cause AVP deficiency
- known as central diabetes insipidus cDI - characterized by polyuria and polydipsia Once diagnosed desmopressin an AVP receptor analogue can be effectively used to treat diabetes insipidus However despite treatment with desmopressin patients often report residual psychological symptoms particularly heightened anxiety levels depressed mood impairment in social interactions leading to an overall reduced quality of life
Due to the anatomical proximity local disruptions of the AVP system could also disturb the OXT system leading to an additional OXT deficiency The additional OXT deficiency could explain at least partially the residual psychological deficits in patients with cDI OXT replacement therapy to improve psychological symptoms would have great clinical implications This randomized placebo-controlled double-blind trial aims to investigate intranasal OXT as a novel therapeutical option in cDI to improve psychological symptoms and socio-emotional functioning
Optional fMRI sub-study Participants will undergo a structural sequence to investigate grey and white matter anatomy T1- weighted Functional neuronal responses will be assessed through the surrogate of blood oxygenated level dependent BOLD signal an indirect measure of neural activity Three functional sequences echo planar imaging EPI will investigate group differences in various aspects of brain activity a resting state sequence and the EFMT
Optional Social-stress sub-study The three main components are an anticipation phase a 5-minute interview and a surprise mental arithmetic task Acute stress is measured by cortisol increase
Disruption of the hypothalamic-pituitary axis can cause AVP deficiency
- known as central diabetes insipidus cDI - characterized by polyuria and polydipsia Once diagnosed desmopressin an AVP receptor analogue can be effectively used to treat diabetes insipidus However despite treatment with desmopressin patients often report residual psychological symptoms particularly heightened anxiety levels depressed mood impairment in social interactions leading to an overall reduced quality of life
Due to the anatomical proximity local disruptions of the AVP system could also disturb the OXT system leading to an additional OXT deficiency The additional OXT deficiency could explain at least partially the residual psychological deficits in patients with cDI OXT replacement therapy to improve psychological symptoms would have great clinical implications This randomized placebo-controlled double-blind trial aims to investigate intranasal OXT as a novel therapeutical option in cDI to improve psychological symptoms and socio-emotional functioning
Optional fMRI sub-study Participants will undergo a structural sequence to investigate grey and white matter anatomy T1- weighted Functional neuronal responses will be assessed through the surrogate of blood oxygenated level dependent BOLD signal an indirect measure of neural activity Three functional sequences echo planar imaging EPI will investigate group differences in various aspects of brain activity a resting state sequence and the EFMT
Optional Social-stress sub-study The three main components are an anticipation phase a 5-minute interview and a surprise mental arithmetic task Acute stress is measured by cortisol increase
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