Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364228
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-04-08
Brief Title:
Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The proposed study is a double-blind randomized placebo-controlled study of intranasal oxytocin OXT to determine its efficacy in improving quality of life and reducing stress in caregivers to persons with dementia Planned enrollment is 32 participants over 2 years
Detailed Description:
The overall aim of this study is to determine the efficacy and safety of intranasal oxytocin OXT to improve the quality of life and reduce chronic stress levels in the caregivers to the persons with dementia Randomized double-blind placebo-controlled clinical trial of intranasal oxytocin 12 or 24 IU will be conducted by daily administration once a day for 21 days 3 weeks
Endogenous neuropeptide oxytocin OXT has been a focus of prior psychiatric research based upon its role in pro-social behavior and modulation of response to socialemotional stimuli However currently there is no comprehensive study examining its role in the caregivers to chronic medicalpsychiatric illnesses including dementia for potential beneficial impact as well as reducing chronic stress levels
The current study aims to establish intranasal OXTs efficacy and safety for these clinical implications Investigators will also apply methods task related functional MRI that have shown verifiable and measurable ability to capture the core target area mPFC and amygdala and its change in response to OXT
This project will lead to progress in understanding the potential role of OXT on the relationship between caregiver and the person with chronic medicalpsychiatric illnesses such as dementia It will also guide future direction for clinical use of intranasal OXT for this critical population
Endogenous neuropeptide oxytocin OXT has been a focus of prior psychiatric research based upon its role in pro-social behavior and modulation of response to socialemotional stimuli However currently there is no comprehensive study examining its role in the caregivers to chronic medicalpsychiatric illnesses including dementia for potential beneficial impact as well as reducing chronic stress levels
The current study aims to establish intranasal OXTs efficacy and safety for these clinical implications Investigators will also apply methods task related functional MRI that have shown verifiable and measurable ability to capture the core target area mPFC and amygdala and its change in response to OXT
This project will lead to progress in understanding the potential role of OXT on the relationship between caregiver and the person with chronic medicalpsychiatric illnesses such as dementia It will also guide future direction for clinical use of intranasal OXT for this critical population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None