Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

More than 15 million family caregivers provide support for individuals with Alzheimer's disease (AD) or related dementias. This number is expected to grow with the increasing population of persons with dementia (PWD). Stress in caregivers to older adults with chronic diseases is already a significant public health issue because it is associated with multiple negative physical and mental health outcomes for the caregiver (e.g., depression, cardiovascular disease) and can negatively impact the health of the PWD as well. Importantly, stress levels are even higher in female than male caregivers and in caregivers to PWD than other chronic conditions that affect older adults. There are numerous interventions to improve well-being in caregivers to PWD, but only two have been shown to moderately improve caregiver depression and quality of life in the PWD. However, both of the interventions are time and energy intensive. One promising candidate to reduce stress and improve quality of life is the endogenous neuropeptide oxytocin (OXT). Intranasal OXT interventions have been shown to successfully reduce stress and increase quality of life in other populations, including patients with borderline personality disorder, Post-traumatic Stress Disorder (PTSD), Anxiety Disorder, and Depressive Disorder. This study will assess the efficacy and safety of intranasal oxytocin (OXT) to improve the quality of life and reduce chronic stress levels in the caregivers to PWD. Participants will be randomly enrolled to one of three groups: 12 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo. The study drug will be administered daily for 21 days.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 50
Healthy Volunteers: t
View:

• Females 50 years of age or older

• Currently an unpaid family caregiver to an older adult (50 years and older) with dementia for at least five hours a week for at least six months

• Normal or corrected to normal vision and hearing

• Mobility to travel to University of Nebraska Medical Center (UNMC) for study procedures including brain imaging

• Right-handed

• Capacity to read and write English

Locations
United States
Nebraska
University of Nebraska Medical Center, Department of Psychiatry
RECRUITING
Omaha
Contact Information
Primary
Soonjo Hwang, MD
soonjo.hwang@unmc.edu
402-552-6351
Backup
Minjoo Kang, MEd
mkang@unmc.edu
402-552-6239
Time Frame
Start Date: 2025-07-28
Estimated Completion Date: 2026-12
Participants
Target number of participants: 32
Treatments
Placebo_comparator: Intranasal Spray Placebo
Nasal spray of placebo liquid solution is administered as 2 puffs of daily dose (every morning) for 3 weeks. Functional magnetic resonance imaging (fMRI) scan will be done pre- and post-administration.
Active_comparator: Oxytocin Intranasal Spray 12 International Units
Nasal spray of Oxytocin 12 International Units (12IU) liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. Functional magnetic resonance imaging (fMRI) scan pre- and post-administration.
Active_comparator: Oxytocin Intranasal Spray 24 International Units
Nasal spray of Oxytocin 24 International Units (24IU) liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. Functional magnetic resonance imaging (fMRI) scan pre- and post-administration.
Sponsors
Leads: University of Nebraska

This content was sourced from clinicaltrials.gov