Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia
University of Nebraska
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.
Description
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 an…
Eligibility
- Age range
- 50+ years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 Exclusion Criteria: * Major medical illness that contraindicates oxytocin (OXT) administration (e.g., severe liver disease, seizure disorder, metabolic disorder) * History of all…
Interventions
- DrugPlacebo
Placebo intranasal spray liquid with no oxytocin will be delivered in 2 puffs to each nostril daily for 21 days. The first single dose will be administered at the clinic (Visit 1).
- DrugOxytocin Intranasal Spray 12 International Unit (12IU)
Participants weighing less than 40 kg (88 pounds) will receive 12 IU of oxytocin delivered as 1 puff (6 IU) to each nostril daily for 21 days. The first single dose will be administered at the clinic (Visit 1).
- DrugOxytocin Intranasal Spray 24 International Unit (24IU)
Participants weighing more than 40 kg (880 pounds) will receive 24 IU of oxytocin delivered as 2 puffs (12 IU) to each nostril daily for 21 days. The first single dose will be administered at the clinic (Visit 1).
- ProcedureFunctional MRI
Functional MRI (fMRI) scan with affective Stroop and Empathy and Theory of Mind task (EmpaTom task will administered pre- and post-administration of oxytocin.
Location
- University of Nebraska Medical Center, Department of PsychiatryOmaha, Nebraska