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Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia

University of Nebraska · NCT06364228

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 50+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
32
US sites recruiting
1
Study start
June 20, 2026
Record last updated
May 5, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Placebo; Oxytocin Intranasal Spray 12 International Unit (12IU); Oxytocin Intranasal Spray 24 International Unit (24IU); Functional MRI

Conditions: Stress

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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 allergic reaction to oxytocin (OXT) and its nasal spray product
  • History of central nervous system (CNS) disease, including history of seizure, epilepsy, CNS tumor, CNS hemorrhage, or serious CNS infection including meningitis or encephalitis
  • Currently pregnant or planning to become pregnant during the course of the study
  • Metal in the body (i.e., hearing aid, cardiac pacemaker, bone plates, braces, non-removable piercing/implants, etc.), claustrophobia, or any other condition that would preclude magnetic resonance imaging (MRI) scanning
  • Mini-mental status exam score of 25 or lower which suggests possible cognitive issues
  • History of or current neurological disease (e.g., stroke, traumatic brain injury, brain tumor, dementia)
  • History of or current severe psychiatric disease (e.g., schizophrenia, bipolar disorder, autism, severe post-traumatic stress disorder)
  • History of, or current drug or alcohol abuse
  • Currently breastfeeding
  • Current coronavirus disease-19 (COVID-19) illness
  • Left-handed due to brain structural difference between right and left-handed individuals
  • Currently taking antipsychotic medications, selective serotonin reuptake inhibitors (SSRIs) or corticosteroid creams/pills

Recruiting US locations

  • University of Nebraska Medical Center, Department of Psychiatry

    Omaha, NE 61898-5581

    Site contact: Chase Brice, B.S. · 402-552-6239 · cbrice@unmc.edu

Study contacts (from the official record)

  • Soonjo Hwang, MD · 402-552-6351 · soonjo.hwang@unmc.edu
  • Minjoo Kang, MEd · 402-552-6239 · mkang@unmc.edu
All neurology studies in Nebraska →
Intranasal Oxytocin Intervention for Caregivers to Persons With… (NCT06364228) | Bored Studies