Actively Recruiting

Phase 2
Age: 50Years +
FEMALE
Healthy Volunteers
NCT06364228

Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia

Led by University of Nebraska · Updated on 2026-05-05

32

Participants Needed

1

Research Sites

49 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia

Who Can Participate

Age: 50Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 50 years or older
  • Currently an unpaid family caregiver to an older adult (50 years and older) with dementia
  • Providing care for at least five hours per week for at least six consecutive months
  • Normal or corrected vision and hearing
  • Able to travel to University of Nebraska Medical Center for study procedures including brain imaging
  • Right-handed
  • Able to read and write English
Not Eligible

You will not qualify if you...

  • Major medical illness that prevents oxytocin use (e.g., severe liver disease, seizure disorder, metabolic disorder)
  • History of allergic reaction to oxytocin or its nasal spray
  • History of central nervous system diseases such as seizure, epilepsy, CNS tumor, hemorrhage, serious infection like meningitis or encephalitis
  • Currently pregnant or planning pregnancy during the study
  • Presence of metal in the body or conditions preventing MRI scanning such as claustrophobia
  • Mini-mental status exam score of 25 or lower indicating possible cognitive issues
  • History or current neurological diseases (e.g., stroke, brain injury, brain tumor, dementia)
  • History or current severe psychiatric diseases (e.g., schizophrenia, bipolar disorder, autism, severe PTSD)
  • History or current drug or alcohol abuse
  • Currently breastfeeding
  • Current COVID-19 illness
  • Left-handedness
  • Currently taking antipsychotic medications, SSRIs, or corticosteroid creams/pills

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Nebraska Medical Center, Department of Psychiatry

Omaha, Nebraska, United States, 61898-5581

Actively Recruiting

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Research Team

S

Soonjo Hwang, MD

CONTACT

M

Minjoo Kang, MEd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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