Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia

April 8, 2024 updated by: University of Nebraska
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 subjects over 2 years.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 social/emotional stimuli. However, currently there is no comprehensive study examining its role in the caregivers to chronic medical/psychiatric illnesses including dementia for potential beneficial impact as well as reducing chronic stress levels.

The current study aims to establish intranasal OXT's efficacy and safety for these clinical implications. We 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 medical/psychiatric illnesses such as dementia. It will also guide future direction for clinical use of intranasal OXT for this critical population.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Minjoo Kang, MEd
  • Phone Number: 402-552-6239
  • Email: mkang@unmc.edu

Study Contact Backup

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 61898-5581
        • University of Nebraska Medical Center, Department of Psychiatry
        • Principal Investigator:
          • Soonjo Hwang, MD
        • Contact:
        • Sub-Investigator:
          • Janelle N Beadle, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 UNMC for study procedures including brain imaging; Right-handed
  • Capacity to read and write in English

Exclusion Criteria:

  • Major medical illness that contraindicates oxytocin (OXT) administration (e.g., severe liver disease, seizure disorder, metabolic disorder)
  • Past history of allergic reaction to OXT and its nasal spray product
  • History of 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 in the next few weeks 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 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 our 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 COVID illness
  • Left-handed due to brain structural difference between right and left-handed individuals
  • Currently taking antiopsychotic medications, SSRI's or corticosteroid creams/pills.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Intranasal Spray Placebo
Nasal Spray of placebo liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. fMRI scan pre and post-administration.
Drug: Placebo
Placebo intranasal spray liquid administration. Oxytocin delivered 2 puffs to each nostril daily for 21 days. The first single dose will be administered at the clinic (visit 1).
Procedure: Functional MRI
Functional MRI (fMRI) scan with affective Stroop and EmpaTom task. fMRI scan will administered pre and post-administeration of oxytocin.
Other Names:
  • fMRI
Active Comparator: Oxytocin Intranasal Spray 12 International Unit (IU)
Nasal spray of Oxytocin 12 International Unit (12IU) liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. fMRI scan pre and post administration.
Procedure: Functional MRI
Functional MRI (fMRI) scan with affective Stroop and EmpaTom task. fMRI scan will administered pre and post-administeration of oxytocin.
Other Names:
  • fMRI
Drug: Oxytocin Intranasal Spray 12 International Unit (12IU)
Oxytocin intranasal spray liquid administration. Subjects weighing < 40 kg 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).
Other Names:
  • Oxytocin 12IU
Active Comparator: Oxytocin Intranasal Spray 24 International Unit (IU)
Nasal spray of Oxytocin 24 International Unit (12IU) liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. fMRI scan pre and post administration.
Procedure: Functional MRI
Functional MRI (fMRI) scan with affective Stroop and EmpaTom task. fMRI scan will administered pre and post-administeration of oxytocin.
Other Names:
  • fMRI
Drug: Oxytocin Intranasal Spray 24 International Unit (24IU)
Oxytocin intranasal spray liquid administration. Subjects weighing > 40 kg 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).
Other Names:
  • Oxytocin 24IU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants' chronic stress levels in the past thirty days.
Time Frame: 15 min
Will be assessed by the Perceived Stress Scale total score.
15 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Quality of Life survey
Time Frame: 15 min
Will be assessed by the Health Organization Quality of Life- Short version (WHO-QOL-BREF) which measures general perceptions about quality of life as well as four aspects of life: Physical health, psychological health, social relationships, and environment.
15 min
Blood Oxygen Level Dependent (BOLD) responses in neural areas during the Affective Stroop task (AS) and EmpaTom task.
Time Frame: 60 min
Neural level changes as measured by fMRI
60 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

  • Principal Investigator: Soonjo Hwang, MD, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Estimated)

April 15, 2024

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0133-24-FB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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