Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia

Stress Clinical Trial

Official title:

Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06364228
• Other study ID #: 0133-24-FB
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Est. completion date: April 2026

Study information

• Verified date: April 2024
• Source: University of Nebraska
• Contact: Soonjo Hwang, MD
• Phone: 402-552-6351
• Email: soonjo.hwang[@]unmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Stress

Intervention

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).
• 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).
• 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).

Procedure:
• Functional MRI
Functional MRI (fMRI) scan with affective Stroop and EmpaTom task. fMRI scan will administered pre and post-administeration of oxytocin.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center, Department of Psychiatry	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants' chronic stress levels in the past thirty days.	Will be assessed by the Perceived Stress Scale total score.	15 min
Secondary	Participant Quality of Life survey	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
Secondary	Blood Oxygen Level Dependent (BOLD) responses in neural areas during the Affective Stroop task (AS) and EmpaTom task.	Neural level changes as measured by fMRI	60 min