Intranasal Oxytocin for Caregiver Stress

Phase 2

Waitlist Available

Led By Soonjo Hwang, MD

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 1 (baseline visit) and visit 2 (post-intervention visit). it will take about 60 minutes to complete at each time point.

Summary

This trial will test if a nasal spray called oxytocin can help improve the quality of life and reduce stress in caregivers of people with dementia. The study will involve 32 participants and will last for

Who is the study for?

This trial is for caregivers of individuals with dementia. Participants should be in good general health and able to undergo an MRI scan. Specific details about who can join are not provided, but typically there would be age limits and other health requirements.

What is being tested?

The study tests if a nasal spray containing oxytocin (at two different doses: 12IU or 24IU) can improve life quality and reduce stress compared to a placebo. It's double-blind, meaning neither the researchers nor participants know who gets oxytocin or placebo.

What are the potential side effects?

While specific side effects aren't listed here, intranasal oxytocin could potentially cause nasal irritation, headaches, changes in heart rate or blood pressure, emotional changes, or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 1 (baseline visit) and visit 2 (post-intervention visit). it will take about 60 minutes to complete at each time point.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 1 (baseline visit) and visit 2 (post-intervention visit). it will take about 60 minutes to complete at each time point.

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1 (baseline visit) and visit 2 (post-intervention visit). it will take about 60 minutes to complete at each time point. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Participants' chronic stress levels in the past thirty days.

Secondary study objectives

Blood Oxygen Level Dependent (BOLD) responses in neural areas during the Affective Stroop task (AS) and Empathy and Theory of Mind(EmpaToM) task.

Participant Quality of Life survey

Other study objectives

Alcohol Use Disorders Identification Test (AUDIT Alcohol Screening Tool)

Cognitive Orientation Screening

Geriatric Anxiety Scale (GAS-10)

+4 more

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Oxytocin Intranasal Spray 12 International Unit (IU)Active Control2 Interventions

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.

Group II: Oxytocin Intranasal Spray 24 International Unit (IU)Active Control2 Interventions

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.

Group III: Intranasal Spray PlaceboPlacebo Group2 Interventions

Nasal Spray of placebo liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. fMRI scan pre and post-administration.

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