StressPhase 2NCT06364228
Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia
A Phase 2 study testing Oxytocin Intranasal Spray 12 International Unit (12IU), Oxytocin Intranasal Spray 24 International Unit (24IU) and Functional MRI in people with Stress, run by University of Nebraska at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Oxytocin Intranasal Spray 12 International Unit (12IU), Oxytocin Intranasal Spray 24 International Unit (24IU) and Functional MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2026to Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Nebraska Medical Center, Department of Psychiatry
Omaha, Nebraska, 61898-5581
Chase Brice, B.S., 402-552-6239, cbrice@unmc.edu
Soonjo Hwang, MD
About this study
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.
Read the detailed description
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 a PWD than other chronic conditions that affect older adults. 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. 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.
Eligible females who are family caregivers to a PWD for a least five hours a week for six consecutive months 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. Surveys and questionnaires that evaluate mental and emotional health and functional magnetic resonance imaging (fMRI) will be administered before and after the study treatment to see if oxytocin will help improve quality of life better and lower stress levels in caregivers to people who have dementia. Additionally, the study will find out if the brain responds to oxytocin.
- Conditions
- Stress
- Being tested
- Placebo, Oxytocin Intranasal Spray 12 International Unit (12IU), Oxytocin Intranasal Spray 24 International Unit (24IU), Functional MRI
- Keywords
- Oxytocin, Stress level, Caregivers, Dementia, fMRI, Neuroimaging, Quality of Life
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo intranasal spray liquid with no oxytocin will be delivered in 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)Drug
Also called Oxytocin 12IU
Participants weighing less than 40 kg (88 pounds) 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)Drug
Also called Oxytocin 24IU
Participants weighing more than 40 kg (880 pounds) 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).
Functional MRIProcedure or surgery
Also called fMRI
Functional MRI (fMRI) scan with affective Stroop and Empathy and Theory of Mind task (EmpaTom task will administered pre- and post-administration of oxytocin.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Spray Placebo | Placebo comparator | Nasal spray of placebo liquid solution is administered as 2 puffs of daily dose (every morning) for 3 weeks. Functional magnetic resonance imaging (fMRI) scan will be done pre- and post-administration. Receives: Drug: Placebo; Procedure: Functional MRI |
| Oxytocin Intranasal Spray 12 International Units | Active comparator | Nasal spray of Oxytocin 12 International Units (12IU) liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. Functional magnetic resonance imaging (fMRI) scan pre- and post-administration. Receives: Drug: Oxytocin Intranasal Spray 12 International Unit (12IU); Procedure: Functional MRI |
| Oxytocin Intranasal Spray 24 International Units | Active comparator | Nasal spray of Oxytocin 24 International Units (24IU) liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. Functional magnetic resonance imaging (fMRI) scan pre- and post-administration. Receives: Drug: Oxytocin Intranasal Spray 24 International Unit (24IU); Procedure: Functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Stress Level in the Past Thirty Days
Participant's chronic ctress levels in the past thirty Days will be assessed by the Perceived Stress Scale (PSS) which asks ten questions about participant stress within the last 30 days. The questions are scored from 0 ("never") to 4 ("very often) with specific items needing to be reverse scored. Higher scores indicate higher levels of perceived stress (a worse outcome). The instrument takes about 5 minutes to complete.
Measured: Baseline (Visit 1) and Post-intervention (Visit 2)
Secondary outcomes (2)
Participant Quality of Life
Participant quality of life will be assessed by the Health Organization Quality of Life- Short version (WHO-QOL-BREF) survey which measures general perceptions about quality of life in four aspects: physical health, psychological health, social relationships, and environment. The aspects are scored from 1 ('very poor') to 5 ('very good'). Aspect scores are totaled with higher scores indicating a better outcome. The instrument takes about 15 minutes to complete.
Measured: Baseline (Visit 1) and Post-intervention (Visit 2)
Blood Oxygen Level Dependent (BOLD) responses in neural areas during the Affective Stroop task (AS) and Empathy and Theory of Mind(EmpaToM) task
Neural level changes will be measured by Functional Magnetic Resonance Imaging (fMRI).
Measured: Baseline (Visit 1) and Post-intervention (Visit 2) It will take about 60 minutes to complete at each time point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start20 Dec 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soonjo Hwang, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364228
- Sponsor's protocol ID
- 0133-24-FB
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alzheimers Association. 2015 Alzheimers Disease Facts and Figures. (2015).
Pinquart M, Sorensen S. Differences between caregivers and noncaregivers in psychological health and physical health: a meta-analysis. Psychol Aging. 2003 Jun;18(2):250-67. doi: 10.1037/0882-7974.18.2.250.
PubMed 12825775Peavy G, Mayo AM, Avalos C, Rodriguez A, Shifflett B, Edland SD. Perceived Stress in Older Dementia Caregivers: Mediation by Loneliness and Depression. Am J Alzheimers Dis Other Demen. 2022 Jan-Dec;37:15333175211064756. doi: 10.1177/15333175211064756.
PubMed 34986661Sheehan OC, Haley WE, Howard VJ, Huang J, Rhodes JD, Roth DL. Stress, Burden, and Well-Being in Dementia and Nondementia Caregivers: Insights From the Caregiving Transitions Study. Gerontologist. 2021 Jul 13;61(5):670-679. doi: 10.1093/geront/gnaa108.
PubMed 32816014Bouchard K, Greenman PS, Pipe A, Johnson SM, Tulloch H. Reducing Caregiver Distress and Cardiovascular Risk: A Focus on Caregiver-Patient Relationship Quality. Can J Cardiol. 2019 Oct;35(10):1409-1411. doi: 10.1016/j.cjca.2019.05.007. Epub 2019 Sep 9.
PubMed 31515084Losada-Baltar A, Vara-Garcia C, Pedroso-Chaparro MDS, Cabrera I, Jimenez-Gonzalo L, Fernandes-Pires J, Huertas-Domingo C, Barrera-Caballero S, Gallego-Alberto L, Romero-Moreno R, Marquez-Gonzalez M. Family caregivers of people with dementia in the context of the sociocultural stress and coping model: An examination of gender differences. J Women Aging. 2023 Jul-Aug;35(4):354-368. doi: 10.1080/08952841.2022.2052705. Epub 2022 Mar 26.
PubMed 35343403Riffin C, Van Ness PH, Wolff JL, Fried T. Multifactorial Examination of Caregiver Burden in a National Sample of Family and Unpaid Caregivers. J Am Geriatr Soc. 2019 Feb;67(2):277-283. doi: 10.1111/jgs.15664. Epub 2018 Nov 19.
PubMed 30452088Marques MJ, Tan EYL, Woods B, Jelley H, Kerpershoek L, Hopper L, Irving K, Bieber A, Stephan A, Skoldunger A, Sjolund BM, Selbaek G, Rosvik J, Zanetti O, Portolani DM, Maroco J, de Vugt M, Verhey F, Goncalves-Pereira M; Actifcare Consortium. Trajectories of relationship quality in dementia: a longitudinal study in eight European countries. Aging Ment Health. 2022 Nov;26(11):2307-2315. doi: 10.1080/13607863.2021.1969641. Epub 2021 Sep 6.
PubMed 34486887National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Care Services; Board on Health Sciences Policy; Committee on Care Interventions for Individuals with Dementia and Their Caregivers; Stroud C, Larson EB, editors. Meeting the Challenge of Caring for Persons Living with Dementia and Their Care Partners and Caregivers: A Way Forward. Washington (DC): National Academies Press (US); 2021 Feb 23. Available from http://www.ncbi.nlm.nih.gov/books/NBK567818/
PubMed 33625814Butler M, et al. Care Interventions for People Living With Dementia and Their Caregivers. Comparative Effectiveness Review No. 231. (Prepared by the Minnesota Evidence-based Practice Center under Contract No. 290-2015-00008-I.) AHRQ Publication No. 20-EHC023. Rockville, MD: Agency for Healthcare Research and Quality; August 2020. Errata December 2020. DOI: https://doi.org/10.23970/AHRQEPCCER231.
Cochran DM, Fallon D, Hill M, Frazier JA. The role of oxytocin in psychiatric disorders: a review of biological and therapeutic research findings. Harv Rev Psychiatry. 2013 Sep-Oct;21(5):219-47. doi: 10.1097/HRP.0b013e3182a75b7d.
PubMed 24651556Viero C, Shibuya I, Kitamura N, Verkhratsky A, Fujihara H, Katoh A, Ueta Y, Zingg HH, Chvatal A, Sykova E, Dayanithi G. REVIEW: Oxytocin: Crossing the bridge between basic science and pharmacotherapy. CNS Neurosci Ther. 2010 Oct;16(5):e138-56. doi: 10.1111/j.1755-5949.2010.00185.x. Epub 2010 Jul 7.
PubMed 20626426Simeon D, Bartz J, Hamilton H, Crystal S, Braun A, Ketay S, Hollander E. Oxytocin administration attenuates stress reactivity in borderline personality disorder: a pilot study. Psychoneuroendocrinology. 2011 Oct;36(9):1418-21. doi: 10.1016/j.psyneuen.2011.03.013. Epub 2011 May 4.
PubMed 21546164Olff M, Frijling JL, Kubzansky LD, Bradley B, Ellenbogen MA, Cardoso C, Bartz JA, Yee JR, van Zuiden M. The role of oxytocin in social bonding, stress regulation and mental health: an update on the moderating effects of context and interindividual differences. Psychoneuroendocrinology. 2013 Sep;38(9):1883-94. doi: 10.1016/j.psyneuen.2013.06.019. Epub 2013 Jul 12.
PubMed 23856187De Cagna F, Fusar-Poli L, Damiani S, Rocchetti M, Giovanna G, Mori A, Politi P, Brondino N. The Role of Intranasal Oxytocin in Anxiety and Depressive Disorders: A Systematic Review of Randomized Controlled Trials. Clin Psychopharmacol Neurosci. 2019 Feb 28;17(1):1-11. doi: 10.9758/cpn.2019.17.1.1.
PubMed 30690935
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia
- ClinicalTrials.gov ID
- NCT06364228
- Acronym / sponsor ID
- 0133-24-FB
- Conditions
- Stress
- Keywords
- Oxytocin, Stress level, Caregivers, Dementia, fMRI, Neuroimaging, Quality of Life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 20 Dec 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 a PWD than other chronic conditions that affect older adults. 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. 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.
Eligible females who are family caregivers to a PWD for a least five hours a week for six consecutive months 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. Surveys and questionnaires that evaluate mental and emotional health and functional magnetic resonance imaging (fMRI) will be administered before and after the study treatment to see if oxytocin will help improve quality of life better and lower stress levels in caregivers to people who have dementia. Additionally, the study will find out if the brain responds to oxytocin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Randomized, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intranasal Spray Placebo | Placebo comparator | Drug: Placebo, Procedure: Functional MRINasal spray of placebo liquid solution is administered as 2 puffs of daily dose (every morning) for 3 weeks. Functional magnetic resonance imaging (fMRI) scan will be done pre- and post-administration. |
| Oxytocin Intranasal Spray 12 International Units | Active comparator | Drug: Oxytocin Intranasal Spray 12 International Unit (12IU), Procedure: Functional MRINasal spray of Oxytocin 12 International Units (12IU) liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. Functional magnetic resonance imaging (fMRI) scan pre- and post-administration. |
| Oxytocin Intranasal Spray 24 International Units | Active comparator | Drug: Oxytocin Intranasal Spray 24 International Unit (24IU), Procedure: Functional MRINasal spray of Oxytocin 24 International Units (24IU) liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. Functional magnetic resonance imaging (fMRI) scan pre- and post-administration. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo intranasal spray liquid with no oxytocin will be delivered in 2 puffs to each nostril daily for 21 days. The first single dose will be administered at the clinic (Visit 1). | Drug | Intranasal Spray Placebo |
| Oxytocin Intranasal Spray 12 International Unit (12IU)Also: Oxytocin 12IUParticipants weighing less than 40 kg (88 pounds) 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). | Drug | Oxytocin Intranasal Spray 12 International Units |
| Oxytocin Intranasal Spray 24 International Unit (24IU)Also: Oxytocin 24IUParticipants weighing more than 40 kg (880 pounds) 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). | Drug | Oxytocin Intranasal Spray 24 International Units |
| Functional MRIAlso: fMRIFunctional MRI (fMRI) scan with affective Stroop and Empathy and Theory of Mind task (EmpaTom task will administered pre- and post-administration of oxytocin. | Procedure or surgery | Intranasal Spray Placebo, Oxytocin Intranasal Spray 12 International Units, Oxytocin Intranasal Spray 24 International Units |
Primary outcome
Chronic Stress Level in the Past Thirty Days
Time frame: Baseline (Visit 1) and Post-intervention (Visit 2)
Participant's chronic ctress levels in the past thirty Days will be assessed by the Perceived Stress Scale (PSS) which asks ten questions about participant stress within the last 30 days. The questions are scored from 0 ("never") to 4 ("very often) with specific items needing to be reverse scored. Higher scores indicate higher levels of perceived stress (a worse outcome). The instrument takes about 5 minutes to complete.
2 secondary outcomes
Participant Quality of Life
Time frame: Baseline (Visit 1) and Post-intervention (Visit 2)
Blood Oxygen Level Dependent (BOLD) responses in neural areas during the Affective Stroop task (AS) and Empathy and Theory of Mind(EmpaToM) task
Time frame: Baseline (Visit 1) and Post-intervention (Visit 2) It will take about 60 minutes to complete at each time point.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- BackgroundAlzheimers Association. 2015 Alzheimers Disease Facts and Figures. (2015).
- Background: PubMed 12825775Pinquart M, Sorensen S. Differences between caregivers and noncaregivers in psychological health and physical health: a meta-analysis. Psychol Aging. 2003 Jun;18(2):250-67. doi: 10.1037/0882-7974.18.2.250.
- Background: PubMed 34986661Peavy G, Mayo AM, Avalos C, Rodriguez A, Shifflett B, Edland SD. Perceived Stress in Older Dementia Caregivers: Mediation by Loneliness and Depression. Am J Alzheimers Dis Other Demen. 2022 Jan-Dec;37:15333175211064756. doi: 10.1177/15333175211064756.
- Background: PubMed 32816014Sheehan OC, Haley WE, Howard VJ, Huang J, Rhodes JD, Roth DL. Stress, Burden, and Well-Being in Dementia and Nondementia Caregivers: Insights From the Caregiving Transitions Study. Gerontologist. 2021 Jul 13;61(5):670-679. doi: 10.1093/geront/gnaa108.
- Background: PubMed 31515084Bouchard K, Greenman PS, Pipe A, Johnson SM, Tulloch H. Reducing Caregiver Distress and Cardiovascular Risk: A Focus on Caregiver-Patient Relationship Quality. Can J Cardiol. 2019 Oct;35(10):1409-1411. doi: 10.1016/j.cjca.2019.05.007. Epub 2019 Sep 9.
- Background: PubMed 35343403Losada-Baltar A, Vara-Garcia C, Pedroso-Chaparro MDS, Cabrera I, Jimenez-Gonzalo L, Fernandes-Pires J, Huertas-Domingo C, Barrera-Caballero S, Gallego-Alberto L, Romero-Moreno R, Marquez-Gonzalez M. Family caregivers of people with dementia in the context of the sociocultural stress and coping model: An examination of gender differences. J Women Aging. 2023 Jul-Aug;35(4):354-368. doi: 10.1080/08952841.2022.2052705. Epub 2022 Mar 26.
- Background: PubMed 30452088Riffin C, Van Ness PH, Wolff JL, Fried T. Multifactorial Examination of Caregiver Burden in a National Sample of Family and Unpaid Caregivers. J Am Geriatr Soc. 2019 Feb;67(2):277-283. doi: 10.1111/jgs.15664. Epub 2018 Nov 19.
- Background: PubMed 34486887Marques MJ, Tan EYL, Woods B, Jelley H, Kerpershoek L, Hopper L, Irving K, Bieber A, Stephan A, Skoldunger A, Sjolund BM, Selbaek G, Rosvik J, Zanetti O, Portolani DM, Maroco J, de Vugt M, Verhey F, Goncalves-Pereira M; Actifcare Consortium. Trajectories of relationship quality in dementia: a longitudinal study in eight European countries. Aging Ment Health. 2022 Nov;26(11):2307-2315. doi: 10.1080/13607863.2021.1969641. Epub 2021 Sep 6.
- Background: PubMed 33625814National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Care Services; Board on Health Sciences Policy; Committee on Care Interventions for Individuals with Dementia and Their Caregivers; Stroud C, Larson EB, editors. Meeting the Challenge of Caring for Persons Living with Dementia and Their Care Partners and Caregivers: A Way Forward. Washington (DC): National Academies Press (US); 2021 Feb 23. Available from http://www.ncbi.nlm.nih.gov/books/NBK567818/
- BackgroundButler M, et al. Care Interventions for People Living With Dementia and Their Caregivers. Comparative Effectiveness Review No. 231. (Prepared by the Minnesota Evidence-based Practice Center under Contract No. 290-2015-00008-I.) AHRQ Publication No. 20-EHC023. Rockville, MD: Agency for Healthcare Research and Quality; August 2020. Errata December 2020. DOI: https://doi.org/10.23970/AHRQEPCCER231.
- Background: PubMed 24651556Cochran DM, Fallon D, Hill M, Frazier JA. The role of oxytocin in psychiatric disorders: a review of biological and therapeutic research findings. Harv Rev Psychiatry. 2013 Sep-Oct;21(5):219-47. doi: 10.1097/HRP.0b013e3182a75b7d.
- Background: PubMed 20626426Viero C, Shibuya I, Kitamura N, Verkhratsky A, Fujihara H, Katoh A, Ueta Y, Zingg HH, Chvatal A, Sykova E, Dayanithi G. REVIEW: Oxytocin: Crossing the bridge between basic science and pharmacotherapy. CNS Neurosci Ther. 2010 Oct;16(5):e138-56. doi: 10.1111/j.1755-5949.2010.00185.x. Epub 2010 Jul 7.
- Individual participant dataSharing planned: No
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Soonjo Hwang, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin Intranasal Spray 12 International Unit (12IU), Oxytocin Intranasal Spray 24 International Unit (24IU) and Functional MRI in people with Stress, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soonjo Hwang, MD (402-552-6351, soonjo.hwang@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Stress Level in the Past Thirty Days (time frame: Baseline (Visit 1) and Post-intervention (Visit 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06364228, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.