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NCT06364228 · ClinicalTrials.gov registry record · Phase 2
Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia
A Phase 2 study of Stress, sponsored by University of Nebraska.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT06364228: Recruiting Phase 2 study of Stress, sponsored by University of Nebraska.
NCT06364228 is a Phase 2 study of Stress that is actively recruiting participants, run by University of Nebraska. The registered enrollment target is 32 participants, below the 786-participant average among 152 other Stress trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06364228, a Phase 2 study of Stress, is actively recruiting participants, sponsored by University of Nebraska.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study 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). 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Oxytocin Intranasal Spray 12 International Unit (12IU)
- DRUG Oxytocin Intranasal Spray 24 International Unit (24IU)
- PROCEDURE Functional MRI
Study Locations (1)
Nebraska
- University of Nebraska Medical Center, Department of Psychiatry - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2026-01-05 |
| Est. Completion | 2027-02 |
| Phase | Phase 2 |
What NCT06364228 shows while recruiting
NCT06364228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 786-participant average among 152 other Stress trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Stress appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT06364228 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT06364228 about?
NCT06364228 is a clinical study titled "Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia". 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 significan...
What is the current status of trial NCT06364228?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2026-01-05. Estimated completion is 2027-02.
What conditions does trial NCT06364228 study?
This clinical trial studies the following conditions: Stress.
What interventions are being tested in trial NCT06364228?
The interventions under investigation include: Placebo (DRUG), Oxytocin Intranasal Spray 12 International Unit (12IU) (DRUG), Oxytocin Intranasal Spray 24 International Unit (24IU) (DRUG), Functional MRI (PROCEDURE).
Who is sponsoring clinical trial NCT06364228?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06364228 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stress
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06364228's enrollment target sits among peer trials
32 129th of 152 higher than 23 of 152 other Stress trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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