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Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Jan 5, 2026 to Jun 20, 2026 Primary completion date: Feb 2027 to May 2027 · Completion date: Feb 2027 to Jun 2027v11 Show 2 more changesShow less
    • Primary completion date: Feb 2027 to May 2027
    • Completion date: Feb 2027 to Jun 2027
  2. Start date: Jul 28, 2025 to Jan 5, 2026 Primary and study completion dates: Dec 2026 to Feb 2027v10 Show 1 more changeShow less
    • Primary and study completion dates: Dec 2026 to Feb 2027
  3. Trial status: Not Yet Recruiting to Recruiting Start date: Jun 26, 2025 to Jul 28, 2025 · Site details revisedv9 Show 2 more changesShow less
    • Start date: Jun 26, 2025 to Jul 28, 2025
    • Site details revised
  4. Primary endpoint revised Start date: May 2025 to Jun 26, 2025 · Secondary endpoints revised (2) · Study description expanded, about 82 wordsv8 Show 3 more changesShow less
    • Start date: May 2025 to Jun 26, 2025
    • Secondary endpoints revised (2)
    • Study description expanded, about 82 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary endpoint revised Eligibility criteria shortened, about 8 words · Secondary endpoints revised (2) · Study description shortened, about 1 wordv7 Show 3 more changesShow less
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints revised (2)
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

Show 5 earlier versionsHide 5 earlier versions
  1. Primary and study completion dates: Apr 2026 to Dec 2026 Start date: Feb 2025 to May 2025v6 Show 1 more changeShow less
    • Start date: Feb 2025 to May 2025
  2. Start date: Nov 2024 to Feb 2025v5
  3. Start date: Jul 2024 to Nov 2024v4
  4. Secondary endpoints revised (2)v3 See this version in full on ClinicalTrials.gov ↗
  5. Eligibility criteria expanded, about 18 words Secondary endpoints revised (2) · Study description expanded, about 1 wordv2 Show 2 more changesShow less
    • Secondary endpoints revised (2)
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06364228
Lead Sponsor University of Nebraska
Conditions Stress
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov