Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia

PHASE2RecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

July 28, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Stress
Interventions
DRUG

Placebo

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).

DRUG

Oxytocin Intranasal Spray 12 International Unit (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).

DRUG

Oxytocin Intranasal Spray 24 International Unit (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).

PROCEDURE

Functional MRI

Functional MRI (fMRI) scan with affective Stroop and Empathy and Theory of Mind task (EmpaTom task will administered pre- and post-administration of oxytocin.

Trial Locations (1)

61898-5581

RECRUITING

University of Nebraska Medical Center, Department of Psychiatry, Omaha

All Listed Sponsors
lead

University of Nebraska

OTHER

NCT06364228 - Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia | Biotech Hunter | Biotech Hunter