Effects of Intranasal Oxytocin on Emotion Regulation
1 other identifier
interventional
80
1 country
1
Brief Summary
The aim is to examine whether intranasal oxytocin will influence the individuals' emotion regulation ability and related neural mechanisms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1 healthy
Started Feb 2016
Longer than P75 for early_phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 15, 2016
CompletedFirst Posted
Study publicly available on registry
February 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedOctober 29, 2018
October 1, 2018
2.8 years
April 15, 2016
October 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oxytocin effects on neural activity during emotion regulation task
Neural activity will be measured by functional magnetic resonance imaging (fMRI). Differences in activity of prefrontal cortex (PFC) and amygdala will be compared between oxytocin and placebo groups during emotional go-nogo task and cognitive reappraisal task.
Between 45-110 minutes after the intranasal administration of oxytocin
Secondary Outcomes (4)
Oxytocin effects on heart rate variability during emotion regulation task
Between 45-110 minutes after the intranasal administration of oxytocin
Oxytocin effects on behavior response during emotion regulation task
Between 45-110 minutes after the intranasal administration of oxytocin
Oxytocin effects on heart rate variability during resting-state
Between 35-45 minutes after the intranasal administration of oxytocin
Oxytocin effects on neural activity during resting-state
Between 35-45 minutes after the intranasal administration of oxytocin
Study Arms (2)
Oxytocin
EXPERIMENTALintranasal administration of oxytocin
Placebo
PLACEBO COMPARATORintranasal administration of placebo
Interventions
Eligibility Criteria
You may qualify if:
- healthy subjects without past or current psychiatric or neurological disorders
You may not qualify if:
- history of head injury;
- claustrophobia;
- medical or psychiatric illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Life Science and Technology, University of Electronic Science and Technology
Chengdu, Sichuan, 611731, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Keith Kendrick, Dr.
University of Electronic Science and Technology of China
- PRINCIPAL INVESTIGATOR
Benjamin Becker
University of Electronic Science and Technology of China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor / Research group leader
Study Record Dates
First Submitted
April 15, 2016
First Posted
February 16, 2017
Study Start
February 1, 2016
Primary Completion
December 1, 2018
Study Completion
March 1, 2019
Last Updated
October 29, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share