Effects of Oxytocin on the Functional Architecture of the Brain Before and After Prolonged Naturalistic Fear Induction

Healthy Clinical Trial

Official title:

Effects of Oxytocin on the Functional Architecture of the Brain Before and After Prolonged Naturalistic Fear Induction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05896553
• Other study ID #: UESTC-BAM-08
• Status: Recruiting
• Phase: N/A
• Start date: May 29, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: June 2023
• Source: University of Electronic Science and Technology of China
• Contact: Weihua Zhao, Dr.
• Phone: 86-28-61830811
• Email: zarazhao.uestc[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main aim of the pharmacological resting-state fMRI study is to investigate the modulatory effects of intranasal Oxytocin (24IU) on task and intrinsic functional connectivity before and after prolonged exposure to naturalistic fear induction via a movie.

Description:

In a double-blind placebo-controlled between-subject experimental design, 60 adult male subjects will be randomly allocated to either receive intranasal Oxytocin (24IU, n= 30) or intranasal placebo (nasal spray administration without oxytocin, n = 30). Following treatment administration subjects will undergo a resting state functional magnetic resonance imaging (fMRI) assessment (8min) and next watch a long fear-inducing (horror) movie (10min) followed by a resting state fMRI assessment (8min). Effects of treatment on subjective experience will be assessed using 1-9 Likert scales assessing subjective fear, emotional arousal and escape. Ratings will be acquired before the start of the experiment, after the movie and at the end of the experiment. Participants will undergo screening for psychopathological and emotional states before treatment. Together with a randomized assignment to the treatment groups, this will allow controlling for confounding between-group differences.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Healthy subjects without past or current psychiatric or neurological disorders

• Right-handedness

• Normal or corrected-normal version

Exclusion Criteria:

• History of head injury

• Medical or psychiatric illness

• Hypertension

• General cardio-vascular alteration or diseases

• Allergy against medications

• Visual or motor impairments

• Claustrophobia

• Drug addiction

• Nicotine dependence

• FMRI contradictions

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• intranasal Oxytocin(24IU)
Administration of intranasal Oxytocin(24IU)
• intranasal Placebo
Administration of intranasal Placebo

Locations

Country	Name	City	State
China	University of Electronic Science and Technology of China	Chendu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
University of Electronic Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional connectivity during the resting state between brain systems involved in emotional processing.	1.During the 8min resting state before and after the movie clips the intrinsic connectivity of the brain will be assessed. The intrinsic connectivity will be computed as temporal correlation between spatially remote neurophysiological events, expressed as deviation from statistical independence across these events in distributed neuronal groups and areas. Effects of Oxytocin on the intrinsic architecture of the brain will be examined by comparing the Oxytocin- and Placebo- treated groups.	Change between the time windows 72-80 minutes (before emotion induction) and 90-98 minutes (after emotion induction) following treatment
Secondary	Functional and dynamic connectivity during the movie clip will be examined during the fear-induction period (10min movie clip).	Effects of treatment on dynamic functional connectivity during the fear clip watching phase will be examined by comparing dynamic functional connectivity indices between the Oxytoxin- and Placebo-treated group.	80 minutes to 90 minutes after treatment