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

Sponsor

University of Electronic Science and Technology of China (Other)

Overall Status

Recruiting

CT.gov ID

NCT05896553

Collaborator

(none)

Enrollment

Location

Arms

30.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: intranasal Oxytocin(24IU) Drug: intranasal Placebo	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized placebo-controlled double-blind between-subject designRandomized placebo-controlled double-blind between-subject design

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

May 29, 2023

Anticipated Primary Completion Date :

May 31, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oxytoxin group Drug: intranasal Oxytocin(24IU)	Drug: intranasal Oxytocin(24IU) Administration of intranasal Oxytocin(24IU)
Placebo Comparator: Placebo group Drug: intranasal Placebo	Drug: intranasal Placebo Administration of intranasal Placebo

Arm

Intervention/Treatment

Experimental: Oxytoxin group

Drug: intranasal Oxytocin(24IU)

Drug: intranasal Oxytocin(24IU)

Administration of intranasal Oxytocin(24IU)

Placebo Comparator: Placebo group

Drug: intranasal Placebo

Drug: intranasal Placebo

Administration of intranasal Placebo

Outcome Measures

Primary Outcome Measures

Functional connectivity during the resting state between brain systems involved in emotional processing. [Change between the time windows 72-80 minutes (before emotion induction) and 90-98 minutes (after emotion induction) following treatment]
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.

Secondary Outcome Measures

Functional and dynamic connectivity during the movie clip will be examined during the fear-induction period (10min movie clip). [80 minutes to 90 minutes after treatment]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Electronic Science and Technology of China	Chendu	Sichuan	China	611731

Sponsors and Collaborators

University of Electronic Science and Technology of China

Investigators

Principal Investigator: Benjamin Becker, Dr., University of Electronic Science and Technology of China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Benjamin Becker, Professor, University of Electronic Science and Technology of China

ClinicalTrials.gov Identifier:

NCT05896553

Other Study ID Numbers:

UESTC-BAM-08

First Posted:

Jun 9, 2023

Last Update Posted:

Jun 9, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Benjamin Becker, Professor, University of Electronic Science and Technology of China

Oxytoxin

Fear

fMRI

Functional Connectivity

Additional relevant MeSH terms:

Oxytocin

Study Results

No Results Posted as of Jun 9, 2023