Effects of Intranasal Oxytocin on Fear Processing in Naturalistic Contexts

Sponsor

University of Electronic Science and Technology of China (Other)

Overall Status

Recruiting

CT.gov ID

NCT05892939

Collaborator

(none)

Enrollment

Location

Arms

30.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main aim of the study is to investigate the modulatory effects of intranasal oxytocin (24IU) on fear in naturalistic social and non-social contexts and the underlying neural mechanisms.

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 receive either intranasal oxytocin (24IU, n= 30) or placebo (n = 30) nasal spray. 45 minutes after treatment the participants will undergo a naturalistic fear induction paradigm during fMRI. During the paradigm video clips of 25s lengths will be presented showing fear-inducing situations in social and non-social contexts as well as corresponding control video clips. Following each clip subjects are required to rate their level of subjective fear on a rating scale ranging from 1 (no fear) to 9 (highest fear). 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 Intranasal Oxytocin on Fear Processing in Naturalistic Contexts

Actual Study Start Date :

May 23, 2023

Anticipated Primary Completion Date :

Mar 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

BOLD-level activity as assessed by functional magnetic resonance imaging (fMRI) [45 minutes to 70 minutes after treatment]
BOLD-level activity as assessed by functional magnetic resonance imaging (fMRI) in response to four conditions of movie clips (Fear-Social\FS, Fear-Non-social\FNS, Neutral-Social\NS, Neutral-Non-social\NNS). Effects of Oxytocin on the neural basis of fear will be examined by comparing the treatment groups (Oxytocin versus Placebo) with respect to fearful versus non fearful conditions. The investigators expect that Oxytocin will decrease reactivity in emotion reactive brain regions as compared to Placebo.

Secondary Outcome Measures

Experienced fear during the paradigm as assessed by self-reported ratings [45 minutes to 70 minutes after treatment]
Experienced fear during the paradigm as assessed by self-reported ratings on a 1-9 point Likert-scale ranging from 1 (no fear) to 9 (highest fear). Participants will rate their subjective level of fear following each video clip. Effects of Oxytocin on the level of subjective fear will be examined by comparing the treatment groups (Oxytocin versus Placebo) with respect to the self-reported fear levels. The investigators expect that Oxytocin will decrease the level of subjective fear experience compared to Placebo.

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	Chengdu	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:

NCT05892939

Other Study ID Numbers:

UESTC-BAM-06

First Posted:

Jun 7, 2023

Last Update Posted:

Jun 12, 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

Additional relevant MeSH terms:

Oxytocin

Study Results

No Results Posted as of Jun 12, 2023