Effects of Intranasal Oxytocin on Fear Processing in Naturalistic Contexts

NCT ID: NCT05892939

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-23
• Study Completion Date: 2024-04-15

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Oxytoxin group

Drug: intranasal Oxytocin(24IU)

Group Type: EXPERIMENTAL

intranasal Oxytocin(24IU)

Intervention Type: DRUG

Administration of intranasal Oxytocin(24IU)

Placebo group

Drug: intranasal Placebo

Group Type: PLACEBO_COMPARATOR

intranasal Placebo

Intervention Type: DRUG

Administration of intranasal Placebo

Interventions

intranasal Oxytocin(24IU)

Administration of intranasal Oxytocin(24IU)

Intervention Type: DRUG

intranasal Placebo

Administration of intranasal Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Electronic Science and Technology of China

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Becker

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Becker, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Electronic Science and Technology of China

Locations

University of Electronic Science and Technology of China

Chengdu, Sichuan, China

Countries

China

Other Identifiers

UESTC-BAM-06

Identifier Type: -

Identifier Source: org_study_id