Effects of Intranasal Oxytocin on Fear Processing in Naturalistic Contexts

NCT05892939 | Completed

• 1 other identifier: UESTC-BAM-06
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Oxytoxin; Fear; Social; fMRI

Outcome Measures

Primary Outcomes (1)

• BOLD-level activity as assessed by functional magnetic resonance imaging (fMRI)

  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.

  45 minutes to 70 minutes after treatment

Secondary Outcomes (1)

• Experienced fear during the paradigm as assessed by self-reported ratings

  45 minutes to 70 minutes after treatment

Study Arms (2)

Oxytoxin group

EXPERIMENTAL

Drug: intranasal Oxytocin(24IU)

Drug: intranasal Oxytocin(24IU)

Placebo group

PLACEBO COMPARATOR

Drug: intranasal Placebo

Drug: intranasal Placebo

Interventions

intranasal Oxytocin(24IU) DRUG

Administration of intranasal Oxytocin(24IU)

Oxytoxin group

intranasal Placebo DRUG

Administration of intranasal Placebo

Placebo group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects without past or current psychiatric or neurological disorders
• Right-handedness
• Normal or corrected-normal version

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Electronic Science and Technology of China: lead

Study Sites (1)

University of Electronic Science and Technology of China

Chengdu, Sichuan, 611731, China

Location

Study Officials

• Benjamin Becker, Dr.

  University of Electronic Science and Technology of China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized placebo-controlled double-blind between-subject design

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 7, 2023
• Study Start: May 23, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 15, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

CN (1)