Effects of Intranasal Oxytocin on Fear Processing in Naturalistic Contexts

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: intranasal Oxytocin(24IU); Drug: intranasal Placebo

• Registration Number: NCT05892939
• Lead Sponsor: University of Electronic Science and Technology of China

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.

Study Timeline

• Study Start: 2023-05-23
• Study First Submitted: 2023-05-29
• Study First Submitted QC: 2023-05-29
• Study First Posted: 2023-06-07
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytoxin group	intranasal Oxytocin(24IU)	Drug: intranasal Oxytocin(24IU)
Placebo group	intranasal Placebo	Drug: intranasal Placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Electronic Science and Technology of China; 🇨🇳 Chengdu, Sichuan, China