Effects of Intranasal Oxytocin on Fear Processing in Naturalistic Contexts

Healthy Clinical Trial

Official title:

Effects of Intranasal Oxytocin on Fear Processing in Naturalistic Contexts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05892939
• Other study ID #: UESTC-BAM-06
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: June 2023
• Source: University of Electronic Science and Technology of China
• Contact: Weihua Zhao, Dr.
• Phone: 86-28-61830811
• Email: zarazhao.uestc[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• intranasal Oxytocin(24IU)
Administration of intranasal Oxytocin(24IU)
• intranasal Placebo
Administration of intranasal Placebo

Locations

Country	Name	City	State
China	University of Electronic Science and Technology of China	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
University of Electronic Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Experienced fear during the paradigm as assessed by self-reported ratings	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.	45 minutes to 70 minutes after treatment