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Effects of Intranasal Oxytocin on Fear Processing in Naturalistic Contexts

Effects of Intranasal Oxytocin on Fear Processing in Naturalistic Contexts

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05892939
Enrollment
69
Registered
2023-06-07
Start date
2023-05-23
Completion date
2024-04-15
Last updated
2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Oxytoxin, Fear, Social, fMRI

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.

Interventions

Administration of intranasal Oxytocin(24IU)

DRUGintranasal Placebo

Administration of intranasal Placebo

Sponsors

University of Electronic Science and Technology of China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Intervention model description

Randomized placebo-controlled double-blind between-subject design

Eligibility

Sex/Gender
MALE
Age
18 Years to 30 Years
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

Design outcomes

Primary

MeasureTime frameDescription
BOLD-level activity as assessed by functional magnetic resonance imaging (fMRI)45 minutes to 70 minutes after treatmentBOLD-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

MeasureTime frameDescription
Experienced fear during the paradigm as assessed by self-reported ratings45 minutes to 70 minutes after treatmentExperienced 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026