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Completed

NCT Number: NCT05892939

Effects of Intranasal Oxytocin on Fear Processing in Naturalistic Contexts

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.

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Key information

Conditions

Healthy

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Electronic Science and Technology of China

Chengdu, Sichuan, 611731, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intranasal Oxytocin(24IU)

Drug

Administration of intranasal Oxytocin(24IU)

Intranasal placebo

Drug

Administration of intranasal Placebo

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Electronic Science and Technology of China

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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