NCT05896553

Brief Summary

The main aim of the pharmacological resting-state fMRI study is to investigate the modulatory effects of intranasal Oxytocin (24IU) on task and intrinsic functional connectivity before and after prolonged exposure to naturalistic fear induction via a movie.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 29, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

10 months

First QC Date

May 29, 2023

Last Update Submit

April 1, 2025

Conditions

Keywords

OxytoxinFearfMRIFunctional Connectivity

Outcome Measures

Primary Outcomes (1)

  • Functional connectivity during the resting state between brain systems involved in emotional processing.

    1.During the 8min resting state before and after the movie clips the intrinsic connectivity of the brain will be assessed. The intrinsic connectivity will be computed as temporal correlation between spatially remote neurophysiological events, expressed as deviation from statistical independence across these events in distributed neuronal groups and areas. Effects of Oxytocin on the intrinsic architecture of the brain will be examined by comparing the Oxytocin- and Placebo- treated groups.

    Change between the time windows 72-80 minutes (before emotion induction) and 90-98 minutes (after emotion induction) following treatment

Secondary Outcomes (1)

  • Functional and dynamic connectivity during the movie clip will be examined during the fear-induction period (10min movie clip).

    80 minutes to 90 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

Administration of intranasal Oxytocin(24IU)

Oxytoxin group

Administration of intranasal Placebo

Placebo group

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
Model Details: Randomized placebo-controlled double-blind between-subject design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 29, 2023

First Posted

June 9, 2023

Study Start

May 29, 2023

Primary Completion

April 1, 2024

Study Completion

April 15, 2024

Last Updated

April 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations