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Recruiting NCT07425938

Oxytocin's Effects on Emotional Processing and Its Acting Routes

No phase Interventional Healthy Adult Male

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: placebo (compared to vasoconstrictor), vasoconstrictor (Otrivin), placebo (compared to oxytocin), oxytocin.
Who it may be relevant to
Registry conditions: Healthy Adult Male. Basic parameters: 18 years — 30 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Modulatory Effects of Oxytocin on Emotional Processing and Its Acting Routes

Overview

The main goal of this study is to investigate the modulatory effects of intranasally administrated oxytocin on the processing of emotional stimuli and its acting routes.

Detailed description

In recent years ample studies have reported that intranasally administered oxytocin (OT) can facilitate social motivation and cognition in healthy and clinical populations. However, it is still unclear how effects are mediated since intranasally administered OT can both directly enter the brain (nose to brain) and increase peripheral vascular concentrations (nose to blood). The relative functional contributions of these routes are not established and have received insufficient attention in the field. Therefore, the investigators use the vasoconstrictor (VC) pretreatment to prevent intranasal OT (24 IU) from increasing peripheral concentrations and combine fMRI, behavioral measures, with physiological recording to examine the modulatory effects of OT on implicit emotional processing and its acting routes. In total 120 male participants are recruited for this double-blind, between-subject, placebo-controlled study. After arriving at the laboratory, participants first completed questionnaires for about 30 minutes, and were then randomly assigned into 3 groups receiving intranasal administration of "VC + OT", "placebo (PLC) + OT", or "VC + PLC". Then, they complete a resting-state scan and two task-based scans lasting approximately 65 minutes in total. There is a sencond resting-state scan between two task-based scans, which is mainly used as a break between the two tasks. Blood samples are collected twice (after finishing questionnaires and 30 minutes post-treatment) for subsequent analyses of plasma OT concentrations. The two task-based scans consist of an implicit face-emotion processing task (gender judgments of faces) and an emotional scene processing task (judging whether a child/old people/building/dog is present in the picture). After scanning, there is a 40-minute picture rating task (emotional valence, intensity, and arousal). Questionnaires include State-Trait Anxiety Inventory, Beck Depression Inventory II, Liebowitz Social Anxiety Scale, Autism Spectrum Quotient, Social Responsiveness Scale-2, Interpersonal Reactivity Index, Childhood Trauma Questionnaire, Toronto Alexithymia Scale and Positive and Negative Affect Schedule.

Interventions

  • Drug placebo (compared to vasoconstrictor)
    intranasal administration of placebo (4 sprays of 0.9% saline and glycerin)
  • Drug vasoconstrictor (Otrivin)
    intranasal administration of vasoconstrictor (4 sprays of 0.9% Otrivin)
  • Drug placebo (compared to oxytocin)
    intranasal administration of placebo (24 IU)
  • Drug oxytocin
    intranasal administration of oxytocin (24IU)

Primary outcome measures

  • Brain activity in response to emotional stimuli during task-based fMRI scanning [Time frame: 1 hour]
  • Changes in plasma oxytocin concentrations [Time frame: After finishing questionnaires and 30-minute post-treatment]
Secondary outcome measures (4)
  • The valence rating in response to different emotional stimuli [Time frame: 40 minutes]
  • The intensity rating in response to different emotional stimuli [Time frame: 40 minutes]
  • The arousal rating in response to different emotional stimuli [Time frame: 40 minutes]
  • Resting-state fMRI [Time frame: 17 minutes in total with each lasting around 8.5 minutes.]

Eligibility criteria

Inclusion criteria

  • Healthy subjects without past or current psychiatric or neurological disorders

Exclusion criteria

  • History of head injury.
  • Medical or psychiatric illness.
  • Subjects take a certain drug for a long period of time.
  • Subjects have metal implants in their bodies.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

China · 1 center
  • University of Electronic Science and Technology of China (UESTC) — Chengdu

Identifiers

NCT: NCT07425938 · UESTC-neuSCAN-106

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗