Effects of Intranasal Oxytocin on Functional Brain Network in Resting-state and Tasks

NCT03428906 | Completed

• 1 other identifier: IN-OT functional network
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate whether and how intranasal oxytocin of 8IU treatment will alter the topology of functional brain network in resting-state and multiple tasks in healthy males.

Conditions

Healthy

Keywords

intranasal oxytocin; functional brain network; multiple tasks; resting state

Outcome Measures

Primary Outcomes (4)

• Functional network organization alterations in brain under resting state fMRI after drug administration

  Using seed-based and network level functional connectivity analysis, as well as graph theory analysis , functional network organization in brain under eight minutes resting state will be detected and compared between oxytocin and placebo group.

  70~85 minutes after drug administration

• Behavior,brain activities and representation patterns in the emotional judgement task after drug administration

  Friend or Foe Task is used to measure the verbal versus nonverbal emotional judgement of subjects. Both the response of subjects and the brain activity are recorded in the task. How oxytocin influences the relationship between subjects' behavior and representation pattern of emotional judgement will be investigated through RSA(representation similarity analysis) of brain pattern.

  60~75 minutes after drug administration

• Behavior, dynamics brain activities and networks in the model-based decision making task after drug administration

  Two-Stage Decision Making Task is used to measure the model-based and model-free decision making process of subjects. The degree of model-based will be calculated by Computational modelling of Subjects' decision making process, and entering as modulation parameter in the OT effect on dynamic brain seed-based and network-based connectivity pattern.

  35~60 minutes after drug administration

• Relationship of functional network organization in brain across resting state and task-based fMRI after drug administration

  The functional brain activity in resting state, emotional judgement and decision making task will be compared. Both the functional segregation and integration will be measured using graph theory and network connectivity analysis to discover the OT effect on brain network organization across multiple cognitive states.

  60~85 minutes after drug administration

Study Arms (2)

Oxytocin

EXPERIMENTAL

Oxytocin (OXT), a neuropeptide produced in the hypothalamus, is a key modulator of complex socioaffective responses including affiliation, social approach and attachment, stress and anxiety. Subjects receiving an intranasal spray of OXT (8 IU or 13.44 mg; Syntocinon-spray; Novartis, Switzerland) .

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Placebo contains all ingredients except for the peptide in three puffs of 1.33 IU per 2.24mg nostril.

Drug: Placebo

Interventions

Oxytocin DRUG

intranasally administrated

Oxytocin

Placebo DRUG

intranasally administrated

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: we opted to recruit only males for the present study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy subjects without past or current psychiatric or neurological disorders

You may not qualify if:

• with MRI Contraindications

Sponsors & Collaborators

• Beijing Normal University: lead

Study Sites (1)

School of Brain and Cognitive Sciences, Beijing Nornal University

Beijing, Beijing Municipality, 100875, China

Location

MeSH Terms

Interventions

Oxytocin; Sodium Chloride

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Yina Ma, PhD

  School of Brain and Cognitive Sciences, Beijing Nornal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study utilized a randomized, double-blind, PBO controlled, within-subject design, in which each participant was tested under two acute treatment conditions separated by at least 1 wk wash-out period.

Study Record Dates

• First Submitted: February 4, 2018
• First Posted: February 12, 2018
• Study Start: May 24, 2016
• Primary Completion: April 25, 2017
• Study Completion: September 12, 2017
• Last Updated: February 12, 2018

Record last verified: 2018-02

Locations

CN (1)