The Interaction Between Oxytocin and Serotonin

NCT03577457 | Unknown

• 1 other identifier: SANP-2017-3-ATD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to identify any interaction between oxytocin and serotonin on neural and behavioral activity related to social reward and decision making by a double-blind, placebo-controlled, between-subject, pharmacological fMRI design

Conditions

Healthy

Keywords

oxytocin; serotonin; social reward; decision making

Outcome Measures

Primary Outcomes (2)

• Changes in brain neural activity during the social reward processing as assessed via fMRI

  Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in response to social reward task in different treatment groups.

  approximately 45 minutes after intranasal administration of oxytocin, or placebo, approximately 5.5h after administration of ATD, or placebo

• Changes in the resting state as assessed via fMRI

  Resting state activity in the social reward related and decision making brain networks will be compared between the treatment groups

  Time Frame: approximately 45 minutes after intranasal administration of oxytocin, or placebo, approximately 5.5h after administration of ATD, or placebo

Secondary Outcomes (3)

• Associations with Personalities of subjects

  before 30mins ATD or placebo administration

• Behavioral performance in decision making task

  approximately 4h after administration of ATD, or placebo, before nasal spray

• Behavioral performance in social reward related task

  approximately 105 minutes after intranasal administration of oxytocin, or placebo, approximately 6.5h after administration of ATD, or placebo

Study Arms (4)

male oxytocin and ATD group

EXPERIMENTAL

male subjects receiving oxytocin and ATD treatment

Drug: oxytocin nasal spray; Drug: ATD treatment

male oxytocin and placebo group

EXPERIMENTAL

male subjects receiving oxytocin and ATD-placebo treatment

Drug: oxytocin nasal spray; Drug: oral placebo treatment (placebo-control for ATD)

male placebo and ATD group

EXPERIMENTAL

male subjects receiving oxytocin placebo and ATD treatment

Drug: ATD treatment; Drug: intranasal placebo treatment (placebo-control for oxytocin)

male placebo group

PLACEBO COMPARATOR

male subjects receiving oxytocin placebo and ATD placebo treatment

Drug: intranasal placebo treatment (placebo-control for oxytocin); Drug: oral placebo treatment (placebo-control for ATD)

Interventions

oxytocin nasal spray DRUG

intranasal administration of oxytocin (24 IU)

male oxytocin and ATD group; male oxytocin and placebo group

ATD treatment DRUG

oral administration of ATD (75.2g) (Acute Tryptophan Depletion)

male oxytocin and ATD group; male placebo and ATD group

intranasal placebo treatment (placebo-control for oxytocin) DRUG

intranasal administration of placebo nasal spray

male placebo and ATD group; male placebo group

oral placebo treatment (placebo-control for ATD) DRUG

oral administration of a tryptophan-balanced mixture (78.2g)

male oxytocin and placebo group; male placebo group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects without past or current psychiatric or neurological disorders
• Right-handedness

You may not qualify if:

• History of head injury;
• Medical or psychiatric illness.
• High blood pressure, general cardio-vascular alterations
• History of drug or alcohol abuse or addiction.
• Allergy against medications or general strong allergies
• Sleep disorders.
• Visual or motor impairments

Sponsors & Collaborators

• University of Electronic Science and Technology of China: lead

Study Sites (1)

Beijing Normal University

Beijing, 100875, China

RECRUITING

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Yina Ma, Dr.

CONTACT

+86-15221877059; yma@bnu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: July 5, 2018
• Study Start: February 1, 2018
• Primary Completion: June 20, 2019
• Study Completion: July 20, 2019
• Last Updated: July 12, 2018

Record last verified: 2018-07

Locations

CN (1)