The Interaction Between Oxytocin and Serotonin

The Interaction Between Oxytocin and Serotonin on the Social-emotional Brain Networks

the study aims to explore whether there is an interaction between oxytocin and serotonin in the regulation of emotion-based behavior by using a between-subject randomized double blind pharmacological fMRI design during which 4 groups of healthy male subjects will receive combinations of oxytocin nasal-spray (versus placebo) and acute tryptophan depletion (ATD, versus placebo)

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: oxytocin nasal spray; Drug: ATD treatment; Drug: oral placebo treatment (placebo-control for ATD); Drug: intranasal placebo treatment (placebo-control for oxytocin)

Detailed Description

Convergent evidence from animal models and human studies suggests that both, serotonin and oxytocin are important regulators of social emotional behavior. Evidence is emerging that both systems interact in this domain. To determine the interaction of both systems on human social behavior, the present study aims to combine a randomized placebo-controlled administration of modulators of both systems (Oxytocin nasal-spray and acute tryptophan depletion, ATD) and their combination within a pharmaco-fMRI experiment. To determine effects on the neural networks engaged in social emotional processing, healthy male subjects will receive single doses of oxytocin (24IU) versus placebo and ATD (75.2g) versus placebo before fMRI measures of emotion perception and resting state will be acquired. To control for potential effects of pre-medication personality traits as well as effects of medicines on mood, subjects will be administered pre-treatment assessing relevant personality traits and post-treatment assessments of mood.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 611731
      • Recruiting
      • School of Life Science and Technology
      • Contact: Weihua Zhao; Email: zarazhao.uestc@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: male oxytocin and ATD group; male subjects receiving oxytocin and ATD treatment	Drug: oxytocin nasal spray; intranasal administration of oxytocin (24 IU); Drug: ATD treatment; oral administration of ATD (75.2g) (Acute Tryptophan Depletion)
Experimental: male oxytocin and placebo group; male subjects receiving oxytocin and ATD-placebo treatment	Drug: oxytocin nasal spray; intranasal administration of oxytocin (24 IU); Drug: oral placebo treatment (placebo-control for ATD); oral administration of a tryptophan-balanced mixture (78.2g)
Experimental: male placebo and ATD group; male subjects receiving oxytocin placebo and ATD treatment	Drug: ATD treatment; oral administration of ATD (75.2g) (Acute Tryptophan Depletion); Drug: intranasal placebo treatment (placebo-control for oxytocin); intranasal administration of placebo nasal spray
Placebo Comparator: male placebo group; male subjects receiving oxytocin placebo and ATD placebo treatment	Drug: oral placebo treatment (placebo-control for ATD); oral administration of a tryptophan-balanced mixture (78.2g); Drug: intranasal placebo treatment (placebo-control for oxytocin); intranasal administration of placebo nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neural processing during the emotion processing as assessed via fMRI	fMRI BOLD indices of neural processing in emotion related brain regions will be compared between the treatment groups	6h after treatment
Neural processing during the resting state as assessed via fMRI	Resting state activity in the emotional brain networks will be compared between the treatment groups	6h after treatment

Collaborators and Investigators

• Sponsor: University of Electronic Science and Technology of China

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Anticipated): June 15, 2019
• Study Completion (Anticipated): July 15, 2019

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 8, 2018

Study Record Updates

• Last Update Posted (Actual): February 8, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: oxytocin; emotion; acute tryptophan depletion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: UESTC-neuSCAN-29

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No