The Interaction Between Oxytocin and Serotonin

The Interaction Between Oxytocin and Serotonin on the Social-reward Brain Networks and Decision Making

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

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

Serotonin and oxytocin have been proved to play an important role in social reward processing and decision making in human. The aim of this study is to determine whether they interact in those essential human behaviors by a double-blind, placebo-controlled, between-subject, pharmacological fMRI design, in which 4 groups of healthy males will be administered with a random combination of nasal oxytocin (24 international units, IU) or placebo and acute tryptophan depletion (ATD, 75.2g) or placebo (a tryptophan-balanced mixture, 78.2g). The social-reward related neural activity and behavior will be assessed by a series of social reward task in and out of fMRI scanner and the decision making will be assessed by reversal learning task, ultimatum game (UG) and loss aversion task. The interaction between serotonin and oxytocin on brain networks will also be tested by resting state.

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

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100875
    • Recruiting
    • Beijing Normal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy 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
• 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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Associations with Personalities of subjects	Personalities of subjects will be measured by a series of scales related to decision making and social reward, such as the Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), which measures participants' sensitivity to reward and punishment. SPSRQ is a self-reported instrument that includes 48 yes/no questions divided into two subscales: Sensitivity to Reward (SR, 24 items, ranging from 0 (insensitive) to 24 (sensitive) to reward) and Sensitivity to Punishment (SP, 24 items, ranging from 0 (insensitive) to 24 (sensitive) to punishment). Associations between individual differences in personalities of subjects and differences in behaviors will be measured.	before 30mins ATD or placebo administration
Behavioral performance in decision making task	Behavioral performance in reversal learning task will be measured and compared between treatment groups.	approximately 4h after administration of ATD, or placebo, before nasal spray
Behavioral performance in social reward related task	Behavioral performance will be measured and compared between treatment groups	approximately 105 minutes after intranasal administration of oxytocin, or placebo, approximately 6.5h after administration of ATD, or placebo

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 20, 2019
• Study Completion (ANTICIPATED): July 20, 2019

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (ACTUAL): July 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: oxytocin; decision making; serotonin; social reward
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: SANP-2017-3-ATD

Drug and device information, study documents

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