The Interaction Between Oxytocin and Serotonin

Not Applicable

• Conditions: Healthy
• Interventions: Drug: oxytocin nasal spray; Drug: ATD treatment; Drug: oral placebo treatment (placebo-control for ATD); Drug: intranasal placebo treatment (placebo-control for oxytocin)

• Registration Number: NCT03577457
• Lead Sponsor: University of Electronic Science and Technology of China

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

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 Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-02-05
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-05
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-07-12
• Primary Completion: 2019-06-20
• Study Completion: 2019-07-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
male oxytocin and placebo group	oxytocin nasal spray	male subjects receiving oxytocin and ATD-placebo treatment
male oxytocin and placebo group	oral placebo treatment (placebo-control for ATD)	male subjects receiving oxytocin and ATD-placebo treatment
male placebo and ATD group	ATD treatment	male subjects receiving oxytocin placebo and ATD treatment
male placebo and ATD group	intranasal placebo treatment (placebo-control for oxytocin)	male subjects receiving oxytocin placebo and ATD treatment
male placebo group	intranasal placebo treatment (placebo-control for oxytocin)	male subjects receiving oxytocin placebo and ATD placebo treatment
male oxytocin and ATD group	oxytocin nasal spray	male subjects receiving oxytocin and ATD treatment
male oxytocin and ATD group	ATD treatment	male subjects receiving oxytocin and ATD treatment
male placebo group	oral placebo treatment (placebo-control for ATD)	male subjects receiving oxytocin placebo and ATD placebo treatment

Primary Outcome Measures

Name	Time	Method
Changes in brain neural activity during the social reward processing as assessed via fMRI	approximately 45 minutes after intranasal administration of oxytocin, or placebo, approximately 5.5h after administration of ATD, or placebo	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.
Changes in the resting state as assessed via fMRI	Time Frame: approximately 45 minutes after intranasal administration of oxytocin, or placebo, approximately 5.5h after administration of ATD, or placebo	Resting state activity in the social reward related and decision making brain networks will be compared between the treatment groups

Secondary Outcome Measures

Name	Time	Method
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	Behavioral performance will be measured and compared between treatment groups
Associations with Personalities of subjects	before 30mins ATD or placebo administration	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.
Behavioral performance in decision making task	approximately 4h after administration of ATD, or placebo, before nasal spray	Behavioral performance in reversal learning task will be measured and compared between treatment groups.

Trial Locations

Locations (1)

Beijing Normal University; 🇨🇳 Beijing, China