The Interaction Between Oxytocin and Serotonin

NCT ID: NCT03426176

Last Updated: 2018-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2019-07-15

Brief Summary

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)

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

male oxytocin and ATD group

male subjects receiving oxytocin and ATD treatment

Group Type: EXPERIMENTAL

oxytocin nasal spray

Intervention Type: DRUG

intranasal administration of oxytocin (24 IU)

ATD treatment

Intervention Type: DRUG

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

male oxytocin and placebo group

male subjects receiving oxytocin and ATD-placebo treatment

Group Type: EXPERIMENTAL

oxytocin nasal spray

Intervention Type: DRUG

intranasal administration of oxytocin (24 IU)

oral placebo treatment (placebo-control for ATD)

Intervention Type: DRUG

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

male placebo and ATD group

male subjects receiving oxytocin placebo and ATD treatment

Group Type: EXPERIMENTAL

intranasal placebo treatment (placebo-control for oxytocin)

Intervention Type: DRUG

intranasal administration of placebo nasal spray

ATD treatment

Intervention Type: DRUG

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

male placebo group

male subjects receiving oxytocin placebo and ATD placebo treatment

Group Type: PLACEBO_COMPARATOR

intranasal placebo treatment (placebo-control for oxytocin)

Intervention Type: DRUG

intranasal administration of placebo nasal spray

oral placebo treatment (placebo-control for ATD)

Intervention Type: DRUG

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

Interventions

oxytocin nasal spray

intranasal administration of oxytocin (24 IU)

Intervention Type: DRUG

intranasal placebo treatment (placebo-control for oxytocin)

intranasal administration of placebo nasal spray

Intervention Type: DRUG

ATD treatment

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

Intervention Type: DRUG

oral placebo treatment (placebo-control for ATD)

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Electronic Science and Technology of China

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Becker

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Life Science and Technology

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Benjamin Becker, Dr.

Role: CONTACT

ben_becker@gmx.de

86-28-61830988

Facility Contacts

Weihua Zhao

Role: primary

zarazhao.uestc@outlook.com

Other Identifiers

UESTC-neuSCAN-29

Identifier Type: -

Identifier Source: org_study_id