The Interaction Between Oxytocin and Serotonin

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03426176
• Other study ID #: UESTC-neuSCAN-29
• Status: Recruiting
• Phase: N/A
• First received: February 1, 2018
• Last updated: February 6, 2018
• Start date: February 1, 2018
• Est. completion date: July 15, 2019

Study information

• Verified date: February 2018
• Source: University of Electronic Science and Technology of China
• Contact: Benjamin Becker, Dr.
• Phone: 86-28-61830988
• Email: ben_becker[@]gmx.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 15, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• oxytocin nasal spray
intranasal administration of oxytocin (24 IU)
• intranasal placebo treatment (placebo-control for oxytocin)
intranasal administration of placebo nasal spray
• ATD treatment
oral administration of ATD (75.2g) (Acute Tryptophan Depletion)
• oral placebo treatment (placebo-control for ATD)
oral administration of a tryptophan-balanced mixture (78.2g)

Locations

Country	Name	City	State
China	School of Life Science and Technology	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
University of Electronic Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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