The Interaction Between Oxytocin and Serotonin

University of Electronic Science and Technology of China

Status: Unknown

Conditions: Healthy

Treatments: Drug: oral placebo treatment (placebo-control for ATD); Drug: ATD treatment; Drug: oxytocin nasal spray; Drug: intranasal placebo treatment (placebo-control for oxytocin)

Study type: Interventional

Funder types: Other

Identifiers

NCT03426176

UESTC-neuSCAN-29

Details and patient eligibility

About

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)

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups, including a placebo group

male oxytocin and ATD group

Experimental group

Description:

male subjects receiving oxytocin and ATD treatment

Treatment:

Drug: oxytocin nasal spray

Drug: ATD treatment

male oxytocin and placebo group

Experimental group

Description:

male subjects receiving oxytocin and ATD-placebo treatment

Treatment:

Drug: oxytocin nasal spray

Drug: oral placebo treatment (placebo-control for ATD)

male placebo and ATD group

Experimental group

Description:

male subjects receiving oxytocin placebo and ATD treatment

Treatment:

Drug: intranasal placebo treatment (placebo-control for oxytocin)

Drug: ATD treatment

male placebo group

Placebo Comparator group

Description:

male subjects receiving oxytocin placebo and ATD placebo treatment

Treatment:

Drug: intranasal placebo treatment (placebo-control for oxytocin)

Drug: oral placebo treatment (placebo-control for ATD)