The Interaction Between Oxytocin and Serotonin

NCT ID: NCT03577457

Last Updated: 2018-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-07-20

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

ATD treatment

Intervention Type DRUG

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

intranasal placebo treatment (placebo-control for oxytocin)

Intervention Type DRUG

intranasal administration of placebo nasal spray

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

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oxytocin nasal spray

intranasal administration of oxytocin (24 IU)

Intervention Type DRUG

ATD treatment

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

Intervention Type DRUG

intranasal placebo treatment (placebo-control for oxytocin)

intranasal administration of placebo nasal spray

Intervention Type DRUG

oral placebo treatment (placebo-control for ATD)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Electronic Science and Technology of China

OTHER

Sponsor Role lead

Responsible Party

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Benjamin Becker

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Normal University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yina Ma, Dr.

Role: CONTACT

+86-15221877059

Other Identifiers

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SANP-2017-3-ATD

Identifier Type: -

Identifier Source: org_study_id

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