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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03577457
Other study ID # SANP-2017-3-ATD
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date July 20, 2019

Study information

Verified date July 2018
Source University of Electronic Science and Technology of China
Contact Yina Ma, Dr.
Phone +86-15221877059
Email yma@bnu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 20, 2019
Est. primary completion date June 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Beijing Normal University Beijing

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 Changes in brain neural activity during the social reward processing as assessed via fMRI 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. approximately 45 minutes after intranasal administration of oxytocin, or placebo, approximately 5.5h after administration of ATD, or placebo
Primary Changes in the resting state as assessed via fMRI Resting state activity in the social reward related and decision making brain networks will be compared between the treatment groups Time Frame: approximately 45 minutes after intranasal administration of oxytocin, or placebo, approximately 5.5h after administration of ATD, or placebo
Secondary Associations with Personalities of subjects 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. before 30mins ATD or placebo administration
Secondary Behavioral performance in decision making task Behavioral performance in reversal learning task will be measured and compared between treatment groups. approximately 4h after administration of ATD, or placebo, before nasal spray
Secondary Behavioral performance in social reward related task Behavioral performance will be measured and compared between treatment groups approximately 105 minutes after intranasal administration of oxytocin, or placebo, approximately 6.5h after administration of ATD, or placebo
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