Serotonin, Serotonin Genetics(TPH2) and Emotion and Interference Processing

NCT03549182 | Unknown

• 1 other identifier: UESTC-neuSCAN-51
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to explore whether acute tryptophan depletion can affect the emotion and interference processing whether this effect is moderated by the TPH2 genotype

Conditions

Healthy

Keywords

acute tryptophan depletion; tryptophan hydroxylase 2 gene; emotion

Outcome Measures

Primary Outcomes (3)

• Neural processing during emotion processing as assessed via fMRI

  Subjects will undergo a validated emotional face paradigm. To assess genotype x ATD interaction effects on neural emotional reactivity effects of ATD depletion on the corresponding neural activity will be compared between the TPH2 genotype groups.

  5-6h after administration of ATD, or placebo

• Neural processing during interference processing as assessed via fMRI

  Subjects will undergo a validated cognitive-emotional interference paradigm. To assess genotype x ATD interaction effects on neural interference control effects of ATD depletion on the corresponding neural activity will be compared between the TPH2 genotype groups.

  5-6h after administration of ATD, or placebo

• Neural processing during the resting state as assessed via fMRI

  Subjects will undergo a validated resting state assessment. To assess genotype x ATD interaction effects on intrinsic brain activity in the emotion and interreference related neural networks effects of ATD depletion on the corresponding neural activity will be compared between the TPH2 genotype groups.

  5-6h after administration of ATD, or placebo

Secondary Outcomes (1)

• Behavioral interference performance

  5-6h after administration of ATD, or placebo

Study Arms (4)

male TPH2-GG carriers with ATD then placebo group

EXPERIMENTAL

male TPH2-GG carriers will first receive ATD, then will receive placebo at least 5 weeks later.

Drug: ATD treatment; Drug: placebo treatment

male TPH2-GG carriers with placebo then ATD group

EXPERIMENTAL

male TPH2-GG carriers will first receive placebo, then will receive ATD at least 5 weeks later.

Drug: ATD treatment; Drug: placebo treatment

male TPH2-TTcarriers with ATD then placebo group

EXPERIMENTAL

male TPH2-TT carriers will first receive ATD, then will receive placebo at least 5 weeks later.

Drug: ATD treatment; Drug: placebo treatment

male TPH2-TTcarriers with placebo then ATD group

EXPERIMENTAL

male TPH2-TT carriers will first receive placebo,then will receive ATD at least 5 weeks later.

Drug: ATD treatment; Drug: placebo treatment

Interventions

ATD treatment DRUG

oral administration of ATD (100g)(Acute Tryptophan Depletion)

male TPH2-GG carriers with ATD then placebo group; male TPH2-GG carriers with placebo then ATD group; male TPH2-TTcarriers with ATD then placebo group; male TPH2-TTcarriers with placebo then ATD group

placebo treatment DRUG

oral administration of placebo (102.3g)

male TPH2-GG carriers with ATD then placebo group; male TPH2-GG carriers with placebo then ATD group; male TPH2-TTcarriers with ATD then placebo group; male TPH2-TTcarriers with placebo then ATD group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects without past or current psychiatric or neurological disorders
• Right-handedness

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Electronic Science and Technology of China: lead

Study Sites (1)

School of Life Science and Technology

Chengdu, Sichuan, 611731, China

RECRUITING

Central Study Contacts

Benjamin Becker, Dr.

CONTACT

86-28-61830988; ben_becker@gmx.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: June 7, 2018
• Study Start: March 1, 2017
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)