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

December 20, 2020 updated by: Benjamin Becker, University of Electronic Science and Technology of China

The Influence of Acute Tryptophan Depletion on Emotion and Interference Processing and Potential Moderation by 5HT Genetics (TPH2)

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Based on previous studies suggesting that serotonin, a neurotransmitter, is associated with social & emotional behavior, including emotional reactivity and emotion regulation, the present study aims to explore effects of acute tryptophan depletion (ATD) on emotion processing and emotional interference processing within a randomized double-blind, with-subject, placebo-controlled pharmaco-fMRI experiment. To further examine the potential moderating effects of the genetic makeup of the serotonin system the present study will include a pharmacogenetics imaging approach. Given that TPH2 is the key regulator of the serotonergic signaling pathway, we therefore assessed whether such the effects of tryptophan depletion vary according to the TPH2 genotype. To this end, healthy male TPH2-GG or TPH2-TT carriers will be recruited and will receive ATD (100g) and placebo (102.3g) in a within subject design. 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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: male TPH2-GG carriers with ATD then placebo group
male TPH2-GG carriers will first receive ATD, then will receive placebo at least 5 weeks later.
Drug: ATD treatment
oral administration of ATD (100g)(Acute Tryptophan Depletion)
Drug: placebo treatment
oral administration of placebo (102.3g)
Experimental: male TPH2-GG carriers with placebo then ATD group
male TPH2-GG carriers will first receive placebo, then will receive ATD at least 5 weeks later.
Drug: ATD treatment
oral administration of ATD (100g)(Acute Tryptophan Depletion)
Drug: placebo treatment
oral administration of placebo (102.3g)
Experimental: male TPH2-TTcarriers with ATD then placebo group
male TPH2-TT carriers will first receive ATD, then will receive placebo at least 5 weeks later.
Drug: ATD treatment
oral administration of ATD (100g)(Acute Tryptophan Depletion)
Drug: placebo treatment
oral administration of placebo (102.3g)
Experimental: male TPH2-TTcarriers with placebo then ATD group
male TPH2-TT carriers will first receive placebo,then will receive ATD at least 5 weeks later.
Drug: ATD treatment
oral administration of ATD (100g)(Acute Tryptophan Depletion)
Drug: placebo treatment
oral administration of placebo (102.3g)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neural processing during emotion processing as assessed via fMRI
Time Frame: 5-6h after administration of ATD, or placebo
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
Time Frame: 5-6h after administration of ATD, or placebo
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
Time Frame: 5-6h after administration of ATD, or placebo
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral interference performance
Time Frame: 5-6h after administration of ATD, or placebo
Subjects will undergo a emotion-cognition interference paradigm. To assess genotype x ATD interaction effects on behavioral indices of interference (congruent vs incongruent trials) behavioral performance (accuracy/reaction time) effects of ATD depletion on the corresponding behavioral indices will be compared between the TPH2 genotype groups.
5-6h after administration of ATD, or placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Electronic Science and Technology of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

February 5, 2018

First Submitted That Met QC Criteria

June 5, 2018

First Posted (Actual)

June 7, 2018

Study Record Updates

Last Update Posted (Actual)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 20, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UESTC-neuSCAN-51

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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