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

Sponsor

University of Electronic Science and Technology of China (Other)

Overall Status

Recruiting

CT.gov ID

NCT03549182

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: ATD treatment Drug: placebo treatment	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Mar 1, 2017

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

Neural processing during emotion processing as assessed via fMRI [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.
Neural processing during interference processing as assessed via fMRI [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.
Neural processing during the resting state as assessed via fMRI [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.

Secondary Outcome Measures

Behavioral interference performance [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Life Science and Technology	Chengdu	Sichuan	China	611731

Sponsors and Collaborators

University of Electronic Science and Technology of China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Benjamin Becker, Professor, University of Electronic Science and Technology of China

ClinicalTrials.gov Identifier:

NCT03549182

Other Study ID Numbers:

UESTC-neuSCAN-51

First Posted:

Jun 7, 2018

Last Update Posted:

Dec 22, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Benjamin Becker, Professor, University of Electronic Science and Technology of China

acute tryptophan depletion

tryptophan hydroxylase 2 gene

emotion

Study Results

No Results Posted as of Dec 22, 2020