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

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ClinicalTrials.gov Identifier: NCT03549182
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
Benjamin Becker, University of Electronic Science and Technology of China

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 1, 2017
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 1, 2021
Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549182


Contacts
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Contact: Benjamin Becker, Dr. 86-28-61830988 ben_becker@gmx.de

Locations
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China, Sichuan
School of Life Science and Technology Recruiting
Chengdu, Sichuan, China, 611731
Contact: Weihua Zhao       zarazhao.uestc@outlook.com   
Sponsors and Collaborators
University of Electronic Science and Technology of China
More Information
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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: June 7, 2018    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benjamin Becker, University of Electronic Science and Technology of China:
acute tryptophan depletion
tryptophan hydroxylase 2 gene
emotion