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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03549182
Other study ID # UESTC-neuSCAN-51
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2017
Est. completion date December 1, 2021

Study information

Verified date December 2020
Source University of Electronic Science and Technology of China
Contact Benjamin Becker, Dr.
Phone 86-28-61830988
Email ben_becker@gmx.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 1, 2021
Est. primary completion date June 1, 2021
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:
ATD treatment
oral administration of ATD (100g)(Acute Tryptophan Depletion)
placebo treatment
oral administration of placebo (102.3g)

Locations

Country Name City State
China School of Life Science and Technology Chengdu Sichuan

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 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
Primary 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
Primary 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 Behavioral interference performance 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
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