HealthyNCT03549182
Serotonin, Serotonin Genetics(TPH2) and Emotion and Interference Processing
A study testing ATD treatment in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ATD treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects without past or current psychiatric or neurological disorders
- Right-handedness
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
School of Life Science and Technology
Chengdu, Sichuan, 611731
Weihua Zhao, zarazhao.uestc@outlook.com
About this study
Official title: 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
Read the 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.
- Conditions
- Healthy
- Being tested
- ATD treatment, placebo treatment
- Keywords
- acute tryptophan depletion, tryptophan hydroxylase 2 gene, emotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATD treatmentDrug
oral administration of ATD (100g)(Acute Tryptophan Depletion)
placebo treatmentDrug
oral administration of placebo (102.3g)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: ATD treatment; Drug: placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 5-6h after administration of ATD, or placebo
Secondary outcomes (1)
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.
Measured: 5-6h after administration of ATD, or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start1 Mar 2017
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Becker, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549182
- Sponsor's protocol ID
- UESTC-neuSCAN-51
- Status last verified
- Dec 2020
- First submitted
- 5 Feb 2018
- Last updated
- 22 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Acute Tryptophan Depletion on Emotion and Interference Processing and Potential Moderation by 5HT Genetics (TPH2)
- ClinicalTrials.gov ID
- NCT03549182
- Acronym / sponsor ID
- UESTC-neuSCAN-51
- Conditions
- Healthy
- Keywords
- acute tryptophan depletion, tryptophan hydroxylase 2 gene, emotion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 7 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| male TPH2-GG carriers with ATD then placebo group | Experimental | Drug: ATD treatment, Drug: placebo treatmentmale TPH2-GG carriers will first receive ATD, then will receive placebo at least 5 weeks later. |
| male TPH2-GG carriers with placebo then ATD group | Experimental | Drug: ATD treatment, Drug: placebo treatmentmale TPH2-GG carriers will first receive placebo, then will receive ATD at least 5 weeks later. |
| male TPH2-TTcarriers with ATD then placebo group | Experimental | Drug: ATD treatment, Drug: placebo treatmentmale TPH2-TT carriers will first receive ATD, then will receive placebo at least 5 weeks later. |
| male TPH2-TTcarriers with placebo then ATD group | Experimental | Drug: ATD treatment, Drug: placebo treatmentmale TPH2-TT carriers will first receive placebo,then will receive ATD at least 5 weeks later. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects without past or current psychiatric or neurological disorders
- Right-handedness
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATD treatmentoral administration of ATD (100g)(Acute Tryptophan Depletion) | Drug | 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 treatmentoral administration of placebo (102.3g) | Drug | 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 |
Primary outcome
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.
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.
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.
1 secondary outcome
Behavioral interference performance
Time frame: 5-6h after administration of ATD, or placebo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATD treatment in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Becker, Dr. (86-28-61830988, ben_becker@gmx.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural processing during emotion processing as assessed via fMRI (time frame: 5-6h after administration of ATD, or placebo). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020; AzTrials last refreshed its copy on 1 Nov 2026.