Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090831
Status:
COMPLETED
Last Update Posted:
2019-12-03
First Post:
2004-09-03
Brief Title:
Investigating the Role of Serotonin in Emotional Processing Through the Use of Tryptophan Depletion
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Investigating the Role of Serotonin in Emotional Processing Through the Use of Tryptophan Depletion
Status:
COMPLETED
Status Verified Date:
2012-09-17
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the role of serotonin function in the brain Serotonin one of the brains natural chemicals connects with receptors on brain cells to regulate emotion anxiety sleep stress hormones and other body functions that are disturbed in various mood and anxiety disorders Also the research will look at the function of particular brain areas how they are involved in regulating emotions and how serotonin is involved in the regulation of their function The procedures entailed are tryptophan depletion and magnetic resonance imagining MRI Also researchers understanding of the genetic causes of mood and anxiety disorders will increase through examination of participants DNA
Adults in good health ages 20 through 50 may be eligible for this study Among those not eligible are females who are pregnant or breast feeding patients with psychiatric or central nervous system disease and those taking medications that would interfere with study results
At the first visit patients will be asked about their general mood degree of nervousness thinking skills and behavior The session will last from 15 to 20 hours A blood sample of about 2 tablespoons will be drawn for DNA study
Participants will undergo the following procedures and tests
Physical examination
Test of vital signs lying and standing
Electrocardiogram
Collection of blood for chemistry and hematology
Urinalysis
HIV urine drug and hepatitis screening
Psychiatric screening
SqrRoot -HCG pregnancy test if applicable
At the second visit patients will receive either tryptophan depletion or placebo and 5 hours later the study will begin to last up to 2 additional hours Patients will be asked periodically about their emotional state or changes in their well-being The MRI system will create images of the brains blood flow and measure glucose metabolism as a measure of brain activity During the MRI scan patients will hear knocking or beeping sounds and they will wear earplugs to reduce the noise Patients will be able to communicate with the MRI staff at all times during the scan and they may ask to be moved out of the machine at any time The MRI session lasts up to 15 hours
Results of any medical tests or other information will not be provided to participants because further research may be needed before such results are meaningful But if meaningful information develops from this study that may be important for a participants health he or she will be notified about it when it becomes available
Adults in good health ages 20 through 50 may be eligible for this study Among those not eligible are females who are pregnant or breast feeding patients with psychiatric or central nervous system disease and those taking medications that would interfere with study results
At the first visit patients will be asked about their general mood degree of nervousness thinking skills and behavior The session will last from 15 to 20 hours A blood sample of about 2 tablespoons will be drawn for DNA study
Participants will undergo the following procedures and tests
Physical examination
Test of vital signs lying and standing
Electrocardiogram
Collection of blood for chemistry and hematology
Urinalysis
HIV urine drug and hepatitis screening
Psychiatric screening
SqrRoot -HCG pregnancy test if applicable
At the second visit patients will receive either tryptophan depletion or placebo and 5 hours later the study will begin to last up to 2 additional hours Patients will be asked periodically about their emotional state or changes in their well-being The MRI system will create images of the brains blood flow and measure glucose metabolism as a measure of brain activity During the MRI scan patients will hear knocking or beeping sounds and they will wear earplugs to reduce the noise Patients will be able to communicate with the MRI staff at all times during the scan and they may ask to be moved out of the machine at any time The MRI session lasts up to 15 hours
Results of any medical tests or other information will not be provided to participants because further research may be needed before such results are meaningful But if meaningful information develops from this study that may be important for a participants health he or she will be notified about it when it becomes available
Detailed Description:
Objective
The goal of this protocol is to use a targeted serotonergic manipulation acute tryptophan depletion ATD and specific neurocognitive and neuroimaging paradigms to consider the role of serotonin 5-HT in emotional processing In particular we wish to evaluate claims that serotonin has a role in the effective processing of aversive signals Additionally we wish to examine whether tryptophan depletion will attenuate the neural response to aversive material
Study population
Healthy human adult volunteers ages 20-50 years old with no DSM-IV-defined Axis I mental disease and who fulfill the remainder of the inclusionexclusion criteria
Design
This is a prospective randomized double-blind placebo-controlled single-dose outpatient study in eligible healthy volunteers Participants will be randomly assigned in a 11 ratio to single doses of drug ATD or placebo The National Institutes of Health NIH Clinical Center Pharmacy will facilitate randomization and supply the randomization code to the Clinical Center s Metabolic Nutrition Department see below All subjects will be monitored for adverse events Participants will give written informed consent prior to any assessments and procedures covered by this protocol
The study will be conducted in the NIH Clinical Center 5SW Day Hospital and the NMRF center for the imaging arm of the study Subjects will arrive in the morning of the testing day and complete baseline measurements ie mood and anxiety ratings and serum tryptophan levels Participants will then receive an oral dose of ATD capsules or placebo Participants will consume two meals during the study day the placebo group control subjects will be given high-tryptophan meals and tryptophan-depleted subjects will receive low-tryptophan meals Meals will be designed and supplied by the NIH Clinical Center Metabolic Nutrition Department At specified times subjects will complete primary measures either neurocognitive or neuroimaging fMRI paradigms and secondary measures mood and anxiety ratings and serum levels of tryptophan as detailed in the protocol Adverse events will be monitored throughout the study day A post-study evaluation will occur prior to discharging the participant to verify that heshe is physically and mentally well and fit to leave the Clinical Center
Outcome Measures
Primary Outcome Measures
Neurocognitive Paradigms Behavioral measures including reaction time and accuracy
Neuroimaging Paradigms Blood-oxygen-level-dependent BOLD response
Secondary Outcome Measurements
Serum tryptophan levels
Mood and Anxiety Rating Scales
The goal of this protocol is to use a targeted serotonergic manipulation acute tryptophan depletion ATD and specific neurocognitive and neuroimaging paradigms to consider the role of serotonin 5-HT in emotional processing In particular we wish to evaluate claims that serotonin has a role in the effective processing of aversive signals Additionally we wish to examine whether tryptophan depletion will attenuate the neural response to aversive material
Study population
Healthy human adult volunteers ages 20-50 years old with no DSM-IV-defined Axis I mental disease and who fulfill the remainder of the inclusionexclusion criteria
Design
This is a prospective randomized double-blind placebo-controlled single-dose outpatient study in eligible healthy volunteers Participants will be randomly assigned in a 11 ratio to single doses of drug ATD or placebo The National Institutes of Health NIH Clinical Center Pharmacy will facilitate randomization and supply the randomization code to the Clinical Center s Metabolic Nutrition Department see below All subjects will be monitored for adverse events Participants will give written informed consent prior to any assessments and procedures covered by this protocol
The study will be conducted in the NIH Clinical Center 5SW Day Hospital and the NMRF center for the imaging arm of the study Subjects will arrive in the morning of the testing day and complete baseline measurements ie mood and anxiety ratings and serum tryptophan levels Participants will then receive an oral dose of ATD capsules or placebo Participants will consume two meals during the study day the placebo group control subjects will be given high-tryptophan meals and tryptophan-depleted subjects will receive low-tryptophan meals Meals will be designed and supplied by the NIH Clinical Center Metabolic Nutrition Department At specified times subjects will complete primary measures either neurocognitive or neuroimaging fMRI paradigms and secondary measures mood and anxiety ratings and serum levels of tryptophan as detailed in the protocol Adverse events will be monitored throughout the study day A post-study evaluation will occur prior to discharging the participant to verify that heshe is physically and mentally well and fit to leave the Clinical Center
Outcome Measures
Primary Outcome Measures
Neurocognitive Paradigms Behavioral measures including reaction time and accuracy
Neuroimaging Paradigms Blood-oxygen-level-dependent BOLD response
Secondary Outcome Measurements
Serum tryptophan levels
Mood and Anxiety Rating Scales
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-M-0270 | None | None | None |