The purpose of this study is to examine the effects of individualized aerobic exercise regimen on recovery after traumatic brain injury (TBI).Investigators will determine if exercise facilitates recovery by facilitating neuroplasticity and decreasing neuroinflammation.
Exercise-based therapies can promote recovery of function and are easily implemented in the clinical rehabilitation setting. This study will determine if exercise facilitates recovery by improving markers of neuroplasticity and decreasing neuroinflammatory responses. The investigators will also determine if variations in genes involved in neuroplasticity, and inflammation influence the responsiveness to exercise and rehabilitation. Recovery will be determined by assessing cognitive function, life quality and balance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
190
Aerobic exercise will be performed by utilizing aerobic exercise equipment 3 times per week.
Rehabilitative program is focused on completion of activities of daily living, initiation, appropriate behavior and community integration for five days per week at the Centre for Neuro Skills.
Centre for Neuro Skills
Bakersfield, California, United States
Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at baseline
CPET will allow us to determine oxygen consumption (VO2). Results will be reported as change in VO2 levels.
Time frame: Baseline
Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at Week 4
CPET will allow us to determine oxygen consumption (VO2). Results will be reported as change in VO2 levels.
Time frame: Week 4
Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at Week 8
CPET will allow us to determine oxygen consumption (VO2). Results will be reported as change in VO2 levels.
Time frame: Week 8
Aerobic Exercise Induced Changes in Cardio Pulmonary (CPET) at Week 12
CPET will allow us to determine oxygen consumption (VO2). Results will be reported as change in VO2 levels.
Time frame: Week 12
Aerobic Exercise Induced Changes in Cognitive Function at baseline
Attention, processing speed, reaction times, memory and nonverbal reasoning are evaluated by CNS Vital Signs. All scores are aggregated to one reported value (Neurocognitive Index). Scoring is by a computer based auto-scored multivariate scoring system developed by the manufacturers.
Time frame: Baseline
Aerobic Exercise Induced Changes in Cognitive Function at Week 4
Attention, processing speed, reaction times, memory and nonverbal reasoning are evaluated by CNS Vital Signs. All scores are aggregated to one reported value (Neurocognitive Index). Scoring is by a computer based auto-scored multivariate scoring system developed by the manufacturers.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Week 4
Aerobic Exercise Induced Changes in Cognitive Function at Week 8
Attention, processing speed, reaction times, memory and nonverbal reasoning are evaluated by CNS Vital Signs. All scores are aggregated to one reported value (Neurocognitive Index). Scoring is by a computer based auto-scored multivariate scoring system developed by the manufacturers.
Time frame: Week 8
Aerobic Exercise Induced Changes in Cognitive Function at Week 12
Attention, processing speed, reaction times, memory and nonverbal reasoning are evaluated by CNS Vital Signs. All scores are aggregated to one reported value (Neurocognitive Index). Scoring is by a computer based auto-scored multivariate scoring system developed by the manufacturers.
Time frame: Week 12
Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at baseline
The California Verbal Learning Test (CVLT II) is a verbal memory cognitive assessment. It assesses repetition learning, serial position effects, semantic organization, intrusions, and proactive interference. CVLT II scores have a mean of 0 and a SD of 1. The range of scores is +5 to -5 reported in increments of .5.
Time frame: Baseline
Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 4
The California Verbal Learning Test (CVLT II) is a verbal memory cognitive assessment. It assesses repetition learning, serial position effects, semantic organization, intrusions, and proactive interference. CVLT II scores have a mean of 0 and a SD of 1. The range of scores is +5 to -5 reported in increments of .5.
Time frame: Week 4
Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 8
The California Verbal Learning Test (CVLT II) is a verbal memory cognitive assessment. It assesses repetition learning, serial position effects, semantic organization, intrusions, and proactive interference. CVLT II scores have a mean of 0 and a SD of 1. The range of scores is +5 to -5 reported in increments of .5.
Time frame: Week 8
Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 12
The California Verbal Learning Test (CVLT II) is a verbal memory cognitive assessment. It assesses repetition learning, serial position effects, semantic organization, intrusions, and proactive interference. CVLT II scores have a mean of 0 and a SD of 1. The range of scores is +5 to -5 reported in increments of .5.
Time frame: Week 12
Quality of Life Measured by the NeuroQOL at baseline
The NeuroQOL assesses quality of life in the domains of Physical Domain, Mental Domain, Cognitive Domain, and Social Domain. Items are scored on a 5-point scale that uses different language depending on assessment. The questions range from least (1) to most (5) based on frequency of behavior, amount of difficulty, or degree of agreement. T-score are used, mean of 50 and SD of 10
Time frame: Baseline
Quality of Life Measured by the NeuroQOL at Week 4
The NeuroQOL assesses quality of life in the domains of Physical Domain, Mental Domain, Cognitive Domain, and Social Domain. Items are scored on a 5-point scale that uses different language depending on assessment. The questions range from least (1) to most (5) based on frequency of behavior, amount of difficulty, or degree of agreement. T-score are used, mean of 50 and SD of 10
Time frame: Week 4
Quality of Life Measured by the NeuroQOL at Week 8
The NeuroQOL assesses quality of life in the domains of Physical Domain, Mental Domain, Cognitive Domain, and Social Domain. Items are scored on a 5-point scale that uses different language depending on assessment. The questions range from least (1) to most (5) based on frequency of behavior, amount of difficulty, or degree of agreement. T-score are used, mean of 50 and SD of 10
Time frame: Week 8
Quality of Life Measured by the NeuroQOL at Week 12
The NeuroQOL assesses quality of life in the domains of Physical Domain, Mental Domain, Cognitive Domain, and Social Domain. Items are scored on a 5-point scale that uses different language depending on assessment. The questions range from least (1) to most (5) based on frequency of behavior, amount of difficulty, or degree of agreement. T-score are used, mean of 50 and SD of 10
Time frame: Week 12
Depression measured by the Beck Depression Inventory-II at baseline
The Beck Depression Inventory- II (BDI-II) assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe.
Time frame: Baseline
Depression measured by the Beck Depression Inventory-II at Week 4
The Beck Depression Inventory- II (BDI-II) assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe.
Time frame: Week 4
Depression measured by the Beck Depression Inventory-II at Week 8
The Beck Depression Inventory- II (BDI-II) assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe.
Time frame: Week 8
Depression measured by the Beck Depression Inventory-II at Week 12
The Beck Depression Inventory- II (BDI-II) assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe.
Time frame: Week 12
Visual Search/ Processing Speed measured by Trail Making Test (TMT) at baseline
The Trail Making Test (TMT) provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. The TMT consists of two parts. TMT-A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for TMT-B except the person must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). The score on each part represents the amount of time required to complete the task.
Time frame: Baseline
Visual Search/ Processing Speed measured by Trail Making Test (TMT) at Week 4
The Trail Making Test (TMT) provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. The TMT consists of two parts. TMT-A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for TMT-B except the person must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). The score on each part represents the amount of time required to complete the task.
Time frame: Week 4
Visual Search/ Processing Speed measured by Trail Making Test (TMT) at Week 8
The Trail Making Test (TMT) provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. The TMT consists of two parts. TMT-A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for TMT-B except the person must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). The score on each part represents the amount of time required to complete the task.
Time frame: Week 8
Visual Search/ Processing Speed measured by Trail Making Test (TMT) at Week 12
The Trail Making Test (TMT) provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. The TMT consists of two parts. TMT-A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for TMT-B except the person must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). The score on each part represents the amount of time required to complete the task.
Time frame: Week 12
Sleepiness will be measured by the Epworth Sleepiness Scale at baseline
The Epworth Sleepiness Scale is used to measure a patient's sleepiness. The test is a list of eight situations in which the patient rates their tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. Total score is based on a scale of 0 to 24. The scale estimates whether you are experiencing excessive sleepiness.
Time frame: Baseline
Sleepiness will be measured by the Epworth Sleepiness Scale at Week 4
The Epworth Sleepiness Scale is used to measure a patient's sleepiness. The test is a list of eight situations in which the patient rates their tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. Total score is based on a scale of 0 to 24. The scale estimates whether you are experiencing excessive sleepiness.
Time frame: Week 4
Sleepiness will be measured by the Epworth Sleepiness Scale at Week 8
The Epworth Sleepiness Scale is used to measure a patient's sleepiness. The test is a list of eight situations in which the patient rates their tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. Total score is based on a scale of 0 to 24. The scale estimates whether you are experiencing excessive sleepiness.
Time frame: Week 8
Sleepiness will be measured by the Epworth Sleepiness Scale at Week 12
The Epworth Sleepiness Scale is used to measure a patient's sleepiness. The test is a list of eight situations in which the patient rates their tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. Total score is based on a scale of 0 to 24. The scale estimates whether you are experiencing excessive sleepiness.
Time frame: Week 12
Vestibular function will be measured by the Berg Balance Test at baseline
The Berg Balance Scale is used to determine vestibular function through a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
Time frame: Baseline
Vestibular function will be measured by the Berg Balance Test at Week 4
The Berg Balance Scale is used to determine vestibular function through a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
Time frame: Week 4
Vestibular function will be measured by the Berg Balance Test at Week 8
The Berg Balance Scale is used to determine vestibular function through a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
Time frame: Week 8
Vestibular function will be measured by the Berg Balance Test at Week 12
The Berg Balance Scale is used to determine vestibular function through a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
Time frame: Week 12
Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at baseline
The 6 Minute Walk Test (6MWT) is a exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. A lower score (reflecting less distance covered in 6 minutes) indicates worse function. An increase in the distance walked indicates improvement in basic mobility.
Time frame: Baseline
Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at Week 4
The 6 Minute Walk Test (6MWT) is a exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. A lower score (reflecting less distance covered in 6 minutes) indicates worse function. An increase in the distance walked indicates improvement in basic mobility.
Time frame: Week 4
Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at Week 8
The 6 Minute Walk Test (6MWT) is a exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. A lower score (reflecting less distance covered in 6 minutes) indicates worse function. An increase in the distance walked indicates improvement in basic mobility.
Time frame: Week 8
Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at Week 12
The 6 Minute Walk Test (6MWT) is a exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. A lower score (reflecting less distance covered in 6 minutes) indicates worse function. An increase in the distance walked indicates improvement in basic mobility.
Time frame: Week 12
Evaluation of Inflammatory Biomarkers at Baseline
Biomarkers IL10, IL12, IL-1β, IL-4 , IL-5, IL-6, IL-7, IL-8, TNFα, will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.
Time frame: Baseline
Evaluation of Inflammatory Biomarkers at Week 4
Biomarkers IL10, IL12, IL-1β, IL-4 , IL-5, IL-6, IL-7, IL-8, TNFα, will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.
Time frame: Week 4
Evaluation of Inflammatory Biomarkers at Week 8
Biomarkers IL10, IL12, IL-1β, IL-4 , IL-5, IL-6, IL-7, IL-8, TNFα, will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.
Time frame: Week 8
Evaluation of Inflammatory Biomarkers at Week 12
Biomarkers IL10, IL12, IL-1β, IL-4 , IL-5, IL-6, IL-7, IL-8, TNFα, will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.
Time frame: Week 12
Evaluation of Neuroplasticity, Stress Biomarkers at Baseline
Biomarkers BDNF, GH, ACTH, Cortisol, Melatonin, VEGF will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.
Time frame: Baseline
Evaluation of Neuroplasticity, Stress Biomarkers at Week 4
Biomarkers BDNF, GH, ACTH, Cortisol, Melatonin, VEGF will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.
Time frame: Week 4
Evaluation of Neuroplasticity, Stress Biomarkers at Week 8
Biomarkers BDNF, GH, ACTH, Cortisol, Melatonin, VEGF will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.
Time frame: Week 8
Evaluation of Neuroplasticity, Stress Biomarkers at Week 12
Biomarkers BDNF, GH, ACTH, Cortisol, Melatonin, VEGF will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.
Time frame: Week 12
Evaluation of Neurodegeneration Biomarkers at Baseline
Biomarkers sCAM1, vCAM-1, sFAS will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.
Time frame: Baseline
Evaluation of Neurodegeneration Biomarkers at Week 4
Biomarkers sCAM1, vCAM-1, sFAS will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.
Time frame: Week 4
Evaluation of Neurodegeneration Biomarkers at Week 8
Biomarkers sCAM1, vCAM-1, sFAS will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.
Time frame: Week 8
Evaluation of Neurodegeneration Biomarkers at Week 12
Biomarkers sCAM1, vCAM-1, sFAS will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.
Time frame: Week 12
BDNF / Val66Met at baseline
Evaluation of genetic material BDNF / Val66Met will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Baseline
BDNF / Val66Met at Week 4
Evaluation of genetic material BDNF / Val66Met will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 4
BDNF / Val66Met at Week 8
Evaluation of genetic material BDNF / Val66Met will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 8
BDNF / Val66Met at Week 12
Evaluation of genetic material BDNF / Val66Met will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 12
IL-1β / rs16944 at baseline
Evaluation of genetic material IL-1β / rs16944 will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Baseline
IL-1β / rs16944 at Week 4
Evaluation of genetic material IL-1β / rs16944 will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 4
IL-1β / rs16944 at Week 8
Evaluation of genetic material IL-1β / rs16944 will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 8
IL-1β / rs16944 at Week 12
Evaluation of genetic material IL-1β / rs16944 will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 12
TrkB at baseline
Evaluation of genetic material TrkB will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Baseline
TrkB at Week 4
Evaluation of genetic material TrkB will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 4
TrkB at Week 8
Evaluation of genetic material TrkB will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 8
TrkB at Week 12
Evaluation of genetic material TrkB will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 12
COMT / VAll58Met at baseline
Evaluation of genetic material COMT / VAll58Met will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Baseline
COMT / VAll58Met at Week 4
Evaluation of genetic material COMT / VAll58Met will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 4
COMT / VAll58Met at Week 8
Evaluation of genetic material COMT / VAll58Met will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 8
COMT / VAll58Met at Week 12
Evaluation of genetic material COMT / VAll58Met ewill be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 12
DRD2 / A to T & A to G at baseline
Evaluation of genetic material DRD2 / A to T \& A to G will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Baseline
DRD2 / A to T & A to G at Week 4
Evaluation of genetic material DRD2 / A to T \& A to G will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 4
DRD2 / A to T & A to G at Week 8
Evaluation of genetic material DRD2 / A to T \& A to G will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 8
DRD2 / A to T & A to G at Week 12
Evaluation of genetic material DRD2 / A to T \& A to G will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 12
ANKKI / TAQIA at baseline
Evaluation of genetic material ANKKI / TAQIA will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Baseline
ANKKI / TAQIA at Week 4
Evaluation of genetic material ANKKI / TAQIA will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 4
ANKKI / TAQIA at Week 8
Evaluation of genetic material ANKKI / TAQIA will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 8
ANKKI / TAQIA at Week 12
Evaluation of genetic material ANKKI / TAQIA will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 12
PPPIRIB / C to T at baseline
Evaluation of genetic material PPPIRIB / C to T will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Baseline
PPPIRIB / C to T at Week 4
Evaluation of genetic material PPPIRIB / C to T will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: week 4
PPPIRIB / C to T at Week 8
Evaluation of genetic material PPPIRIB / C to T will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: week 8
PPPIRIB / C to T at Week 12
Evaluation of genetic material PPPIRIB / C to T will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: week 12
MAO-A /MAOA-H & MAOA-L at baseline
Evaluation of genetic material MAO-A /MAOA-H \& MAOA-L will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Baseline
MAO-A /MAOA-H & MAOA-L at Week 4
Evaluation of genetic material MAO-A /MAOA-H \& MAOA-L will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 4
MAO-A /MAOA-H & MAOA-L at Week 8
Evaluation of genetic material MAO-A /MAOA-H \& MAOA-Lwill be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 8
MAO-A /MAOA-H & MAOA-L at Week 12
Evaluation of genetic material MAO-A /MAOA-H \& MAOA-L will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 12
5-HTR2A / AI438G at baseline
Evaluation of genetic material 5-HTR2A / AI438G will be measured in a saliva sample. Results will be reported as % difference from the general population.
Time frame: Baseline
5-HTR2A / AI438G at Week 4
Evaluation of genetic material 5-HTR2A / AI438G will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 4
5-HTR2A / AI438G at Week 8
Evaluation of genetic material 5-HTR2A / AI438G will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 8
5-HTR2A / AI438G at Week 12
Evaluation of genetic material 5-HTR2A / AI438G will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 12
5-HT1A / C1019G at baseline
Evaluation of genetic material 5-HT1A / C1019G will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Baseline
5-HT1A / C1019G at Week 4
Evaluation of genetic material 5-HT1A / C1019G will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 4
5-HT1A / C1019G at Week 8
Evaluation of genetic material 5-HT1A / C1019G will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 8
5-HT1A / C1019G at Week 12
Evaluation of genetic material 5-HT1A / C1019G will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 12
5-HTR2B / HTR2B Q20 at baseline
Evaluation of genetic material 5-HTR2B / HTR2B Q20 will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Baseline
5-HTR2B / HTR2B Q20 at Week 4
Evaluation of genetic material 5-HTR2B / HTR2B Q20 will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 4
5-HTR2B / HTR2B Q20 at Week 8
Evaluation of genetic material 5-HTR2B / HTR2B Q20 will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 8
5-HTR2B / HTR2B Q20 at Week 12
Evaluation of genetic material 5-HTR2B / HTR2B Q20 will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 12
TPH / A218C & A779C at baseline
Evaluation of genetic material TPH / A218C \& A779C will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Baseline
TPH / A218C & A779C at Week 4
Evaluation of genetic material TPH / A218C \& A779C will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 4
TPH / A218C & A779C at Week 8
Evaluation of genetic material TPH / A218C \& A779C will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 8
TPH / A218C & A779C at Week 12
Evaluation of genetic material TPH / A218C \& A779C will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time frame: Week 12