Back to resultsInflammation-related Alterations in Neurocircuitry: Reversal With Levodopa
Primary Purpose
Depression
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Levodopa+carbidopa
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Inflammation, Anhedonia, Psychomotor retardation
Eligibility Criteria
Inclusion Criteria:
- Subjects have signed a current version of the Informed Consent and HIPAA documents prior to initiation of study procedures
- Able to comprehend English
- Diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM)-V major depression and currently off antidepressant medication, unless otherwise approved by the PI or PI's designee
- Depression as the primary axis I disorder
- Negative pregnancy test for women of childbearing potential
- Not breast feeding
- At least two CRP tests conducted to establish reliability
Exclusion Criteria:
- Evidence of untreated or poorly controlled endocrine, cardiovascular, pulmonary, hematological, renal, or neurological disease
- History of central nervous system (CNS) trauma or active seizure disorder requiring medication unless otherwise approved by principal investigator, or PI's designee
- Current or history of migraines, glaucoma, melanoma, or bleeding disorder of any kind
- Autoimmune or inflammatory disorder of any kind
- Embedded metallic objects, prosthetics made of paramagnetic metals, aneurysmal clips and/or a history of claustrophobia
- Chronic infection (e.g. hepatitis B or C or Human Immunodeficiency Virus infection)
- Chronic use of agents known to affect the immune system including glucocorticoid therapy within the past 6 months, methotrexate within the past 1 year, chemotherapy of any kind (past or present), immunotherapy of any kind (past or present), aspirin or non-steroidal anti-inflammatory drugs (NSAIDs; within the past 2 weeks), statins (within the past 1 month), vaccinations (within the past 2 weeks), topical steroids (within the past 2 weeks), and antibiotics (within the past two weeks) unless otherwise approved by principal investigator or PI's designee.
- Suicide attempt within six months of screening, or active suicidal intent or plan, or score >2 on Hamilton Depression Rating Scale (HDRS), or Quick Inventory of Depressive Symptomatology Self-Report (QIDS) or Patient Health Questionnaire (PHQ-9) Suicide Item, unless otherwise approved by the PI or PI's designee
- A positive pregnancy test
- Organ transplants
- Current or history of cancer within the past five years besides basal cell carcinoma, unless otherwise approved by the PI or PI's designee
- A score of <28 on the Mini Mental Status Exam (MMSE), unless otherwise approved by the PI or PI's designee
- Wide Range Achievement Test (WRAT-3) score indicating less than 8th grade reading level, unless otherwise approved by the PI or PI's designee
- Either QIDS <14 or PHQ-9 <15, or HDRS <18, unless otherwise approved by the principal investigator or PI's designee
- History of the following: schizophrenia, schizoaffective disorder, other (non mood disorder) psychosis, depression secondary to a medical condition, mental retardation, dementia, or delirium
- Substance dependence [or abuse within the past year (except nicotine)], unless otherwise approved by the PI or PI's designee
- Body Mass Index >40 to limit the impact of morbid obesity on the results, unless otherwise approved by the principal investigator or PI's designee
- Antisocial personality disorder diagnosis as assessed during clinical interview, as well as a history of hospitalization and/or recurrent suicidal behavior judged to be directly due to the personality disorder
- Current eating disorder (except binge eating related to depression) unless approved by PI or PI's designee
- Current obsessive-compulsive disorder (OCD), exclusionary only if impacting daily functioning, as assessed by clinical interview
- Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with participating in or completing the protocol
- Smoking more than 1/2 pack a day or e-cigarette equivalent, unless approved by the PI or PI's designee
- Initiation of any of the following medications, unless otherwise approved by the PI or PI's designee: Aspirin or Aspirin-like compounds, Ibuprofen or Naproxen Sodium, Cholesterol medications, Antibiotics, Herbal Medications, Psychiatric or Psychotropic Medications, Omega-3 supplements, Topical Steroids, Vaccinations
- Currently on antidepressant medication, unless otherwise approved by the PI or PI's designee
Sites / Locations
- Emory University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sinemet/Placebo
Placebo/Sinemet
Arm Description
Subjects with major depression will be given Sinemet (a combination of 250 mg of levodopa and 50 mg of carbidopa) at one study visit and placebo at the other study visit. Sinemet will be given first followed by placebo at the subsequent visit.
Subjects with major depression will be given placebo at one study visit and Sinemet (a combination of 250 mg of levodopa and 50 mg of carbidopa) at the other study visit. Placebo will be given first followed by Sinemet at the subsequent visit.
Outcomes
Primary Outcome Measures
Change in Functional Corticostriatal Connectivity
Corticostriatal connectivity was assessed by functional magnetic resonance imaging (fMRI). Resting-state and task-based (monetary incentive delay [MID]) fMRI scans were conducted on a 3 Tesla Siemens Trio MRI scanner. Subject-level correlations for degree of cortical and striatal functional connectivity were Fisher's Z transformed {Z(R)=0.5ln[(1+R)/(1-R)]}, a standard method for calculating fMRI functional connectivity. Greater Fisher's Z-scores reflected stronger correlated fMRI activity (i.e., higher corticostriatal connectivity).
Correlation Coefficient Between Change in Corticostriatal Connectivity and Levels of Plasma C-reactive Protein and Other Immune Markers
Peripheral blood samples were analyzed for levels of immune markers like plasma C-reactive protein (CRP), interleukin-6 (IL-6), soluble interleukin-6 receptor (sIL-6R), tumor necrosis factor (TNF) -alpha, soluble cytokine receptor2 (TNFR 2), interleukin-1 beta (IL-1 beta), interleukin-1 receptor antagonist (IL-1Ra), interleukin 10 (IL-10) and monocyte chemoattractant protein-1 (MCP-1).
Secondary Outcome Measures
Effort-Expenditure for Rewards Task (EEfRT) Neurocognitive Test
The Effort-Expenditure for Rewards Task (EEfRT) is a computer-based multi-trial task used to objectively assess motivation. Possible results range between 0 to1 with 1 being a better outcome. Results show mean probability of hard (high effort) choice.
The Trail Making Test (TMT) Neurocognitive Assessment
The Trail Making Test (TMT) is used to measure basic attention and psychomotor processing speed. Time taken to complete each task is recorded in seconds, whereby the greater the number of seconds, the slower the psychomotor speed.
Digit Symbol Task Neurocognitive Test
The Digit Symbol Task was used to assess graphomotor speed, visual scanning and memory processing speed involving numbers and a corresponding blank box where subjects are asked to fill in matching symbol as fast as they can. Results show the average number of correct symbols completed in up to 100 boxes in 90 seconds.
Finger Tapping Task (FTT) Neurocognitive Test
The Finger Tapping Task (FTT) assesses motor speed and can detect subtle motor impairment. The test measures the average number of taps per 10 second trial. A greater number of taps reflects faster motor speed.
Reaction Time Task (CANTAB) Neurocognitive Test
The reaction time test includes simple and choice reaction time tasks and is divided into 5 stages requiring increasingly complex chains of responses. The task provided distinction between reaction (or decision) time and movement latencies (milliseconds) based on touch responses made to a single (simple) or chosen from multiple (choice) stimuli flashed on a computer screen. Results show mean response latency in milliseconds.
Multidimensional Fatigue Inventory (MFI) Self-report Questionnaire
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure severity of fatigue based on five dimensions of fatigue, general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The total MFI scores range from 20 to 100 where high scores indicate greater fatigue.
Snaith-Hamilton Pleasure Scale (SHAPS) Self-report Questionnaire
The Snaith-Hamilton Pleasure Scale (SHAPS), a 14-item self-report scale with high psychometric validity for assessing the presence of anhedonia, was used to assess hedonic capacity. Participants rated how much they agreed or disagreed with the 14 items phrased as "I would enjoy __" based on their ability to experience pleasure. Of the four possible response categories (Definitely Agree, Agree, Disagree, and Strongly Disagree), either of the Disagree responses received a score of 1 and either of the Agree responses received a score of 0. The SHAPS score calculated as the sum of these 14 items ranged from 0 to 14, and higher SHAPS scores indicated greater anhedonia.
Inventory of Depressive Symptoms-Self Report (IDS-SR) Questionnaire
The Inventory of Depressive Symptoms-Self Report (IDS-SR) is a 30-item self-report instrument with excellent psychometric properties for measuring symptom constructs consistent with current Diagnostic and Statistical Manual of Mental Disorders (DSM) nosology and that is widely used to measure depression severity in clinical trials. Response scores are summed and range from 0 to 84, with higher scores reflecting greater depression severity.
Beck Depression Inventory (BDI-II), Anhedonia Subscale Score
The Beck Depression Inventory-II (BDI-II) is a widely used self-report for measuring depression severity over the past two weeks and the anhedonia subscale is one of several validated subscales in the BDI-II. Responses are given on a 4-point scale where 0 = the symptom of depression has not been experienced and 3 = the symptom of depression is severe. The anhedonia subscale score is created by summing responses to four items of the BDI-II that assess loss of pleasure, loss of interest, loss of energy, loss of sex drive. The total score of the anhedonia subscale ranges from 0 to 12 where higher scores reflect greater severity of anhedonia symptoms.
Profile of Mood States (POMS) Scale
The Profile of Mood States (POMS) scale is a 30-item psychological rating scale used to assess transient, distinct mood states. Participants rate the extent to which they feel unhappy, blue, lonely, gloomy, and worthless on a scale from 0 (not at all) to 4 (extremely). Scores range from 0 to 120 with higher scores reflecting a more negative mood state.
State-Trait Anxiety Inventory (STAI) State Scale
The 20-item self-report State-Trait Anxiety Inventory (STAI) State scale was used to measure severity of anxiety symptoms. Total scores range from 20 to 80 with higher scores reflecting greater anxiety. Scores in the high 40s are considered clinically significant.
Change in Motivation and Pleasure (MAP) Scale Score
The motivation and pleasure (MAP) questionnaire is an 18-item self-report inventory that was created to disentangle state-wise motivational and consummatory components of everyday activities over a 24-hour period. This scale was used to assess self-reported changes in symptoms of anhedonia before and after inflammation blockade. Respondents respond to statements about daily activities on a scale from 0 (no pleasure/not at all) to 4 (extreme pleasure/very often). Total scores range from 0 to 72 where higher scores indicate greater motivation and effort given to everyday situations.
Full Information
NCT ID
NCT02513485
First Posted
July 29, 2015
Last Updated
August 24, 2022
Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT02513485
Brief Title
Inflammation-related Alterations in Neurocircuitry: Reversal With Levodopa
Official Title
"Inflammation-related Alterations in Neurocircuitry: Reversal With Levodopa"; "Inflammation Effects on Corticostriatal Connectivity and Reward: Role of Dopamine"
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 9, 2015 (Actual)
Primary Completion Date
February 21, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to learn more about the changes that happen in the brain and the body when a person is depressed. This study will determine if the level of inflammation in the body is related to symptoms of depression, how well the person thinks, and how certain brain regions communicate.
Detailed Description
Cytokines released by an activated immune system have been associated with decreased brain dopamine and the development of depression. Biomarkers of inflammation, such as inflammatory cytokines and acute-phase proteins like C-reactive protein (CRP), are elevated in a significant proportion of patients with mood and psychiatric disorders. The investigators will study if administration of Levodopa (L- 3,4-dihydroxyphenylalanine [DOPA]-carbidopa, 250/25mg) to depressed patients with high inflammation will 1) increase corticostriatal functional connectivity, and 2) improve objective measures of motivation compared to placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Inflammation, Anhedonia, Psychomotor retardation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sinemet/Placebo
Arm Type
Active Comparator
Arm Description
Subjects with major depression will be given Sinemet (a combination of 250 mg of levodopa and 50 mg of carbidopa) at one study visit and placebo at the other study visit. Sinemet will be given first followed by placebo at the subsequent visit.
Arm Title
Placebo/Sinemet
Arm Type
Active Comparator
Arm Description
Subjects with major depression will be given placebo at one study visit and Sinemet (a combination of 250 mg of levodopa and 50 mg of carbidopa) at the other study visit. Placebo will be given first followed by Sinemet at the subsequent visit.
Intervention Type
Drug
Intervention Name(s)
Levodopa+carbidopa
Other Intervention Name(s)
Sinemet
Intervention Description
Sinemet is a combination of 250 mg levodopa and 50 mg carbidopa. Sinemet will be administered orally at Visit 1 or Visit 2.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A placebo is a sugar pill that has no therapeutic effect and will be administered orally at Visit 1 or Visit 2.
Primary Outcome Measure Information:
Title
Change in Functional Corticostriatal Connectivity
Description
Corticostriatal connectivity was assessed by functional magnetic resonance imaging (fMRI). Resting-state and task-based (monetary incentive delay [MID]) fMRI scans were conducted on a 3 Tesla Siemens Trio MRI scanner. Subject-level correlations for degree of cortical and striatal functional connectivity were Fisher's Z transformed {Z(R)=0.5ln[(1+R)/(1-R)]}, a standard method for calculating fMRI functional connectivity. Greater Fisher's Z-scores reflected stronger correlated fMRI activity (i.e., higher corticostriatal connectivity).
Time Frame
Scans approximately 45 min post drug/placebo administration at Visit 1, Visit 2 (spaced by approximately 1 week)
Title
Correlation Coefficient Between Change in Corticostriatal Connectivity and Levels of Plasma C-reactive Protein and Other Immune Markers
Description
Peripheral blood samples were analyzed for levels of immune markers like plasma C-reactive protein (CRP), interleukin-6 (IL-6), soluble interleukin-6 receptor (sIL-6R), tumor necrosis factor (TNF) -alpha, soluble cytokine receptor2 (TNFR 2), interleukin-1 beta (IL-1 beta), interleukin-1 receptor antagonist (IL-1Ra), interleukin 10 (IL-10) and monocyte chemoattractant protein-1 (MCP-1).
Time Frame
Scans approximately 45 minutes post drug/placebo administration at Visit 1, Visit 2 (spaced by approximately 1 week)
Secondary Outcome Measure Information:
Title
Effort-Expenditure for Rewards Task (EEfRT) Neurocognitive Test
Description
The Effort-Expenditure for Rewards Task (EEfRT) is a computer-based multi-trial task used to objectively assess motivation. Possible results range between 0 to1 with 1 being a better outcome. Results show mean probability of hard (high effort) choice.
Time Frame
At baseline and approximately 2-3 hours post drug/placebo administration at Visit 1, Visit 2 (spaced by approximately 1 week)
Title
The Trail Making Test (TMT) Neurocognitive Assessment
Description
The Trail Making Test (TMT) is used to measure basic attention and psychomotor processing speed. Time taken to complete each task is recorded in seconds, whereby the greater the number of seconds, the slower the psychomotor speed.
Time Frame
At baseline and approximately 2-3 hours post drug/placebo administration at Visit 1, Visit 2 (spaced by approximately 1 week)
Title
Digit Symbol Task Neurocognitive Test
Description
The Digit Symbol Task was used to assess graphomotor speed, visual scanning and memory processing speed involving numbers and a corresponding blank box where subjects are asked to fill in matching symbol as fast as they can. Results show the average number of correct symbols completed in up to 100 boxes in 90 seconds.
Time Frame
At baseline and approximately 2-3 hours post drug/placebo administration at Visit 1, Visit 2 (spaced by approximately 1 week)
Title
Finger Tapping Task (FTT) Neurocognitive Test
Description
The Finger Tapping Task (FTT) assesses motor speed and can detect subtle motor impairment. The test measures the average number of taps per 10 second trial. A greater number of taps reflects faster motor speed.
Time Frame
At baseline and approximately 2-3 hours post drug/placebo administration at Visit 1, Visit 2 (spaced by approximately 1 week)
Title
Reaction Time Task (CANTAB) Neurocognitive Test
Description
The reaction time test includes simple and choice reaction time tasks and is divided into 5 stages requiring increasingly complex chains of responses. The task provided distinction between reaction (or decision) time and movement latencies (milliseconds) based on touch responses made to a single (simple) or chosen from multiple (choice) stimuli flashed on a computer screen. Results show mean response latency in milliseconds.
Time Frame
At baseline and approximately 2-3 hours post drug/placebo administration at Visit 1, Visit 2 (spaced by approximately 1 week)
Title
Multidimensional Fatigue Inventory (MFI) Self-report Questionnaire
Description
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure severity of fatigue based on five dimensions of fatigue, general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The total MFI scores range from 20 to 100 where high scores indicate greater fatigue.
Time Frame
At baseline and Visit 1, Visit 2 (spaced by approximately 1 week)
Title
Snaith-Hamilton Pleasure Scale (SHAPS) Self-report Questionnaire
Description
The Snaith-Hamilton Pleasure Scale (SHAPS), a 14-item self-report scale with high psychometric validity for assessing the presence of anhedonia, was used to assess hedonic capacity. Participants rated how much they agreed or disagreed with the 14 items phrased as "I would enjoy __" based on their ability to experience pleasure. Of the four possible response categories (Definitely Agree, Agree, Disagree, and Strongly Disagree), either of the Disagree responses received a score of 1 and either of the Agree responses received a score of 0. The SHAPS score calculated as the sum of these 14 items ranged from 0 to 14, and higher SHAPS scores indicated greater anhedonia.
Time Frame
Visit 1: Pre drug/placebo, Visit 1: 1-2 hrs post drug/placebo, Visit 2: Pre drug/placebo, Visit 2: 1-2 hrs post drug/placebo
Title
Inventory of Depressive Symptoms-Self Report (IDS-SR) Questionnaire
Description
The Inventory of Depressive Symptoms-Self Report (IDS-SR) is a 30-item self-report instrument with excellent psychometric properties for measuring symptom constructs consistent with current Diagnostic and Statistical Manual of Mental Disorders (DSM) nosology and that is widely used to measure depression severity in clinical trials. Response scores are summed and range from 0 to 84, with higher scores reflecting greater depression severity.
Time Frame
At baseline and Visit 1: Pre drug/placebo, Visit 2: Pre drug/placebo (spaced by approximately 1 week)
Title
Beck Depression Inventory (BDI-II), Anhedonia Subscale Score
Description
The Beck Depression Inventory-II (BDI-II) is a widely used self-report for measuring depression severity over the past two weeks and the anhedonia subscale is one of several validated subscales in the BDI-II. Responses are given on a 4-point scale where 0 = the symptom of depression has not been experienced and 3 = the symptom of depression is severe. The anhedonia subscale score is created by summing responses to four items of the BDI-II that assess loss of pleasure, loss of interest, loss of energy, loss of sex drive. The total score of the anhedonia subscale ranges from 0 to 12 where higher scores reflect greater severity of anhedonia symptoms.
Time Frame
Visit 1: Pre drug/placebo, Visit 2: Pre drug/placebo (spaced by approximately 1 week)
Title
Profile of Mood States (POMS) Scale
Description
The Profile of Mood States (POMS) scale is a 30-item psychological rating scale used to assess transient, distinct mood states. Participants rate the extent to which they feel unhappy, blue, lonely, gloomy, and worthless on a scale from 0 (not at all) to 4 (extremely). Scores range from 0 to 120 with higher scores reflecting a more negative mood state.
Time Frame
Visit 1: Pre drug/placebo, Visit 1: 1-2 hrs post drug/placebo, Visit 2: Pre drug/placebo, Visit 2: 1-2 hrs post drug/placebo
Title
State-Trait Anxiety Inventory (STAI) State Scale
Description
The 20-item self-report State-Trait Anxiety Inventory (STAI) State scale was used to measure severity of anxiety symptoms. Total scores range from 20 to 80 with higher scores reflecting greater anxiety. Scores in the high 40s are considered clinically significant.
Time Frame
Visit 1: Pre drug/placebo, Visit 1: 1-2 hrs post drug/placebo, Visit 2: Pre drug/placebo, Visit 2: 1-2 hrs post drug/placebo
Title
Change in Motivation and Pleasure (MAP) Scale Score
Description
The motivation and pleasure (MAP) questionnaire is an 18-item self-report inventory that was created to disentangle state-wise motivational and consummatory components of everyday activities over a 24-hour period. This scale was used to assess self-reported changes in symptoms of anhedonia before and after inflammation blockade. Respondents respond to statements about daily activities on a scale from 0 (no pleasure/not at all) to 4 (extreme pleasure/very often). Total scores range from 0 to 72 where higher scores indicate greater motivation and effort given to everyday situations.
Time Frame
Visit 1: Pre drug/placebo, Visit 1: 1-2 hrs post drug/placebo, Visit 2: Pre drug/placebo, Visit 2: 1-2 hrs post drug/placebo
Other Pre-specified Outcome Measures:
Title
Correlation Coefficient Between Change in Cerebral Blood Flow (CBF) and Change in Functional Connectivity
Description
The cerebral blood flow (CBF) before and after Sinemet (250 mg levodopa/ 50mg carbidopa) or placebo administration was assessed by arterial spin labeling (ASL) fMRI.
Time Frame
Scans approximately 45 minutes post drug/placebo administration at Visit 1, Visit 2 (spaced by approximately 1 week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects have signed a current version of the Informed Consent and HIPAA documents prior to initiation of study procedures
Able to comprehend English
Diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM)-V major depression and currently off antidepressant medication, unless otherwise approved by the PI or PI's designee
Depression as the primary axis I disorder
Negative pregnancy test for women of childbearing potential
Not breast feeding
At least two CRP tests conducted to establish reliability
Exclusion Criteria:
Evidence of untreated or poorly controlled endocrine, cardiovascular, pulmonary, hematological, renal, or neurological disease
History of central nervous system (CNS) trauma or active seizure disorder requiring medication unless otherwise approved by principal investigator, or PI's designee
Current or history of migraines, glaucoma, melanoma, or bleeding disorder of any kind
Autoimmune or inflammatory disorder of any kind
Embedded metallic objects, prosthetics made of paramagnetic metals, aneurysmal clips and/or a history of claustrophobia
Chronic infection (e.g. hepatitis B or C or Human Immunodeficiency Virus infection)
Chronic use of agents known to affect the immune system including glucocorticoid therapy within the past 6 months, methotrexate within the past 1 year, chemotherapy of any kind (past or present), immunotherapy of any kind (past or present), aspirin or non-steroidal anti-inflammatory drugs (NSAIDs; within the past 2 weeks), statins (within the past 1 month), vaccinations (within the past 2 weeks), topical steroids (within the past 2 weeks), and antibiotics (within the past two weeks) unless otherwise approved by principal investigator or PI's designee.
Suicide attempt within six months of screening, or active suicidal intent or plan, or score >2 on Hamilton Depression Rating Scale (HDRS), or Quick Inventory of Depressive Symptomatology Self-Report (QIDS) or Patient Health Questionnaire (PHQ-9) Suicide Item, unless otherwise approved by the PI or PI's designee
A positive pregnancy test
Organ transplants
Current or history of cancer within the past five years besides basal cell carcinoma, unless otherwise approved by the PI or PI's designee
A score of <28 on the Mini Mental Status Exam (MMSE), unless otherwise approved by the PI or PI's designee
Wide Range Achievement Test (WRAT-3) score indicating less than 8th grade reading level, unless otherwise approved by the PI or PI's designee
Either QIDS <14 or PHQ-9 <15, or HDRS <18, unless otherwise approved by the principal investigator or PI's designee
History of the following: schizophrenia, schizoaffective disorder, other (non mood disorder) psychosis, depression secondary to a medical condition, mental retardation, dementia, or delirium
Substance dependence [or abuse within the past year (except nicotine)], unless otherwise approved by the PI or PI's designee
Body Mass Index >40 to limit the impact of morbid obesity on the results, unless otherwise approved by the principal investigator or PI's designee
Antisocial personality disorder diagnosis as assessed during clinical interview, as well as a history of hospitalization and/or recurrent suicidal behavior judged to be directly due to the personality disorder
Current eating disorder (except binge eating related to depression) unless approved by PI or PI's designee
Current obsessive-compulsive disorder (OCD), exclusionary only if impacting daily functioning, as assessed by clinical interview
Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with participating in or completing the protocol
Smoking more than 1/2 pack a day or e-cigarette equivalent, unless approved by the PI or PI's designee
Initiation of any of the following medications, unless otherwise approved by the PI or PI's designee: Aspirin or Aspirin-like compounds, Ibuprofen or Naproxen Sodium, Cholesterol medications, Antibiotics, Herbal Medications, Psychiatric or Psychotropic Medications, Omega-3 supplements, Topical Steroids, Vaccinations
Currently on antidepressant medication, unless otherwise approved by the PI or PI's designee
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Felger, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35927580
Citation
Bekhbat M, Li Z, Mehta ND, Treadway MT, Lucido MJ, Woolwine BJ, Haroon E, Miller AH, Felger JC. Functional connectivity in reward circuitry and symptoms of anhedonia as therapeutic targets in depression with high inflammation: evidence from a dopamine challenge study. Mol Psychiatry. 2022 Oct;27(10):4113-4121. doi: 10.1038/s41380-022-01715-3. Epub 2022 Aug 4. Erratum In: Mol Psychiatry. 2022 Sep 5;:
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Inflammation-related Alterations in Neurocircuitry: Reversal With Levodopa
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