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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23MH114037-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will recruit persons with schizophrenia or schizoaffective disorder and will use an oral glucose tolerance test to test the hypothesis that insulin resistance drives inflammation.
Schizophrenia is a severe mental illness that affects 1% of the population, but accounts for over $60 billion in costs to the national healthcare system. Negative symptoms of schizophrenia, including motivational deficits, are some of the most debilitating aspects of the disorder, being both difficult to treat and representing one of the most significant barriers to functional recovery. One pathophysiologic pathway that may contribute to these alterations in reward circuitry in schizophrenia is inflammation. Increased inflammation has been reliably linked to deficits in reward processing and decreased motivation via effects of inflammatory cytokines on regions of the basal ganglia, including the ventral striatum. Previous findings show that some patients with schizophrenia reliably exhibit elevated concentrations of inflammatory markers and that inflammatory cytokines may be related to negative symptoms including decreased motivation. Relevant to the impact of inflammation on insulin signaling, measures of insulin sensitivity are significantly worse in patients with schizophrenia, including at illness onset. Moreover, antipsychotic medications lead to metabolic syndrome, contributing to risk for insulin resistance and ultimately diabetes. Insulin resistance is believed to be caused by increased inflammation, and in turn can contribute to inflammation through alterations in glucose metabolism.
This study uses an oral glucose tolerance test to test the hypothesis that insulin resistance drives inflammation. The researchers will recruit subjects with a range of insulin resistance, as measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). This will allow the researchers to investigate the contributions of metabolic dysfunction and inflammation on inflammatory and metabolic markers, brain reward circuitry, motivational deficits, and negative symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Glucose Tolerance Test (OGTT) | Experimental | Medically stable participants with schizophrenia and a range of insulin resistance will have an oral glucose tolerance test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Glucose Tolerance Test (OGTT) | Other | Participants will undergo a fasting blood draw for inflammatory and metabolic markers before a 75gm oral glucose tolerance test (OGTT) and at 1, 2 and 3 hours post-OGTT. Behavioral assessments will also be administered pre- and post-OGTT administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Effort-Expenditure for Rewards Task (EEfRT) Score | EEfRT is a multitrial game task assessing motivation in which participants choose between 2 different task difficulty levels to obtain monetary rewards. For all trials, participants make repeated manual button presses which raises the level of a virtual ''bar'' viewed onscreen by the participant. Participants are eligible to win the money allotted for each trial if they raise the bar to the ''top''. Each trial presents subjects with a choice between 'high effort' and 'low effort' tasks that require different amounts of button pressing. Reward magnitudes for the high-effort task vary between amounts, while reward magnitudes for the low-effort task remain constant. Trials also vary in terms of 3 levels of probability of winning the amount associated with the choice selected. The first 50 trials are used for analysis. Percentage of hard-task choices across all levels of probability is calculated from all hard choices. Lower percentages of hard task choices indicate decreased motivation. | Baseline, Hour 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Finger Tapping Task (FTT) Score | The Finger Tapping Task (FTT) uses a specially adapted tapper that the subject is asked to tap as fast as possible. The subject is given 5 consecutive 10-second trials for the preferred and non-preferred hands.The FTT is design to assess subtle motor impairment and found to be altered in subjects with basal ganglia disorders and lesions. The finger tapping score is the mean number of taps of 5 trials and is computed for each hand. |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Blood Glucose | Fasting blood glucose will be assessed to determine the impact of insulin resistance on inflammatory markers. | Baseline, Hours 1, 2, and 3 |
| Fasting Blood Insulin | Fasting blood insulin will be assessed to determine the impact of insulin resistance on inflammatory markers. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Goldsmith, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Department of Psychiatry and Behavioral Sciences | Atlanta | Georgia | 30030 | United States | ||
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This was an optional substudy underpowered to identify relationships between changes in inflammatory and metabolic markers pre- and post-OGTT with reward circuitry or motivational deficits. These analyses are thus exploratory and would serve as preliminary data for future research proposals.
Participants were recruited from Grady Health System in Atlanta, Georgia, USA. Participant enrollment began August 31, 2020, and all follow-up was complete by March 1, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Glucose Tolerance Test (OGTT) | Medically stable participants with schizophrenia and a range of insulin resistance will have an oral glucose tolerance test. Oral Glucose Tolerance Test (OGTT): Participants will undergo a fasting blood draw for inflammatory and metabolic markers before a 75gm oral glucose tolerance test (OGTT) and at 1, 2 and 3 hours post-OGTT. Behavioral assessments will also be administered pre- and post-OGTT administration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who met all screening requirements.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Oral Glucose Tolerance Test (OGTT) | Medically stable participants with schizophrenia and a range of insulin resistance will have an oral glucose tolerance test. Oral Glucose Tolerance Test (OGTT): Participants will undergo a fasting blood draw for inflammatory and metabolic markers before a 75gm oral glucose tolerance test (OGTT) and at 1, 2 and 3 hours post-OGTT. Behavioral assessments will also be administered pre- and post-OGTT administration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effort-Expenditure for Rewards Task (EEfRT) Score | EEfRT is a multitrial game task assessing motivation in which participants choose between 2 different task difficulty levels to obtain monetary rewards. For all trials, participants make repeated manual button presses which raises the level of a virtual ''bar'' viewed onscreen by the participant. Participants are eligible to win the money allotted for each trial if they raise the bar to the ''top''. Each trial presents subjects with a choice between 'high effort' and 'low effort' tasks that require different amounts of button pressing. Reward magnitudes for the high-effort task vary between amounts, while reward magnitudes for the low-effort task remain constant. Trials also vary in terms of 3 levels of probability of winning the amount associated with the choice selected. The first 50 trials are used for analysis. Percentage of hard-task choices across all levels of probability is calculated from all hard choices. Lower percentages of hard task choices indicate decreased motivation. | Posted | Mean | Standard Deviation | proportion of hard-task choices | Baseline, Hour 1 |
|
Information on adverse events was collected beginning at the time of consent to participate in the study throughout study participation up to 10 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Glucose Tolerance Test (OGTT) | Medically stable participants with schizophrenia and a range of insulin resistance will have an oral glucose tolerance test. Oral Glucose Tolerance Test (OGTT): Participants will undergo a fasting blood draw for inflammatory and metabolic markers before a 75gm oral glucose tolerance test (OGTT) and at 1, 2 and 3 hours post-OGTT. Behavioral assessments will also be administered pre- and post-OGTT administration. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David R. Goldsmith, MD | Emory University | 404-727-3735 | drgolds@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 31, 2022 | Nov 29, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 15, 2023 | Dec 1, 2023 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005951 | Glucose Tolerance Test |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Baseline, Hour 1 |
| Trail Making Test Part A (TMT-A) Score | The Trail Making Test-A is a timed task that provides information on motor function and speed of processing. In Part A of the TMT participants connect circles labeled with numbers, in ascending order. The score is the amount of time it takes for the participant to complete the task. The average time it takes to complete the task is 29 seconds and times longer than 78 seconds suggest a deficiency. | Baseline, Hour 1 |
| Digit Symbol Substitution Task (DSST) Score | The DSST is a subtest of the Wechsler Adult Intelligence Scale and involves graphimotor speed, visual scanning and memory, with about half of the variance being accounted for by graphimotor speed, a third by visual scanning and 4-5% by memory. Performance on the Digit Symbol Test has been found to correlate with subcortical (caudate) atrophy in disorders involving the basal ganglia. Respondents match symbols to numbers using a key presented at the top of the test page. The score is the number of correctly entered symbols in the given time period and higher scores indicate better performance. | Baseline, Hour 1 |
| Profile of Mood States (POMS) Brief Score | The POMS is a 30-item rating scale designed to measure mood states across short periods. The POMS assess six mood factors: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Each item is rated on a 5-point scale where 0 = not at all and 4 = extremely. Total scores range from 0 to 120 and lower scores indicate a better state of mood. | Baseline, Hour 1 |
| Baseline, Hours 1, 2, and 3 |
| Neural Response to Reward Motivation Assessed by fMRI-adapted Version of the EEfRT | Assessment of effort-based decision-making will be made using the EEfRT task adapted for fMRI. During each trial, subjects are presented with a choice between two levels of task difficulty, a High Effort option, and a Low Effort option. Unlike in the behavioral version of the task, subjects will not be required to make button presses during the scan. The reward magnitude for a No Effort option remains constant, while the reward magnitude for the High Effort option varies. Additionally, the amount of effort required for the High Effort option will vary between 20%, 50%, 80%, and 100% of the subject's maximum effort (set for each individual before the scan). | Baseline, Hour 3 |
| Change in Neural Response to Anticipating and Receiving Monetary Rewards Assessed by Monetary Incentive Delay (MID) Task | Assessment of reward anticipation will be achieved using the MID task, conducted during functional MRI (fMRI) neuroimaging. Briefly, during this task participants have the opportunity to win or lose money by making a rapid button press in response to a target visual stimulus. The primary epoch of interest is the "anticipatory delay" - a period of ~2000ms that occurs after participants have been informed how much money they can win or lose on a given trial, but prior to the presentation of the target. This epoch has repeatedly been associated with robust ventral striatal activity. Participants will complete 2 functional runs of between 50 and 200 trials each (the number of trials will be decided at the discretion of the PI), with evenly distributed reward magnitudes. | Baseline, Hour 3 |
| Change in Cambridge Neuropsychological Test Automated Battery (CANTAB) Reaction Time Score | This reaction time test includes simple and choice reaction time tasks and is divided into 5 stages requiring increasingly complex chains of responses and providing a distinction between reaction (or decision) time and movement latencies. Movement times on the CANTAB reaction time task have been slowed during interferon-alpha (IFN-α) treatment and correlated with IFN-alpha-induced depression and fatigue. | Baseline, Hour 1 |
| Plasma C-reactive Protein (CRP) Levels | Plasma CRP will be assessed to determine the impact of insulin resistance on inflammatory markers. | Baseline, Hours 1, 2, and 3 |
| Change in Monocyte Chemoattractant Protein-1 (MCP-1) Levels | Fluorokine MAP Multiplex Human Biomarker Panels will be used to measure plasma inflammatory markers that have been found to be altered in schizophrenia. MCP-1 levels before and after the OGTT will be examined. | Baseline, Hours 1, 2, and 3 |
| Change in Interleukin-10 (IL-10) Levels | Fluorokine MAP Multiplex Human Biomarker Panels will be used to measure plasma inflammatory markers that have been found to be altered in schizophrenia. IL-10 levels before and after the OGTT will be examined. | Baseline, Hours 1, 2, and 3 |
| Change in Soluble Interleukin-6 Receptor (sIL-6R) Levels | Fluorokine MAP Multiplex Human Biomarker Panels will be used to measure plasma inflammatory markers that have been found to be altered in schizophrenia. sIL-6R levels before and after the OGTT will be examined. | Baseline, Hours 1, 2, and 3 |
| Change in Interleukin-6 (IL-6) Levels | Fluorokine MAP Multiplex Human Biomarker Panels will be used to measure plasma inflammatory markers that have been found to be altered in schizophrenia. IL-6 levels before and after the OGTT will be examined. | Baseline, Hours 1, 2, and 3 |
| Change in Soluble TNF Receptor 2 (sTNFR2) Levels | Fluorokine MAP Multiplex Human Biomarker Panels will be used to measure plasma inflammatory markers that have been found to be altered in schizophrenia. sTNFR2 levels before and after the OGTT will be examined. | Baseline, Hours 1, 2, and 3 |
| Change in Interleukin-1beta (IL-1beta) Levels | Fluorokine MAP Multiplex Human Biomarker Panels will be used to measure plasma inflammatory markers that have been found to be altered in schizophrenia. IL-1beta levels before and after the OGTT will be examined. | Baseline, Hours 1, 2, and 3 |
| Change in Interleukin-1 Receptor Antagonist (IL-1RA) Levels | Fluorokine MAP Multiplex Human Biomarker Panels will be used to measure plasma inflammatory markers that have been found to be altered in schizophrenia. IL-1RA levels before and after the OGTT will be examined. | Baseline, Hours 1, 2, and 3 |
| Change in Tumor Necrosis Factor (TNF)-Alpha Levels | Fluorokine MultiAnalyte Profiling (MAP) Multiplex Human Biomarker Panels will be used to measure plasma inflammatory markers that have been found to be altered in schizophrenia. TNF-alpha levels before and after the OGTT will be examined. | Baseline, Hours 1, 2, and 3 |
| Change in Resting State Scan | For the resting state and task-based functional connectivity analysis, whole brain, subject-level correlation maps indicating regional similarity with the striatal seed region time series will be generated and Fisher transformed to Z-score maps. In addition, data reduction strategies will be employed to address inflammatory marker collinearity in analyses combining relevant inflammatory markers. To assess the significance of correlated activity with each bilateral seed region, paired t-tests will be conducted on participants' Z-score maps, adjusted for multiple comparisons. For significant brain regions, descriptive statistics will be used to characterize the mean, standard deviation, and standard error of the Z scores. | Baseline, Hour 3 |
| Grady Health System (non-CRN), Grady Health System (CRN), Ponce Center |
| Atlanta |
| Georgia |
| 30303 |
| United States |
| Emory Clinic, Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Emory University Clinical Research Network | Atlanta | Georgia | 30322 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Emory Universtiy | Atlanta | Georgia | 30322 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Oral Glucose Tolerance Test (OGTT) |
Medically stable participants with schizophrenia and a range of insulin resistance will have an oral glucose tolerance test. Oral Glucose Tolerance Test (OGTT): Participants will undergo a fasting blood draw for inflammatory and metabolic markers before a 75gm oral glucose tolerance test (OGTT) and at 1, 2 and 3 hours post-OGTT. Behavioral assessments will also be administered pre- and post-OGTT administration. |
|
|
| Secondary | Finger Tapping Task (FTT) Score | The Finger Tapping Task (FTT) uses a specially adapted tapper that the subject is asked to tap as fast as possible. The subject is given 5 consecutive 10-second trials for the preferred and non-preferred hands.The FTT is design to assess subtle motor impairment and found to be altered in subjects with basal ganglia disorders and lesions. The finger tapping score is the mean number of taps of 5 trials and is computed for each hand. | 11 participants analyzed for baseline, but only 10 completed the 1-hour measurements. One participant could not complete the tasks for the left hand. | Posted | Mean | Standard Deviation | number of taps on a 10 second counter | Baseline, Hour 1 |
|
|
|
| Secondary | Trail Making Test Part A (TMT-A) Score | The Trail Making Test-A is a timed task that provides information on motor function and speed of processing. In Part A of the TMT participants connect circles labeled with numbers, in ascending order. The score is the amount of time it takes for the participant to complete the task. The average time it takes to complete the task is 29 seconds and times longer than 78 seconds suggest a deficiency. | Posted | Mean | Standard Deviation | Seconds | Baseline, Hour 1 |
|
|
|
| Secondary | Digit Symbol Substitution Task (DSST) Score | The DSST is a subtest of the Wechsler Adult Intelligence Scale and involves graphimotor speed, visual scanning and memory, with about half of the variance being accounted for by graphimotor speed, a third by visual scanning and 4-5% by memory. Performance on the Digit Symbol Test has been found to correlate with subcortical (caudate) atrophy in disorders involving the basal ganglia. Respondents match symbols to numbers using a key presented at the top of the test page. The score is the number of correctly entered symbols in the given time period and higher scores indicate better performance. | Posted | Mean | Standard Deviation | Number of correct entered symbols | Baseline, Hour 1 |
|
|
|
| Secondary | Profile of Mood States (POMS) Brief Score | The POMS is a 30-item rating scale designed to measure mood states across short periods. The POMS assess six mood factors: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Each item is rated on a 5-point scale where 0 = not at all and 4 = extremely. Total scores range from 0 to 120 and lower scores indicate a better state of mood. | Only participants with available data are included in the analysis. Baseline data was inadvertently lost and only available for two (2) participants. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Hour 1 |
|
|
|
| Other Pre-specified | Fasting Blood Glucose | Fasting blood glucose will be assessed to determine the impact of insulin resistance on inflammatory markers. | Only baseline values were analyzed. Blood samples for exploratory outcome measures were not analyzed due to lack of funding. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Hours 1, 2, and 3 |
|
|
|
| Other Pre-specified | Fasting Blood Insulin | Fasting blood insulin will be assessed to determine the impact of insulin resistance on inflammatory markers. | Only baseline values were analyzed. Blood samples for exploratory outcome measures were not analyzed due to lack of funding. | Posted | Mean | Standard Deviation | mIU/L | Baseline, Hours 1, 2, and 3 |
|
|
|
| Other Pre-specified | Neural Response to Reward Motivation Assessed by fMRI-adapted Version of the EEfRT | Assessment of effort-based decision-making will be made using the EEfRT task adapted for fMRI. During each trial, subjects are presented with a choice between two levels of task difficulty, a High Effort option, and a Low Effort option. Unlike in the behavioral version of the task, subjects will not be required to make button presses during the scan. The reward magnitude for a No Effort option remains constant, while the reward magnitude for the High Effort option varies. Additionally, the amount of effort required for the High Effort option will vary between 20%, 50%, 80%, and 100% of the subject's maximum effort (set for each individual before the scan). | Not Posted | Baseline, Hour 3 | Participants |
| Other Pre-specified | Change in Neural Response to Anticipating and Receiving Monetary Rewards Assessed by Monetary Incentive Delay (MID) Task | Assessment of reward anticipation will be achieved using the MID task, conducted during functional MRI (fMRI) neuroimaging. Briefly, during this task participants have the opportunity to win or lose money by making a rapid button press in response to a target visual stimulus. The primary epoch of interest is the "anticipatory delay" - a period of ~2000ms that occurs after participants have been informed how much money they can win or lose on a given trial, but prior to the presentation of the target. This epoch has repeatedly been associated with robust ventral striatal activity. Participants will complete 2 functional runs of between 50 and 200 trials each (the number of trials will be decided at the discretion of the PI), with evenly distributed reward magnitudes. | Not Posted | Baseline, Hour 3 | Participants |
| Other Pre-specified | Change in Cambridge Neuropsychological Test Automated Battery (CANTAB) Reaction Time Score | This reaction time test includes simple and choice reaction time tasks and is divided into 5 stages requiring increasingly complex chains of responses and providing a distinction between reaction (or decision) time and movement latencies. Movement times on the CANTAB reaction time task have been slowed during interferon-alpha (IFN-α) treatment and correlated with IFN-alpha-induced depression and fatigue. | Not Posted | Baseline, Hour 1 | Participants |
| Other Pre-specified | Plasma C-reactive Protein (CRP) Levels | Plasma CRP will be assessed to determine the impact of insulin resistance on inflammatory markers. | One participant did not get CRP drawn. Only the baseline sample was analyzed. Blood samples for exploratory outcome measures were not analyzed due to lack of funding. | Posted | Mean | Standard Deviation | mg/L | Baseline, Hours 1, 2, and 3 |
|
|
|
| Other Pre-specified | Change in Monocyte Chemoattractant Protein-1 (MCP-1) Levels | Fluorokine MAP Multiplex Human Biomarker Panels will be used to measure plasma inflammatory markers that have been found to be altered in schizophrenia. MCP-1 levels before and after the OGTT will be examined. | Blood samples for exploratory outcome measures were not analyzed due to lack of funding. | Posted | Baseline, Hours 1, 2, and 3 |
|
|
| Other Pre-specified | Change in Interleukin-10 (IL-10) Levels | Fluorokine MAP Multiplex Human Biomarker Panels will be used to measure plasma inflammatory markers that have been found to be altered in schizophrenia. IL-10 levels before and after the OGTT will be examined. | Blood samples for exploratory outcome measures were not analyzed due to lack of funding. | Posted | Baseline, Hours 1, 2, and 3 |
|
|
| Other Pre-specified | Change in Soluble Interleukin-6 Receptor (sIL-6R) Levels | Fluorokine MAP Multiplex Human Biomarker Panels will be used to measure plasma inflammatory markers that have been found to be altered in schizophrenia. sIL-6R levels before and after the OGTT will be examined. | Only the baseline sample was analyzed. Blood samples for exploratory outcome measures were not analyzed due to lack of funding. | Posted | Baseline, Hours 1, 2, and 3 |
|
|
| Other Pre-specified | Change in Interleukin-6 (IL-6) Levels | Fluorokine MAP Multiplex Human Biomarker Panels will be used to measure plasma inflammatory markers that have been found to be altered in schizophrenia. IL-6 levels before and after the OGTT will be examined. | Blood samples for exploratory outcome measures were not analyzed due to lack of funding. | Posted | Baseline, Hours 1, 2, and 3 |
|
|
| Other Pre-specified | Change in Soluble TNF Receptor 2 (sTNFR2) Levels | Fluorokine MAP Multiplex Human Biomarker Panels will be used to measure plasma inflammatory markers that have been found to be altered in schizophrenia. sTNFR2 levels before and after the OGTT will be examined. | Blood samples for exploratory outcome measures were not analyzed due to lack of funding. | Posted | Baseline, Hours 1, 2, and 3 |
|
|
| Other Pre-specified | Change in Interleukin-1beta (IL-1beta) Levels | Fluorokine MAP Multiplex Human Biomarker Panels will be used to measure plasma inflammatory markers that have been found to be altered in schizophrenia. IL-1beta levels before and after the OGTT will be examined. | Only the baseline sample was analyzed. Blood samples for exploratory outcome measures were not analyzed due to lack of funding. | Posted | Baseline, Hours 1, 2, and 3 |
|
|
| Other Pre-specified | Change in Interleukin-1 Receptor Antagonist (IL-1RA) Levels | Fluorokine MAP Multiplex Human Biomarker Panels will be used to measure plasma inflammatory markers that have been found to be altered in schizophrenia. IL-1RA levels before and after the OGTT will be examined. | Blood samples for exploratory outcome measures were not analyzed due to lack of funding. | Posted | Baseline, Hours 1, 2, and 3 |
|
|
| Other Pre-specified | Change in Tumor Necrosis Factor (TNF)-Alpha Levels | Fluorokine MultiAnalyte Profiling (MAP) Multiplex Human Biomarker Panels will be used to measure plasma inflammatory markers that have been found to be altered in schizophrenia. TNF-alpha levels before and after the OGTT will be examined. | Blood samples for exploratory outcome measures were not analyzed due to lack of funding. | Posted | Baseline, Hours 1, 2, and 3 |
|
|
| Other Pre-specified | Change in Resting State Scan | For the resting state and task-based functional connectivity analysis, whole brain, subject-level correlation maps indicating regional similarity with the striatal seed region time series will be generated and Fisher transformed to Z-score maps. In addition, data reduction strategies will be employed to address inflammatory marker collinearity in analyses combining relevant inflammatory markers. To assess the significance of correlated activity with each bilateral seed region, paired t-tests will be conducted on participants' Z-score maps, adjusted for multiple comparisons. For significant brain regions, descriptive statistics will be used to characterize the mean, standard deviation, and standard error of the Z scores. | Not Posted | Baseline, Hour 3 | Participants |
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
Not provided
Not provided
Not provided
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |
|
| Left hand Baseline |
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| Left hand- Hour 1 |
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