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| Name | Class |
|---|---|
| Takeda Pharmaceuticals North America, Inc. | INDUSTRY |
| ElMindA Ltd | INDUSTRY |
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The purpose of this study is to explore patterns of Brain Network Activation (BNA) changes from baseline to endpoint on 1) efficacy of core symptoms of Major Depressive Disorder (MDD) and 2) improvement of cognitive dysfunction with acute treatment with flexible dose vortioxetine in adult outpatients with MDD and subjective complaints of cognitive dysfunction.
Vortioxetine is a novel antidepressant with hypothetical multimodal mechanism of action. It is thought to work through a combination of multiple pharmacological modes of action: 5-HT (hydroxytryptamine, or serotonin) reuptake inhibition, 5-HT3 (hydroxytryptamine, or serotonin) and 5-HT7 (hydroxytryptamine, or serotonin) receptor antagonism, 5-HT1A (hydroxytryptamine, or serotonin) receptor agonism, and 5-HT1B (hydroxytryptamine, or serotonin) receptor partial agonism. In vivo nonclinical studies have demonstrated that vortioxetine enhances levels of the neurotransmitters 5-HT (hydroxytryptamine, or serotonin), norepinephrine (NE), dopamine (DA), acetylcholine and histamine in specific areas of the brain. These affinities are all considered to be of clinical relevance and involved in the mechanism of action at therapeutic doses.
Vortioxetine has been shown to improve core depressive symptoms and improve cognitive function in adult outpatients with MDD and subjective complaints of cognitive function. This pilot study is intended to evaluate the extent to which BNA technology can provide clinically valuable information and provide information toward designing a subsequent confirmatory study that will further elucidate the effect of vortioxetine on MDD and cognitive function in this population. This exploratory study will ascertain the acute changes in core depression symptoms, cognitive function, tolerability, and safety using flexible-dose vortioxetine in adult outpatients with MDD with subjective complaints of cognitive functioning, as measured by BNA changes and standard outcome measures for depression and cognition.
The study consists of 8 weeks of open-label treatment for MDD with response to treatment measured by standard research depression scales and BNA electroencephalogram (EEG) readings taken at certain points during the trial. An important aim in this study is to explore what correlations may exist between changes in measured brainwave patterns and reported change in depressive symptoms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Other - vortioxetine | Other | Open-label vortioxetine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vortioxetine | Drug | Open-label vortioxetine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montgomery and Asberg Depression Rating Scale (MADRS) | The MADRS is a 10-item rating scale designed to assess the severity of symptoms of depression. Range is 0-60. Higher score means more severe. | from baseline to endpoint (up to 8 weeks) |
| Change From Baseline to Endpoint in Digital Symbol Substitution Test. | Change in cognitive function defined as change from baseline to endpoint. The Digital Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making and motor skills. The DSST consists of 133 digits and requires the subject to substitute each digit with a simple symbol in a 90-second period. The number of correct symbols within the allowed time (eg, 90 sec) is measured. It takes approximately 5 minutes to complete and score the DSST. | Baseline to endpoint (week 8) |
| BNA Scores Amplitudes | Brain Network Analytics (BNA) is a tool intended for the post-hoc statistical analysis of the human EEG, utilizing both resting-state EEG and event-related potentials (ERP) waveforms. The BNA algorithm compares a patient's ERP amplitudes and latencies to those of a large group of healthy, age-matched subjects in order to visualize and quantify changes in specific brain functions. The BNA algorithm was used to detect subjects' P200 and P300 ERP components from EEG data recorded during the AOB and VGNG tasks. BNA scores represent these ERP components in terms of amplitude (in microvolts) and latency (in milliseconds). | Baseline to Endpoint (8 weeks) |
| BNA Scores Latencies | Brain Network Analytics (BNA) is a tool intended for the post-hoc statistical analysis of the human EEG, utilizing both resting-state EEG and event-related potentials (ERP) waveforms. The BNA algorithm compares a patient's ERP amplitudes and latencies to those of a large group of healthy, age-matched subjects in order to visualize and quantify changes in specific brain functions. The BNA algorithm was used to detect subjects' P200 and P300 ERP components from EEG data recorded during the AOB and VGNG tasks. BNA scores represent these ERP components in terms of amplitude (in microvolts) and latency (in milliseconds). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Hamilton Depression Rating Scale (HDRS) 17 From Baseline to 8 Week Endpoint | The HDRS is a clinician-rated used to rate the patient's depressive state. The 17 question version of the scale rates depressive state based on feelings of depression, guilt, suicidality, anxiety, agitation, somatic symptoms, level of insight, patterns of insomnia, loss of interest in work and other activities, weight loss, and hypochondriasis. Additionally, the 28 question version rates depersonalization, paranoia, obsessions/compulsions, hypersomnia, appetite increase, and psychomotor slowing. The total score is obtained by summing the score of each item, 0-4 (symptom is absent, mild, moderate, or severe) or 0-2 (absent, slight or trivial, clearly present). Scores can range from 0 to 54 for the 17 question version and 0 to 83 for the 28 question version. Scores between 0 and 6 do not indicate the presence of depression, scores between 7 and 17 indicate mild depression, scores between 18 and 24 indicate moderate depression, and scores over 24 indicate severe depression. |
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Inclusion Criteria:
Exclusion Criteria:
The subject has a score of ≥70 on the Digit Symbol Substitution Test (DSST) at the Baseline Visit.
Failure to respond to or inability to tolerate an adequate trial of vortioxetine in the past.
Exposure to an investigational compound 30 days prior to enrollment
Exposure to any psychoactive or otherwise excluded medication within five half-lives of the baseline visit or during the study. Excluded medications include: antidepressants, anxiolytics, anticonvulsants, barbiturates, chloral hydrate, lithium, antipsychotics, benzodiazepines, hypnotics, monoamine oxidase inhibitors (MAOIs), muscle relaxers, triptans, centrally-acting antihistamines, central alpha-2 agonists, decongestants, psychostimulants, dopamine agonists, opioid pain medications, oral corticosteroids, L-methylfolate, S-adenosyl methionine (SAMe), 5-HTP (hydroxytryptophan), St. John's Wort,
The subject has 1 or more of the following:
The subject has any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with study treatment or impair treatment compliance.
The subject has physical, cognitive, or language impairment of such severity as to adversely affect the validity of the data derived from the neuropsychological tests.
The subject has a significant risk of suicide according to the PI's clinical judgment.
The subject, in the opinion of the PI, poses a risk of harm to others.
The subject has initiated formal cognitive or behavioral therapy, systemic psychotherapy within less than 6 months of study screening, or has plans to initiate such therapy during the study.
The subject has received electroconvulsive therapy, vagus nerve stimulation, or repetitive transcranial magnetic stimulation within 12 months prior to Screening.
The current MDE is considered by the PI to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each at the recommended dose.
The subject is pregnant or breastfeeding, or is intending to become pregnant before, during, or within 30 days after participating in this study.
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| Name | Affiliation | Role |
|---|---|---|
| John M Zajecka, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States | ||
| Rush University Medical Center |
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Participants were screened over a 1-2 week period to assess inclusion/exclusion criteria (i.e., to obtain lab results, to ensure adequate washout of any prohibited concomitant medications, etc).
Subjects were recruited from several sources, including referrals, advertisements and following completion of another clinical trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vortioxetine | vortioxetine 5-20 mg/day |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening |
|
| ||||||||||||||||||||||||
| 8-week Open-Label Treatment Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vortioxetine | vortioxetine 5-20 mg/day |
| 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 | Change in Montgomery and Asberg Depression Rating Scale (MADRS) | The MADRS is a 10-item rating scale designed to assess the severity of symptoms of depression. Range is 0-60. Higher score means more severe. | 25 subjects were included in the baseline analysis, and 22 subjects completed all visits and were included in subsequent analyses | Posted | Mean | Full Range | score on a scale | from baseline to endpoint (up to 8 weeks) |
|
|
8 weeks
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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 | Vortioxetine | vortioxetine 5-20 mg/day | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
Secondary outcomes #4 and #7, part c were not included in the results section for the following reasons: analysis became too complex based on low sample size; too many subgroups were needed. There were changes in BNA regardless of changes in symptoms and couldn't isolate meaningful or clinical useful data. In addition, several cognitive and functionality scores (i.e., CGI-I, TMT, UPSA, Stroop) were not collected at baseline and therefore not included in the "correlation with BNA" analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Zajecka | Rush University Medical Center | 312-942-5592 | John_Zajecka@rush.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 | May 16, 2017 | Nov 24, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Consent version 08-29-16 IRB APPROVED | Aug 29, 2016 | Dec 1, 2020 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: onsent version 08-29-16 IRB APPROVED for 2017 | Apr 26, 2017 | Dec 1, 2020 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: consent version 04-09-18 IRB APPROVED | Apr 9, 2018 | Dec 1, 2020 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Baseline to Endpoint (8 weeks) |
| Baseline to endpoint (week 8) |
| Changes in Hamilton Depression Rating Scale (HDRS) 28 From Baseline to 8 Week Endpoint | The HDRS is a clinician-rated used to rate the patient's depressive state. The 17 question version of the scale rates depressive state based on feelings of depression, guilt, suicidality, anxiety, agitation, somatic symptoms, level of insight, patterns of insomnia, loss of interest in work and other activities, weight loss, and hypochondriasis. Additionally, the 28 question version rates depersonalization, paranoia, obsessions/compulsions, hypersomnia, appetite increase, and psychomotor slowing. The total score is obtained by summing the score of each item, 0-4 (symptom is absent, mild, moderate, or severe) or 0-2 (absent, slight or trivial, clearly present). Scores can range from 0 to 54 for the 17 question version and 0 to 83 for the 28 question version. Scores between 0 and 6 do not indicate the presence of depression, scores between 7 and 17 indicate mild depression, scores between 18 and 24 indicate moderate depression, and scores over 24 indicate severe depression. | Baseline to endpoint (week 8) |
| Changes in Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-16-SR) From Baseline to 8 Week Endpoint | The QIDS-16-SR is a 16-item self-rated assessment of the severity of depressive symptoms. The assessments can be used to screen for depression, although they have been used predominantly as measures of symptom severity. The nine domains comprise 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease or increase in appetite or weight; and 9) psychomotor agitation or retardation. The total score ranges from 0 to 27 with higher scores equating to more severe symptomatology. The seven day period prior to assessment is the usual time frame for assessing symptom severity. | Baseline to endpoint (week 8) |
| Changes in Clinical Global Impression Scale (CGI-S) From Baseline to 8 Week Endpoint | The CGI-S assesses the clinician's impression of the subject's current mental illness state (considering their total clinical experience with this particular population) via 7 point scale (ranging from 1-7) with higher scores equating to more symptoms. For example, a score of 1 = normal, not at all ill and a score of 7 = severely ill. | Baseline to endpoint (week 8) |
| Correlations Between BNA Amplitude Scores and Clinical, Cognitive, and Functionality Assessments Using Baseline Scores | Pearson correlation was used to examine the associations between baseline BNA amplitude scores and outcomes including measures of MDD symptoms, cognitive function and functionality. | Baseline to Endpoint (8 weeks) |
| Correlations Between BNA Latency Scores and Clinical, Cognitive, and Functionality Assessments Using Baseline Scores | Pearson correlation was used to examine the associations between baseline BNA latency scores and outcomes including measures of MDD symptoms, cognitive function and functionality. | Baseline to Endpoint (8 weeks) |
| Skokie |
| Illinois |
| 60076 |
| United States |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Major Depressive Disorder-single or recurrent | Number | participants |
|
|
|
|
| Primary | Change From Baseline to Endpoint in Digital Symbol Substitution Test. | Change in cognitive function defined as change from baseline to endpoint. The Digital Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making and motor skills. The DSST consists of 133 digits and requires the subject to substitute each digit with a simple symbol in a 90-second period. The number of correct symbols within the allowed time (eg, 90 sec) is measured. It takes approximately 5 minutes to complete and score the DSST. | 25 subjects were included in the baseline analysis, and 22 subjects completed all visits and were included in subsequent analyses | Posted | Mean | Full Range | number of correct symbols within 90 sec | Baseline to endpoint (week 8) |
|
|
|
|
| Primary | BNA Scores Amplitudes | Brain Network Analytics (BNA) is a tool intended for the post-hoc statistical analysis of the human EEG, utilizing both resting-state EEG and event-related potentials (ERP) waveforms. The BNA algorithm compares a patient's ERP amplitudes and latencies to those of a large group of healthy, age-matched subjects in order to visualize and quantify changes in specific brain functions. The BNA algorithm was used to detect subjects' P200 and P300 ERP components from EEG data recorded during the AOB and VGNG tasks. BNA scores represent these ERP components in terms of amplitude (in microvolts) and latency (in milliseconds). | Posted | Mean | Standard Deviation | microvolts | Baseline to Endpoint (8 weeks) |
|
|
|
|
| Primary | BNA Scores Latencies | Brain Network Analytics (BNA) is a tool intended for the post-hoc statistical analysis of the human EEG, utilizing both resting-state EEG and event-related potentials (ERP) waveforms. The BNA algorithm compares a patient's ERP amplitudes and latencies to those of a large group of healthy, age-matched subjects in order to visualize and quantify changes in specific brain functions. The BNA algorithm was used to detect subjects' P200 and P300 ERP components from EEG data recorded during the AOB and VGNG tasks. BNA scores represent these ERP components in terms of amplitude (in microvolts) and latency (in milliseconds). | These correlation analyses were done only on participants in the vortioxetine arm and did not include the group of healthy controls | Posted | Mean | Standard Deviation | milliseconds | Baseline to Endpoint (8 weeks) |
|
|
|
|
| Secondary | Changes in Hamilton Depression Rating Scale (HDRS) 17 From Baseline to 8 Week Endpoint | The HDRS is a clinician-rated used to rate the patient's depressive state. The 17 question version of the scale rates depressive state based on feelings of depression, guilt, suicidality, anxiety, agitation, somatic symptoms, level of insight, patterns of insomnia, loss of interest in work and other activities, weight loss, and hypochondriasis. Additionally, the 28 question version rates depersonalization, paranoia, obsessions/compulsions, hypersomnia, appetite increase, and psychomotor slowing. The total score is obtained by summing the score of each item, 0-4 (symptom is absent, mild, moderate, or severe) or 0-2 (absent, slight or trivial, clearly present). Scores can range from 0 to 54 for the 17 question version and 0 to 83 for the 28 question version. Scores between 0 and 6 do not indicate the presence of depression, scores between 7 and 17 indicate mild depression, scores between 18 and 24 indicate moderate depression, and scores over 24 indicate severe depression. | 25 subjects were included in the baseline analysis, and 22 subjects completed all visits and were included in subsequent analyses | Posted | Mean | Full Range | score on a scale | Baseline to endpoint (week 8) |
|
|
|
|
| Secondary | Changes in Hamilton Depression Rating Scale (HDRS) 28 From Baseline to 8 Week Endpoint | The HDRS is a clinician-rated used to rate the patient's depressive state. The 17 question version of the scale rates depressive state based on feelings of depression, guilt, suicidality, anxiety, agitation, somatic symptoms, level of insight, patterns of insomnia, loss of interest in work and other activities, weight loss, and hypochondriasis. Additionally, the 28 question version rates depersonalization, paranoia, obsessions/compulsions, hypersomnia, appetite increase, and psychomotor slowing. The total score is obtained by summing the score of each item, 0-4 (symptom is absent, mild, moderate, or severe) or 0-2 (absent, slight or trivial, clearly present). Scores can range from 0 to 54 for the 17 question version and 0 to 83 for the 28 question version. Scores between 0 and 6 do not indicate the presence of depression, scores between 7 and 17 indicate mild depression, scores between 18 and 24 indicate moderate depression, and scores over 24 indicate severe depression. | 25 subjects were included in the baseline analysis, and 22 subjects completed all visits and were included in subsequent analyses | Posted | Mean | Full Range | score on a scale | Baseline to endpoint (week 8) |
|
|
|
|
| Secondary | Changes in Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-16-SR) From Baseline to 8 Week Endpoint | The QIDS-16-SR is a 16-item self-rated assessment of the severity of depressive symptoms. The assessments can be used to screen for depression, although they have been used predominantly as measures of symptom severity. The nine domains comprise 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease or increase in appetite or weight; and 9) psychomotor agitation or retardation. The total score ranges from 0 to 27 with higher scores equating to more severe symptomatology. The seven day period prior to assessment is the usual time frame for assessing symptom severity. | 25 subjects were included in the baseline analysis, and 22 subjects completed all visits and were included in subsequent analyses | Posted | Mean | Full Range | score on a scale | Baseline to endpoint (week 8) |
|
|
|
|
| Secondary | Changes in Clinical Global Impression Scale (CGI-S) From Baseline to 8 Week Endpoint | The CGI-S assesses the clinician's impression of the subject's current mental illness state (considering their total clinical experience with this particular population) via 7 point scale (ranging from 1-7) with higher scores equating to more symptoms. For example, a score of 1 = normal, not at all ill and a score of 7 = severely ill. | 25 subjects were included in the baseline analysis, and 22 subjects completed all visits and were included in subsequent analyses | Posted | Mean | Full Range | score on a scale | Baseline to endpoint (week 8) |
|
|
|
|
| Secondary | Correlations Between BNA Amplitude Scores and Clinical, Cognitive, and Functionality Assessments Using Baseline Scores | Pearson correlation was used to examine the associations between baseline BNA amplitude scores and outcomes including measures of MDD symptoms, cognitive function and functionality. | These correlation analyses were done only on participants in the vortioxetine arm and did not include the group of healthy controls | Posted | Mean | Standard Deviation | microvolts | Baseline to Endpoint (8 weeks) |
|
|
|
|
| Secondary | Correlations Between BNA Latency Scores and Clinical, Cognitive, and Functionality Assessments Using Baseline Scores | Pearson correlation was used to examine the associations between baseline BNA latency scores and outcomes including measures of MDD symptoms, cognitive function and functionality. | These correlation analyses were done only on participants in the vortioxetine arm and did not include the group of healthy controls | Posted | Mean | Standard Deviation | milliseconds | Baseline to Endpoint (8 weeks) |
|
|
|
|
| 25 |
| 0 |
| 25 |
| 9 |
| 25 |
| Headache | General disorders | 7 | Systematic Assessment |
|
| Upper respiratory infection | General disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Somnolence | General disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Esophageal reflux | General disorders | Systematic Assessment |
|
| Sweating | General disorders | Systematic Assessment |
|
| Dental/tooth pain | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D001519 |
| Behavior |
|
|
| AOB P3a amplitude Endpoint (8 weeks) |
|
| AOB P3b amplitude Baseline |
|
| AOB P3b amplitude Endpoint (8 weeks) |
|
| VGNG P200 amplitude Baseline |
|
| VGNG P200 amplitude Endpoint (8 weeks) |
|
| VGNG P3a amplitude Baseline |
|
| VGNG P3a amplitude Endpoint (8 weeks) |
|
| 0.288 |
| Pearson's R |
| -0.294 |
| 2-Sided |
| Other |
| Correlation between MADRS and AOB P3b (amplitude) baseline scores | Pearson's correlation | 0.134 | Pearson's R | -0.405 | 2-Sided | Other |
| Correlation between MADRS and VGNG P200 (amplitude) baseline scores | Pearson's correlation | 0.083 | Pearson's R | -0.397 | 2-Sided | Other |
| Correlation between MADRS and VGNG P3a (amplitude) baseline scores | Pearson's correlation | 0.034 | Pearson's R | -0.476 | 2-Sided | Other |
| Correlation between DSST and AOB P200 baseline scores | Pearson's correlation | 0.031 | Pearson's R | -0.509 | 2-Sided | Other |
| Correlation between DSST and AOB P3a (amplitude) baseline scores | Pearson's correlation | 0.500 | Pearson's R | -0.197 | 2-Sided | Other |
| Correlation between DSST and AOB P3b baseline scores | Pearson's correlation | 0.185 | Pearson's R | 0.376 | 2-Sided | Other |
| Correlation between DSST and VGNG P200 baseline scores | Pearson's correlation | 0.659 | Pearson's R | -0.108 | 2-Sided | Other |
| Correlation between DSST and VGNG P3a baseline scores | Pearson's correlation | 0.611 | Pearson's R | 0.125 | 2-Sided | Other |
| Correlation between AOB P200 (amplitude) and MADRS (baseline to endpoint percent change) | Pearson's correlation | 0.671 | Pearson's R | -0.111 | 2-Sided | Other |
| Correlation between AOB P3a (amplitude) and MADRS (baseline to endpoint percent change) | Pearson's correlation | 0.931 | Pearson's R | -0.026 | 2-Sided | Other |
| Correlation between AOB P3b (amplitude) and MADRS (baseline to endpoint percent change) | Pearson's correlation | 0.155 | Pearson's R | 0.516 | 2-Sided | Other |
| Correlation between VGNG P200 (amplitude) and MADRS (baseline to endpoint percent change) | Pearson's correlation | 0.297 | Pearson's R | 0.268 | 2-Sided | Other |
| Correlation between VGNG P3a (amplitude) and MADRS (baseline to endpoint percent change) | Pearson's correlation | 0.494 | Pearson's R | 0.184 | 2-Sided | Other |
| Correlation between AOB P200 (amplitude) and DSST (baseline to endpoint percent change) | Pearson's correlation | 0.811 | Pearson's R | -0.065 | 2-Sided | Other |
| Correlation between AOB P3a (amplitude) and DSST (baseline to endpoint percent change) | Pearson's correlation | 0.877 | Pearson's R | -0.048 | 2-Sided | Other |
| Correlation between AOB P3b (amplitude) and DSST (baseline to endpoint percent change) | Pearson's correlation | 0.557 | Pearson's R | -0.246 | 2-Sided | Other |
| Correlation between VGNG P200 (amplitude) and DSST (baseline to endpoint percent change) | Pearson's correlation | 0.500 | Pearson's R | 0.182 | 2-Sided | Other |
| Correlation between VGNG P3a (amplitude) and DSST (baseline to endpoint percent change) | Pearson's correlation | 0.297 | Pearson's R | 0.288 | 2-Sided | Other |
| A comparison between vortioxetine arm patients' and healthy controls' AOB P200 amplitudes at baseline. The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US). | ANCOVA | 0.575 | F statistic | 0.318 | 2-Sided | Other | Differences in BNA scores between MDD and healthy subjects were analyzed for baseline visits using an ANCOVA model with group as a factor, and age as a covariate. |
| A comparison between vortioxetine arm patients' and healthy controls' AOB P200 amplitudes at Endpoint. The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US). | ANCOVA | 0.541 | F statistic | 0.378 | 2-Sided | Other |
| A comparison between vortioxetine arm patients' and healthy controls' AOB P3a amplitudes at baseline. The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US). | ANCOVA | 0.912 | F | 0.012 | 2-Sided | Other |
| A comparison between vortioxetine arm patients' and healthy controls' AOB P3a amplitudes at Endpoint. The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US). | ANCOVA | 0.214 | F statistic | 1.586 | 2-Sided | Other |
| A comparison between vortioxetine arm patients' and healthy controls' AOB P3b amplitudes at baseline. The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US). | ANCOVA | 0.504 | F statistic | 0.453 | 2-Sided | Other |
| A comparison between vortioxetine arm patients' and healthy controls' AOB P3b amplitudes at Endpoint. The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US). | ANCOVA | 0.546 | F statistic | 0.37 | 2-Sided | Other |
| A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 amplitudes at baseline. The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US). | ANCOVA | 0.895 | F statistic | 0.017 | 2-Sided | Other |
| A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 amplitudes at Endpoint. The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US). | ANCOVA | 0.673 | F statistic | 0.179 | 2-Sided | Other |
| A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a amplitudes at baseline. The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US). | ANCOVA | 0.27 | F statistic | 1.241 | 2-Sided | Other |
| A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a amplitudes at Endpoint. The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US). | ANCOVA | 0.837 | F statistic | 0.042 | 2-Sided | Other |
|
| AOB P3a latency Endpoint (8 weeks) |
|
| AOB P3b latency Baseline |
|
| AOB P3b latency Endpoint (8 weeks) |
|
| VGNG P200 latency Baseline |
|
| VGNG P200 latency Endpoint (8 weeks) |
|
| VGNG P3a latency Baseline |
|
| VGNG P3a latency Endpoint (8 weeks) |
|
| 0.500 |
| Pearson's R |
| -0.197 |
| 2-Sided |
| Other |
| Correlation between DSST and AOB P3b (latency) baseline scores | Pearson's correlation | 0.337 | Pearson's R | 0.277 | 2-Sided | Other |
| Correlation between DSST and VGNG P200 (latency) baseline scores | Pearson's correlation | 0.832 | Pearson's R | 0.052 | 2-Sided | Other |
| Correlation between DSST and VGNG P3a (latency) baseline scores | Pearson's correlation | 0.68 | Pearson's R | 0.103 | 2-Sided | Other |
| Correlation between DSST and AOB P200 (Latency) baseline to endpoint percentage change | Pearson's correlation | 0.777 | Pearson's R | -0.074 | 2-Sided | Other |
| Correlation between DSST and AOB P3a (Latency) baseline to endpoint percentage change | Pearson's correlation | 0.834 | Pearson's R | 0.061 | 2-Sided | Other |
| Correlation between DSST and AOB P3b (Latency) baseline to endpoint percentage change | Pearson's correlation | 0.988 | Pearson's R | -0.006 | 2-Sided | Other |
| Correlation between DSST and VGNG P200 (Latency) baseline to endpoint percentage change | Pearson's correlation | 0.788 | Pearson's R | 0.073 | 2-Sided | Other |
| Correlation between DSST and VGNG P3a (Latency) baseline to endpoint percentage change | Pearson's correlation | 0.168 | Pearson's R | 0.375 | 2-Sided | Other |
| Correlation between MADRS and AOB P200 (Latency) baseline scores | Pearson's correlation | 0.108 | Pearson's R | -0.392 | 2-Sided | Other |
| Correlation between MADRS and AOB P3a (Latency) baseline scores | Pearson's correlation | 0.124 | Pearson's R | 0.415 | 2-Sided | Other |
| Correlation between MADRS and AOB P3b (Latency) baseline scores | Pearson's correlation | 0.185 | Pearson's R | 0.362 | 2-Sided | Other |
| Correlation between MADRS and VGNG P200 (Latency) baseline scores | Pearson's correlation | 0.923 | Pearson's R | -0.023 | 2-Sided | Other |
| Correlation between MADRS and VGNG P3a (Latency) baseline scores | Pearson's correlation | 0.77 | Pearson's R | 0.071 | 2-Sided | Other |
| Correlation between MADRS and AOB P200 (Latency) baseline to endpoint percent change | Pearson's correlation | 0.712 | Pearson's R | 0.097 | 2-Sided | Other |
| Correlation between MADRS and AOB P3a (Latency) baseline to endpoint percent change | Pearson's correlation | 0.845 | Pearson's R | -0.058 | 2-Sided | Other |
| Correlation between MADRS and AOB P3b (Latency) baseline to endpoint percent change | Pearson's correlation | 0.616 | Pearson's R | 0.194 | 2-Sided | Other |
| Correlation between MADRS and VGNG P200 (Latency) baseline to endpoint percent change | Pearson's correlation | 0.323 | Pearson's R | 0.255 | 2-Sided | Other |
| Correlation between MADRS and VGNG P3a (Latency) baseline to endpoint percent change | Pearson's correlation | 0.473 | Pearson's R | -0.193 | 2-Sided | Other |
| A comparison between vortioxetine arm patients' and healthy controls' AOB P200 latencies at baseline. The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US). | ANCOVA | 0.031 | F statistic | 4.909 | 2-Sided | Other |
| A comparison between vortioxetine arm patients' and healthy controls' AOB P200 latencies at Endpoint. The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US). | ANCOVA | 0.281 | F statistic | 1.189 | 2-Sided | Other |
| A comparison between vortioxetine arm patients' and healthy controls' AOB P3a latencies at baseline. The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US). | ANCOVA | 0.966 | F statistic | 0.001 | 2-Sided | Other |
| A comparison between vortioxetine arm patients' and healthy controls' AOB P3a latencies at Endpoint. The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US). | ANCOVA | 0.048 | F statistic | 4.121 | 2-Sided | Other |
| A comparison between vortioxetine arm patients' and healthy controls' AOB P3b latencies at baseline. The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US). | ANCOVA | 0.005 | F statistic | 8.573 | 2-Sided | Other |
| A comparison between vortioxetine arm patients' and healthy controls' AOB P3b latencies at Endpoint. The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US). | ANCOVA | 0.101 | F statistic | 2.823 | 2-Sided | Other |
| A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 latencies at baseline. The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US). | ANCOVA | 0.373 | F statistic | 0.806 | 2-Sided | Other |
| A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 latencies at Endpoint. The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US). | ANCOVA | 0.183 | F statistic | 1.822 | 2-Sided | Other |
| A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a latencies at baseline. The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US). | ANCOVA | 0.475 | F statistic | 0.516 | 2-Sided | Other |
| A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a latencies at Endpoint. The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US). | ANCOVA | 0.645 | F statistic | 0.214 | 2-Sided | Other |
|
|
|
|
|
| AOB P3a amplitude Endpoint (8 weeks) |
|
| AOB P3b amplitude Baseline |
|
| AOB P3b amplitude Endpoint (8 weeks) |
|
| VGNG P200 amplitude Baseline |
|
| VGNG P200 amplitude Endpoint (8 weeks) |
|
| VGNG P3a amplitude Baseline |
|
| VGNG P3a amplitude Endpoint (8 weeks) |
|
| 0.451 |
| Pearson's R |
| -0.211 |
| 2-Sided |
| Other |
| AOB P3b (amplitude) | Pearson's correlation | 0.957 | Pearson's R | 0.015 | 2-Sided | Other |
| VGNG P200 (amplitude) | Pearson's correlation | 0.166 | Pearson's R | -0.322 | 2-Sided | Other |
| VGNG P3a (amplitude) | Pearson's correlation | 0.105 | Pearson's R | -0.374 | 2-Sided | Other |
| Correlation between AOB P200 (amplitude) and HDRS-28 baseline to endpoint percent change | Pearson's correlation | 0.601 | Pearson's R | -0.137 | 2-Sided | Other |
| Correlation between AOB P3a (amplitude) and HDRS-28 baseline to endpoint percent change | Pearson's correlation | 0.421 | Pearson's R | -0.234 | 2-Sided | Other |
| Correlation between AOB P3b (amplitude) and HDRS-28 baseline to endpoint percent change | Pearson's correlation | 0.316 | Pearson's R | 0.378 | 2-Sided | Other |
| Pearson's correlation | 0.478 | Pearson's R | 0.185 | 2-Sided | Other |
| Correlation between AOB P3a (amplitude) and HDRS-28 baseline to endpoint percent change | Pearson's correlation | 0.969 | Pearson's R | 0.011 | 2-Sided | Other |
| Correlation between AOB P200 (amplitude) and HDRS-17 baseline scores | Pearson's correlation | 0.943 | Pearson's R | -0.018 | 2-Sided | Other |
| Correlation between AOB P3a (amplitude) and HDRS-17 baseline scores | Pearson's correlation | 0.795 | Pearson's R | -0.074 | 2-Sided | Other |
| Correlation between AOB P3b (amplitude) and HDRS-17 baseline scores | Pearson's correlation | 0.969 | Pearson's R | -0.011 | 2-Sided | Other |
| Correlation between VGNG P200 (amplitude) and HDRS-17 baseline scores | Pearson's correlation | 0.406 | Pearson's R | -0.197 | 2-Sided | Other |
| Correlation between VGNG P3a (amplitude) and HDRS-17 baseline scores | Pearson's correlation | 0.185 | Pearson's R | -0.309 | 2-Sided | Other |
| Correlation between AOB P200 (amplitude) and HDRS-17 baseline to endpoint percent change | Pearson's correlation | 0.454 | Pearson's R | -0.195 | 2-Sided | Other |
| Correlation between AOB P3a (amplitude) and HDRS-17 baseline to endpoint percent change | Pearson's correlation | 0.579 | Pearson's R | -0.162 | 2-Sided | Other |
| Correlation between AOB P3b (amplitude) and HDRS-17 baseline to endpoint percent change | Pearson's correlation | 0.549 | Pearson's R | 0.232 | 2-Sided | Other |
| Correlation between VGNG P200 (amplitude) and HDRS-17 baseline to endpoint percent change | Pearson's correlation | 0.518 | Pearson's R | 0.169 | 2-Sided | Other |
| Correlation between VGNG P3a (amplitude) and HDRS-17 baseline to endpoint percent change | Pearson's correlation | 0.922 | Pearson's R | 0.027 | 2-Sided | Other |
| Correlation between AOB P200 (amplitude) and QIDS-SR baseline scores | Pearson's correlation | 0.796 | Pearson's R | -0.064 | 2-Sided | Other |
| Correlation between AOB P3a (amplitude) and QIDS-SR baseline scores | Pearson's correlation | 0.054 | Pearson's R | -0.506 | 2-Sided | Other |
| Correlation between AOB P3b (amplitude) and QIDS-SR baseline scores | Pearson's correlation | 0.995 | Pearson's R | 0.002 | 2-Sided | Other |
| Correlation between VGNG P200 (amplitude) and QIDS-SR baseline scores | Pearson's correlation | 0.668 | Pearson's R | 0.102 | 2-Sided | Other |
| Correlation between VGNG P3a (amplitude) and QIDS-SR baseline scores | Pearson's correlation | 0.875 | Pearson's R | 0.037 | 2-Sided | Other |
| Correlation between AOB P200 (amplitude) and QIDS-SR baseline to endpoint percent change | Pearson's correlation | 0.852 | Pearson's R | -0.049 | 2-Sided | Other |
| Correlation between AOB P3a (amplitude) and QIDS-SR baseline to endpoint percent change | Pearson's correlation | 0.234 | Pearson's R | -0.340 | 2-Sided | Other |
| Pearson's correlation | 0.056 | Pearson's R | 0.655 | 2-Sided | Other |
| Correlation between VGNG P200 (amplitude) and QIDS-SR baseline to endpoint percent change | Pearson's correlation | 0.248 | Pearson's R | 0.297 | 2-Sided | Other |
| Correlation between VGNG P3a (amplitude) and QIDS-SR baseline to endpoint percent change | Pearson's correlation | 0.507 | Pearson's R | 0.179 | 2-Sided | Other |
| Correlation between AOB P200 (amplitude) and PDQ baseline scores | Pearson's correlation | 0.841 | Pearson's R | 0.049 | 2-Sided | Other |
| Correlation between AOB P3a (amplitude) and PDQ baseline scores | Pearson's correlation | 0.508 | Pearson's R | -0.185 | 2-Sided | Other |
| Correlation between AOB P3b (amplitude) and PDQ baseline scores | Pearson's correlation | 0.916 | Pearson's R | -0.030 | 2-Sided | Other |
| Correlation between VGNG P200 (amplitude) and PDQ baseline scores | Pearson's correlation | 0.147 | Pearson's R | -0.345 | 2-Sided | Other |
| Correlation between VGNG P3a (amplitude) and PDQ baseline scores | Pearson's correlation | 0.225 | Pearson's R | -0.284 | 2-Sided | Other |
| Correlation between AOB P200 (amplitude) and PDQ baseline to endpoint percent change | Pearson's correlation | 0.868 | Pearson's R | -0.044 | 2-Sided | Other |
| Correlation between AOB P3a (amplitude) and PDQ baseline to endpoint percent change | Pearson's correlation | 0.537 | Pearson's R | -0.180 | 2-Sided | Other |
| Correlation between AOB P3b (amplitude) and PDQ baseline to endpoint percent change | Pearson's correlation | 0.195 | Pearson's R | 0.476 | 2-Sided | Other |
| Correlation between VGNG P200 (amplitude) and PDQ baseline to endpoint percent change | Pearson's correlation | 0.015 | Pearson's R | 0.594 | 2-Sided | Other |
| Correlation between VGNG P3a (amplitude) and PDQ baseline to endpoint percent change | Pearson's correlation | 0.972 | Pearson's R | -0.009 | 2-Sided | Other |
| Correlation between AOB P200 (amplitude) and MGH-CPFQ baseline scores | Pearson's correlation | 0.785 | Pearson's R | 0.067 | 2-Sided | Other |
| Correlation between AOB P3a (amplitude) and MGH-CPFQ baseline scores | Pearson's correlation | 0.646 | Pearson's R | -0.129 | 2-Sided | Other |
| Correlation between AOB P3b (amplitude) and MGH-CPFQ baseline scores | Pearson's correlation | 0.182 | Pearson's R | 0.364 | 2-Sided | Other |
| Correlation between VGNG P200 (amplitude) and MGH-CPFQ baseline scores | Pearson's correlation | 0.069 | Pearson's R | -0.414 | 2-Sided | Other |
| Correlation between VGNG P3a (amplitude) and MGH-CPFQ baseline scores | Pearson's correlation | 0.068 | Pearson's R | -0.416 | 2-Sided | Other |
| Correlation between AOB P200 (amplitude) and MGH-CPFQ baseline to endpoint percent change | Pearson's correlation | 0.929 | Pearson's R | -0.023 | 2-Sided | Other |
| Correlation between AOB P3a (amplitude) and MGH-CPFQ baseline to endpoint percent change | Pearson's correlation | 0.802 | Pearson's R | -0.074 | 2-Sided | Other |
| Correlation between AOB P3b (amplitude) and MGH-CPFQ baseline to endpoint percent change | Pearson's correlation | 0.153 | Pearson's R | 0.518 | 2-Sided | Other |
| Correlation between VGNG P200 (amplitude) and MGH-CPFQ baseline to endpoint percent change | Pearson's correlation | 0.298 | Pearson's R | 0.268 | 2-Sided | Other |
| Correlation between VGNG P3a (amplitude) and MGH-CPFQ baseline to endpoint percent change | Pearson's correlation | 0.996 | Pearson's R | -0.001 | 2-Sided | Other |
| Correlation between AOB P200 (amplitude) and WLQ baseline scores | Pearson's correlation | 0.531 | Pearson's R | 0.242 | 2-Sided | Other |
| Correlation between AOB P3a (amplitude) and WLQ baseline scores | Pearson's correlation | 0.210 | Pearson's R | -0.598 | 2-Sided | Other |
| Correlation between AOB P3b (amplitude) and WLQ baseline scores | Pearson's correlation | 0.899 | Pearson's R | 0.054 | 2-Sided | Other |
| Pearson's correlation | 0.087 | Pearson's R | 0.568 | 2-Sided | Other |
| Correlation between VGNG P3a (amplitude) and WLQ baseline scores | Pearson's correlation | 0.087 | Pearson's R | 0.568 | 2-Sided | Other |
| Correlation between AOB P200 (amplitude) and WLQ baseline to endpoint percent change | Pearson's correlation | 0.550 | Pearson's R | 0.231 | 2-Sided | Other |
| Correlation between AOB P3a (amplitude) and WLQ baseline to endpoint percent change | Pearson's correlation | 0.766 | Pearson's R | 0.158 | 2-Sided | Other |
| Correlation between AOB P3b (amplitude) and WLQ baseline to endpoint percent change | Pearson's correlation | 0.498 | Pearson's R | -0.406 | 2-Sided | Other |
| Correlation between VGNG P200 (amplitude) and WLQ baseline to endpoint percent change | Pearson's correlation | 0.599 | Pearson's R | 0.221 | 2-Sided | Other |
| Correlation between VGNG P3a (amplitude) and WLQ baseline to endpoint percent change | Pearson's correlation | 0.064 | Pearson's R | 0.679 | 2-Sided | Other |
|
| AOB P3a latency Endpoint (8 weeks) |
|
| AOB P3b latency Baseline |
|
| AOB P3b latency Endpoint (8 weeks) |
|
| VGNG P200 latency Baseline |
|
| VGNG P200 latency Endpoint (8 weeks) |
|
| VGNG P3a latency Baseline |
|
| VGNG P3a latency Endpoint (8 weeks) |
|
| 0.279 |
| Pearson's R |
| 0.299 |
| 2-Sided |
| Other |
| Correlation between AOB P3b (latency) and HDRS-28 baseline scores | Pearson's correlation | 0.039 | Pearson's R | 0.538 | 2-Sided | Other |
| Correlation between VGNG P200 (latency) and HDRS-28 baseline scores | Pearson's correlation | 0.940 | Pearson's R | -0.018 | 2-Sided | Other |
| Correlation between VGNG P3a (latency) and HDRS-28 baseline scores | Pearson's correlation | 0.65 | Pearson's R | 0.107 | 2-Sided | Other |
| Correlation between AOB P200 (latency) and HDRS-28 baseline to endpoint percentage change | Pearson's correlation | 0.340 | Pearson's R | 0.247 | 2-Sided | Other |
| Correlation between AOB P3a (latency) and HDRS-28 baseline to endpoint percentage change | Pearson's correlation | 0.819 | Pearson's R | 0.067 | 2-Sided | Other |
| Correlation between AOB P3b (latency) and HDRS-28 baseline to endpoint percentage change | Pearson's correlation | 0.400 | Pearson's R | 0.321 | 2-Sided | Other |
| Correlation between VGNG P200 (latency) and HDRS-28 baseline to endpoint percentage change | Pearson's correlation | 0.278 | Pearson's R | 0.279 | 2-Sided | Other |
| Correlation between VGNG P3a (latency) and HDRS-28 baseline to endpoint percentage change | Pearson's correlation | 0.614 | Pearson's R | -0.136 | 2-Sided | Other |
| Correlation between AOB P200 (latency) and HDRS-17 baseline scores | Pearson's correlation | 0.999 | Pearson's R | 0.000 | 2-Sided | Other |
| Correlation between AOB P3a (latency) and HDRS-17 baseline scores | Pearson's correlation | 0.491 | Pearson's R | 0.193 | 2-Sided | Other |
| Correlation between AOB P3b (latency) and HDRS-17 baseline scores | Pearson's correlation | 0.028 | Pearson's R | 0.567 | 2-Sided | Other |
| Correlation between VGNG P200 (latency) and HDRS-17 baseline scores | Pearson's correlation | 0.900 | Pearson's R | -0.030 | 2-Sided | Other |
| Correlation between VGNG P3a (latency) and HDRS-17 baseline scores | Pearson's correlation | 0.55 | Pearson's R | 0.141 | 2-Sided | Other |
| Correlation between AOB P200 (latency) and HDRS-17 baseline to endpoint percent change | Pearson's correlation | 0.373 | Pearson's R | 0.231 | 2-Sided | Other |
| Correlation between AOB P3a (latency) and HDRS-17 baseline to endpoint percent change | Pearson's correlation | 0.949 | Pearson's R | 0.019 | 2-Sided | Other |
| Correlation between AOB P3b (latency) and HDRS-17 baseline to endpoint percent change | Pearson's correlation | 0.754 | Pearson's R | 0.122 | 2-Sided | Other |
| Correlation between VGNG P200 (latency) and HDRS-17 baseline to endpoint percent change | 0.176 | 0.499 | Pearson's R | 0.176 | 2-Sided | Other |
| Correlation between VGNG P3a (latency) and HDRS-17 baseline to endpoint percent change | Pearson's correlation | 0.549 | Pearson's R | -0.162 | 2-Sided | Other |
| Correlation between AOB P200 (latency) and QIDS-SR baseline scores | Pearson's correlation | 0.617 | Pearson's R | -0.126 | 2-Sided | Other |
| Correlation between AOB P3a (latency) and QIDS-SR baseline scores | Pearson's correlation | 0.722 | Pearson's R | 0.100 | 2-Sided | Other |
| Correlation between AOB P3b (latency) and QIDS-SR baseline scores | Pearson's correlation | 0.371 | Pearson's R | 0.249 | 2-Sided | Other |
| Correlation between VGNG P200 (latency) and QIDS-SR baseline scores | Pearson's correlation | 0.764 | Pearson's R | -0.072 | 2-Sided | Other |
| Correlation between VGNG P3a (latency) and QIDS-SR baseline scores | Pearson's correlation | 0.34 | Pearson's R | -0.225 | 2-Sided | Other |
| Correlation between AOB P200 (latency) and QIDS-SR baseline to endpoint percent change | Pearson's correlation | 0.570 | Pearson's R | 0.148 | 2-Sided | Other |
| Correlation between AOB P3a (latency) and QIDS-SR baseline to endpoint percent change | Pearson's correlation | 0.434 | Pearson's R | 0.228 | 2-Sided | Other |
| Correlation between AOB P3b (latency) and QIDS-SR baseline to endpoint percent change | Pearson's correlation | 0.569 | Pearson's R | 0.220 | 2-Sided | Other |
| Correlation between VGNG P200 (latency) and QIDS-SR baseline to endpoint percent change | Pearson's correlation | 0.005 | Pearson's R | 0.645 | 2-Sided | Other |
| Correlation between VGNG P3a (latency) and QIDS-SR baseline to endpoint percent change | Pearson's correlation | 0.698 | Pearson's R | 0.105 | 2-Sided | Other |
| Correlation between AOB P200 (latency) and PDQ baseline scores | Pearson's correlation | 0.774 | Pearson's R | -0.073 | 2-Sided | Other |
| Correlation between AOB P3a (latency) and PDQ baseline score | Pearson's correlation | 0.024 | Pearson's R | 0.577 | 2-Sided | Other |
| Correlation between AOB P3b (latency) and PDQ baseline scores | Pearson's correlation | 0.603 | Pearson's R | 0.146 | 2-Sided | Other |
| Correlation between VGNG P200 (latency) and PDQ baseline scores | Pearson's correlation | 0.326 | Pearson's R | -0.232 | 2-Sided | Other |
| Correlation between VGNG P3a (latency) and PDQ baseline scores | Pearson's correlation | 0.68 | Pearson's R | 0.098 | 2-Sided | Other |
| Correlation between AOB P200 (latency) and PDQ baseline to endpoint percent change | Pearson's correlation | 0.774 | Pearson's R | -0.073 | 2-Sided | Other |
| Correlation between AOB P3a (latency) and PDQ baseline to endpoint percent change | Pearson's correlation | 0.024 | Pearson's R | 0.577 | 2-Sided | Other |
| Correlation between AOB P3b (latency) and PDQ baseline to endpoint percent change | Pearson's correlation | 0.603 | Pearson's R | 0.146 | 2-Sided | Other |
| Correlation between VGNG P200 (latency) and PDQ baseline to endpoint percent change | Pearson's correlation | 0.326 | Pearson's R | -0.232 | 2-Sided | Other |
| Correlation between VGNG P3a (latency) and PDQ baseline to endpoint percent change | Pearson's correlation | 0.68 | Pearson's R | 0.098 | 2-Sided | Other |
| Correlation between AOB P200 (latency) and MGH-CPFQ baseline scores | Pearson's correlation | 0.692 | Pearson's R | -0.100 | 2-Sided | Other |
| Correlation between AOB P3a (latency) and MGH-CPFQ baseline scores | Pearson's correlation | 0.059 | Pearson's R | 0.498 | 2-Sided | Other |
| Correlation between AOB P3b (latency) and MGH-CPFQ baseline scores | Pearson's correlation | 0.227 | Pearson's R | -0.332 | 2-Sided | Other |
| Correlation between VGNG P200 (latency) and MGH-CPFQ baseline scores | Pearson's correlation | 0.600 | Pearson's R | -0.125 | 2-Sided | Other |
| Correlation between VGNG P3a (latency) and MGH-CPFQ baseline scores | Pearson's correlation | 0.69 | Pearson's R | -0.096 | 2-Sided | Other |
| Correlation between AOB P200 (latency) and MGH-CPFQ baseline to endpoint percent change | Pearson's correlation | 0.315 | Pearson's R | 0.259 | 2-Sided | Other |
| Correlation between AOB P3a (latency) and MGH-CPFQ baseline to endpoint percent change | Pearson's correlation | 0.996 | Pearson's R | 0.002 | 2-Sided | Other |
| Correlation between AOB P3b (latency) and MGH-CPFQ baseline to endpoint percent change | Pearson's correlation | 0.544 | Pearson's R | 0.234 | 2-Sided | Other |
| Correlation between VGNG P200 (latency) and MGH-CPFQ baseline to endpoint percent change | Pearson's correlation | 0.066 | Pearson's R | 0.455 | 2-Sided | Other |
| Correlation between VGNG P3a (latency) and MGH-CPFQ baseline to endpoint percent change | Pearson's correlation | 0.293 | Pearson's R | -0.280 | 2-Sided | Other |
| Correlation between AOB P200 (latency) and WLQ baseline scores | Pearson's correlation | 0.013 | Pearson's R | 0.783 | 2-Sided | Other |
| Correlation between AOB P3a (latency) and WLQ baseline scores | Pearson's correlation | 0.799 | Pearson's R | 0.135 | 2-Sided | Other |
| Correlation between AOB P3b (latency) and WLQ baseline scores | Pearson's correlation | 0.201 | Pearson's R | 0.506 | 2-Sided | Other |
| Correlation between VGNG P200 (latency) and WLQ baseline scores | Pearson's correlation | 0.586 | Pearson's R | -0.197 | 2-Sided | Other |
| Correlation between VGNG P3a (latency) and WLQ baseline scores | Pearson's correlation | 0.95 | Pearson's R | -0.024 | 2-Sided | Other |
| Correlation between AOB P200 (latency) and WLQ baseline to endpoint percent change | Pearson's correlation | 0.920 | Pearson's R | 0.039 | 2-Sided | Other |
| Correlation between AOB P3a (latency) and WLQ baseline to endpoint percent change | Pearson's correlation | 0.831 | Pearson's R | 0.113 | 2-Sided | Other |
| Correlation between AOB P3b (latency) and WLQ baseline to endpoint percent change | Pearson's correlation | 0.230 | Pearson's R | 0.655 | 2-Sided | Other |
| Correlation between VGNG P200 (latency) and WLQ baseline to endpoint percent change | Pearson's correlation | 0.115 | Pearson's R | -0.602 | 2-Sided | Other |
| Correlation between VGNG P3a (latency) and WLQ baseline to endpoint percent change | Pearson's correlation | 0.450 | Pearson's R | -0.313 | 2-Sided | Other |