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| Name | Class |
|---|---|
| Hackensack Meridian Health | OTHER |
| Horizon Blue Cross Blue Shield of New Jersey | OTHER |
| MYnd Analytics | INDUSTRY |
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The MYnd Analytics PEER Online strategy utilizes EEG diagnostics to direct patients with psychiatric illnesses to the best medication treatments. This trial will evaluate patients with a diagnosis of depression who will either receive (1) PEER Online directed therapy or (2) conventional treatment without EEG guidance and will compare 6 month clinical and economic outcomes between these groups.
Mynd Analytics has developed the Psychiatric Electroencephalography Evaluation Registry (PEER) Online® clinical decision support database that uses a combination of software, analytics, and clinical outcomes to provide objective, adjunctive medication response information to physicians treating patients with non-psychotic behavioral disorders. PEER Online uses a statistical analysis of EEG outputs and other patient information to generate a report that indicates the statistical likelihood of the patient's responsiveness to classes of central nervous system (CNS) medications (i.e. antidepressants), groups (i.e. SSRI) and individual agents (i.e. fluoxetine). A discriminant analysis compares neurophysiologic abnormalities of the patient to patterns of abnormalities of known responders to CNS drugs in the company's outcomes database of symptomatic patients. This provides a probability estimate of the similarity of the patient's profile with the profile of groups of individuals constituting the normative and clinical (symptomatic) database, which provides the treating physician guidance to which treatments the patient will most likely respond to, and those treatments to which the patient is least likely to respond.
Procedurally, PEER Online utilizes standard 21-lead digital electroencephalographic equipment measuring the patient in a resting (but awake) state. The recording generally takes 30-60 minutes. Patients are classified based upon the 1,142 variables calculated in the recording (FDA-approved neurometric system) and categorized based on the outcome history in treating patients with similar neurophysiologic outputs. From these outputs and the correlation to the outcome database, reports may indicate single or multiple medications based on the nature of the physiologic abnormality discovered. The entire procedure is rapid, non-invasive, devoid of radiation or high strength magnetic fields, and results in a report, the PEER Outcome Report that is provided to clinicians in a format similar to antibiotic sensitivity testing.
Study Design (summary)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MYnd Analytics PEER Online directed therapy | Experimental | Patients in this arm will receive anti-depressants as recommended by the PEER Online algorithm as described below. |
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| Conventional therapy | Sham Comparator | Patients in this arm will receive anti-depressants as chosen by the physician without guidance by the PEER Online algorithm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MYnd Analytics PEER Online directed antidepressant therapy | Device | PEER Online is similar to a standard QEEG in that it uses QEEG output variables, but differs from a standard QEEG in that it references the QEEG to a normative and then symptomatic database. By comparing a given patient's QEEG to a database of QEEGs of subjects who have tried and responded to a specific medication, PEER Online can provide useful information regarding the response of neuro-physiologically similar patients to a wide number of medications. PEER Online may thus have the advantage of providing physicians with useful information as to medication outcomes before a medication regime is started. It has also been used to help select the medication that best matches the QEEG brainwave pattern, regardless of "symptom clusters," currently used for diagnostic nomenclature. Patients will receive anti-depressant therapy guide by the results of the PEER Online algorithm. |
| Measure | Description | Time Frame |
|---|---|---|
| 50% Reduction From Baseline in Self-rated Severity of Depressive Symptoms as Measured by Quick Inventory of Depressive Symptomatology Self-Rated 16-item Scale (QIDS-SR-16) | QIDS-SR-16 is a 16-question self-report inventory that includes the 9 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria symptom domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance (4 items: initial, middle, late insomnia, and hypersomnia), appetite/weight increased or decrease (4 items), and psychomotor agitation/retardation (2 items). The QIDS-SR-16 total scores range from 0 (least severe) to 27 (most severe). This study will examine the percentage of patients with improvement in depression as assessed by the QIDS-SR-16 at the 6 month treatment visit [repeated measures from all visits - for patients who received the intervention ie. MD followed PEER recommended therapy]. Response will be defined as a >50% reduction in QIDS-SR-16 score from baseline. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvement based on physician access to MyND Analytic PEER Online report. | Percentage of patients improving on the standardized assessments stratified by whether the physician had access to the MyND Analytic PEER Online report. | 6 months |
| Persistence of PEER recommended therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Total cost of care. | Total cost of care (all cause) for patients on PEER Online concordant therapy vs discordant therapy. Sub-analysis will focus on total cost of care based on whether the physician had access to the PEER report. | 6 months |
| Exploring use of Cota Nodal Address (CNA) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ramon Solhkhah, MD | Contact | 732-776-4930 | ramon.solhkhah@hackensackmeridian.org | |
| Stuart Goldberg, MD | Contact | 201-741-0566 | stuartgoldberg@cotahealthcare.com |
| Name | Affiliation | Role |
|---|---|---|
| Ramon Solhkhah, MD | Hackensack Meridian Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack Meridian Health Network | Recruiting | Brick | New Jersey | 08723 | United States |
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| Label | URL |
|---|---|
| MYnd Analytics | View source |
| COTA Healthcare | View source |
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All patients undergo EEG, but results are not released to physician or patient in the control group.
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| Conventional antidepressant therapy | Other | Anti-depressant therapy chosen based on physician best judgement. |
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Percentage of patients remaining on PEER Online concordant therapy vs discordant therapy at the 3 month visit. Sub-analysis will include whether the patient was on the original therapy or whether changes were made due to lack of efficacy or toxicity. Switches in medications from a PEER recommended therapy to another recommended therapy based on a physician assessment of lack of efficacy will be counted as a failure, however a switch for toxicity will not be counted as failure. |
| 3 months |
CNA is a unique prognostic classification schema. All patients will undergo classification at time of diagnosis and exploratory analysis for patterns of responsiveness will be undertaken. |
| 6 months |
| Hackensack Meridian Health Network | Recruiting | Brick | New Jersey | 08724 | United States |
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| Hackensack Meridian Health Network | Recruiting | Hackensack | New Jersey | 07601 | United States |
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| Hackensack Meridian Health Network | Recruiting | Hackensack | New Jersey | 07601 | United States |
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| Hackensack Meridian Health Network | Recruiting | Holmdel | New Jersey | 07733 | United States |
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| Hackensack Meridian Health Network | Recruiting | Jackson | New Jersey | 08527 | United States |
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| Hackensack Meridian Health Network | Recruiting | Lodi | New Jersey | 07644 | United States |
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| Hackensack Meridian Health Network | Recruiting | Lodi | New Jersey | 07644 | United States |
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| Hackensack Meridian Health Network | Recruiting | Neptune City | New Jersey | 07753 | United States |
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| Hackensack Meridian Health Network | Recruiting | Oakhurst | New Jersey | 07755 | United States |
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| Hackensack Meridian Health Network | Recruiting | Old Bridge | New Jersey | 08857 | United States |
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| Hackensack Meridian Health Network | Recruiting | Paramus | New Jersey | 07652 | United States |
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| Hackensack Meridian Health Network | Recruiting | Point Pleasant | New Jersey | 08742 | United States |
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| Hackensack Meridian Health Network | Recruiting | Saddle Brook | New Jersey | 07653 | United States |
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| Hackensack Meridian Health Network | Recruiting | Tinton Falls | New Jersey | 07724 | United States |
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| Hackensack Meridian Health Network | Recruiting | Toms River | New Jersey | 08753 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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