Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
600 participants
INTERVENTIONAL
2017-10-01
2020-10-01
Brief Summary
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Detailed Description
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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)
1. The patient population will consist of individuals with depression who in the opinion of their physician require medication management. A score of 10 or more on the PHQ-9 instrument will be required for enrollment. Non-psychotic co-morbid illnesses will be permitted. Patients must not currently be receiving psychotropic medications (including stimulants, benzodiazepines, or THC). Patients previously on these medications but off treatment for \>30 days are permitted.
2. The physician will declare whether they wish to treat the depression or refer to a participating psychiatrist. Individual physicians (prior to enrolling any patients) will be assigned to either agree to utilize MYnd Analytic directed care or to be part of the control cohort. This will minimize any physician learning effect.
3. The patient will sign informed consent to participate.
4. All patients will undergo a study related EEG and MYnd Analytics will develop a PEER Online report. The report will be released to the treating physicians in the directed care group but will not be released to the control physicians.
5. All patients will complete a disease specific assessment tool (QIDS-SR16) at every office visit (at a minimum assessments at baseline, 3 months into treatment, and 6 months into treatment). Patients choosing to withdraw from the study or from treatment will also be offered the assessment at participation endpoint. COTA will score each patient based on the standardized tools as either improved, stable, or worsened. The primary endpoint for this study is QIDS-SR16 percent mean change from baseline, with response being defined as a reduction of \>50% from baseline. Physicians may know the results of these tests and may alter therapy per their usual practice.
6. Medication management will be at the final discretion of the treating physician. Physicians assigned to the MYnd Analytics directed care cohort will be encouraged, but not required, to follow the PEER Online report. Any change in therapy will be documented by the physician with reason (lack of efficacy, toxicity, patient preference).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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MYnd Analytics PEER Online directed therapy
Patients in this arm will receive anti-depressants as recommended by the PEER Online algorithm as described below.
MYnd Analytics PEER Online directed antidepressant therapy
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.
Conventional therapy
Patients in this arm will receive anti-depressants as chosen by the physician without guidance by the PEER Online algorithm.
Conventional antidepressant therapy
Anti-depressant therapy chosen based on physician best judgement.
Interventions
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MYnd Analytics PEER Online directed antidepressant therapy
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.
Conventional antidepressant therapy
Anti-depressant therapy chosen based on physician best judgement.
Eligibility Criteria
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Inclusion Criteria
* Some practices utilize the PHQ-2 and PHQ-9 are part of routine screening for depression. If the tests are performed routinely, they do not need to be repeated for study eligibility, and may be performed prior to informed consent for this study. If, however, the PHQ-9 is not routinely performed, informed consent must be performed prior to administration. Patients with a score below 10 will be considered screen failures and will not be enrolled or offered the MYnd testing.
* Patients with non-psychotic comorbid conditions may be included.
* Patients must be either medication treatment naïve for behavioral illnesses or have no active medication treatments for at least 1 month prior to enrollment. Prohibited medications at the time of enrollment will include stimulants, benzodiazepines and THC. Prior therapy with these agents is permitted with a washout of \>30 days.
* Patients must have private medical insurance coverage through Horizon Blue Cross Blue Shield. This is limited to insured commercial members, including HMO, and excluding, for the avoidance of doubt, members of self-insured customers or Medicare or Medicaid programs.
Exclusion Criteria
* History of, or current, open head brain trauma. Candidates with any metal, shrapnel or other similar objects in the head that could affect the QEEG
* History of: craniotomy, cerebral metastases, cerebrovascular accident; current diagnosis of seizure disorder, schizophrenia, schizo-affective disorder, dementia, mental retardation, or major depression with psychotic features; or use of depot neuroleptics in last 12 months.
* Uncontrolled thyroid disorders.
* Known pregnancy and/or lactation, or intent to become pregnant during this study.
* Chronic or acute pain requiring prescription pain medication(s) (narcotic or synthetic narcotic)
* Participation in any other therapeutic drug study within 60 days preceding inclusion.
18 Years
ALL
No
Sponsors
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Hackensack Meridian Health
OTHER
Horizon Blue Cross Blue Shield of New Jersey
OTHER
MYnd Analytics
INDUSTRY
Cota Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ramon Solhkhah, MD
Role: PRINCIPAL_INVESTIGATOR
Hackensack Meridian Health
Locations
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Hackensack Meridian Health Network
Brick, New Jersey, United States
Hackensack Meridian Health Network
Brick, New Jersey, United States
Hackensack Meridian Health Network
Hackensack, New Jersey, United States
Hackensack Meridian Health Network
Hackensack, New Jersey, United States
Hackensack Meridian Health Network
Holmdel, New Jersey, United States
Hackensack Meridian Health Network
Jackson, New Jersey, United States
Hackensack Meridian Health Network
Lodi, New Jersey, United States
Hackensack Meridian Health Network
Lodi, New Jersey, United States
Hackensack Meridian Health Network
Neptune City, New Jersey, United States
Hackensack Meridian Health Network
Oakhurst, New Jersey, United States
Hackensack Meridian Health Network
Old Bridge, New Jersey, United States
Hackensack Meridian Health Network
Paramus, New Jersey, United States
Hackensack Meridian Health Network
Point Pleasant, New Jersey, United States
Hackensack Meridian Health Network
Saddle Brook, New Jersey, United States
Hackensack Meridian Health Network
Tinton Falls, New Jersey, United States
Hackensack Meridian Health Network
Toms River, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Richard Reisher, DO
Role: primary
Jay Vida, DO
Role: primary
Timothy Kowal, DO
Role: primary
Arthur Chaney, MD
Role: primary
Anthony DeTulio, MD
Role: primary
Scott Druckman, DO
Role: primary
Lisa Raacke, MD
Role: primary
Aurora Andreescu, MD
Role: primary
Richard Abramowitz, MD
Role: primary
John Ciciarelli, MD
Role: primary
James Demos, MD
Role: primary
Morey Menacker, DO
Role: primary
Richard Murachanian, MD
Role: primary
Mathew Silverman, DO
Role: primary
Robert Carracino, MD
Role: primary
Brenard Wayman, MD
Role: primary
Related Links
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MYnd Analytics
COTA Healthcare
Other Identifiers
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MYnd 001
Identifier Type: -
Identifier Source: org_study_id