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MYnd Analytics Directed Therapy in Depression

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ClinicalTrials.gov Identifier: NCT03328052
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
Hackensack Meridian Health Network
Horizon Blue Cross Blue Shield of New Jersey
MYnd Analytics
Information provided by (Responsible Party):
Cota Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Device: MYnd Analytics PEER Online directed antidepressant therapy Other: Conventional antidepressant therapy Phase 4

Detailed Description:

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)

  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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: All patients undergo EEG, but results are not released to physician or patient in the control group.
Primary Purpose: Treatment
Official Title: Randomized Trial Evaluating the Effectiveness of MYnd Analytics Directed Therapy in Depression
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Experimental: MYnd Analytics PEER Online directed therapy
Patients in this arm will receive anti-depressants as recommended by the PEER Online algorithm as described below.
Device: 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.

Sham Comparator: Conventional therapy
Patients in this arm will receive anti-depressants as chosen by the physician without guidance by the PEER Online algorithm.
Other: Conventional antidepressant therapy
Anti-depressant therapy chosen based on physician best judgement.




Primary Outcome Measures :
  1. 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) [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Clinical improvement based on physician access to MyND Analytic PEER Online report. [ Time Frame: 6 months ]
    Percentage of patients improving on the standardized assessments stratified by whether the physician had access to the MyND Analytic PEER Online report.

  2. Persistence of PEER recommended therapy. [ Time Frame: 3 months ]
    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.


Other Outcome Measures:
  1. Total cost of care. [ Time Frame: 6 months ]
    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.

  2. Exploring use of Cota Nodal Address (CNA) [ Time Frame: 6 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a clinical diagnosis of depression who in the judgement of their physician require medication management may be eligible for enrollment. A score of 10 or more on the PHQ-9 instrument will be required for enrollment.
  • 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:

  • Diagnosis of a psychotic disorder.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328052


Contacts
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Contact: Ramon Solhkhah, MD 732-776-4930 ramon.solhkhah@hackensackmeridian.org
Contact: Stuart Goldberg, MD 201-741-0566 stuartgoldberg@cotahealthcare.com

Locations
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United States, New Jersey
Hackensack Meridian Health Network Recruiting
Brick Township, New Jersey, United States, 08723
Contact: Richard Reisher, DO    732-477-5600      
Hackensack Meridian Health Network Recruiting
Brick Township, New Jersey, United States, 08724
Contact: Jay Vida, DO    732-892-4548      
Hackensack Meridian Health Network Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Timothy Kowal, DO    201-343-2434      
Hackensack Meridian Health Network Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Arthur Chaney, MD    201-881-0721      
Hackensack Meridian Health Network Recruiting
Holmdel, New Jersey, United States, 07733
Contact: Anthony DeTulio, MD    732-264-8484      
Hackensack Meridian Health Network Recruiting
Jackson, New Jersey, United States, 08527
Contact: Scott Druckman, DO    732-987-5780      
Hackensack Meridian Health Network Recruiting
Lodi, New Jersey, United States, 07644
Contact: Lisa Raacke, MD    551-996-8111      
Hackensack Meridian Health Network Recruiting
Lodi, New Jersey, United States, 07644
Contact: Aurora Andreescu, MD    973-473-3896      
Hackensack Meridian Health Network Recruiting
Neptune City, New Jersey, United States, 07753
Contact: Richard Abramowitz, MD    732-897-3990      
Hackensack Meridian Health Network Recruiting
Oakhurst, New Jersey, United States, 07755
Contact: John Ciciarelli, MD    732-663-0900      
Hackensack Meridian Health Network Recruiting
Old Bridge, New Jersey, United States, 08857
Contact: James Demos, MD    732-753-9890      
Hackensack Meridian Health Network Recruiting
Paramus, New Jersey, United States, 07652
Contact: Morey Menacker, DO    201-986-1881      
Hackensack Meridian Health Network Recruiting
Point Pleasant, New Jersey, United States, 08742
Contact: Richard Murachanian, MD    732-899-2353      
Hackensack Meridian Health Network Recruiting
Saddle Brook, New Jersey, United States, 07653
Contact: Mathew Silverman, DO    201-845-4048      
Hackensack Meridian Health Network Recruiting
Tinton Falls, New Jersey, United States, 07724
Contact: Robert Carracino, MD    732-450-0961      
Hackensack Meridian Health Network Recruiting
Toms River, New Jersey, United States, 08753
Contact: Brenard Wayman, MD    732-349-8866      
Sponsors and Collaborators
Cota Inc.
Hackensack Meridian Health Network
Horizon Blue Cross Blue Shield of New Jersey
MYnd Analytics
Investigators
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Principal Investigator: Ramon Solhkhah, MD Hackensack Meridian Health Network

Additional Information:
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Responsible Party: Cota Inc.
ClinicalTrials.gov Identifier: NCT03328052     History of Changes
Other Study ID Numbers: MYnd 001
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs