Clinical trial NCT03328052: MYnd Analytics Directed Therapy in Depression
Official title: Randomized Trial Evaluating the Effectiveness of MYnd Analytics Directed Therapy in Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Depression
Lead sponsor: Cota Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hackensack Meridian Health
name: Horizon Blue Cross Blue Shield of New Jersey
name: MYnd Analytics
First posted: 2017-11-01
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: 6 months
Secondary outcomes:
measure: Clinical improvement based on physician access to MyND Analytic PEER Online report.
timeFrame: 6 months
measure: Persistence of PEER recommended therapy.
timeFrame: 3 months
Other outcomes:
measure: Total cost of care.
timeFrame: 6 months
measure: Exploring use of Cota Nodal Address (CNA)
timeFrame: 6 months
Locations:
city: Brick Township
country: United States
facility: Hackensack Meridian Health Network
state: New Jersey
city: Brick Township
country: United States
facility: Hackensack Meridian Health Network
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack Meridian Health Network
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack Meridian Health Network
state: New Jersey
city: Holmdel
country: United States
facility: Hackensack Meridian Health Network
state: New Jersey
city: Jackson
country: United States
facility: Hackensack Meridian Health Network
state: New Jersey
city: Lodi
country: United States
facility: Hackensack Meridian Health Network
state: New Jersey
city: Lodi
country: United States
facility: Hackensack Meridian Health Network
state: New Jersey
city: Neptune City
country: United States
facility: Hackensack Meridian Health Network
state: New Jersey
city: Oakhurst
country: United States
facility: Hackensack Meridian Health Network
state: New Jersey
city: Old Bridge
country: United States
facility: Hackensack Meridian Health Network
state: New Jersey
city: Paramus
country: United States
facility: Hackensack Meridian Health Network
state: New Jersey
city: Point Pleasant
country: United States
facility: Hackensack Meridian Health Network
state: New Jersey
city: Saddle Brook
country: United States
facility: Hackensack Meridian Health Network
state: New Jersey
city: Tinton Falls
country: United States
facility: Hackensack Meridian Health Network
state: New Jersey
city: Toms River
country: United States
facility: Hackensack Meridian Health Network
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Ramon Solhkhah, MD
role: PRINCIPAL_INVESTIGATOR
References: