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MYnd Analytics Directed Therapy in Depression

1. november 2017 opdateret af: Cota Inc.

Randomized Trial Evaluating the Effectiveness of MYnd Analytics Directed Therapy in Depression

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

600

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New Jersey
      • Brick Township, New Jersey, Forenede Stater, 08723
        • Rekruttering
        • Hackensack Meridian Health Network
        • Kontakt:
          • Richard Reisher, DO
          • Telefonnummer: 732-477-5600
      • Brick Township, New Jersey, Forenede Stater, 08724
        • Rekruttering
        • Hackensack Meridian Health Network
        • Kontakt:
          • Jay Vida, DO
          • Telefonnummer: 732-892-4548
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Rekruttering
        • Hackensack Meridian Health Network
        • Kontakt:
          • Arthur Chaney, MD
          • Telefonnummer: 201-881-0721
      • Holmdel, New Jersey, Forenede Stater, 07733
        • Rekruttering
        • Hackensack Meridian Health Network
        • Kontakt:
          • Anthony DeTulio, MD
          • Telefonnummer: 732-264-8484
      • Jackson, New Jersey, Forenede Stater, 08527
        • Rekruttering
        • Hackensack Meridian Health Network
        • Kontakt:
          • Scott Druckman, DO
          • Telefonnummer: 732-987-5780
      • Lodi, New Jersey, Forenede Stater, 07644
        • Rekruttering
        • Hackensack Meridian Health Network
        • Kontakt:
          • Aurora Andreescu, MD
          • Telefonnummer: 973-473-3896
      • Neptune City, New Jersey, Forenede Stater, 07753
        • Rekruttering
        • Hackensack Meridian Health Network
        • Kontakt:
          • Richard Abramowitz, MD
          • Telefonnummer: 732-897-3990
      • Oakhurst, New Jersey, Forenede Stater, 07755
        • Rekruttering
        • Hackensack Meridian Health Network
        • Kontakt:
          • John Ciciarelli, MD
          • Telefonnummer: 732-663-0900
      • Old Bridge, New Jersey, Forenede Stater, 08857
        • Rekruttering
        • Hackensack Meridian Health Network
        • Kontakt:
          • James Demos, MD
          • Telefonnummer: 732-753-9890
      • Paramus, New Jersey, Forenede Stater, 07652
        • Rekruttering
        • Hackensack Meridian Health Network
        • Kontakt:
          • Morey Menacker, DO
          • Telefonnummer: 201-986-1881
      • Point Pleasant, New Jersey, Forenede Stater, 08742
        • Rekruttering
        • Hackensack Meridian Health Network
        • Kontakt:
          • Richard Murachanian, MD
          • Telefonnummer: 732-899-2353
      • Saddle Brook, New Jersey, Forenede Stater, 07653
        • Rekruttering
        • Hackensack Meridian Health Network
        • Kontakt:
          • Mathew Silverman, DO
          • Telefonnummer: 201-845-4048
      • Tinton Falls, New Jersey, Forenede Stater, 07724
        • Rekruttering
        • Hackensack Meridian Health Network
        • Kontakt:
          • Robert Carracino, MD
          • Telefonnummer: 732-450-0961
      • Toms River, New Jersey, Forenede Stater, 08753
        • Rekruttering
        • Hackensack Meridian Health Network
        • Kontakt:
          • Brenard Wayman, MD
          • Telefonnummer: 732-349-8866

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: MYnd Analytics PEER Online directed therapy
Patients in this arm will receive anti-depressants as recommended by the PEER Online algorithm as described below.
Enhed: 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-komparator: Conventional therapy
Patients in this arm will receive anti-depressants as chosen by the physician without guidance by the PEER Online algorithm.
Andet: Conventional antidepressant therapy
Anti-depressant therapy chosen based on physician best judgement.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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)
Tidsramme: 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.
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical improvement based on physician access to MyND Analytic PEER Online report.
Tidsramme: 6 months
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.
Tidsramme: 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.
3 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total cost of care.
Tidsramme: 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.
6 months
Exploring use of Cota Nodal Address (CNA)
Tidsramme: 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.
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cota Inc.

Samarbejdspartnere

Hackensack Meridian Health
MYnd Analytics
Horizon Blue Cross Blue Shield of New Jersey

Efterforskere

  • Ledende efterforsker: Ramon Solhkhah, MD, Hackensack Meridian Health

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2017

Primær færdiggørelse (Forventet)

1. oktober 2020

Studieafslutning (Forventet)

1. oktober 2020

Datoer for studieregistrering

Først indsendt

27. oktober 2017

Først indsendt, der opfyldte QC-kriterier

27. oktober 2017

Først opslået (Faktiske)

1. november 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. november 2017

Sidst verificeret

1. november 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MYnd 001

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