Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

MYnd Analytics Directed Therapy in Depression

1. November 2017 aktualisiert von: 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.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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).

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

600

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Gerät: 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.
Schein-Komparator: Conventional therapy
Patients in this arm will receive anti-depressants as chosen by the physician without guidance by the PEER Online algorithm.
Sonstiges: Conventional antidepressant therapy
Anti-depressant therapy chosen based on physician best judgement.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Clinical improvement based on physician access to MyND Analytic PEER Online report.
Zeitfenster: 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.
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Total cost of care.
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Cota Inc.

Mitarbeiter

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

Ermittler

  • Hauptermittler: Ramon Solhkhah, MD, Hackensack Meridian Health

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Oktober 2017

Primärer Abschluss (Voraussichtlich)

1. Oktober 2020

Studienabschluss (Voraussichtlich)

1. Oktober 2020

Studienanmeldedaten

Zuerst eingereicht

27. Oktober 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Oktober 2017

Zuerst gepostet (Tatsächlich)

1. November 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. November 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. November 2017

Zuletzt verifiziert

1. November 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MYnd 001

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Depression

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Venezuela

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren