MYnd Analytics Directed Therapy in Depression
1 de novembro de 2017 atualizado por: 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.
Visão geral do estudo
Status
Desconhecido
Condições
Descrição detalhada
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)
- 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.
- 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.
- The patient will sign informed consent to participate.
- 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.
- 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.
- 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).
Tipo de estudo
Intervencional
Inscrição (Antecipado)
600
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
New Jersey
-
Brick Township, New Jersey, Estados Unidos, 08723
- Recrutamento
- Hackensack Meridian Health Network
-
Contato:
- Richard Reisher, DO
- Número de telefone: 732-477-5600
-
Brick Township, New Jersey, Estados Unidos, 08724
- Recrutamento
- Hackensack Meridian Health Network
-
Contato:
- Jay Vida, DO
- Número de telefone: 732-892-4548
-
Hackensack, New Jersey, Estados Unidos, 07601
- Recrutamento
- Hackensack Meridian Health Network
-
Contato:
- Arthur Chaney, MD
- Número de telefone: 201-881-0721
-
Holmdel, New Jersey, Estados Unidos, 07733
- Recrutamento
- Hackensack Meridian Health Network
-
Contato:
- Anthony DeTulio, MD
- Número de telefone: 732-264-8484
-
Jackson, New Jersey, Estados Unidos, 08527
- Recrutamento
- Hackensack Meridian Health Network
-
Contato:
- Scott Druckman, DO
- Número de telefone: 732-987-5780
-
Lodi, New Jersey, Estados Unidos, 07644
- Recrutamento
- Hackensack Meridian Health Network
-
Contato:
- Aurora Andreescu, MD
- Número de telefone: 973-473-3896
-
Neptune City, New Jersey, Estados Unidos, 07753
- Recrutamento
- Hackensack Meridian Health Network
-
Contato:
- Richard Abramowitz, MD
- Número de telefone: 732-897-3990
-
Oakhurst, New Jersey, Estados Unidos, 07755
- Recrutamento
- Hackensack Meridian Health Network
-
Contato:
- John Ciciarelli, MD
- Número de telefone: 732-663-0900
-
Old Bridge, New Jersey, Estados Unidos, 08857
- Recrutamento
- Hackensack Meridian Health Network
-
Contato:
- James Demos, MD
- Número de telefone: 732-753-9890
-
Paramus, New Jersey, Estados Unidos, 07652
- Recrutamento
- Hackensack Meridian Health Network
-
Contato:
- Morey Menacker, DO
- Número de telefone: 201-986-1881
-
Point Pleasant, New Jersey, Estados Unidos, 08742
- Recrutamento
- Hackensack Meridian Health Network
-
Contato:
- Richard Murachanian, MD
- Número de telefone: 732-899-2353
-
Saddle Brook, New Jersey, Estados Unidos, 07653
- Recrutamento
- Hackensack Meridian Health Network
-
Contato:
- Mathew Silverman, DO
- Número de telefone: 201-845-4048
-
Tinton Falls, New Jersey, Estados Unidos, 07724
- Recrutamento
- Hackensack Meridian Health Network
-
Contato:
- Robert Carracino, MD
- Número de telefone: 732-450-0961
-
Toms River, New Jersey, Estados Unidos, 08753
- Recrutamento
- Hackensack Meridian Health Network
-
Contato:
- Brenard Wayman, MD
- Número de telefone: 732-349-8866
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
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.
|
|
Comparador Falso: Conventional therapy
Patients in this arm will receive anti-depressants as chosen by the physician without guidance by the PEER Online algorithm.
|
Anti-depressant therapy chosen based on physician best judgement.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Clinical improvement based on physician access to MyND Analytic PEER Online report.
Prazo: 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.
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Total cost of care.
Prazo: 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)
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ramon Solhkhah, MD, Hackensack Meridian Health
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de outubro de 2017
Conclusão Primária (Antecipado)
1 de outubro de 2020
Conclusão do estudo (Antecipado)
1 de outubro de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
27 de outubro de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de outubro de 2017
Primeira postagem (Real)
1 de novembro de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
6 de novembro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de novembro de 2017
Última verificação
1 de novembro de 2017
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MYnd 001
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Não
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Sim
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .