MYnd Analytics Directed Therapy in Depression
2017年11月1日 更新者：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.
研究概览
地位
未知
条件
详细说明
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).
研究类型
介入性
注册 (预期的)
600
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New Jersey
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Brick Township、New Jersey、美国、08723
- 招聘中
- Hackensack Meridian Health Network
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接触：
- Richard Reisher, DO
- 电话号码：732-477-5600
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Brick Township、New Jersey、美国、08724
- 招聘中
- Hackensack Meridian Health Network
-
接触：
- Jay Vida, DO
- 电话号码：732-892-4548
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Hackensack、New Jersey、美国、07601
- 招聘中
- Hackensack Meridian Health Network
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接触：
- Arthur Chaney, MD
- 电话号码：201-881-0721
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Holmdel、New Jersey、美国、07733
- 招聘中
- Hackensack Meridian Health Network
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接触：
- Anthony DeTulio, MD
- 电话号码：732-264-8484
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Jackson、New Jersey、美国、08527
- 招聘中
- Hackensack Meridian Health Network
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接触：
- Scott Druckman, DO
- 电话号码：732-987-5780
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Lodi、New Jersey、美国、07644
- 招聘中
- Hackensack Meridian Health Network
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接触：
- Aurora Andreescu, MD
- 电话号码：973-473-3896
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Neptune City、New Jersey、美国、07753
- 招聘中
- Hackensack Meridian Health Network
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接触：
- Richard Abramowitz, MD
- 电话号码：732-897-3990
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Oakhurst、New Jersey、美国、07755
- 招聘中
- Hackensack Meridian Health Network
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接触：
- John Ciciarelli, MD
- 电话号码：732-663-0900
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Old Bridge、New Jersey、美国、08857
- 招聘中
- Hackensack Meridian Health Network
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接触：
- James Demos, MD
- 电话号码：732-753-9890
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Paramus、New Jersey、美国、07652
- 招聘中
- Hackensack Meridian Health Network
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接触：
- Morey Menacker, DO
- 电话号码：201-986-1881
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Point Pleasant、New Jersey、美国、08742
- 招聘中
- Hackensack Meridian Health Network
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接触：
- Richard Murachanian, MD
- 电话号码：732-899-2353
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Saddle Brook、New Jersey、美国、07653
- 招聘中
- Hackensack Meridian Health Network
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接触：
- Mathew Silverman, DO
- 电话号码：201-845-4048
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Tinton Falls、New Jersey、美国、07724
- 招聘中
- Hackensack Meridian Health Network
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接触：
- Robert Carracino, MD
- 电话号码：732-450-0961
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Toms River、New Jersey、美国、08753
- 招聘中
- Hackensack Meridian Health Network
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接触：
- Brenard Wayman, MD
- 电话号码：732-349-8866
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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假比较器：Conventional therapy
Patients in this arm will receive anti-depressants as chosen by the physician without guidance by the PEER Online algorithm.
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Anti-depressant therapy chosen based on physician best judgement.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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)
大体时间：6 months
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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.
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Clinical improvement based on physician access to MyND Analytic PEER Online report.
大体时间：6 months
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Percentage of patients improving on the standardized assessments stratified by whether the physician had access to the MyND Analytic PEER Online report.
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6 months
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Persistence of PEER recommended therapy.
大体时间：3 months
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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.
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3 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Total cost of care.
大体时间：6 months
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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.
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6 months
|
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Exploring use of Cota Nodal Address (CNA)
大体时间：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.
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6 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Ramon Solhkhah, MD、Hackensack Meridian Health
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年10月1日
初级完成 (预期的)
2020年10月1日
研究完成 (预期的)
2020年10月1日
研究注册日期
首次提交
2017年10月27日
首先提交符合 QC 标准的
2017年10月27日
首次发布 (实际的)
2017年11月1日
研究记录更新
最后更新发布 (实际的)
2017年11月6日
上次提交的符合 QC 标准的更新
2017年11月1日
最后验证
2017年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.