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.
調査の概要
状態
わからない
条件
詳細な説明
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).
研究の種類
介入
入学 (予想される)
600
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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New Jersey
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Brick Township、New Jersey、アメリカ、08723
- 募集
- Hackensack Meridian Health Network
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コンタクト：
- Richard Reisher, DO
- 電話番号：732-477-5600
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Brick Township、New Jersey、アメリカ、08724
- 募集
- Hackensack Meridian Health Network
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コンタクト：
- Jay Vida, DO
- 電話番号：732-892-4548
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Hackensack、New Jersey、アメリカ、07601
- 募集
- Hackensack Meridian Health Network
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コンタクト：
- Arthur Chaney, MD
- 電話番号：201-881-0721
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Holmdel、New Jersey、アメリカ、07733
- 募集
- Hackensack Meridian Health Network
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コンタクト：
- Anthony DeTulio, MD
- 電話番号：732-264-8484
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Jackson、New Jersey、アメリカ、08527
- 募集
- Hackensack Meridian Health Network
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コンタクト：
- Scott Druckman, DO
- 電話番号：732-987-5780
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Lodi、New Jersey、アメリカ、07644
- 募集
- Hackensack Meridian Health Network
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コンタクト：
- Aurora Andreescu, MD
- 電話番号：973-473-3896
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Neptune City、New Jersey、アメリカ、07753
- 募集
- Hackensack Meridian Health Network
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コンタクト：
- Richard Abramowitz, MD
- 電話番号：732-897-3990
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Oakhurst、New Jersey、アメリカ、07755
- 募集
- Hackensack Meridian Health Network
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コンタクト：
- John Ciciarelli, MD
- 電話番号：732-663-0900
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Old Bridge、New Jersey、アメリカ、08857
- 募集
- Hackensack Meridian Health Network
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コンタクト：
- James Demos, MD
- 電話番号：732-753-9890
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Paramus、New Jersey、アメリカ、07652
- 募集
- Hackensack Meridian Health Network
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コンタクト：
- Morey Menacker, DO
- 電話番号：201-986-1881
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Point Pleasant、New Jersey、アメリカ、08742
- 募集
- Hackensack Meridian Health Network
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コンタクト：
- Richard Murachanian, MD
- 電話番号：732-899-2353
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Saddle Brook、New Jersey、アメリカ、07653
- 募集
- Hackensack Meridian Health Network
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コンタクト：
- Mathew Silverman, DO
- 電話番号：201-845-4048
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Tinton Falls、New Jersey、アメリカ、07724
- 募集
- Hackensack Meridian Health Network
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コンタクト：
- Robert Carracino, MD
- 電話番号：732-450-0961
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Toms River、New Jersey、アメリカ、08753
- 募集
- Hackensack Meridian Health Network
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コンタクト：
- Brenard Wayman, MD
- 電話番号：732-349-8866
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
偽コンパレータ：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Clinical improvement based on physician access to MyND Analytic PEER Online report.
時間枠：6 months
|
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.
時間枠：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.
|
3 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total cost of care.
時間枠：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
|
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Exploring use of Cota Nodal Address (CNA)
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Ramon Solhkhah, MD、Hackensack Meridian Health
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年10月1日
一次修了 (予想される)
2020年10月1日
研究の完了 (予想される)
2020年10月1日
試験登録日
最初に提出
2017年10月27日
QC基準を満たした最初の提出物
2017年10月27日
最初の投稿 (実際)
2017年11月1日
学習記録の更新
投稿された最後の更新 (実際)
2017年11月6日
QC基準を満たした最後の更新が送信されました
2017年11月1日
最終確認日
2017年11月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。