Study to Evaluate the Safety and Efficacy of PEER Interactive to Inform Medication Prescription for Subjects With a Primary Diagnosis of Depression (SMART-MD)
A Prospective, Double Blind, Randomized, Controlled, Multisite Study to Evaluate the Utility, Safety, and Efficacy of Using PEER Interactive to Inform Medication Prescription to Subjects With a Primary Diagnosis of a Depressive Disorder(SMART-MD)
研究概览
详细说明
This study is prospective in nature. Subjects in the control group will be treated according to treatment as usual and best judgment of the treating physician. For the experimental group the treating physician will follow the guidance of the subject's PEER Interactive Report as regards sensitivity to on-label medications and classes of medication.
The subjects will be washed out of all current medications prior to having an electroencephalogram (EEG), which is necessary to generate the PEER Interactive Report. The wash out period for outpatients is no longer than 14 days.
The subjects will be followed for 3 months after the initial treatment. The patient will be seen on a routine basis and assessments will be made at each interaction to evaluate the patient's improvement in mental health. The subjects will also be closely evaluated to determine if they are experiencing any psychiatric specific adverse events. The investigator is allowed to treat the patient according to their best medical judgment, which may include adding or changing medications, seeing the patient more frequently, or other interventions such as the use of sleep aids.
研究类型
注册 (预期的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
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North Carolina
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Raleigh、North Carolina、美国、27609
- Carolina Partners
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male and female subjects between the ages of 18 - 65 years of age or older who speak and read English.
- Subjects able to provide written informed consent to participate in the study.
- Subjects with a primary diagnosis of a Diagnostic and Statistical Manual of Mental Disorders (DSM-V) depressive disorder. Please see Appendix D for definitions.
- Subjects with comorbidity of a non-psychotic behavioral disorder. Please see Appendix D for definitions.
- Subjects with comorbidity of mild traumatic brain injury (mTBI) are eligible for inclusion in this study.
- Subjects with comorbidity of post-traumatic stress disorder (PTSD) are eligible for inclusion in this study. A score of 45 or greater on the PTSD Checklist Civilian (PCL-C) measurement tool will qualify a subject for inclusion of diagnosis of PTSD as a comorbid condition.
- Able to stop specified medications, including drugs of abuse, for 5 half-lives of the medication(s). See Appendix E for a list of the withdrawal periods for medications. The potential subject's primary care physician may be consulted to make these determinations.
- Able to be washed out of medications within 14 days, i.e. 5 half-lives are not longer than 14 days (See Appendix E).
Ability to comply with the requirements of the study.
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Exclusion Criteria:
- Male and female subjects less than 18 years old or greater than 65 years old.
- Subjects who cannot provide written informed consent.
- Diagnosis of a psychotic disorder. Please see Appendix D for definitions.
- History of, or current, open head brain trauma.
- Subjects with comorbidity of traumatic brain injury (TBI) who experienced greater than 30 minutes loss of consciousness, greater than 24 hour alteration in consciousness or mental status, greater than 24 hours of post traumatic amnesia, or a Glasgow Coma Scale (best available score in first 24 hours) of less than 13.
- Subjects who, in the opinion of the investigator would not be good candidates to be washed out of specified medications (Appendix E) and are unable to washout medications and/or supplements in a period of 14 days or less.
- 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.
- Clinically significant medical illness, including thyroid disorders, diabetes, etc., which cannot be remediated with medication, e.g. synthroid, insulin, etc.
- Participation in any other therapeutic drug study within 60 days preceding inclusion.
- 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).
- Candidates with any metal, shrapnel or other similar objects in the head that could affect the QEEG.
- Candidates currently stable on current medications.
Pre-entry subject whose urine drug screen is positive for drugs of abuse.
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学习计划
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:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:Control
The Control group subjects will undergo all procedures e.g.
medication washout and baseline electroencephalogram, administered to the Treatment/Experimental group.
A clinician treating a Control Group subject will NOT receive the Psychiatric Electroencephalogram Evaluation Registry (PEER) Interactive Report (of probable medication response) under investigation and will treat the Subject with Standard of Care.
The subject will be blinded to group assignment and will provide the primary outcome measure - Quick Inventory of Depressive Symptomatology - Self Report 16 item questionnaire.
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有源比较器:Treatment
Intervention - Psychiatric Electroencephalogram Evaluation Registry (PEER) Interactive Report - Treatment group subjects will undergo all procedures e.g.
medication washout and baseline electroencephalogram, administered to the Control group.
A clinician treating a Treatment Group subject will receive the Psychiatric Electroencephalogram Evaluation Registry (PEER) Report (of probable medication response) under investigation and will incorporate the Report information during prescription of medications to the Subject.
The subject will be blinded to group assignment and will provide the primary outcome measure - Quick Inventory of Depressive Symptomatology - Self Report 16 item questionnaire.
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A subinvestigator treating a Treatment Group subject will receive the Psychiatric Electroencephalogram Evaluation Registry (PEER) Interactive Report (of probable medication response) under investigation and will incorporate the Report information during prescription of medications to the Subject.
A subinvestigator treating a Control Group subject will NOT receive the PEER Report and will treat the Subject with Standard of Care.
The subject will be blinded to group assignment and will provide the primary outcome measure - Quick Inventory of Depressive Symptomatology - Self Report 16 item questionnaire.
其他名称:
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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 |
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Quick Inventory of Depressive Symptomatology - Self Report 16 questionnaire (QIDS-SR16)
大体时间:4 months
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A self reported survey - blinded subject acts as blinded rater/outcomes assessor.
We will use this survey to measure the subject's self-reported change in symptoms of depression.
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4 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 Global Impressions - Improvement (CGI-I)
大体时间:4 months
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Commonly used measure of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders
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4 months
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Clinical Global Impressions - Severity (CGI-S)
大体时间:4 months
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Commonly used measure of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders.
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4 months
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Concise Health Risk Tracking Scale - 7 item Self Report Survey (CHRT- SR7)
大体时间:4 months
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A 7 question self-report questionnaire that assesses suicidal risk of subjects in clinical practice
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4 months
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合作者和调查者
调查人员
- 首席研究员:Daniel Iosifescu, PhD、Mount Sinai Hospital, New York, N.Y.
出版物和有用的链接
一般刊物
- Rush AJ, Bernstein IH, Trivedi MH, Carmody TJ, Wisniewski S, Mundt JC, Shores-Wilson K, Biggs MM, Woo A, Nierenberg AA, Fava M. An evaluation of the quick inventory of depressive symptomatology and the hamilton rating scale for depression: a sequenced treatment alternatives to relieve depression trial report. Biol Psychiatry. 2006 Mar 15;59(6):493-501. doi: 10.1016/j.biopsych.2005.08.022. Epub 2005 Sep 30.
- DeBattista C, Kinrys G, Hoffman D, Goldstein C, Zajecka J, Kocsis J, Teicher M, Potkin S, Preda A, Multani G, Brandt L, Schiller M, Iosifescu D, Fava M. The use of referenced-EEG (rEEG) in assisting medication selection for the treatment of depression. J Psychiatr Res. 2011 Jan;45(1):64-75. doi: 10.1016/j.jpsychires.2010.05.009. Epub 2010 Jul 3.
- Demyttenaere K, Desaiah D, Petit C, Croenlein J, Brecht S. Patient-assessed versus physician-assessed disease severity and outcome in patients with nonspecific pain associated with major depressive disorder. Prim Care Companion J Clin Psychiatry. 2009;11(1):8-15. doi: 10.4088/pcc.08m00670.
- Duffy FH, Burchfiel JL, Lombroso CT. Brain electrical activity mapping (BEAM): a method for extending the clinical utility of EEG and evoked potential data. Ann Neurol. 1979 Apr;5(4):309-21. doi: 10.1002/ana.410050402.
- Hughes JR, John ER. Conventional and quantitative electroencephalography in psychiatry. J Neuropsychiatry Clin Neurosci. 1999 Spring;11(2):190-208. doi: 10.1176/jnp.11.2.190.
- Hoffman DA, Debattista C, Valuck RJ, Iosifescu DV. Measuring severe adverse events and medication selection using a "PEER Report" for nonpsychotic patients: a retrospective chart review. Neuropsychiatr Dis Treat. 2012;8:277-84. doi: 10.2147/NDT.S31665. Epub 2012 Jun 21.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
研究数据/文件
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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PEER Interactive Report的临床试验
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Mental Health Services in the Capital Region, DenmarkThe Peer partnership association完全的
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UConn HealthUniversity of Texas at Austin; Oregon Social Learning Center邀请报名
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动,不招人
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Rutgers, The State University of New JerseyMerck Sharp & Dohme LLC; Thomas Jefferson University完全的
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University of Maryland, College ParkUniversity of Maryland, Baltimore; National Center for Complementary and Integrative Health...完全的物质使用 | 物质使用障碍 | 阿片类药物使用障碍 | 保留护理 | 美沙酮治疗 | 同行交付 | 阿片类药物使用障碍 (MOUD) 的药物治疗 | 行为激活美国
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Potomac Health FoundationsNational Institutes of Health (NIH); National Institute of Drug Abuse招聘中
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Fundacio d'Investigacio en Atencio Primaria Jordi...完全的
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Florida State UniversityNational Institute on Drug Abuse (NIDA); National Center for Advancing Translational Sciences...完全的
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Boston UniversityNational Institute of Mental Health (NIMH); Massachusetts General Hospital; New York University; Desmond Tutu HIV Foundation主动,不招人