Phenotype Depression Study
2016年6月20日 更新者：Andrew H Miller、Emory University
Phenotyping Major Depression With Increased Inflammation
To facilitate the development of a personalized approach to the treatment of patients with major depression, this study is designed to elaborate the clinical and neurobiological phenotype of depressed patients with increased inflammation.
The data obtained in this proposal will allow the investigators to test the hypothesis that depression and inflammation interact to elaborate a relatively discreet phenotype that warrants an individualized approach to diagnosis and treatment of patients with depression.
Moreover, the identification of specific environmental risk factors for inflammation will foster the elaboration of preventative strategies for patients at risk.
研究概览
地位
完全的
条件
详细说明
One hundred and thiry-five patients with major depression diagnosed based on DSM-IV TR criteria between the ages of 21 and 65 (males, females and minorities) will be recruited.
Forty-five patients with high inflammation as defined by a CRP >3 mg/L will be enrolled along with 45 depressed patients with medium inflammation (CRP=1-3mg/L) and 45 depressed patients with low inflammation (CRP<1mg/L) will complete a 2 night inpatient stay in Emory University Hospital's research unit, the Atlanta Clinical and Translational Science Institute (ACTSI).
Participants will undergo psychiatric and neurocognitive assessments, sleep studies and blood and cerebral spinal fluid (CSF) sampling.
研究类型
观察性的
注册 (实际的)
279
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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Georgia
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Atlanta、Georgia、美国、30322
- Emory University Department of Psychiatry and Behavioral Sciences
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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
21年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
One hundred and thiry-five patients with major depression diagnosed based on DSM-IV TR criteria between the ages of 21 and 65 (males, females and minorities) will be recruited.
Forty-five patients with high inflammation as defined by a CRP >3 mg/L will be enrolled along with 45 depressed patients with medium inflammation (CRP=1-3mg/L) and 45 depressed patients with low inflammation (CRP<1mg/L)
描述
Inclusion Criteria:
- age 21-65 years including males, females and minorities
- diagnosis of DSM-IV major depression or Bipolar I or II with current episode of depression
- HDRS-17 > 20 and HDRS-24 > 24
- negative pregnancy test for women of childbearing potential
- not breast feeding
- stable on current dose of psychotropic medication or free from all psychotropic medications for 4 weeks prior to EUH CIN admission (8 weeks for fluoxetine)
- no suicide attempt within six months of screening
Exclusion Criteria:
- evidence of untreated or poorly controlled endocrine, cardiovascular, pulmonary, hematological, renal, or neurological disease
- history of CNS trauma or active seizure disorder requiring medication unless otherwise approved by principle investigator
- autoimmune or inflammatory disorder of any kind
- chronic infection (e.g. hepatitis B or C or HIV)
- chronic use of agents known to affect the immune system including glucocorticoid therapy within the past 1 year, methotrexate within the past 1 year, chemotherapy of any kind (past or present), immunotherapy of any kind (past or present), aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) (within the past 2 weeks) and statins (within the past 1 month) unless otherwise approved by principle investigator
- hemoglobinopathies (e.g. thalassemia)
- a positive pregnancy test
- organ transplants
- cancer of any type
- a score of <28 on the Mini Mental Status Exam (MMSE)unless otherwise approved by principle investigator
- meets criteria for schizophrenia (Given overlap of generalized anxiety disorder (GAD) with major depression, GAD will not be exclusionary)
- current eating disorders
- active abuse of alcohol or illicit/prescription drugs within the past year unless otherwise approved by principle investigator.
- MGH-S >3 unless otherwise approved by principle investigator
- BMI >40 unless otherwise approved by the principle investigator
- active suicidal intent or plan and a score >2 on the HDRS suicide item (item #3).
- any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with participating in or completing the protocol
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
队列和干预
团体/队列 |
|---|
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High inflammation group (CRP>3 mg/L)
Forty-five participants each with a diagnosis of major depressive disorder and a CRP level >3 mg/L
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Medium inflammation group (CRP=1-3 mg/L)
Forty-five participants each with a diagnosis of major depressive disorder and a CRP level = 1-3 mg/L
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Low inflammation group (CRP<1 mg/L).
Forty-five participants each with a diagnosis of major depressive disorder and a CRP level <1 mg/L
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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 |
|---|---|---|
|
We are using clinician administered and self report psychiatric measurements to compare relevant symptom domains in patients with major depression and increased inflammation versus patients with major depression without increased inflammation.
大体时间：Inpatient visit
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Behavior: Hamilton Depression Rating Scale (HAM-D); Inventory of Depressive Symptoms-Self Report (IDS-SR); Salpetriere Retardation Rating Scale (SRRS); Snaith-Hamilton Pleasure Scale (SHAPS); Multidimensional Fatigue Inventory (MFI); Neuropsychology: Finger tapping task; Reaction Time Task (CANTAB); Trial Making Test, Part A; Digit Symbol Test; Stocking of Cambridge
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Inpatient visit
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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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We are measuring immune markers for the identification of relevant immunologic patterns of activation in patients with major depression and increased inflammation versus patients with major depression without increased inflammation.
大体时间：Inpatient visit; Day #2
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Immune Markers: plasma and CSF IFN-alpha, IL-6, sIL-6R, TNF-alpha, sTNFR 1 and 2, IL-1 beta, IL-1ra, sIL-2R and MCP-1; PBMC mRNA expression of genes with responsive elements for NF-kB and MAPK gene expression as well as intracellular phosphorylated p38 as determined by flow cytometry; polymorphisms in genes encoding for IL-1, IL-6, TNF-alpha (and their soluble receptors) as well as MCP-1
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Inpatient visit; Day #2
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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。
调查人员
- 首席研究员：Andrew H. Miller, MD、Emory University
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
2010年7月1日
初级完成 (实际的)
2016年5月1日
研究完成 (实际的)
2016年5月1日
研究注册日期
首次提交
2011年8月30日
首先提交符合 QC 标准的
2011年8月31日
首次发布 (估计)
2011年9月1日
研究记录更新
最后更新发布 (估计)
2016年6月22日
上次提交的符合 QC 标准的更新
2016年6月20日
最后验证
2016年4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.
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