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临床试验/NCT03572426
NCT03572426已完成不适用

Ion Channel Genetic Biomarkers: Diagnostic Capabilities in the Assessment of Bipolar Disorder

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2018年6月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
164
试验地点
1
主要终点
Logistic Regression

研究概览

简要总结

Genotype 164 adults to evaluate six selected single nucleotide polymorphisms (SNPs) (rs1006737, rs10994336, rs10994133, rs2238071, rs1051375, rs1024582) for use as a genetic biomarker to differentiate between bipolar depression and unipolar depression.

详细描述

Adults ages 18-80 will be recruited if they are diagnosed with bipolar disorder, major depression, or have no mood symptoms. The adults will undergo a diagnostic interview, the Mini International Neuropsychiatric Interview (MINI) for the diagnosis. The subjects will also complete the Adverse Childhood Events Scale to evaluate for a genetic x environmental interaction in detecting bipolar disorder at initial assessment. Genotyping will be done by SNaPshot genotyping method and genetic sample will be collected via buccal swab.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • presenting to one of 4 Denver Metro Area clinics
  • Subjects must fall into one of 3 diagnostic categories, bipolar, MDD, or no mood symptoms.

排除标准

  • Inability to provide informed consent
  • history of TBI
  • history of untreated seizure disorder
  • substance abuse in the last 8 hours
  • moderate-severe substance abuse disorder diagnosed in the last 6 months

结局指标

主要结局

Logistic Regression

时间窗: 1 year

Logistic regression will be used to examine a genetic risk score using a risk allele count as the independent variable, with a diagnosis of BD versus MDD versus those with no mood diagnosis as the dependent variable.

次要结局

  • Genetic Risk Score(1 year)
  • Family History(1 year)
  • Adverse Childhood Experiences Scale(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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