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临床试验/NCT00209105
NCT00209105已完成不适用

Emory Conte Center for the Neuroscience of Mental Disorders: Psychobiology of Childhood Trauma

Emory University1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
113
试验地点
1
主要终点
Pathophysiological pathways (e.g., blood chemicals, physiological measures, brain images, behavioral measures), as assessed by diagnostic tests

研究概览

简要总结

This study will characterize the mental health consequences of early-life trauma.

详细描述

This primary goal of this Center is to characterize the neurobiological consequences of early-life trauma. The Center comprises 6 projects that include human subjects. Human subjects are recruited through Project 6.

Project 2: Psychoimmunology (PI A.H. Miller) Project 4: A Model of Learned Safety(PI: M. Davis) Project 6: Clinical Psychobiology(PI: C. Heim) Project 7: Children of Depressed Mothers(PI: Z. Stowe) Project 8: Functional Brain Imaging (PIs: H.S. Mayberg, G. Berns) Project 9: Structural & Anatomical Connectivity Studies (PI: C.Kilts, X. Hu).

Project 2: The study seeks to examine the impact of psychosocial stress on neuroendocrine and immune signaling pathways of adult men and women with and without major depression who have experienced serious trauma (abuse, loss) during development. Serial blood samples will be collected at baseline and after an acute speech/math stressor (see Project 6). Assessments include IL-1alpha, and beta, IL-6, TNF alpha as well as DNS binding of relevant neuroendocrine-immune transcription factors, i.e. GR, CREB, and NFkB.

Project 4: This study uses a model of that allows for the independent evaluation of excitation and inhibition of fear-conditioning measured with the acoustic startle reflex. In addition, a dark-enhanced startle paradigm will be used that tests for anxiety. The effects of early-life stress will be evaluated in humans with and without major depressive disorder.

Project 6: This study assesses neuroendocrine and autonomic responses to stress and pharmacological challenge in subjects with and without major depression who have or have nor experienced early life stress. We seek to identify causes of variability in neuroendocrine-autonomic outcome after early life stress. To achieve this principle aim, we study the role of moderating and mediating factors including gender, genotype, type/timing of childhood trauma, as well as the role of adulthood trauma, comorbidity and cognitive dysfunction. The projects serves as a human subjects core for the other projects.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • For participants assigned to the MDD groups: current DSM-IV diagnosis of MDD
  • For participants assigned to the early-life stress group: repeated (once per month or more for at least year) sexual or physical abuse before the age of 13 years by a perpetrator at least 5 years older at the time
  • For female participants: regular menstrual cycle and assessment in the early follicular phase as verified by sex steroid measures

排除标准

  • Meets DSM-IV criteria for a gender identity disorder
  • For all participants assigned to non-MDD groups: DSM-IV diagnosis of current MDD
  • For all participants assigned to the group without early-life stress: major stress experiences before the age of 12 years, such as separation from parents, neglect, parental loss, accidents, severe illness, or natural disaster
  • Significant medical illness, such as gastrointestinal, neurological, hormonal, heart, lung, kidney, liver, immunological or hematological disease, organic brain disease, or cancer as determined by history, physical examination, ECG, and laboratory tests
  • Pregnant or breastfeeding
  • Past or current presence of psychotic symptoms or bipolar disorder
  • Current presence of psychoactive substance abuse/dependency or eating disorders
  • Currently taking hormonal medication
  • Taking psychotropic medication within 4 weeks of study entry
  • General exclusion criteria for PET and fMRI

研究组 & 干预措施

1

Participants who have experienced early-life trauma will undergo a series of diagnostic tests.

干预措施: DEX-CRF stimulation test (Drug)

1

Participants who have experienced early-life trauma will undergo a series of diagnostic tests.

干预措施: Psychosocial stress induction (Behavioral)

1

Participants who have experienced early-life trauma will undergo a series of diagnostic tests.

干预措施: Brain imaging of sad mood , self-reference, reward (Procedure)

1

Participants who have experienced early-life trauma will undergo a series of diagnostic tests.

干预措施: Acoustic startle (Behavioral)

结局指标

主要结局

Pathophysiological pathways (e.g., blood chemicals, physiological measures, brain images, behavioral measures), as assessed by diagnostic tests

时间窗: Measured at Day 2.5

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Becky Kinkead, PhD

Assocate Professor

Emory University

研究点 (1)

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