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临床试验/NCT01607710
NCT01607710已完成不适用

Locating Regions of Interest in Generalized Anxiety Disorder Using Function Magnetic Resonance Imaging (fMRI)

Hartford Hospital1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
1
主要终点
Brain activation while undergoing the fMRI

研究概览

简要总结

The investigators are seeking to locate the brain regions of interest in generalized anxiety disorder (GAD) using both structural (sMRI) and functional magnetic resonance imaging (fMRI). The MRI will be used to measure changes in blood flow in the brain while at rest and while completing tasks designed to elicit symptoms of anxiety. Results from a nonclinical control group and a GAD group will be compared to determine whether they exhibit different areas of brain activity during the tasks.

详细描述

20 healthy controls and 20 participants with GAD will be recruited. Each participant will undergo an MRI session that will last approximately 2 hours. The structural MRI will be used when the participant is at rest. During the functional MRI (fMRI), a computer screen inside the scanner will display four tasks the participant must complete: (1)Gambling Task, (2)Risk & Ambiguity Task, (3)Reading Emotion from the Eyes (REE) Task, and (4)Emotional Counting Task.

研究设计

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

入排标准

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

入选标准

  • Clinical diagnosis of Generalized Anxiety Disorder
  • Hamilton Anxiety Rating Scale score of 18 or higher
  • Hamilton Rating Scale for Depression score of 17 or less
  • Fluency in English
  • Capacity to understand the nature of the study and willingness to sign informed consent for

排除标准

  • History of epilepsy or head trauma (Loss of consciousness>5 minutes) with the past 6 months
  • Lifetime history of increased intracranial pressure, seizure disorder, stroke, brain tumor, multiple sclerosis or brain surgery
  • A review of patient medications by the study physician indicates an increased risk of seizure
  • An active autoimmune, endocrine, viral, or vascular disorder affecting the brain; any unstable cardiac disease; hypertension; or severe renal or liver insufficiency
  • Substance use disorder or posttraumatic stress disorder (PTSD) within the past 6 months
  • Lifetime bipolar disorder, obsessive-compulsive disorder (OCD), psychotic disorder, mental retardation, or pervasive development disorder
  • Any psychotic features, including dementia or delirium
  • Medication change within past 3 months
  • Current serious suicidal or homicidal ideation, and/or serious suicidal attempt within past 6 months
  • Serious, unstable, or terminal medical condition or clinically judged too psychiatrically unstable to participate in the study
  • Any contraindication for participation in MRI scan
  • Nonclinical Control Group:
  • Inclusion Criteria:
  • Absence of any psychiatric diagnosis
  • Exclusion Criteria:
  • History of epilepsy or head trauma (Loss of Consciousness>5 minutes) with the past 6 months
  • Lifetime history of increased intracranial pressure, seizure disorder, stroke, brain tumor, multiple sclerosis or brain surgery
  • A review of patient medications by the study physician indicates an increased risk of seizure
  • An active autoimmune, endocrine, viral, or vascular disorder affecting the brain; any unstable cardiac disease; hypertension; or severe renal or liver insufficiency
  • Substance use disorder or PTSD within the past 6 months
  • Lifetime bipolar disorder, OCD, psychotic disorder, mental retardation, or pervasive development disorder
  • Any psychotic features, including dementia or delirium
  • Medication change within past 3 months
  • Current serious suicidal or homicidal ideation, and/or serious suicidal attempt within past 6 months
  • Serious, unstable, or terminal medical condition or clinically judged too psychiatrically unstable to participate in the study
  • Any contraindication for participation in MRI scan

结局指标

主要结局

Brain activation while undergoing the fMRI

时间窗: Throughout the fMRI

Main effects for each condition will be calculated to elucidate brain activations relevant to the tasks. Random effect 2 sample t-tests will assess group differences (i.e., GAD patients vs. healthy controls) to identify regions that demonstrate hyperactivation in patients.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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