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临床试验/NCT00275288
NCT00275288已完成不适用

"Brain Correlates Of Affect Regulation In BPD"

University of Minnesota1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2005年1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
20
试验地点
1
主要终点
To refine and pilot test functional neuroimaging paradigms to assess the amygdala response to neutral facial expressions across positive and negative emotional contexts.

研究概览

简要总结

MRI Study for females ages 18-45 with Borderline Personality Disorder(BPD): This study is a non-treatment study that involves 2 visits. Study Hypothesis:

  1. To refine and pilot test functional neuroimaging paradigms to assess the amygdala response to neutral facial expressions across positive and negative emotional contexts.
  2. To assess whether patients with borderline personality disorder show a heightened amygdala response to neutral facial expressions relative to healthy controls (20 female healthy controls, 20 females with borderline personality disorder).
  3. To assess the relationship between individual differences in clinical ratings of personality and affective regulation, and the amygdala response to facial expressions.

详细描述

The first visit will be an interview assessment and will take place at the Ambulatory Research Center (ARC), Fairview University-Riverside Campus. In addition to the interview assessment, we will ask you to complete a set of questionnaires about your behavior and mood. This first visit will last approximately 2.5-3 hours. Following the interview assessment, if you are eligible for the MRI study we will contact you to schedule an MRI scan on a separate visit. This visit will last approximately 2 hours. At this visit you will have an MRI scan of your brain. Prior to the MRI scan, you will have a practice session in an MRI simulator.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

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

入选标准

  • Female subjects ages 18-45 whom meet criteria for BPD will be included in the study. The healthy controls will also be females between the ages 18-
  • The healthy controls will undergo the same diagnostic and symptom evaluations as the female patients - these interview schedules will be used mainly for determining exclusion criteria.

排除标准

  • Neither borderline personality disorder subjects or healthy controls may have a history of schizophrenia, schizoaffective disorder, bipolar illness, major depression with psychotic features, Obsessive-Compulsive Disorder (OCD), Post-Traumatic Stress Disorder (PTSD), or Generalized Anxiety Disorder (GAD).
  • Patients and healthy controls may not have a serious neurologic or other metabolic disorder or any medical condition or treatment known to affect the parameters of this study.
  • Neither patients nor healthy controls will be included in the study if they are receiving a medical treatment that requires a medication that may have psychotropic effects.
  • Neither patients nor healthy controls can have any contraindications to MRI scanning such as a metal implant, a pacemaker, or a history of claustrophobia. At the Center for Magnetic Resonance Research (CMRR), we have developed a highly specific and detailed questionnaire to ensure the safety of all participants. This questionnaire is administered prior to any and all scans.
  • Pregnant women will be excluded from the study. This will be assessed by history, date of last menstrual period and urine pregnancy test if necessary.
  • Neither patients nor healthy controls who fulfill criteria for developmental deficiency will be included.
  • Healthy controls with more than two borderline personality disorder criteria will not be eligible for study. This is to reduce the possibility of healthy controls being "near misses" to the patients and diminishing the possibility of finding difference between the patients and the healthy controls.

结局指标

主要结局

To refine and pilot test functional neuroimaging paradigms to assess the amygdala response to neutral facial expressions across positive and negative emotional contexts.

时间窗: 2 years

1. To refine and pilot test functional neuroimaging paradigms to assess the amygdala response to neutral facial expressions across positive and negative emotional contexts. 2. To assess whether patients with borderline personality disorder show a heightened amygdala response to neutral facial expressions relative to healthy controls (20 female healthy controls, 20 females with borderline personality disorder). 3. To assess the relationship between individual differences in clinical ratings of personality and affective regulation, and the amygdala response to facial expressions

次要结局

  • Secondary Outcomes(2 years)

研究者

申办方类型
Other

研究点 (1)

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