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临床试验/NCT00596622
NCT00596622已完成4 期

Dysfunctional Cortico-Limbic Activity and Connectivity in Bipolar Disorder Before and After Lithium Treatment: An fMRI Study

Indiana University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
46
试验地点
1
主要终点
17-item Hamilton Depression Rating Scale (HDRS)

研究概览

简要总结

This study will assess the effects of bipolar disorder on brain activity and will determine if medication changes the brain activity in people with bipolar disorder.

详细描述

Bipolar disorder (BD) is a chronic brain disorder that causes dramatic changes in a person's mood and energy. People with BD undergo periods of extreme happiness and extreme sadness, known as episodes of mania and depression. A person undergoing an episode of mania often experiences euphoric moods, increased energy, and aggressive behaviors, while a person in a depressed state often experiences low moods, lack of energy, and feelings of sadness. Researchers have recently discovered that abnormalities in certain brain areas that control emotion are often present in those with BD. It is believed that the severe mood shifts in BD may cause alterations in normal brain activity, specifically in corticolimbic activation and connectivity. Current mood stabilizing medications used to treat people with BD may help normalize these brain activity abnormalities. This study will assess the effects of BD on brain activity using functional magnetic resonance imaging (fMRI) and will determine if treatment with lithium changes the brain activity in people with BD.

This 9-week study will include participants who are healthy, have BD, or are siblings of subject with BD. All potential participants will undergo initial testing, which will include a physical examination, blood tests, and an electrocardiogram (EKG). Participants will also be asked to answer questions about their mental health, drug use, personality, family history, and psychological well-being. Eligible participants will then return on a different day to undergo an MRI scan, taking 4 hours to complete. During the scan, participants will be asked to perform tasks designed to show changes in blood flow in specific brain regions. These tasks will include listening to sounds and looking at various letters, words, and pictures. This will mark the completion of the study for healthy participants, first degree relatives, and those participants with BD who do not wish to receive medication treatment.

Following the first MRI scan, participants with BD who wish to undergo medication treatment will begin an 8-week course of lithium. Participants will be asked to come to the clinic at least once a week for medication monitoring visits. During these visits, participants will undergo blood draws and assessments on depression and mania. Participants will return for two repeat MRI scans after Weeks 2 and 8 of lithium treatment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Bipolar Manic Subjects Treated

Experimental

Bipolar mania picture response during fMRI before and after treatment with lithium

干预措施: Lithium (Drug)

Bipolar Depressed Subjects Treated

Experimental

Bipolar depression picture response during fMRI before and after treatment with lithium

干预措施: Lithium (Drug)

Bipolar Euthymic Subjects Treated

Experimental

Bipolar euthymia picture response before and after treatment with lithium

干预措施: Lithium (Drug)

结局指标

主要结局

17-item Hamilton Depression Rating Scale (HDRS)

时间窗: Measured at Baseline and after 8 weeks of treatment

17-item HDRS is gold standard for measurement of depression with a range from 0 - 52. 10 - 14: mild depression; 14-20 moderate depression; \>20: severe and very severe depression.

次要结局

  • Young Mania Rating Scale(Baseline and 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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