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临床试验/NCT00655057
NCT00655057已完成2 期

SPECT Brain Imaging as a Bio-Marker of Major Depression

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2005年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
66
试验地点
1
主要终点
Change in Dopamine Transporter Binding

研究概览

简要总结

This study will examine changes in brain dopamine transporter activity before and after antidepressant therapy.

详细描述

Depression is a serious psychiatric disorder that affects about 10% of the adult population in the United States in a given year. Common symptoms of depression include a persistent down mood and disinterest in previously enjoyed activities, often causing strain on work, social, and family life. A person's depression can be attributed to a variety of causes, including physiological and sociological factors. Among physiological factors, dopamine (DA), a chemical associated with feelings of happiness and pleasure, may play a key role in the onset of depression and may also be involved in the beneficial effect of antidepressant medication. Recent studies have found that people with depression have increased DA transporter (DAT) levels in a specific region of the inner brain called the striatum. The increased DAT levels might reflect alterations in central DA function. Treatment for depression with selective serotonin reuptake inhibitor (SSRI) antidepressant therapy may help in returning DAT levels to normal and in improving depressive symptoms. Using single photon emission computed tomography (SPECT) imaging, this study will examine changes in brain DAT activity in people with depression before and after they receive SSRI antidepressant therapy or cognitive behavioral therapy (CBT).

Participation in this study will last about 14 weeks and will involve participants who are healthy and depressed. All participants will first undergo baseline assessments that will include a medical history, questions about current and past health, a physical exam, a blood draw, a urine sampling, and an electrocardiogram (ECG). After completing the baseline assessments, participants will undergo a TRODAT-1 SPECT scan, which will involve an injection of TRODAT-1 (a radioactive agent to measure DA) and, after a 3-hour break, a 75-minute SPECT scan. If necessary, participants may also be asked to have a magnetic resonance imaging (MRI) brain scan after completing the SPECT scan.

Participants with depression will then be assigned randomly to undergo 12 weeks of treatment with either the antidepressant medication s-citalopram or CBT. Participants assigned to take s-citalopram will return for study visits weekly for 2 weeks, every other week for 6 weeks, and then monthly for 4 weeks. During study visits, participants will receive their medication, answer questions about depression and medication side effects, and occasionally fill out general health questionnaires. Participants receiving CBT will attend twice weekly sessions for 2 weeks and then once weekly sessions for 10 weeks. Sessions will focus on modifying thoughts and behaviors that may contribute to depression. After 12 weeks, all participants will be re-evaluated by a study doctor and, if still in good health, will undergo a repeat TRODAT-1 SPECT scan.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • DSM-IV diagnosis of major depressive episode (MDE) or major depressive disorder (MDD)
  • Drug free of psychotropic medication for more than 6 months before study entry
  • 17-item Hamilton Depression Scale (HAM-D17) score of greater than 16
  • Woman of childbearing age with a negative pregnancy test within 48 hours of study entry
  • Absence of DSM-IV Axis I diagnosis as determined by Structured Clinical Interview for DSM Disorders (SCID)

排除标准

  • DSM-IV Axis I diagnosis other than MDE
  • History of mania
  • Current alcohol or drug abuse, or alcohol or drug dependence within 6 months before study entry
  • History of sensitivity or intolerance to s-citalopram
  • Medical contraindication to the use of s-citalopram
  • Unstable medical condition (e.g., angina pectoris, untreated hypertension)
  • Pregnant or breastfeeding
  • Woman of childbearing potential not using a medically acceptable form of birth control
  • Actively suicidal or requiring hospitalization
  • Requiring additional psychotropic drug therapy
  • History of transient ischemic attacks
  • History of cerebral infarction (including lacunar infarct with symptoms that last more than 24 hours)
  • History of Binswanger's disease (or a history of hypertensive encephalopathy)
  • History of intracranial hemorrhage
  • History of head trauma with loss of consciousness
  • History of encephalitis
  • History of extended exposure to known neurotoxin (e.g., cyanide, carbon monoxide)
  • Uncontrolled metabolic disorder (e.g., thyroid disease, diabetes mellitus)
  • History of cognitive impairment other than MDE
  • History of normal pressure hydrocephalus
  • History of cancer metastatic to the central nervous system
  • History of Parkinson's disease or other basal ganglia disease
  • History of Guillain-Barre syndrome (chronic or relapsing polyneuropathy)
  • Inability to undergo an MRI scan
  • History of DSM-IV Axis I Mood Disorder

研究组 & 干预措施

1

Active Comparator

Healthy participants will undergo TRODAT-1 SPECT imaging.

干预措施: TRODAT-1 single photon emission computed tomographic (SPECT) imaging (Procedure)

2

Experimental

Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with s-citalopram.

干预措施: S-citalopram (Drug)

2

Experimental

Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with s-citalopram.

干预措施: TRODAT-1 single photon emission computed tomographic (SPECT) imaging (Procedure)

3

Active Comparator

Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with cognitive behavioral therapy.

干预措施: Cognitive behavioral therapy (CBT) (Behavioral)

3

Active Comparator

Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with cognitive behavioral therapy.

干预措施: TRODAT-1 single photon emission computed tomographic (SPECT) imaging (Procedure)

结局指标

主要结局

Change in Dopamine Transporter Binding

时间窗: Measured at Weeks 0 and 12

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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