Functional MRI Before and After Treatment for Depression
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale Percent Change From Day 0 to D56
研究概览
简要总结
The purpose of this study is to help us understand how depression changes brain activity and how this relates to mood, anxiety, and cognitive functions like memory. We also hope to develop a brain imaging test that will predict either before or within two weeks of starting a medicine whether the treatment will work.
详细描述
You were selected as a possible participant because you are suffering from a major depressive episode, and you have not previously tried the medication used in this study to treat depression. Approximately 60 subjects will participate in this study: 30 subjects who are currently suffering from a major depressive episode and 30 subjects who have never suffered from a major depressive episode.
If you choose to participate, you will be seen at the clinic for a total of five times plus three MRI scans. You will be seen once for a screening visit. If you choose to enroll, you will return a week later for the baseline visit and again at weeks 2, 4 and 8. Around the time of week one (baseline), week 2 and week 8 you will also undergo an MRI scan of the brain.
Screening Visit: The study physician and the research study staff will first screen you for eligibility. The screening visit includes meeting with a physician for a discussion of your medical history and current medications, taking your blood pressure, and checking your weight. Women of childbearing potential will also have a urine pregnancy test. You will meet with a member of the research staff for an interview to collect information about your depression and other psychiatric symptoms you have experienced. The purpose of the interview is to confirm your diagnosis and assess the current severity of your depression. The screening visit will take approximately 2 hours.
Week 1 (baseline): If you are eligible to continue with the study, you will return to the clinic within 7 days for a baseline visit. At your baseline visit, you will complete several tests to assess your memory and concentration. These tests are being conducted because problems with memory and concentration are common in people who are depressed and the researchers want to find out if there is a difference in your memory and concentration before and after taking the study medication. We also wish to compare the results to any findings from the brain imaging. Following the baseline visit, you will begin treatment with the antidepressant citalopram. The starting dose is 20 mg once per day.
Week 1 MRI: Around the time of your week one (baseline) visit and before starting medications, you will have your first MRI.
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
- Treatment
- 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
- 是
入选标准
- •Patients will be aged 18-65, have no significant neurologic history, must meet DSM-IV criteria for a diagnosis of major depression and be free of antidepressant or other psychotropic medication for a minimum of two weeks before enrollment. If a subject is talking psychiatric medication he/she may be weaned off of the medication by their treating physician prior to study enrollment. Such a course of action would only be advised if the current medication was not considered to be of any benefit to the subject. In particular, if a patient is on antidepressant medication which is of benefit, we would not advise tapering off medication -- and subsequent risk of relapse -- in order to participate in the study. The same line of thinking applies to all psychiatric diagnoses and associated medications candidate subjects may be taking.
排除标准
- •Significant head trauma with loss of consciousness.
- •Active abuse of alcohol or illegal substances.
- •Excluded psychiatric diagnoses include: Bipolar Affective Disorder, primary psychotic disorders (Schizophrenia, Schizoaffective disorder), Obsessive-Compulsive Disorder
- •Pregnant or nursing women.
- •Any contraindication to being scanned in the 3T scanner at the Lucas Center such as having a pacemaker or any implanted device that has not been cleared for scanning at 3 Tesla.
- •Any significant neurologic history (i.e. seizure, stroke, multiple sclerosis).
- •Use of psychotropic medications within 2 weeks of enrollment.
研究组 & 干预措施
Depressed patients
Depressed patients assigned in an open-label study of citalopram
干预措施: Citalopram (Drug)
结局指标
主要结局
Hamilton Depression Rating Scale Percent Change From Day 0 to D56
时间窗: % change from baseline to Day 56 ( week 8)
Utilized the Hamilton Depression Rating Scale (HAM), 21-item version to assess depressive symptoms, with a range of 0-63. Higher scores indicate more depression. For the change score, it is Baseline less Day 56 HAM total / Baseline. Thus, larger values mean a greater decrease in the level of depression
Voxel-wise Changes in Resting State Functional Connectivity to the Posterior Cingulate Cortex
时间窗: baseline and week 8
The dependent variable, measured in more than 30,000 voxels across the whole brain, was the functional connectivity between the posterior cingulate cortex seed region and each voxel. This is derived as the correlation coefficient between the blood-oxygen-level dependent (BOLD) signal timeseries in the seed region and the BOLD signal timeseries in each voxel.
次要结局
- Hamilton Anxiety Scale(% change in anxiety from Day 1 to Day 56 (week 8))
研究者
Jennifer Keller
Clinical Associate Professor
Stanford University