Ethnic Variations in Antidepressant Response
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Hamilton Rating Scale for Depression
研究概览
简要总结
This 11-week study aims to determine how genetic factors affect the way African Americans and Caucasians with major depression respond to antidepressant medication [citalopram (Celexa®)].
详细描述
Depressed patients vary substantially in their responses to antidepressants. Genetic factors may account for a large part of these differences in response. This study will include both African Americans and Caucasians to examine the role of genetic factors in treatment response.
Participants receive citalopram (Celexa) for 8 weeks and a placebo for 1 week. Visits occur once a week for 11 weeks. A variety of interviews, scales, tests, and questionnaires are used to assess participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV criteria for Major Depression
- •African-American or Caucasian ethnic background (both parents and 3 out of 4 grandparents)
排除标准
- •Schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression, or bipolar disorder
- •Current drug abuse or history of drug abuse within the past 6 months
- •Unstable medical or neurological conditions that interfere with the treatment of depression
- •Allergy to citalopram
- •Failure to respond to adequate citalopram drug trial (40 mg for at least 6 weeks)
- •Seizure disorder
- •Pregnancy
- •Psychotropic medications, including antidepressants and neuroleptics
- •Suicidal ideation or other safety issues
- •Fluoxetine (Prozac) or MAOIs (Nardil, Parnate) in the last 2 months
- •Ongoing cognitive behavioral therapy or intensive psychotherapy. General talk therapy is acceptable
研究组 & 干预措施
Citalopram
All subjects receive an FDA approved dose of Citalopram
干预措施: Citalopram (Drug)
结局指标
主要结局
Hamilton Rating Scale for Depression
时间窗: Measured weekly for 11 weeks
次要结局
未报告次要终点