Treatment of Depression Concurrent With Alcohol Abuse, an Extension of Alcohol Use Disorder in Patients Treated for Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 674
- 试验地点
- 1
- 主要终点
- Quick Inventory of Depression- Self Report 16
研究概览
简要总结
The purpose of this study is to determine if having an alcohol use disorder affects recovery from depression, and also whether recovery from depression in patients who have alcohol use disorders is also accompanied by improvement in the alcohol use disorder.
详细描述
This is an extension of the multi-site sub-study of the National Institute of Mental Health (NIMH) protocol, Sequenced Treatment Alternatives to Relieve Depression (STAR*D), which utilized the infrastructure of the Depression Trials Network to enroll 4,000 subjects diagnosed with Major Depressive Disorder. These subjects initially received 12 weeks of treatment with the anti-depressant citalopram. The thrust of this study was to test treatment algorithms for those subjects who did not respond adequately to initial monotherapy treatment with citalopram or who were unable to tolerate it. The parent protocol also contained several ancillary studies, including a sub-study of subjects with co-morbid alcohol use disorders, which enrolled 130 subjects. Treatment response data was collected at multiple intervals during the 12 week treatment period on depressed subjects both with and without a co-morbid alcohol use disorder.
Comparison: Treatment outcome measures of subjects diagnosed with Major Depressive Disorder will be compared to treatment outcome measures of subjects diagnosed with Major Depressive Disorder and an Alcohol Use Disorder following the initial 12 week citalopram treatment period. This comparison will show whether having a co-morbid alcohol use disorder affects recovery from depression. In addition, alcohol use data of depressed subjects who demonstrated a positive response to anti-depressant treatment will be compared with alcohol use data of depressed subjects who did not have positive treatment outcomes. This comparison will show whether recovery from depression is associated with improvement in the co-morbid alcohol use disorder.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 否
入选标准
- •Males and females aged 18- 75 years
- •Meets criteria for Non-psychotic Major Depression
- •Signs informed consent and able to comply with study
- •Hamilton Depression Scale (HAM-D 17) >14
- •Endorses any drinking items on Short Michigan Alcoholism Screening Test
排除标准
- •Pregnant women and women of childbearing potential who are not using a medically accepted means of contraception.
- •Women who are breast feeding
- •Patients with suicidal ideation that require hospitalization
- •Patients with unstable physical disorders
- •Patients with a history of allergy to citalopram or history of non-response to an adequate dose of citalopram in the current episode.
- •Patients meeting criteria for the following diagnoses as a primary condition: Schizophrenia, Schizoaffective Disorder, Bipolar I, II, and Not Otherwise Specified, Anorexia nervosa, Bulimia, Obsessive Compulsive Disorder
- •Patients abusing substances which require detoxification. American Society for Addiction Medicine standards for detoxification will be used (Level III.7). Patients with substance abuse who are in substance abuse treatment will be eligible.
研究组 & 干预措施
Alcohol and major depression, citalopram
Patients with alcohol use disorder and major depression, treated with citalopram tablets, 20-60 mg, once daily, for 12 weeks
干预措施: citalopram (Drug)
Major Depression, citalopram
Patients with major depression, treated with citalopram tablets 20-60 mg daily, for 12 weeks
干预措施: citalopram (Drug)
结局指标
主要结局
Quick Inventory of Depression- Self Report 16
时间窗: study exit visit, at Week 12
Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit Scale range: Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16 Total scoring ranges (0-48): 0-5, No Depression Likely 6-10, Possibly Mildly Depressed 11-15, Moderate Depression 16-20, Severe Depression 21 or Over, Very Severe Depression
次要结局
- Timeline Follow Back (TLFB) Average Drinks Per Drinking Day(30 days)
- Timeline Follow Back (TLFB) Maximum Drinks Per Drinking Day(30 days)
- Quantitative Substance Use Inventory ((SUI)(30 days)
- Timeline Follow Back (TLFB) Drinking Days Per 30 Days(30 days)
