NCT01797380终止4 期
A Double-Blind, Placebo-Controlled Trial Examining the Efficacy of Escitalopram Oxalate Upon Depressive Symptoms and Fatigue in HIV Seropositive Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Reduction in Depressive Symptoms
研究概览
简要总结
To determine the efficacy of escitalopram in treating depression in HIV seropositive women.
详细描述
To determine the efficacy of escitalopram in treating depression in HIV seropositive women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of major depression based on DSM-IV criteria;
- •age 18-70 years;
- •Greater than 15 on MADRS for severity of depression;
- •HIV seropositive;
- •no new antiviral medications over the past 2 months;
- •involved in active treatment for HIV disease,
- •negative serum pregnancy test
- •Those subjects who are actively being treated for depression but show no improvement as defined by self-reported failure to improve with current treatment or residual depression as demonstrated by a MADRS of 15 or greater will be asked to participate in the study as well.
排除标准
- •The presence of an active and significant psychiatric disease other than Major Depressive Disorder as diagnosed on MINI in the last 3 months;
- •meeting DSM-IV criteria for an Axis I disorder within the last three months, or meeting criteria for substance abuse within the last 12 months;
- •current pregnancy or lactation if breast feeding;
- •history of hypersensitivity, intolerance, or contraindication to LEX;
- •baseline creatinine of 2.5 or greater;
- •patients taking anticoagulants;
- •history of diagnosed gastric or duodenal ulcer;
- •history within past year of bleeding or clotting diathesis;
- •lifetime history of myocardial infarction or cerebrovascular accident;
- •history of surgery within the past 3 months;
- •inability to follow study procedures or complete the study;
- •the use of any antidepressant medications within 5 half-lives of randomization;
- •women of child-bearing potential who will not agree to use approved means of birth control during the trial;
- •other reason that the primary investigator believes that the subject will be unable to complete trial or has medical/psychiatric contraindications to the trial.
- •Individuals who are currently being treated for depression and show significant improvements in their depression such that discontinuing their current antidepressant therapy would likely have negative clinical consequences will be excluded from participating in this study.
- •Individuals who are or become suicidal will be excluded from this study.
研究组 & 干预措施
Sugar Pill
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Active Drug
Active Comparator
Escitalopram tablet, 10mg, daily, 9 weeks.
干预措施: Escitalopram (Drug)
结局指标
主要结局
Reduction in Depressive Symptoms
时间窗: 9 weeks.
Depressive symptoms were assessed by questionaire at baseline and finally at the end of the study at 9 weeks.
次要结局
未报告次要终点
研究者
研究点 (1)
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