NCT00191685已完成3 期
Duloxetine in the Treatment of Melancholic Depression: An 8-Week Open-Label Dose Study
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 24
- 主要终点
- To generate data to compare the proportion of outpatients with major depressive disorder with melancholic features who responded to duloxetine at a given daily dose after initially not responding to duloxetine 60mg once daily for 4 weeks.
研究概览
简要总结
The purpose of this study is to determine the optimal treatment strategy for MDD patients with melancholic features who do not respond to a standard daily dose. This study will allow investigators to mimic standard clinical practice. During the first 2 weeks of treatment, clinical evaluation of individual patient tolerability and efficacy will enable the dose of duloxetine to be adjusted. Patients allocated to the Flex group may have their daily dose of duloxetine adjusted in the attempt to elicit a clinical response.
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
- 否
入选标准
- •Have a diagnosis of major depression with melancholic features, as defined by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition [DSM-IV] criteria.
- •Experienced their first episode of major depression prior to age
- •Have a HAMD17 total score of less than or equal to 20 at Visits 1 and
- •Test negative for a urine pregnancy test at Visit 1 (females).
- •Agree to use medically acceptable and reliable means of birth control during the study, as determined by the investigator (females of child-bearing potential, not surgically sterilized and between menarche, and one year post-menopausal).
排除标准
- •Have any current and primary Axis I mood disorder other than MDD, including, but not limited to, dysthymia, seasonal affective disorder or psychotic depression.
- •Have a current episode of major depression that has failed to respond to two or more courses of antidepressant therapy or, in the judgment of the investigator, meets criteria for treatment-resistant depression
- •Are at serious suicidal risk as determined by the investigator.
- •Have a serious medical illness or clinically significant laboratory abnormalities that, in the judgment of the investigator, are likely to require medication/ intervention/ hospitalization during the course of the study.
- •Had treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 2 or potential need to use a MAOI during the study or within 14 days of discontinuation of study drug.
结局指标
主要结局
To generate data to compare the proportion of outpatients with major depressive disorder with melancholic features who responded to duloxetine at a given daily dose after initially not responding to duloxetine 60mg once daily for 4 weeks.
次要结局
- To compare outpatients with major depressive disorder with melancholic features who achieved remission after treatment with duloxetine;Collect data on the safety of duloxetine.
研究者
研究点 (24)
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