A Pilot Study of Duloxetine in Psychological Resilience and Its Correlation With Blockade of Serotonin and Norepinephrine Transporter
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in Connor Davidson Resilience Scale (CD-RISC) From Baseline to 8 Weeks
研究概览
简要总结
The purpose of this study is to explore benefits of duloxetine in enhancing psychological resilience and to understand the relevance of inhibiting of both serotonin (5HT) and norepinephrine (NE)to therapeutic responses.
详细描述
This is an investigator-initiated, single-site study consisting of 8 weeks of open-label, fixed-dose treatment with duloxetine (30mg-60mg/day) in patients with Major Depressive Disorder (MDD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •ages 18-65
- •primary diagnosis of MDD based on Diagnostic Standard Manual(DSM-IV) criteria and assessed by the MINI International Neuropsychiatric Interview
- •Montgomery-Asberg Depression Rating Scale (MADRS)score of at least 20 on baseline
- •Minimum Clinical Global Impressions of Severity (CGS) severity score of 4
- •Ability to provide written consent form
- •A negative serum pregnancy test for women of childbearing potential
排除标准
- •Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder or cognitive disorder due to a general medical condition
- •History of substance abuse or dependence within the last 6 months
- •Suicide risk or serious suicide attempt within the last year
- •Clinically significant medical condition or laboratory abnormality
- •Women of childbearing potential who are unwilling to practice an acceptable method of contraception
- •Subjects needing concurrent use of psychotropic medications
- •History of sensitivity to duloxetine
- •History of failure to respond to an adequate trial of duloxetine (at least 60mg/day for 4 weeks)
- •Subjects taking monoamine oxidase inhibitors (MAOIs)
- •Subjects with uncontrolled narrow-angle glaucoma
研究组 & 干预措施
1
Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
干预措施: Duloxetine (Drug)
结局指标
主要结局
Change in Connor Davidson Resilience Scale (CD-RISC) From Baseline to 8 Weeks
时间窗: baseline and 8 weeks
CD-RISC has been psychometrically validated, studied in the general population, as well as in clinical samples. Changes in CD-RISC score have been found to be sensitive to the effect of treatment, and impaired resilience has been demonstrated in subjects with depression relative to normal controls using this scale (Connor and Davidson, 2003). The total score ranges from 0-100, with higher scores indicating greater resilience.
次要结局
未报告次要终点