White Matter Structure and Response to Treatment With Antidepressants: a Study of Desvenlafaxine in Major Depression. A Pilot Study
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Anisotropy
研究概览
简要总结
Subjects with major depression will be evaluated and intensively characterized through questionnaires, computerized cognitive evaluation and laboratory investigations. Magnetic resonance imaging will be used to document baseline white matter structure. subjects will then receive desvenlafaxine which will be adjusted as clinically indicated. After 16 weeks the evaluations will be repeated.
详细描述
40 subjects will be included in the study. Diagnosis will be confirmed by MINI. Participants will be characterised using questionnaires, pain threshold, cognition, facial expression recording and MRI. Desvenlafaxine will be initiated at 50mg AM. At week 8 Desvenlafaxine may be increased to 100mg as clinically indicated. Measures will be repeated at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major depression
- •Age 18 to 55
- •Hamilton grater or equal to 20
排除标准
- •Major neurologic disorder
- •Major cardiovascular disorder
- •Unstable medical condition
- •Significant psychiatric co-morbidity
- •Current substance dependance
- •Pregnancy or lactation -Treatment resistance as defined by nonresponse to 2 or more antidepressant treatments (adequate dose and duration) -
结局指标
主要结局
Anisotropy
时间窗: 16 weeks
Degree of anisotropy will be measured at baseline and 16 weeks and correlated to remission status
次要结局
- cognitive measures(16 weeks)
- Pain threshold(16 weeks)
研究者
Valerie Tourjman
Associate director of clinical research
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal