Treatment Prediction in Adolescent and Adult Depression
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Reduction in depressive symptoms
研究概览
简要总结
This study will determine whether there are age-related differences in the body systems controlling sleep and stress hormone patterns. This study will also determine whether the differences in sleep and hormone patterns between depressed adolescents and adults are associated with differences in their response to antidepressant treatment.
详细描述
Adolescent depression is a serious public health concern that may lead to functional disability and death. The problems associated with the condition may continue into adulthood; therefore, early identification and effective treatment of adolescent depression is critical. Studies indicate that depressed adolescents experience greater variations in sleep and hormone patterns than depressed adults. These variations may influence responses to antidepressant treatment. This study will examine the mechanisms underlying developmental differences in sleep and hormone patterns to develop a strategy for identifying adolescents and adults who could benefit from antidepressant treatment.
This study will last approximately 10 weeks. At study start, participants will wear an activity monitor on their wrist and keep track of their nightly sleep schedule to establish baseline measures. This will continue for 2 weeks. During the second week of wearing this watch the participant will be asked to come in for a sleep study. This study will consist of two initial nights in the sleep lab and then two more nights in the lab a week later. Participants will be able to leave during the day. Upon completing the sleep assessment, participants will receive bupropion twice daily for 8 weeks. Upon completion of this 8-week treatment, participants will be interviewed to assess the effectiveness of the treatment. One follow-up meeting will occur 6 months post-treatment.
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
- 12 Years 至 50 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of major depressive disorder and/or dysthymic disorder
排除标准
- •Current treatment with antidepressant drugs
- •Major medical illness
- •Diagnosis of anorexia nervosa or manic-depressive illness
- •Pregnancy
研究组 & 干预措施
1
Participants will receive bupropion in the sleep study
干预措施: Bupropion (Drug)
结局指标
主要结局
Reduction in depressive symptoms
时间窗: Measured at Week 8 and Month 6 post-treatment
次要结局
- Improvement in quality of life(Measured at Week 8 and Month 6 post-treatment)
研究者
Uma Rao
Principal investigator
Meharry Medical College
