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临床试验/NCT00106197
NCT00106197Unknown4 期

Treatment Prediction in Adolescent and Adult Depression

Uma Rao1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2004年6月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

发起方
Uma Rao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Uma Rao

Principal investigator

Meharry Medical College

研究点 (1)

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