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临床试验/NCT00227981
NCT00227981已完成不适用

Maintenance Psychotherapies in Recurrent Depression: Study II

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 93 人开始时间: 1995年3月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
2
主要终点
Score on the Hamilton Rating Scale for Depression (measured at Month 24)

研究概览

简要总结

This study will evaluate the effectiveness of maintenance interpersonal psychotherapy (IPT) in preventing relapse of depression in women who have required combined psychotherapy and pharmacotherapy treatment to obtain a remission of depression symptoms.

详细描述

Depression is a serious medical illness that can recur more than once in a person's lifetime. Effective treatment methods are needed to maintain a state of remission in people who have had prior episodes of depression. IPT is a brief and highly structured type of psychotherapy that addresses interpersonal issues associated with depression. Previous studies have shown that it is an effective method for treating depression. This study will evaluate the effectiveness of maintenance ITP in preventing relapse of depression in women who have required combined psychotherapy and pharmacotherapy treatment to obtain remission of depressive symptoms.

Participants in this open label study will be recruited from a previous study, "Maintenance Psychotherapy in Recurrent Depression: Study I." In this study participants will initially receive weekly sessions of IPT as well as medication treatment with fluoxetine. Any participants who do not reach remission of depressive symptoms after 6 weeks will be given other standard treatments for depression. Once remission of depressive symptoms is reached, participants will continue receiving weekly IPT and fluoxetine treatment for 20 weeks. After 20 weeks, fluoxetine treatment will be discontinued, and all participants will receive IPT alone for 6 weeks before entering the maintenance phase of the study. Upon entrance into this phase, participants will be randomly assigned to receive IPT weekly, biweekly, or monthly for 18 months. Functioning and depressive symptoms will be assessed at Month 24.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Met all entry criteria for the parent study, "Maintenance Psychotherapy in Recurrent Depression, Study I"
  • Began IPT as outlined in the parent study
  • Demostrated compliance with IPT sessions during the parent study
  • Exhibits less than a 50% reduction in score on the Hamilton Rating Scale for Depression after 12 weeks of psychotherapy or fails to meet stabilization criteria after 24 weeks of psychotherapy during the parent study

排除标准

  • Any unstable medical illness

结局指标

主要结局

Score on the Hamilton Rating Scale for Depression (measured at Month 24)

次要结局

  • Score on the Beck Depression Inventory
  • Score on the Global Assessment of Functioning (measured at Month 24)

研究者

申办方类型
Other

研究点 (2)

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