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临床试验/NCT00227968
NCT00227968已完成4 期

Maintenance Therapies in Bipolar Disorder

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 181 人开始时间: 1995年3月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
181
试验地点
2
主要终点
Time to stabilization in the acute phase and time to recurrence in the maintenance phase

研究概览

简要总结

This study will evaluate the effectiveness of interpersonal and social rhythm therapy (IPSRT) versus clinical status and symptom response therapy (CSSRT) in reinforcing the treatment of bipolar disorder in individuals who are currently undergoing medication treatment for the disorder.

详细描述

Bipolar disorder is a serious medical illness that causes shifts in a person's mood, energy, and ability to function. These changes are drastic, and can result in damaged relationships, poor job or school performance, and suicide. Bipolar disorder is also known as manic-depressive disorder because it is characterized by episodes of mania and depression. Some signs and symptoms of a manic episode include the following: increased energy, activity, and restlessness; excessively "high," overly good mood; and extreme irritability. Some signs and symptoms of a depressive episode include the following: sad, anxious, or empty mood; feelings of hopelessness or pessimism; and feelings of guilt, worthlessness, or helplessness. Bipolar disorder is most effectively treated using a strategy that combines medication and psychosocial treatment. This study will evaluate the effectiveness of IPSRT versus CSSRT in reinforcing the treatment of bipolar disorder in individuals who are currently undergoing maintenance medication treatment for the disorder.

Participants in this open-label study will be randomly assigned to one of two treatment strategies: IPSRT or CSSRT. All participants will attend study visits once a week until they have been stable for 4 weeks (acute phase). At this point, they will attend study visits every other week for 12 weeks (continuation phase), and then once a month for 18 months or until another depressive or mixed episode occurs (maintenance phase). Participants who experience a recurrence will be treated with medication and the type of therapy they were assigned upon study entry (IPSRT or CSSRT). These participants will continue to be followed for a period of time equivalent to their remainder of time in the study had they not experienced a recurrence. Outcomes will be measured at Week 12 of the continuation phase and Week 18 of the maintenance phase.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of bipolar disorder
  • Currently in the third episode of mania or major depression
  • History of one other episode of major depression within 5 years prior to study entry

排除标准

  • Currently in the first episode of mania or schizo-affective disorder (manic type)
  • Rapid cycling drug or alcohol abuse
  • Unstable medical illness
  • Index episode caused by medically prescribed drugs

结局指标

主要结局

Time to stabilization in the acute phase and time to recurrence in the maintenance phase

次要结局

  • Measured at Week 12 of the continuation phase and Week 18 of the maintenance phase: Somatic Symptoms Checklist

研究者

申办方类型
Other

研究点 (2)

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