CBASP Augmentation for Treatment of Chronic Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 491
- 试验地点
- 8
- 主要终点
- Remission
研究概览
简要总结
This 24-week study, with a 12-month follow up period, will compare the effectiveness of antidepressant medication alone to the combination of psychotherapy and antidepressant medication in patients with chronic depression.
详细描述
Chronic depression affects approximately 5% of adults in the United States and is associated with significant functional impairment and high health care utilization. The combination of drug treatment and psychotherapy may be most effective in treating depression. This study will determine the effects of adjunctive psychotherapy in depressed patients who have failed to respond or have responded only partially to an initial trial medication.
Participants receive an initial trial of antidepressant medication for 8 to 12 weeks. Participants who continue to have depressive symptoms are randomly assigned to add Cognitive Behavioral Analysis System of Psychotherapy (CBASP) or supportive therapy to their medication regimens or to continue pharmacotherapy alone for an additional 12 weeks. Assessments are made at 6 and 12 months post-treatment.
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
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CBASP
Cognitive Behavioral System of Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)
干预措施: CBASP (Behavioral)
Brief Supportive Psychotherapy
Brief Supportive Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)
干预措施: Brief Supportive Psychotherapy (Behavioral)
Medication Only
Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine
干预措施: Medication Only (Drug)
结局指标
主要结局
Remission
时间窗: 12 weeks
Hamilton Depression Scale (HAM-D)\<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits
次要结局
未报告次要终点
