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临床试验/NCT00057551
NCT00057551已完成4 期

CBASP Augmentation for Treatment of Chronic Depression

Weill Medical College of Cornell University8 个研究点 分布在 1 个国家目标入组 491 人开始时间: 2003年4月最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

CBASP

Experimental

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

Active Comparator

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

Active Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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