Prevention of Recurrence in Depression With Drugs and CT
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 452
- 试验地点
- 3
- 主要终点
- Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD)
研究概览
简要总结
This study will determine whether the addition of Cognitive Therapy (CT) to antidepressant medication (ADM) enhances treatment for depression. This study will also test whether the addition of CT to ADM will prevent recurrences of depression after therapy is over.
详细描述
It is commonly believed that the combination of ADM and psychotherapy is more effective in treating depression than either treatment alone. Data indicate that CT enhances the initial effects of ADM, but little research has been conducted to determine whether prior exposure to CT prevents the onset of new depressive episodes. This study will determine the effectiveness of adding CT to ADM for the treatment of depression.
Participants are randomly assigned to receive either ADM alone or ADM plus CT for up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue cognitive therapy; all recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent or chronic major depressive disorder
排除标准
- •Current diagnosis of psychotic affective disorder
- •History of nonaffective psychotic disorder
- •Substance dependence last three months requiring detox
- •Schizotypal, antisocial, or borderline personality disorder
研究组 & 干预措施
Cognitive therapy plus medications
Participants will receive antidepressant medication plus cognitive therapy
干预措施: Cognitive Therapy (Behavioral)
Cognitive therapy plus medications
Participants will receive antidepressant medication plus cognitive therapy
干预措施: Medications (Drug)
Medications alone
Participants will receive maintenance of antidepressant medication alone
干预措施: Medications (Drug)
结局指标
主要结局
Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD)
时间窗: Through month 18 of treatment
Remission defined as four consecutive weeks of LIFE Problem Symptom Rating (PSR) values of 2 or less and HRSD scores of 8 or less for four consecutive weeks (with partial remission defined as LIFE PSR values of 3 or less and HRSD scores of 12 or less after month 12 only)
Number of Participants in Recovery According to the LIFE and HRSD
时间窗: Through 36 months of treatment
Six consecutive months following remission without relapse (two weeks of elevated LIFE PSR scores of 4 or more and HRSD scores of 14 and above)
Number of Participants in Recurrence According to the LIFE and HRSD
时间窗: Measured up to Month 36 from recovery
Recurrence defined as two consecutive weeks of elevated LIFE PSR scores of 5 or above and HRSD scores of 16 or above (three weeks during period of medication withdrawal)
次要结局
未报告次要终点
研究者
Steven Hollon
Professor of Psychology
Vanderbilt University