Prophylactic Cognitive Therapy for Depression

抑郁症的预防性认知疗法

• 批准号: 6867714
• 负责人: ROBIN B JARRETT
• 金额: $ 71.98万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-03 至 2006-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6867714
• 关键词: behavioral /social science research tag; clinical research; clinical trial phase III; clinical trials; cognitive behavior therapy; combination therapy; fluoxetine; human subject; human therapy evaluation; major depression; mental disorder chemotherapy; patient oriented research; relapse /recurrence

DESCRIPTION (provided by applicant): In this application for competing renewal, we request funding for five years to complete the first adequately powered, placebo (PBO) controlled randomized clinical trial evaluating the efficacy of continuation phase cognitive therapy (C-CT) and fluoxetine (FLX) in outpatients with recurrent Major Depressive Disorder (MDD) who are at high risk for relapse. The trial is being conducted at The University of Texas Southwestern Medical Center and The University of Pittsburgh School of Medicine. "Higher risk" is defined by incomplete remission during the final weeks of acute phase CT, while "lower risk" is defined as a complete and stable remission. This trial has great public health significance because it will help clinicians to identify those patients at greatest risk for relapse who warrant longer courses of treatment. Such empirically-based decision rules could lower the cost of care by providing enough treatment for a depressive episode without either "over-treating" patients at lower risk or "under-treating" those patients at higher risk. This study is the first to evaluate continuation phase pharmacotherapy (FLX) after incomplete remission with acute phase CT. Further, the pharmacotherapy group will permit tests of mode-specific vs. non-specific therapeutic activity. Dependent variables measure response, relapse, recurrence, remission, and recovery. Blind evaluations and survival analyses are planned. A total of 288 new patients will be enrolled in years 06-09 of this competing renewal (Total n=724). Based on results of a planned (blinded) interim analysis, the study will either continue to completion as a three-arm trial (105 patients per arm) or will shift allocation of subjects from year 06 onward into the two active treatment arms (129 patients per arm). This modification has been made to maximize the statistical power for comparisons of C-CT and FLX therapies, without undermining the test efficacy of C-CT versus PBO. Based on results obtained to date (i.e., C-CT 8% relapse, PBO estimate approximately 24% relapse), the interim analysis will determine if more subjects are needed to answer the primary question (i.e., C-CT versus control) or if efforts can be shifted to comparing the relative merits of FLX relative to C-CT. Specifically, if C-CT is significantly more effective than PBO at the end of "Phase 1," then FLX must also have therapeutic activity.

描述（由申请人提供）：在本竞争性续展申请中，我们请求提供五年资金，以完成第一个充分动力的安慰剂 (PBO) 对照随机临床试验，评估持续期认知治疗 (C-CT) 和氟西汀 (FLX) 对复发性重度抑郁症 (MDD) 复发风险高的门诊患者的疗效。该试验正在德克萨斯大学西南医学中心和匹兹堡大学医学院进行。 “较高风险”的定义是急性期 CT 的最后几周内不完全缓解，而“较低风险”的定义是完全且稳定的缓解。这项试验具有重大的公共卫生意义，因为它将帮助临床医生识别那些复发风险最大、需要更长疗程的患者。这种基于经验的决策规则可以通过为抑郁发作提供足够的治疗来降低护理成本，而不会“过度治疗”风险较低的患者或“治疗不足”风险较高的患者。这项研究是第一个评估急性期 CT 不完全缓解后的持续期药物治疗 (FLX) 的研究。此外，药物治疗组将允许测试模式特异性与非特异性治疗活性。因变量衡量反应、复发、复发、缓解和恢复。计划进行盲评估和生存分析。本次竞争更新的 06-09 年将总共招募 288 名新患者（总计 n=724）。根据计划（盲法）中期分析的结果，该研究将继续作为三组试验（每组 105 名患者）完成，或者将从 06 年开始将受试者分配到两个积极治疗组（每组 129 名患者）。这一修改是为了最大限度地提高 C-CT 和 FLX 疗法比较的统计功效，而不损害 C-CT 与 PBO 的测试功效。根据迄今为止获得的结果（即 C-CT 复发率为 8%，PBO 估计复发率约为 24%），中期分析将确定是否需要更多受试者来回答主要问题（即 C-CT 与对照），或者是否可以将工作转移到比较 FLX 相对于 C-CT 的相对优点。具体来说，如果在“第一阶段”结束时 C-CT 明显比 PBO 更有效，那么 FLX 也必须具有治疗活性。