DEPRESSION AND HEALTH OUTCOMES IN REFRACTORY EPILEPSY

难治性癫痫的抑郁和健康结果

• 批准号: 7026780
• 负责人: FRANK G GILLIAM
• 金额: $ 32.14万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-08-24 至 2006-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7026780
• 关键词: anticonvulsants; clinical depression; clinical trials; cognitive behavior therapy; comorbidity; drug interactions; epilepsy; human subject; human therapy evaluation; mental disorder chemotherapy; patient oriented research; quality of life; sertraline; therapy compliance

DESCRIPTION (provided by applicant): Epilepsy is the most prevalent disabling neurologic illness, and depression is the most frequent comorbid condition associated with epilepsy. The prevalence of depression is 20-50 percent in patients with uncontrolled seizures. This combination affects between 250,000 and 450,000 people in the United States. Our recent clinical studies have shown that depression is a strong predictor of function and health outcomes in epilepsy. Despite the marked adverse effects and high prevalence of depression in epilepsy, most affected patients are not treated. This complacency toward treatment may result from insufficient use of diagnostic screening, the widespread belief that antidepressants lower the seizure threshold, or lack of demonstrated efficacy in the only controlled trial of antidepressant medications in epilepsy. The broad aims of this study are to define the benefits of antidepressant treatment on mood, compliance, and health outcomes in epilepsy patients with comorbid major depression. Based on our prior clinical and research experience, we hypothesize that 1) pharmacotherapy or psychotherapy will reduce depression and improve health-related quality of life in patients with refractory epilepsy, 2) antiepileptic medication compliance will improve after reduction of depression, 3) seizure frequency will not significantly increase during treatment with a selective seratonin reuptake inhibitor compared to psychotherapy, and 4) depression and antiepileptic medication toxicity are stronger predictors of health-related quality of life than seizure frequency or severity in patients with refractory epilepsy. The hypotheses will be tested through a randomized trial comparing the efficacy of sertraline (n=127) to cognitive behavior therapy (n=127) for mood and health outcomes in patients with refractory epilepsy and depression. Reliable and valid measures will be used to assess depression and health-related quality of life. Electronic, computer-assisted monitoring will determine compliance. Multivariate repeated-measures analyses will be used to determine the interrelationships of treatment, mood, antiepileptic medication toxicity, seizure frequency and severity, compliance and health-related quality of life. We anticipate that dissemination of the results of a positive study will support the modification of the current model of intervention for epilepsy from predominantly seizure reduction to a more comprehensive approach that includes assessment and treatment of depression

描述（由申请人提供）：癫痫是最常见的残疾 神经系统疾病，抑郁症是最常见的合并症 与癫痫有关。抑郁症的患病率为 20-50% 癫痫发作不受控制的患者。该组合影响 250,000 以及美国的 450,000 人。我们最近的临床研究表明 抑郁症是功能和健康结果的有力预测因子 癫痫。尽管有明显的副作用和抑郁症患病率很高 对于癫痫症，大多数受影响的患者都没有得到治疗。这种自满情绪 治疗可能是由于诊断筛查使用不足造成的， 人们普遍认为抗抑郁药会降低癫痫发作阈值，或缺乏 在唯一的抗抑郁药对照试验中证明了疗效 治疗癫痫的药物。这项研究的主要目标是定义 抗抑郁治疗对情绪、依从性和健康结果的益处 患有严重抑郁症的癫痫患者。根据我们之前的 临床和研究经验，我们假设 1) 药物治疗或 心理治疗将减少抑郁症并改善与健康相关的生活质量 难治性癫痫患者，2）抗癫痫药物依从性 抑郁症减少后会改善，3）癫痫发作频率不会 选择性血清素再摄取治疗期间显着增加 与心理治疗相比的抑制剂，4) 抑郁症和抗癫痫药 药物毒性是健康相关生活质量的更强预测因素 与难治性癫痫患者的癫痫发作频率或严重程度相比。这 假设将通过随机试验进行检验，比较以下方法的功效 舍曲林 (n=127) 与认知行为疗法 (n=127) 治疗情绪和健康 难治性癫痫和抑郁症患者的结果。可靠且 将使用有效的措施来评估抑郁症和健康相关的质量 生活。电子计算机辅助监控将确定合规性。 将使用多变量重复测量分析来确定 治疗、情绪、抗癫痫药物毒性的相互关系， 癫痫发作频率和严重程度、依从性以及与健康相关的生活质量。 我们预计积极研究结果的传播将 支持修改当前的癫痫干预模式 主要是减少癫痫发作采取更全面的方法，包括 抑郁症的评估和治疗