Acute Pharmacotherapy of Psychotic Depression

精神病性抑郁症的急性药物治疗

• 批准号: 7117435
• 负责人: BARNETT MEYERS
• 金额: $ 53.94万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-06 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7117435
• 关键词: adult human (21+); age difference; aging; antidepressants; antipsychotic agents; cerebrovascular disorders; clinical research; clinical trials; cognition; combination chemotherapy; cooperative study; disease /disorder proneness /risk; drug adverse effect; drug tolerance; functional ability; human old age (65+); human subject; human therapy evaluation; longitudinal human study; major depression; mental disorder chemotherapy; patient oriented research; psychosis; remission /regression; serotonin inhibitor; sertraline; adult human (21+); age difference; aging; antidepressants; antipsychotic agents; cerebrovascular disorders; clinical research; clinical trials; cognition; combination chemotherapy; cooperative study; disease /disorder proneness /risk; drug adverse effect; drug tolerance; functional ability; human old age (65+); human subject; human therapy evaluation; longitudinal human study; major depression; mental disorder chemotherapy; patient oriented research; psychosis; remission /regression; serotonin inhibitor; sertraline

DESCRIPTION (provided by applicant): Psychotic depression (PD) is a severe disorder that is present in 20% of mixed-age inpatients and in more than 40% of elderly inpatients hospitalized for the treatment of major depression. Acutely, PD is associated with a greater level of depression severity, functional impairment, and resistance to antidepressant treatment than nonpsychotic depression. Longitudinally, PD is associated with a greater likelihood of recurrence, a shorter symptom-free interval, greater disability, and an increased long-term risk of suicide. Among elderly patients, PD has also been associated with a high one year mortality rate. Although electroconvulsive therapy (ECT) is a highly effective treatment for PD, pharmacotherapy is more easily administered and generally preferred by many patients and psychiatrists. Furthermore, ECT is less available to, and less frequently used by minority ethnic groups, patients with low incomes, and those residing in rural areas. In the early 1980's a landmark NIMH randomized controlled trial demonstrated that a combination of high doses of both a tertiary amine tricyclic and a conventional antipsychotic was more efficacious than monotherapy with either medication. However, this combination has been associated with a high incidence of significant side effects, particularly in elderly patients. This collaborative U01 project builds on findings from the four sites principal investigators and others. Based on preliminary studies suggesting that sertraline, a serotonin-reuptake-inhibitor (SSRI) and olanzapine, an atypical antipsychotic, may be effective in the acute treatment of PD, this study uses a two-armed randomized double-blind parallel-group design to compare the efficacay and tolerability of combining these two medications to olanzapine alone. By blocking recruitment of subjects age greater than or equal to 60 on a 1:1 basis the study will determine the relationship between older age and remission, time to remission and tolerability. A 12-week acute phase efficacy study is followed by a 20-week continuation trial during which subjects who achieved partial remission enter a placebo-controlled augmentation trial that is based on their initial assignment. Remitted subjects are also followed during stabilization to determine the stability of remission and predictors of clinical and functional deterioration.

描述（由申请人提供）：精神病抑郁症（PD）是一种严重的疾病，存在于20％的混合年龄住院患者，以及40％以上的老年住院患者住院治疗重力抑郁症。急性，PD与非精神抑郁症相比，与抑郁症的严重程度更高，功能障碍和对抗抑郁药治疗的抗性有关。纵向，PD与复发的可能性更大，无症状间隔，更大的残疾和自杀的长期风险增加有关。在老年患者中，PD还与高死亡率有关。尽管电击疗法（ECT）是PD高效的治疗方法，但许多患者和精神科医生通常更容易治疗药物治疗。此外，ECT的使用量较低，少数族裔，低收入患者以及居住在农村地区的患者的使用量较低。在1980年代初期，具有里程碑意义的NIMH随机对照试验表明，高剂量的三级胺三环和常规抗精神病药的结合比单药物疗法更有效。但是，这种组合与重大副作用的高发生率有关，尤其是在老年患者中。 该协作U01项目基于四个站点主要研究人员和其他网站的发现。基于初步研究，提示塞塔林，血清素 - 抑制剂抑制剂（SSRI）和奥氮平是一种非典型抗精神病药，可能在PD的急性治疗中有效，该研究使用两臂的随机随机双脑线平行组设计，以比较这些两种药物对这些两种药物的耐受性，以比较这些两种药物。通过阻止大于或等于60岁的受试者的招募，研究将确定年龄与缓解，缓解时间和耐受性之间的关系。一项为期12周的急性期有效性研究之后进行了为期20周的延续试验，在此期间，获得部分缓解的受试者进入了一项基于其初始分配的安慰剂对照的增强试验。在稳定期间，还遵循了恢复受试者，以确定缓解的稳定性和临床和功能恶化的预测指标。