Bipolar II Depression: Lithium, SSRI or the Combination

双相 II 型抑郁症：锂盐、SSRI 或组合

• 批准号: 7874652
• 负责人: SUSAN L MCELROY
• 金额: $ 30.08万
• 依托单位: UNIVERSITY OF CINCINNATI
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-07-01 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7874652
• 关键词: Acute; Adverse effects; Adverse event; Affect; Antidepressive Agents; Attention; Bipolar Disorder; Blood; Client satisfaction; Clinical; Clinical Trials; Costs and Benefits; Data; Data Analyses; Depressed mood; Diagnostic; Disease; Double-Blind Method; Effectiveness; Frequencies; Grant; Incidence; Lithium; Major Depressive Disorder; Manic; Mental Depression; Mood stabilizers; Moods; Outcome; Patients; Pharmaceutical Preparations; Phenotype; Randomized; Recommendation; Relative (related person); Research; Risk; Safety; Selective Serotonin Reuptake Inhibitor; Sertraline; Severities; Statistical Methods; Testing; Therapeutic; Time; comparative efficacy; depressive symptoms; design; experience; hypomania; response; satisfaction; severe mental illness; standard of care; suicidal risk; treatment response; treatment strategy; treatment trial; trial comparing

DESCRIPTION (provided by applicant): This grant proposes to explore the optimal treatment approach to depression in the patient with bipolar II disorder (BDII). BDII represents a critically understudied and important serious mental illness and is characterized by periods of major depression and periods of hypomania. There is now clear recognition of the stability of this diagnostic phenotype of bipolar disorder over time. Further research has revealed that the depressive symptoms in BDII occur frequently and the consequences of this can be severe, as the suicide risk is suggested to be higher than that in patients with BDI. The standard of care in treating depressed BDII patients is to use a mood stabilizer alone or a mood stabilizer and an antidepressant. However, there are virtually no controlled acute treatment trials specifically in patients with BDII to support the validity of these recommendations. Many patients with BDII dislike the idea of taking mood stabilizers and prefer instead to take only an antidepressant. Some open trials suggest good safety and tolerability of antidepressant monotherapy. Yet concerns exist that antidepressant monotherapy could destabilize mood in these patients. Whether taking an antidepressant as monotherapy actually exacerbates the illness (i.e., increases switches into mania or cycling, or intensifies hypomania) has never formally been tested. We propose a randomized, double-blind 16-week acute clinical trial comparing the efficacy and safety of sertraline monotherapy v. lithium monotherapy v. lithium plus sertraline combination in 207 patients with BDII in an acute depressive episode. The application is designed to assess acute treatment response, switch rates into hypomania/mania and side effects in patients with BDII depression undergoing treatment approaches. Primary aims are to compare the 3 treatment strategies in terms of effectiveness, adverse events (e.g., switch rates) and side effects (e.g., tolerability). We hypothesize that all treatment approaches will be equally efficacious in reducing depressive symptoms, but that there will be differences between treatments in regard to switch rates into hypomania/mania. We also hypothesize that the frequency of side effects will be significantly less in patients on SSRI monotherapy. Thus, secondary aims include assessment of patient satisfaction, which may affect compliance in the clinical setting.

描述（由申请人提供）：该赠款建议探索双相情感障碍障碍患者（BDII）的最佳抑郁症治疗方法。 BDII代表了一种严重的严重精神疾病，其特征是严重抑郁症和低摩菌时期。现在，人们清楚地认识到这种诊断性表型随着时间的流逝的稳定性。进一步的研究表明，BDII的抑郁症状经常发生，并且这种后果可能很严重，因为认为自杀风险比BDI患者高。治疗抑郁的BDII患者的护理标准是单独使用情绪稳定剂或情绪稳定剂和抗抑郁药。但是，几乎没有专门针对BDII患者的受控急性治疗试验来支持这些建议的有效性。许多BDII患者不喜欢服用情绪稳定剂的想法，而宁愿仅服用抗抑郁药。一些开放试验表明抗抑郁药单一疗法的良好安全性和耐受性。然而，人们担心抗抑郁药可以使这些患者的情绪稳定。是否服用抗抑郁药作为单一疗法实际上会加剧疾病（即增加转向躁狂症或循环的转换，或者加剧性躁狂症）从未正式测试过。我们提出了一项随机，双盲16周的急性临床试验，比较了在急性抑郁发作中207例BDII患者中，比较了舍曲林单药治疗诉锂单药治疗案诉锂和舍曲林组合的安全性和安全性。该应用旨在评估接受治疗方法的BDII抑郁症患者的急性治疗反应，转换为躁狂/躁狂症的转换率。 主要目的是在有效性，不良事件方面比较三种治疗策略（例如， 开关率）和副作用（例如耐受性）。我们假设所有治疗方法将是 减少抑郁症状同样有效，但在切换率转向躁狂症/躁狂症方面，治疗方法之间会有差异。我们还假设，SSRI单药治疗患者的副作用频率将大大降低。因此，次要目标包括评估患者满意度，这可能会影响临床环境中的依从性。