Combination Therapy in Dual Diagnosis Rapid Cycling BPD in Both the Tertiary Care

MH-50165及其补充剂的初步数据表明，Li/Dvpx组合导致 在快速循环的BPD中具有显著的抗躁狂效果，但抗抑郁效果适中。大多数无反应 归因于难治性抑郁症（73%和62%的难治性抑郁症和27%和38%的难治性抑郁症 轻躁狂/躁狂/混合）。我们认为这些数据表明，更广泛有效的方案是 需要，例如，添加具有更有效抗抑郁特性的第三种药物。为了满足这一需求，R21 MH-62650支持改良的随机分配、单中心、6个月、双盲、平衡平行组 比较两种联合治疗方案（锂/双丙戊酸钠/盲法拉莫三嗪与 锂/双丙戊酸钠/安慰剂），用于抑郁症、轻躁狂和 在90例抑郁症指数发作患者中出现躁狂。项目#3建议进行类似的 设计的研究，但在目前与酒精、可卡因和/或大麻共病的患者中 滥用依赖到目前为止，还没有发表的随机对照试验，在成人BPD谁是 正在酗酒或吸毒

Preliminary data from MH-50165 and its Supplement suggest that combination Li/Dvpx results in marked antimanic effectiveness in rapid-cycling BPD, but modest antidepressant effects. Most of the non-response was attributable to treatment-resistant depression (73% and 62% resistant depression and 27% and 38% resistant hypomania/mania/mixed, respectively). We believe these data suggest that more broadly effective regimens are needed, e.g., the addition of a third agent with more potent antidepressant properties. To address this need, R21 MH-62650 is supporting a modified random assignment, single-center, 6-month, double blind, balanced parallelgroup comparison of two regimens of combination therapy (lithium/divalproex/blinded lamotrigine versus lithium/divalproex/placebo) for the acute and continuation outpatient management of depression, hypomania, and mania in 90 patients presenting in an index episode of depression. Project #3 proposes to carry out a similarly designed study, but in patients who are currently comorbid with alcohol, cocaine, and/or cannabis abuse dependence. To date, there are no published randomized, controlled trials in adults with BPD who are currently abusing alcohol or drugs.