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.? ?
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