Asenapine for Bipolar Depression

Inclusion Criteria: * Meet criteria for bipolar depression based on the MINI and confirmation of a previous manic or mixed episode * 18-55 years of age * Female patients must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence) * Each patient must understand the nature of the study and must provide written informed consent * Patients must have a diagnosis of bipolar disorder, type I and currently display an acute depressive episode as determined by M.I.N.I. (Sheehan et al, 1998) * Patients must have a baseline (day 0) MADRS score ≥26 * Current episode of depression must have persisted for at least one month and no more than six months at study entry * Subjects should be fluent in English Exclusion Criteria: * Female patients who are either pregnant or lactating * Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions * Any history of current or past diabetes that was treated with pharmacological intervention * Neurological disorders including epilepsy, stroke, or severe head trauma * Clinically significant laboratory abnormalities, on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, thyroid indices and EKG * Depression due to a general medical condition or substance-induced depression (DSM-IV) * Mental retardation (IQ \<70) * Meeting criteria for a mixed episode, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) * History of hypersensitivity to or intolerance of asenapine * Prior history of asenapine non-response * DSM-IV substance (except nicotine or caffeine) dependence within the past 3 months * Judged clinically to be at suicidal risk (defined as having active suicidal ideation, intent or plan, or a serious suicide attempt within 30 days, or a baseline MADRS suicide score of \>4) * Participation in a clinical trial of another investigational drug within 1 month (30 days) prior to study entry * Failure of the current depressive episode to respond to two or more pharmacological interventions * Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0 * Schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV * Major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified