Asenapine for Bipolar Depression

• Status: Terminated
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare asenapine with placebo in the treatment of depression associated with bipolar disorder, type I over eight weeks.

We hypothesize that patients will show significantly greater improvement with asenapine than placebo over eight weeks of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Collaborators: Merck Sharp & Dohme Corp.; University of Louisville
• Treatments: Asenapine

Criteria

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