Status:
TERMINATED
Asenapine for Bipolar Depression
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
University of Louisville
Merck Sharp & Dohme LLC
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief 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 signifi...
Detailed Description
86 patients with an episode of major depression associated with bipolar disorder, type I will be recruited by two sites for the study over fifteen months. Medication will be administered in a double-b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01807741
Start Date
September 1 2013
End Date
July 1 2017
Last Update
July 24 2017
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45244