Testing Brexpiprazole for bipolar depression

Exclusion

• −Age: 18-75
• −Known hypersensitivity to Brexpiprazole and any components of its formulation
• −Is at high risk of suicide as defined by a score of \>/= 3 to item 10 of MADRS and/or in the clinical opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →
• −Hypo(mania) episode with YMRS \>/= 8
• −Psychotic symptoms as defined by a score of \>/= 4 to item 8 (content) of YMRS and/or in the opinion of the investigator
• −Is treated with fluoxetine OR carbamazepine
• −Is treated with risperidone OR olanzapine OR quetiapine \> 100mg/day OR ziprazidone OR any other antipsychotic
• −Drug abuse or dependence as per DSM-V (MINI)
• −Unstable medical condition
• −Other unstable and/or untreated psychiatric condition, organic brain disorder, unstable and/or untreated medical condition such as hypothyroidism, hyperthyroidism, diabetes, cardiac condition, hypertension
• −Deficit in vitamin B12 or folate
• −Rapid cycling (more than 4 mood episodes per year)
• −Active or history of difficulty to swallow
• −Seizures not currently controlled with medications
• −Orthostatic hypotension defined as a drop in systolic blood pressure of at least 20 mmHg or of diastolic BP of at least 10 mmHg within 3 minutes of standing
• −A history of clinically significant cardiovascular disorders and cardiac arrhythmias
• −A low white blood cell count
• −Known eye disease
• −Involuntary, irregular muscle movements, especially in the face
• −Known lactose intolerance or have hereditary galactose intolerance or glucose-galactose malabsorption, because Brexpiprazole and placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → tablets contain lactose (a disaccharide of glucose and galactose)
• −Active inflammatory disease including lupus, colitis, Crohn's disease, psoriasis, irritable bowel syndrome (IBS)
• −Mild or major neurocognitive disorder
• −Previous history of sensitivity/low tolerance to medications metabolized by CYP 2D6 inhibitors, or CYP 3A4 inducers
• −ControlControl groupThe group a new treatment is measured against.Read more → Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →:
• −Male or female
• −No current or past history of any psychiatric disorder
• −Patients must have failed at least one other treatment for the current depressive episode
• −The following laboratory values are within normal limits at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →: CBC with differential; ferritin; extended electrolytes (sodium, potassium, chloride, calcium, magnesium, phosphate); thyroid function test(s); kidney function tests; hemoglobin A1c; lipid profile; prolactin
• −Normal EKG at Screening
• −Patient is able to give his(her) consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
• −Control Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
• −Alcohol or drug abuse
• −Deficit in vitamin B12 or folate
• −Seizures not currently controlled with medications
• −History of clinically significant cardiovascular disorders and cardiac arrhythmias
• −Mild or major neurocognitive disorder
• −Patient/Control Exclusion Criteria for MRI:
• −Heart/vascular clip
• −Metal prosthesis
• −Metal fragments in body
• −Transdermal patch
• −Aneurysm clip
• −Prosthetic valve
• −Claustrophobia
• −Is pregnant or lactating or absence of contraceptive treatment
• −If female and of childbearing potential, is using an adequate method of contraception. Adequate methods of contraception include abstinence; oral contraceptive pill or surgically implanted device; intra-uterine device; condom plus spermicidal foam or jelly; or tubal ligation