Biosignatures of Latuda for Bipolar Depression

Inclusion Criteria

• Age 18- 60
• Outpatients with a primary Diagnostic and Statistical Manual of the American Psychiatric Association, Fourth Edition (DSM-IV) diagnosis of Bipolar Disorder I, II, or NOS (Not Otherwise Specified)
• Current episode of Major Depression
• At least moderate severity of depression
• Agrees to, and is eligible for, electroencephalogram (EEG) / psychological testing, magnetic resonance imaging (MRI), and blood draws
• Provides informed consent

Exclusion Criteria

• Current drug or alcohol abuse/dependence, except nicotine (within 6 months for dependence; 2 for abuse)
• Taking any of the following exclusionary medications: antipsychotics, anticonvulsants, mood stabilizers, stimulants, antidepressant medications, medications with significant interactions with lurasidone, except during the washout prior to testing and blood collection
• Unstable medical condition, including significant liver disease, hypothyroidism (i.e., condition not adequately stabilized for 3 months), and conditions likely to require hospitalization or with a life expectancy of 140/90 Torr on repeated measurement (If hypertension becomes stabilized, subject may enroll in study)
• Hepatitis: any liver function test > 2x the upper limit of normal
• Renal failure: estimated Glomerular Filtration Rate (eGFR, corrected for body surface area) repeatedly upper limit of normal (unless accompanied by other euthyroid indices and the confirmation by an internist or endocrinologist that this does not represent hypothyroidism)
• Anemia: hemoglobin < 10 grams/deciliter (borderline hemoglobin must be of known origin, stable, and not clinically significant)