Lurasidone and Cognition in Bipolar I Disorder

Inclusion criteria

• All patients must be taking either lithium or valproate or one of the atypical antipsychotics for mood stabilization.
• Patients who show cognitive impairments (-0.25 standard deviations (SD) or below) on either the Trail Making Test- trial B (TMT-B) or California Verbal Learning Test (CVLT) trials 1 to 5, or CVLT long delay free recall, at baseline visit.
• Males or females aged 19 to 65 years inclusive.
• Diagnostic and Statistical Manual IV edition (DSM-IV TR) diagnosis of Bipolar Type I Disorder, with or without a history of psychosis.
• Clinically stable with a Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) score less than or equal to 8.
• A sufficient level of English using a language screening questionnaire.
• Capability of understanding, consenting to, and complying with the requirements of the study.

Exclusion criteria

• A history of unstable or inadequately treated medical illnesses, including moderate to severe brain injury, or neurological illnesses impacting cognitive function.
• Treatment with Electroconvulsive Therapy (ECT) within eight weeks prior to enrolment; or treatment with an experimental drug within 30 days prior to enrolment.
• Axis I diagnosis of substance abuse or dependence within the past month.
• Significant risk of harm to self or others, in the opinion of the investigator.
• Pregnancy or lactation in female subjects.
• Liver function tests (AST and ALT) three times the upper limit of normal. -