Conditions: Bipolar Depression
Keywords: Bipolar Disorder depression Bipolar depression
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

Brief summary:
The study proposes to conduct a pilot study of biological predictors of lurasidone response in bipolar depression.

Detailed description:
The study proposes to enroll 20 participants with a bipolar disorder who are currently in an episode of major depression.Magnetic resonance imaging (MRI), recordings of brain electrical activity (EEG), and psychological testing to explore possible predictors of lurasidone treatment response will be conducted. Blood samples will be collected for a future study of blood protein predictors of response. After testing, participants will receive an open-label 8-week trial of lurasidone (Latuda™) at approved dosage levels. Participants who attain remission of their major depressive episode will be eligible for a six-month continuation phase to explore predictors of sustained response to continuation treatment. Data analyses will use statistical testing to explore potential biological predictors of lurasidone response. This will provide a framework for clarifying which patients are best suited to this treatment and begin to develop a model for precision treatment of this difficult-to-treat disorder.

Arms:
arm 1: All study participants will receive open-label Latuda.

Interventions: intervention 1: Lurasidone (Latuda)
Intervention descriptions: intervention 1: Antipsychotic medication approved for use with Bipolar disorder

Protocol document: