The study proposes to conduct a pilot study of biological predictors of lurasidone response in bipolar depression.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Antipsychotic medication approved for use with Bipolar disorder
New York State Psychiatric Institute
New York, New York, United States
Montgomery-Asberg Rating Scale for Depression (MADRS)
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Nine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe).
Time frame: Baseline
Montgomery-Asberg Rating Scale for Depression (MADRS) at Week8
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Nine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe).
Time frame: Week 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.