Open-Label Study of Low-Dose Brexpiprazole Added to Treatment for Bipolar I and II Depression Evaluating Effects on Mood, Cognition, and Functioning

What this Trial Is About

Researchers are studying bipolar disorder, a chronic mood condition marked by recurring depressive episodes that are often resistant to treatment. This trial focuses on improving depressive symptoms and cognitive deficits, which significantly impact daily functioning and quality of life. The study evaluates Brexpiprazole, a medication with unique dopamine and serotonin receptor activities, to see if it can enhance mood, cognition, and brain structure in individuals with bipolar I and II depression. Participants will receive an adjunctive, variable dose of Brexpiprazole ranging from 1 to 3 mg per day. The treatment is added to existing mood stabilizers such as lithium, valproate, lamotrigine, or low-dose quetiapine. The study is open-label and will monitor effects over 8 weeks, with assessments continuing up to 6 months to observe changes in mood, cognitive function, and brain imaging. During the trial, participants will undergo evaluations including mood rating scales, cognitive tests, blood tests, and MRI scans. Researchers will track changes in depressive symptoms, global functioning, cognition, and biomarkers like C-reactive protein. Safety assessments will monitor adverse events and the risk of mood switching. The entire observation period includes assessments at 8 weeks, 12 weeks, and 6 months to evaluate both short-term and longer-term effects.

Brexpiprazole Treatment for Bipolar I Depression