bipolar disorder
Bipolar disorder β€” encompassing Bipolar I (manic episodes), Bipolar II (hypomanic and depressive episodes), and cyclothymia β€” affects approximately 2.4% of the global population and carries significant risk of functional impairment and suicide. Clinical trials in bipolar disorder address three distinct phases: acute mania, bipolar depression, and maintenance to prevent episode recurrence. Bipolar depression is the most clinically challenging phase and the subject of the most active current research, as many antidepressants carry a risk of inducing mania.
Active trials investigate cariprazine for bipolar depression and mixed features, lumateperone (approved for bipolar depression), novel glutamate modulators, CGRP antagonists for bipolar with migraine comorbidity, and lithium pharmacogenomics to identify which patients will be optimal responders. Digital phenotyping trials β€” using smartphone data to detect early episode signs β€” are a growing area of clinical research in bipolar monitoring.
Bipolar disorder trials typically separate mania and depression phases and often exclude patients with recent substance use disorder; the MADRS or YMRS scale determines severity at baseline.