Validation of a Composite Medical Device Using a Blood Biomarker-based Algorithm and MDQ for the Diagnosis of Bipolar Disorder

Participants will undergo a venous blood draw for analysis by an investigational composite medical device designed to aid in the diagnosis of bipolar disorder. The device analyzes specific circulating biomarkers hypothesized to differ between patients with bipolar disorder and those with unipolar depression.

Participants will complete validated psychiatric screening tools used as reference standards to evaluate bipolar disorder, including the Mood Disorder Questionnaire (MDQ). These tools will be used to compare their diagnostic output with that of the investigational blood test.