Comparing Compliance, Tolerability, Efficacy and Adverse Events in Bipolar Tients From Valproic Acid to Depakote ER
Mood Disorder
About this trial
This is an interventional treatment trial for Mood Disorder focused on measuring Depakote Er and Valproic Acid
Eligibility Criteria
Inclusion Criteria: Bipolar I and II patients, age 18 and older, currently tolerating a stable dose of Valproic Acid for at least 3 months with a current Valproic Acid level of at least 50 mcg/mL at screening and baseline, Exclusion Criteria: Women who are pregnant or breast feeding or intending to become pregnant, contraindication or history of hypersensitivity to valproic acid, DVPX or DVPX ER. Clinically significant organ disease, clinically significant abnormalities in physical examination, EKG, or lab test, history of any disease which in the investigator's opinion may confound the results of the study or pose additional risk. Other principle nonpsychotic or psychotic psychiatric diagnosis. Patients weighing >300 pounds. Patients taking any other mood stabilizers. Patients not already on a stable dose of valproic acid or have a Valproic Acid level less than 50 mcg/mL at screening.
Sites / Locations
- Cosme Lozano M.D.