Comparing Compliance, Tolerability, Efficacy and Adverse Events in Bipolar Tients From Valproic Acid to Depakote ER

Completed · Phase 4

Conditions studied: Mood Disorder

In brief

The purpose of this study is to compare compliance, tolerability, effectiveness, and side-effects in Bipolar I and II patients switching from Valproic Acid to Depakote ER.

Key facts

Study ID

NCT00211250

Run by

Joliet Center for Clinical Research

People needed

20

Starts

2005-07-01

Expected to finish

2006-09-01

Last updated by the study team

2009-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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,

You may not qualify if…

• 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.

Where it is running

• Cosme Lozano M.D. — Joliet, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.