Status:
COMPLETED
Comparing Compliance, Tolerability, Efficacy and Adverse Events in Bipolar Tients From Valproic Acid to Depakote ER
Lead Sponsor:
Joliet Center for Clinical Research
Collaborating Sponsors:
Abbott
Conditions:
Mood Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
Over the next year between 20 and 40 patients, who meet all inclusion and exclusion criteria, will be entered into the study. The treatment period of the study will last at least 10-13 weeks depending...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00211250
Start Date
July 1 2005
End Date
September 1 2006
Last Update
January 28 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cosme Lozano M.D.
Joliet, Illinois, United States, 60435