drugset / Trial / NCT00211250
Comparing Compliance, Tolerability, Efficacy and Adverse Events in Bipolar Tients From Valproic Acid to Depakote ER
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2005-07
- Primary completion
- 2006-07
- Completion
- 2006-09
Publications
- Background Berk, M & Berk, L. (2004). Mood stabilizers and treatment adherence in bipolar disorder: addressing adverse events. Bowden C.L., Calabrese J.R., McElroy S.L., Gyulai L., Wassef A., Petty F., Pope H.G. Jr, Chou J.C., Keck P.E. Jr, Rhodes L.J., Swann A.C., Hirschfeld R.M., Wozniak P.J., (2000). Valproate in the treatment of acute mania: placebo-controlled study. Archives of General Psychiatry, 48, 62-68. Pope, S. J. (2002). Nonadherence with mood stabilizers: prevalence and predictors. Journal of Clinical Psychiatry, 63, 384-90. Sajatovic, M., Davies M., & Hrouda, D.R. (2004). Enhancement of treatment adherence with patients with bipolar disorder. Psychiatric Services, 55(3), 264-69. Depakote ER package insert, Abbott Laboratories, 2002.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Valproate | Small molecule | — | — |
| Subject | Valproic Acid | Small molecule | — | — |