Primary Outcome Measures:
- The Young Mania Rating Scale (YMRS)will be used daily for the first week and then every three day to assess the severity of mania. [ Time Frame: study duration ]
- The Clinical Global Impression Scale (CGI) will be used daily for teh first week then every 3 days to assess overall functioning. [ Time Frame: study duration ]
- The Udvalg for Kliniske Undersogeiser (UKU) Side Effect Rating Scale will be administered at base line and weekly for the remainder of the study to determine the medication side effect profiles. [ Time Frame: study duration ]
Secondary Outcome Measures:
- The Montgomery-Asberg Depression Rating Scale will be performed daily for the first week and weekly thereafter to assess for any emergent symptoms of depression. [ Time Frame: study duration ]
- The Brief Psychiatric Rating Scale (BPRS) will be performed daily for the first week and weekly thereafter to assess for any emergent symptoms of psychosis. [ Time Frame: study duration ]
- The Drug Attitude Inventory (DAI-10)will measure subjects' attitudes towards medications at the screen and final visit. [ Time Frame: study duration ]
- The Schizophrenia Quality of Life Scale (SQLS)will measure subjects' quality of life at the screen and final visit. [ Time Frame: study duration ]
There are several studies demonstrating the efficacy of divalproex in the acute treatment of mania and mixed mania. In fact, the American Psychiatric Associations Practice Guidelines for Bipolar Disorder recommends divalproex as a first-line treatment for acute mania and acute mixed mania; divalproex is the treatment of choice in the treatment of acute mixed mania. The Food and Drug Administration (FDA) approved divalproex for the acute treatment of mania in the 1990's. A new formulation, divalproex, Depakote ER, was recently FDA approved for the treatment of epilepsy and prophylaxis of migraine headaches. In a pooled data analysis of nine open-labeled trials involving 321 epilepsy and bipolar disorder patients, Smith et al. that Depakote ER was associated with superior tolerability including less frequent tremors, weight gain, and gastrointestinal complaints (all p<0.001) compared with Depakote DR. Depakote ER was preferred by subjects and it provided improved seizure control and a greater reduction in psychiatric symptoms.