An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents

INCLUSION CRITERIA - Current primary diagnosis of bipolar I disorder, mania or mixed type - Outpatient between 10 and 17 years of age - Young Mania Rating Scale score greater than or equal to 20 during screening/washout and at Day 1 EXCLUSION CRITERIA - Axis I other than Attention Deficit Hyperactivity Disorder (ADHD), Obsessive Compulsive Disorder (OCD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Panic Disorder; or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results - Current manic episode is drug-induced or secondary to a medical disorder (e.g., anti-depressants, hyperthyroidism) - Expected to require hospitalization for the current manic episode - Participation in psychotherapy that was started within the past 3 months, or if any significant changes are anticipated - Has taken atomoxetine or has taken allowed stimulant medication that has not been stable for at least 3 months prior to Day 1, or a dosage adjustment is expected during the study, or that may worsen mood symptoms - Unable to swallow tablets - Has received depot psychoactive medication within one inter-injection interval of Day 1 - Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine, barbiturates, benzodiazepines or amphetamines - History of alcohol or substance dependence within past 3 mos. or substance abuse within past month - History of failed treatment on adequate Depakote (DR or ER) for a manic episode within past 12 months - Has taken Depakote (DR or ER) regularly for the current manic episode - Has serious violent, homicidal, or suicidal ideation