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

A Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Depakote ER for the Treatment of Bipolar Disorder in Children and Adolescents

The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years.

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