An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/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.

Official Title

Conditions

Bipolar Disorder

Study Type

Interventional

Study Design

Treatment

Further Details

Study Start

Eligibility & Criteria

KEY 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 KEY EXCLUSION CRITERIA:- Axis I other than Attention Deficit Hyperactiviy 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

Total Enrolment

Contact Details

[1] Stanford University, Stanford, California, 94304, United States; Recruiting Meghan Howe 650-736-2688 meghowe@stanford.edu Kiki Chang, M.D., Principal Investigator[2] Abbott’s pharmaceuticals