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

Abbott

Status and phase

Completed

Phase 3

Conditions

Bipolar Disorder

Treatments

Drug: Divalproex Sodium Extended-Release Tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT00067262

M01-342

Details and patient eligibility

About

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.

Sex

All

Ages

10 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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