Bipolar Disorder
Conditions
Keywords
Bipolar Disorder Type 1 (manic or mixed type)
Brief summary
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.
Interventions
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the final evaluation in Y-MRS score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs | — |
| Adverse events | — |
Countries
United States
Outcome results
None listed