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

Study Overview
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Brief Summary
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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
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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

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Divalproex Sodium Extended-Release Tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Divalproex Sodium Extended-Release Tablets|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to the final evaluation in Y-MRS score. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs |  |  | 
| Adverse events |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar Disorder Type 1 (manic or mixed type)