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.

Condition	Treatment or Intervention	Phase
Bipolar Disorder	Drug: Divalproex Sodium Extended-Release Tablets	Phase III

Ages Eligible for Study:  10 Years   -   17 Years,  Genders Eligible for Study:  Both

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

California
      Stanford University, Stanford,  California,  94304,  United States; Recruiting
District of Columbia
      Childrens National Medical Center, Washington,  District of Columbia,  20010,  United States; Recruiting
Florida
      Altamonte Springs,  Florida,  32701,  United States; Recruiting
      Destin,  Florida,  32541,  United States; Recruiting
      Professional Clinical Research, Inc., Miami,  Florida,  33161,  United States; Recruiting
      Segal Institute for Clinical Research, North Miami,  Florida,  33161,  United States; Recruiting
Idaho
      Mountain West Clinical Trials, Boise,  Idaho,  83704,  United States; Recruiting
Illinois
      Ingenium Clinical Research, Libertyville,  Illinois,  60031,  United States; Recruiting
Kansas
      Cientifica Inc at Praire View, Inc., Newton,  Kansas,  67114,  United States; Recruiting
Kentucky
      Lexington,  Kentucky,  40509,  United States; Recruiting
Louisiana
      LSU - Health Science Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
      Brentwood Research Institute, Shreveport,  Louisiana,  71101,  United States; Recruiting
Michigan
      New Oakland Child/Adoles and Family Center, Clinton Township,  Michigan,  United States; Recruiting
Missouri
      Mercy Health Research, Chesterfield,  Missouri,  63017,  United States; Recruiting
Oklahoma
      Cutting Edge Research Group, Oklahoma City,  Oklahoma,  United States; Recruiting
Texas
      University of Texas Medical Branch, Galveston,  Texas,  77705,  United States; Recruiting
      University of Texas Medical Branch, Houston,  Texas,  77058,  United States; Recruiting

Study ID Numbers:  M01-342
Record last reviewed:  January 2005
Last Updated:  January 10, 2005
Record first received:  August 13, 2003
ClinicalTrials.gov Identifier:  NCT00067262
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08