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

Completed · Phase 3

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT00067262

Run by

Abbott

People needed

150

Starts

2003-03-01

Last updated by the study team

2006-08-04

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University — Stanford, California, United States
• Childrens National Medical Center — Washington D.C., District of Columbia, United States
• Study site — Altamonte Springs, Florida, United States
• Professional Clinical Research, Inc. — Miami, Florida, United States
• Segal Institute for Clinical Research — North Miami, Florida, United States
• Mountain West Clinical Trials — Boise, Idaho, United States
• Capstone Clinical Research — Libertyville, Illinois, United States
• Cientifica Inc at Praire View, Inc. — Newton, Kansas, United States
• Study site — Lexington, Kentucky, United States
• LSU - Health Science Center — New Orleans, Louisiana, United States
• Brentwood Research Institute — Shreveport, Louisiana, United States
• New Oakland Child/Adoles and Family Center — Clinton Township, Michigan, United States
• Mercy Health Research — Chesterfield, Missouri, United States
• Cutting Edge Research Group — Oklahoma City, Oklahoma, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• University of Texas Medical Branch — Houston, Texas, United States

Full record on ClinicalTrials.gov

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