Trial Information

Summary: A 6-month open-label clinical research study to evaluate the safety of Depakote ® ER in the treatment of mania associated with Bipolar I Disorder in children and adolescents.

To evaluate the long-term safety of an investigational medication in the treatment of Bipolar I Disorder, manic or mixed episode, in children and adolescents ages 10-17.

KEY INCLUSION CRITERIA:

• Subject is between 10 and 17 years of age, inclusive, on Day 1 and weighs at least 60 lbs (27 kg).
• Subject has a current psychiatric diagnosis of Bipolar I Disorder, manic or mixed episode
• Subject is an outpatient in a manic or mixed episode

KEY EXCLUSION CRITERIA:

• Has an Axis I disorder other than Attention Deficit Hyperactivity Disorder (ADHD), Obsessive Compulsive Disorder (OCD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Panic Disorder, Enuresis, Encopresis, Parasomnias, Agoraphobia, Specific Phobia, Social Phobia, or Separation Anxiety Disorder
• Has a history of a chronic or acute medical disorder
• Has a history of, or is suspected of having a seizure disorder
• Has any central nervous system (CNS) neoplasm, CNS infection, demyelinating disease, degenerative neurological disease, or any progressive CNS disease

If you would like to learn more about participating in this study, please send an e-mail message using the form below.