Safety And Efficacy Study Of Depakote ER To Treat Pediatric Bipolar Disorder

Completed · Phase 4

Conditions studied: Bipolar Disorder

In brief

The purpose of this research is to compare how safely and how well this medicine works in treating children and teenagers between the ages of 6 and 17 years with a diagnosis of Bipolar Disorder.

Key facts

Study ID

NCT00199966

Run by

Medical College of Wisconsin

People needed

30

Starts

2003-12-01

Expected to finish

2005-11-01

Last updated by the study team

2008-03-07

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Bipolar I or II confirmed by K-SADS and clinical interview.
• Ages 6 to 17 years 11 months.
• YMRS score of <10, this is consistent with minimal symptoms of mania. Or a desire to change medications due to a simplified dosing schedule or to reduce unwanted side effects of divalproex sodium.
• Ability and willingness of subject and parent(s)/guardian(s) to provide informed written assent/consent.

You may not qualify if…

• Diagnosis of: Pervasive Developmental Disorders, Schizophrenia spectrum disorders, Obsessive Compulsive Disorder.
• Concurrent medical conditions requiring medication or that are unstable.
• Current suicidal thoughts.
• Recent suicidal behavior.
• Pregnancy or sexually active female not using a reliable form of contraception.
• Previous inadequate response to DVP ER.
• Known hypersensitivity to DVP or DVP ER.
• Recent inpatient hospitalization for suicidality or homicidality, (last 6 months).
• Subjects who are clinically stable and not suffering significant side effects on their current medical regimen.
• Use of antidepressants within the last 2 weeks, 4 weeks for fluoxetine.
• Recent (last 3 months) substance abuse or dependence. Urine drug screen will be obtained if a question arises.

Where it is running

• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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