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

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical College of Wisconsin
• Treatments: Valproic Acid

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.