Status:
COMPLETED
Safety And Efficacy Study Of Depakote ER To Treat Pediatric Bipolar Disorder
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Bipolar Disorder
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief 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.
Detailed Description
There is no accepted, well-studied treatment for Pediatric Bipolar Disorder and treatment has often followed from adult studies. The primary objectives for this study are to determine if subjects can ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00199966
Start Date
December 1 2003
End Date
November 1 2005
Last Update
March 7 2008
Active Locations (1)
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1
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53201