Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199966
Status:
COMPLETED
Last Update Posted:
2008-03-07
First Post:
2005-09-13
Brief Title:
Safety And Efficacy Study Of Depakote ER To Treat Pediatric Bipolar Disorder
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
A Pilot Study Of Safety And Effectiveness For Depakote ER In Pediatric Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 safely and easily be switched from divalproex sodium to Depakote ER and to determine if Depakote ER is both safe and effective for pediatric patients with Bipolar I or II Secondary objectives include determining the serum levels of valproic acid 20 hours after administration of Depakote ER at a steady rate and determining if co-administration of stimulants will effect the serum levels of valproic acid Thirty subjects ages 6-17 years with a diagnosis of Bipolar I or II who are currently asymptomatic according to a score of less than 10 on the Young Mania Rating Scale or who desire to change to once daily dosing or desire to change because of the likelihood of decreased side-effects will be recruited from our clinic and the community If subjects have completed baseline evaluations including diagnostic confirmation labs and rating scales and are still eligible to participate subjects will be switched in one night from twice-a-day divalproex sodium DVP to divalproex sodium extended release DVP ER
The potential benefits of the research are that new information will be added to the field of child and adolescent psychiatry and the possibility that the medication change may result in improved symptoms of mania or side effects of medications related to peak and trough levels The potential benefits of this study outweigh the possible risks
The potential benefits of the research are that new information will be added to the field of child and adolescent psychiatry and the possibility that the medication change may result in improved symptoms of mania or side effects of medications related to peak and trough levels The potential benefits of this study outweigh the possible risks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None