Safety And Efficacy Study Of Depakote ER To Treat Pediatric Bipolar Disorder
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|ClinicalTrials.gov Identifier: NCT00199966|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 7, 2008
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Drug: Divalproex sodium extended release||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Of Safety And Effectiveness For Depakote ER In Pediatric Bipolar Disorder|
|Study Start Date :||December 2003|
|Actual Study Completion Date :||November 2005|
- Young Mania Rating Scale (YMRS), rate at baseline, Week 2,4,6,&8
- Kiddie version of the Schedule for Affective Disorders and Schizophrenia (KSADS), assessed at baseline only.
- Child Depression Rating Scale (CDRS), rate at baseline through Week 8.
- Clinical Global Impression: Improvement and Severity (CGI), for mania, depression and ADHD. Rate from baseline through Week 8.
- Conner's Parent and Teacher Rating Scales (CRS). Rate from baseline through Week 8.
- Side Effect For Children & Adolescents (SEFCA). Rate from baseline through Week 8.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199966
|United States, Wisconsin|
|Children's Hospital of Wisconsin|
|Milwaukee, Wisconsin, United States, 53201|
|Principal Investigator:||Russell E Scheffer, MD||Medical College of Wisconsin; Children's Hospital of Wisconsin|