Study of Depakote ER for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder
This is an open-labeled study of Divalproex Sodium Extended Release (Depakote ER), testing its efficacy for the treatment of mania in children between the ages of 6-12 who have been diagnosed with Bipolar I, Bipolar II, and Bipolar Spectrum Disorders. This is an exploratory, pilot study, seeking to determine whether Divalproex Sodium Extended Release is efficacious and well tolerated in the treatment of youth with pediatric bipolar and bipolar spectrum disorder, and the study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
Drug: divalproex sodium extended release
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-Label Study of Divalproex Sodium Extended Release for the Treatment of Mania in Children Ages 6-12 With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder|
- Primary Outcomes:
- Scores on the Young Mania Rating Scales, two subscales of the MRS:
- 1) the Manic Syndrome Scale (MSS)
- 2) the Behavior and Ideation Scale (BIS)
|Study Start Date:||January 2004|
|Study Completion Date:||November 2006|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
Initial clinical evidence suggests that Divalproex Sodium may play a therapeutic role in the management of pediatric bipolar disorder. Its new Extended Release formulation offers the advantage of once a day dosing. Although the precise mechanisms by which Divalproex Sodium exerts its therapeutic effects remains unknown, it has been suggested that its activity may be related to increased brain concentrations of gamma-aminobutyric acid (GABA). Although the shorter acting formulation Divalproex Sodium is FDA approved for the treatment of adult bipolar disorder, its Extended Release formulation is currently only FDA approved for adults for the prophylactic treatment of migraine headaches and has not yet been studied in patients with mania. Three studies of Divalproex Sodium have documented safety and efficacy of this compound, as well as superiority over placebo, in the treatment of adults with bipolar disorder.
This medication has not, however, been adequately investigated in children. The proposed study includes 1) an 8-week acute period, during which participants are observed during weekly visits, and up to an 8-month extension period, during which participants see a study clinician on a monthly basis, to document the response rate 2) assessment of the impact of Divalproex Sodium Extended Release on functional capacities (quality of life, psychosocial function) and cognition, 3) careful assessment of safety and tolerability.
|United States, Massachusetts|
|Massachusetts General Hospital|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||Joseph Biederman, MD||Massachusetts General Hospital|