Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181727
Status:
COMPLETED
Last Update Posted:
2013-10-22
First Post:
2005-09-13
Brief Title:
Study of Depakote ER for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-10
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:
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
Detailed Description:
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
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
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