Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334347
Status:
COMPLETED
Last Update Posted:
2007-12-06
First Post:
2006-06-05
Brief Title:
A Comparison Study of the Efficacy and Tolerability of Depakote ER and Depakote DR
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Comparison Study of the Efficacy and Tolerability Between Depakote ER and Depakote in the Acute Treatment of Mania and Mixed Mania
Status:
COMPLETED
Status Verified Date:
2007-12
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:
To compare the time to response response rates remission rates and side effects in Bipolar Disorder inpatients treated with Depakote ER or Depakote DR for acute mania or mixed mania
Detailed Description:
There are several studies demonstrating the efficacy of divalproex in the acute treatment of mania and mixed mania In fact the American Psychiatric Associations Practice Guidelines for Bipolar Disorder recommends divalproex as a first-line treatment for acute mania and acute mixed mania divalproex is the treatment of choice in the treatment of acute mixed mania The Food and Drug Administration FDA approved divalproex for the acute treatment of mania in the 1990s A new formulation divalproex Depakote ER was recently FDA approved for the treatment of epilepsy and prophylaxis of migraine headaches In a pooled data analysis of nine open-labeled trials involving 321 epilepsy and bipolar disorder patients Smith et al that Depakote ER was associated with superior tolerability including less frequent tremors weight gain and gastrointestinal complaints all p0001 compared with Depakote DR Depakote ER was preferred by subjects and it provided improved seizure control and a greater reduction in psychiatric symptoms
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