Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194116
Status:
COMPLETED
Last Update Posted:
2019-07-17
First Post:
2005-09-13
Brief Title:
Double-blind Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
University Hospitals Cleveland Medical Center
Study Overview
Official Title:
Double-blind Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
Status:
COMPLETED
Status Verified Date:
2019-05
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:
Double-Blind Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression Previously Diagnosed and Treated as Recurrent Major Depression This study recruits males and females aged 18 - 70 who currently meet diagnostic criteria for bipolar I or bipolar II disorder and are currently experiencing an episode of major depression Patients are randomized to double-blind treatment with divalproex sodium ER or placebo and remain in the study for up to six weeks This six-week double-blind treatment period is followed by an open-label treatment period of six months duration This study is sponsored by Abbott Laboratories
Detailed Description:
None
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