Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00203567
Status:
COMPLETED
Last Update Posted:
2008-06-24
First Post:
2005-09-12
Brief Title:
Carbamazepine Extended-Release for the Treatment of Bipolar Depression
Sponsor:
Tuscaloosa Research Education Advancement Corporation
Organization:
Tuscaloosa Research Education Advancement Corporation
Study Overview
Official Title:
Carbamazepine Extended-Release for the Treatment of Bipolar Depression
Status:
COMPLETED
Status Verified Date:
2008-06
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 study the efficacy and safety of beaded extended-release Carbamazepine Equetro in the treatment of patients with Bipolar Disorder with a Major Depressive Episode
Detailed Description:
Patients with Bipolar I or II Disorder with a Major Depressive Episode who sign informed consent and meet eligibility criteria will begin treatment with extended release carbamazepine ERC-CBZ The dose of ERC-CBZ will be initiated at 200mg twice daily and increased as tolerated by 200mgday every 3 days up to 1200mgday by week 2 target dose Then the dose may be increased at the investigators discretion up to1600mgday as tolerated by week 8 if needed for a greater therapeutic response Efficacy will be assessed biweekly with the Montgomery-Asberg Depression Rating Scale MADRS and Clinical Global Impression-Bipolar CGI-BP Safety is assessed biweekly with adverse events self-reports and laboratory evaluations
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TREAC Equetro in Bipolar | None | None | None |