Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00143182
Status:
COMPLETED
Last Update Posted:
2022-02-04
First Post:
2005-08-31
Brief Title:
9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania P07007COMPLETED
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A Double-Blind 9-Week Extension Study Evaluating the Safety and Maintenance of Effect of Asenapine vs Olanzapine in the Treatment of Subjects With Acute Mania Clinical Trial Protocol A7501006 Secondary Title ARES
Status:
COMPLETED
Status Verified Date:
2022-02
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:
Bipolar disorder is characterized by mood swings that range from high manic to low depressed states Sometimes symptoms of both depression and mania are present mixed episodes Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder Patients who completed the 3 week trial A7601004 or A7501005 continued on the same treatment that they received in the short term study asenapine or olanzapine a medication already approved for the treatment of bipolar mania for 9 additional weeks The short term studies A7501004 and A7501005 were not unblinded until the 9 week extension study was unblinded Patients treated with placebo in the 3 week short term study were crossed over and treated with Asenapine in the 9 week extension study Patients who complete the 9 week extension study were eligible to continue in another extension A7501007 study for an additional 40 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| A7501006 | OTHER | Schering-Plough | None |