Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00159783
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2005-09-08
Brief Title:
40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder A7501007COMPLETEDP05857
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A Double-Blind 40-Week Continuation Study Evaluating the Safety of Asenapine and Olanzapine in the Treatment of Subjects With Acute Mania Clinical Trial Protocol A7501007 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 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 study A7501006 a 9 week extension study could continue with the same treatment that they had been receiving asenapine or olanzapine a medication that is already approved for the treatment of bipolar mania in a 40 -week continuation study
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 |
|---|---|---|---|
| A7501007 | None | None | None |