Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00159744
Status:
COMPLETED
Last Update Posted:
2022-02-04
First Post:
2005-09-08
Brief Title:
3-Week Study of Asenapine Olanzapine and Placebo for Treatment of Bipolar Mania P07008
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A Phase III Randomized Placebo-Controlled Double-Blind Trial Evaluating the Safety and Efficacy of Sublingual Asenapine vs Olanzapine and Placebo in In-Patients With an Acute Manic Episode Clinical Trial Protocol 7501004 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 This is a 3-week study that will test the safety and efficacy of this medication Patients will receive either asenapine olanzapine a medication that is already approved for the treatment of bipolar mania or placebo no active medication Patients will be required to stay in the hospital for at least the first seven days of treatment Patients that complete the 3 week study may be eligible to continue in extension studies for an additional 9 study A7501006 to 49 study A7501007 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 |
|---|---|---|---|
| A7501004 | OTHER | Schering-Plough | None |