Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145470
Status:
COMPLETED
Last Update Posted:
2024-05-21
First Post:
2005-09-01
Brief Title:
12 Week Study of the SafetyEfficacy of Asenapine When Added to LithiumValproate in the Treatment of Bipolar Disorder A7501008 P05844 MK-8274-017
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A Phase 3 Randomized Placebo-Controlled Double-Blinded Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Continuing Lithium or Valproic AcidDivalproex Sodium for the Treatment of an Acute Manic or Mixed Episode
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:
This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder
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 |
|---|---|---|---|
| P05844 | OTHER | Schering-Plough | None |
| A7501008 | OTHER | None | None |
| 2004-003927-11 | EUDRACT_NUMBER | None | None |
| MK-8274-017 | OTHER | None | None |