Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145509
Status:
COMPLETED
Last Update Posted:
2022-02-08
First Post:
2005-09-01
Brief Title:
40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder A7501009P05786
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A Phase 3 Placebo-Controlled Double-Blinded Continuation Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Completing a 12-week Lead-in Trial and 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:
The primary objective of this trial was to characterize the long-term up to 40 weeks safety and tolerability of asenapine in bipolar I disorder subjects who had not completely responded to continuing treatment with lithium or valproic acid VPA for the treatment of an acute manic or mixed episodes upon enrollment into the 12-week lead-in trial A7501008 NCT00145470 The safety comparison was between the group receiving lithium or VPA and placebo against the group receiving lithium or VPA and asenapine with the caveat that all subjects may have received benzodiazepine andor antidepressant rescue medication as needed
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 |
|---|---|---|---|
| A7501009 | None | None | None |