Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-03 @ 8:05 AM
Study NCT ID:
NCT00665366
Status:
COMPLETED
Last Update Posted:
2013-12-02
First Post:
2008-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Organization:
Study Overview
Official Title:
A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated on Valproate or Lithium and in Need of Further Clinical Improvement
Status:
COMPLETED
Status Verified Date:
2013-02
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 purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| EudraCT number 2007-005959-42 | None | None | View |