Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-25 @ 4:50 PM
Study NCT ID:
NCT01360866
Status:
COMPLETED
Last Update Posted:
2018-09-17
First Post:
2011-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Organization:
Study Overview
Official Title:
A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder, the Orion Trial
Status:
COMPLETED
Status Verified Date:
2018-09
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:
Orion
Brief Summary:
To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: