Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-29 @ 4:40 AM
Study NCT ID:
NCT01737268
Status:
COMPLETED
Last Update Posted:
2024-11-19
First Post:
2012-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Study of FK949E in Elderly Bipolar Disorder Patients
Sponsor:
Astellas Pharma Inc
Organization:
Study Overview
Official Title:
Long-term Study of FK949E in Elderly Patients -Long-term Study in Elderly Bipolar Disorder Patients With Major Depressive Episodes-
Status:
COMPLETED
Status Verified Date:
2024-10
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:
FK949E was administered to elderly bipolar disorder patients with major depressive episode for 52 weeks. Its safety, efficacy, and plasma concentration change were evaluated in an open-label manner.
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?: