Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04812379
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-02
First Post:
2021-03-16
Brief Title:
Specified Drug-use Survey on Abilify Prolonged Release Aqueous Suspension for IM Injection Prevention of Relapse of Mood Episodes in BP
Sponsor:
Otsuka Pharmaceutical Co Ltd
Organization:
Otsuka Pharmaceutical Co Ltd
Study Overview
Official Title:
Abilify Prolonged Release Aqueous Suspension for Intramuscular Injection Specified Drug-use Results Survey Prevention of RecurrenceRelapse of Mood Episodes in Bipolar I Disorder
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
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:
To investigate the safety for an observation period of 52 weeks with use of Abilify prolonged release aqueous suspension for intramuscular IM injection in patients with bipolar I disorder for prevention of recurrencerelapse of mood episodes in the routine clinical setting The early stage safety after the switching from oral aripiprazole to this IM injection is investigated including extrapyramidal syndrome and malignant syndrome Information regarding efficacy is collected as well
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None