Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-04-19 @ 6:53 AM
Study NCT ID:
NCT03005769
Status:
COMPLETED
Last Update Posted:
2017-07-19
First Post:
2016-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Demographic and Clinical Predictors of Persistence in Patients Treated With Aripiprazole Once-monthly in Italy
Sponsor:
Otsuka Pharmaceutical Europe Ltd
Organization:
Study Overview
Official Title:
Demographic and Clinical Predictors of Persistence in Patients Treated With Aripiprazole Once-monthly in the Italian Clinical Practice: a Retrospective Cohort, Observational Study
Status:
COMPLETED
Status Verified Date:
2017-05
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:
DOMINO
Brief Summary:
This is an observational, retrospective, non-interventional study that will include schizophrenic patients who were initiated with aripiprazole once-monthly as per normal clinical practice at least 6 months before the data collection starts (inclusion visit), and is designed to evaluate demographic and clinical predictors of persistence with this treatment.
Data from each patient will be collected after informed consent is signed (inclusion visit), and will include retrospective information from the start of aripiprazole once-monthly treatment initiation (index date) until the follow-up/inclusion visit (minimum of 6 months after the index date). Data will be retrospectively collected from all visits occurring as per clinical practice (usually once monthly).
Data from each patient will be collected after informed consent is signed (inclusion visit), and will include retrospective information from the start of aripiprazole once-monthly treatment initiation (index date) until the follow-up/inclusion visit (minimum of 6 months after the index date). Data will be retrospectively collected from all visits occurring as per clinical practice (usually once monthly).
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?: