Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder
Post-Marketing Surveillance of Safety and Effectiveness of Abilify Maintena® Injections in Korean Patients With Schizophrenia or Bipolar 1 Disorder Under the "New Drug Re-Examination"
1 other identifier
observational
1,030
1 country
1
Brief Summary
This is a Post-Marketing Surveillance (PMS) of Abilify Maintena® Injections in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: Ministry of Food and Drug Safety(MFDS) Notification).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 13, 2016
CompletedFirst Submitted
Initial submission to the registry
December 22, 2017
CompletedFirst Posted
Study publicly available on registry
December 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2021
CompletedFebruary 14, 2022
February 1, 2022
4.4 years
December 22, 2017
February 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence rate and the number of Adverse Events (AE)/ Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR
until 28 days after discontinuation
Secondary Outcomes (4)
Mean change from baseline to last visit in Clinical Global Impression - Severity of Illness scale (CGI-S) score.
at least 12, 24 weeks interval from baseline
Clinical Global Impression - Improvement scale (CGI-I) score at the last visit
at least 12, 24 weeks interval from baseline
Mean change from baseline to last visit inPersonal and Social Performance Scale (PSP) score.
at least 12, 24 weeks interval from baseline
Overall judgement at last visit compared to baseline, judged holistically according to clinical symptoms: "Effective", "No effect", "Worsen"
at least 12, 24 weeks interval from baseline
Eligibility Criteria
Patients with Schizophrenia or bipolar 1 disorder
You may qualify if:
- Adult patients with schizophrenia or bipolar 1 disorder
- Patients who are prescribed Abilify Maintena® Injections treatment as per investigator's medical judgment
- Patients giving written authorization to use their personal and health data and starting Abilify Maintena® Injections treatment after agreement is in place and investigators provide the explanation about objective and feature of the surveillance
You may not qualify if:
- Patients with known hypersensitivity to Aripiprazole or any excipients of Abilify Maintena® Injections
- Elderly patients with dementia related psychosis
- Patients who have been treated with Abilify Maintena® Injections
- Patients with score 0(Not assessed) or 1(Normal, not at all ill) in the Clinical Global Impression-Severity(CGI-S)
- Patients participating in other clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St.John of God Hospital
Gwangju, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2017
First Posted
December 29, 2017
Study Start
December 13, 2016
Primary Completion
May 25, 2021
Study Completion
May 25, 2021
Last Updated
February 14, 2022
Record last verified: 2022-02