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"

Korea Otsuka Pharmaceutical Co., Ltd.1 site in 1 country1,030 target enrollmentDecember 13, 2016

ConditionsSchizophrenia Bipolar 1 Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Schizophrenia
Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Enrollment: 1030
Locations: 1
Primary Endpoint: The incidence rate and the number of Adverse Events (AE)/ Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

December 13, 2016

End Date

May 25, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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
•All patients who in medical judgment of the investigator would not be appropriate for inclusion criteria in the surveillance

Outcomes

Primary Outcomes

The incidence rate and the number of Adverse Events (AE)/ Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR

Time Frame: until 28 days after discontinuation

Secondary Outcomes

Mean change from baseline to last visit inPersonal and Social Performance Scale (PSP) score.(at least 12, 24 weeks interval from baseline)
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)
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)
Clinical Global Impression - Improvement scale (CGI-I) score at the last visit(at least 12, 24 weeks interval from baseline)