Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder

February 10, 2022 updated by: Korea Otsuka Pharmaceutical Co., Ltd.

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"

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1030

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Korea, Republic of
- - Gwangju, Korea, Republic of
    - St.John of God Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Schizophrenia or bipolar 1 disorder

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	until 28 days after discontinuation

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline to last visit in Clinical Global Impression - Severity of Illness scale (CGI-S) score. Time Frame: at least 12, 24 weeks interval from baseline	at least 12, 24 weeks interval from baseline
Clinical Global Impression - Improvement scale (CGI-I) score at the last visit Time Frame: at least 12, 24 weeks interval from baseline	at least 12, 24 weeks interval from baseline
Mean change from baseline to last visit inPersonal and Social Performance Scale (PSP) score. Time Frame: at least 12, 24 weeks interval from baseline	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" Time Frame: at least 12, 24 weeks interval from baseline	at least 12, 24 weeks interval from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 13, 2016

Primary Completion (ACTUAL)

May 25, 2021

Study Completion (ACTUAL)

May 25, 2021

Study Registration Dates

First Submitted

December 22, 2017

First Submitted That Met QC Criteria