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Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder | Clinical Trials | Clareo Health

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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"

NCT03386851•Korea Otsuka Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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).

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

St.John of God Hospital

Gwangju, South Korea

Key Dates

Start Date

December 13, 2016

Primary Completion Date

May 25, 2021

Completion Date

May 25, 2021

Last Updated

February 14, 2022

Enrollment

1,030

ACTUAL participants

Conditions

SchizophreniaBipolar 1 Disorder

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 14, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder

Inclusion Criteria

Exclusion Criteria

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