Status:
COMPLETED
Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder
Lead Sponsor:
Korea Otsuka Pharmaceutical Co., Ltd.
Conditions:
Schizophrenia
Bipolar 1 Disorder
Eligibility:
All Genders
19+ years
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 13 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 25 2021
Estimated Enrollment :
1030 Patients enrolled
Trial Details
Trial ID
NCT03386851
Start Date
December 13 2016
End Date
May 25 2021
Last Update
February 14 2022
Active Locations (1)
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1
St.John of God Hospital
Gwangju, South Korea