Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder

Otsuka

Status: Completed

Conditions: Schizophrenia; Bipolar 1 Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT03386851

031-402-00089

Details and patient eligibility

About

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).

Enrollment: 1,030 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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
• All patients who in medical judgment of the investigator would not be appropriate for inclusion criteria in the surveillance