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 Type
OBSERVATIONAL
Enrollment
1,030
St.John of God Hospital
Gwangju, South Korea
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
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
Clinical Global Impression - Improvement scale (CGI-I) score at the last visit
Time frame: 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
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
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