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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03386851

Enrollment

1030

Registered

2017-12-29

Start date

2016-12-13

Completion date

2021-05-25

Last updated

2022-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar 1 Disorder, Schizophrenia

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 and Drug Safety(MFDS) Notification).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The incidence rate and the number of Adverse Events (AE)/ Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR	until 28 days after discontinuation

Secondary

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

Countries

South Korea

Outcome results