Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder

Schizophrenia Clinical Trial

Official title:

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03386851
• Other study ID #: 031-402-00089
• Status: Completed
• Start date: December 13, 2016
• Est. completion date: May 25, 2021

Study information

• Verified date: February 2022
• Source: Korea Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1030
• Est. completion date: May 25, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar 1 Disorder
• Schizophrenia

Locations

Country	Name	City	State
Korea, Republic of	St.John of God Hospital	Gwangju

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Clinical Global Impression - Improvement scale (CGI-I) score at the last visit		at least 12, 24 weeks interval from baseline
Secondary	Mean change from baseline to last visit inPersonal and Social Performance Scale (PSP) score.		at least 12, 24 weeks interval from baseline
Secondary	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