Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder

Completed

• Conditions: Schizophrenia; Bipolar 1 Disorder

• Registration Number: NCT03386851
• Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-13
• Study First Submitted: 2017-12-22
• Study First Submitted QC: 2017-12-22
• Study First Posted: 2017-12-29
• Primary Completion: 2021-05-25
• Study Completion: 2021-05-25
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-10
• Last Update Posted: 2022-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1030

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Clinical Global Impression - Improvement scale (CGI-I) score at the last visit	at least 12, 24 weeks interval from baseline

Trial Locations

Locations (1)

St.John of God Hospital; 🇰🇷 Gwangju, Korea, Republic of