Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder
Completed
- Conditions
- SchizophreniaBipolar 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
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of aripiprazole in treating schizophrenia and bipolar 1 disorder in Korean populations?
How does Abilify Maintena® compare to other atypical antipsychotics in long-term treatment of schizophrenia and bipolar 1 disorder?
What biomarkers are associated with response to aripiprazole long-acting injections in Korean patients with schizophrenia or bipolar 1 disorder?
What are the potential adverse events and management strategies for Abilify Maintena® in Korean patients with schizophrenia or bipolar 1 disorder?
What are the current combination therapies involving aripiprazole for schizophrenia and bipolar 1 disorder, and how do they compare to standard-of-care treatments?
Trial Locations
- Locations (1)
St.John of God Hospital
🇰🇷Gwangju, Korea, Republic of
St.John of God Hospital🇰🇷Gwangju, Korea, Republic of