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Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder

Sponsor
Korea Otsuka Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03386851
Collaborator
(none)
1,030
Enrollment
1
Location
53.4
Actual Duration (Months)
19.3
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1030 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    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"
    Actual Study Start Date :
    Dec 13, 2016
    Actual Primary Completion Date :
    May 25, 2021
    Actual Study Completion Date :
    May 25, 2021

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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]

    2. Clinical Global Impression - Improvement scale (CGI-I) score at the last visit [at least 12, 24 weeks interval from baseline]

    3. Mean change from baseline to last visit inPersonal and Social Performance Scale (PSP) score. [at least 12, 24 weeks interval from baseline]

    4. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St.John of God Hospital Gwangju Korea, Republic of

    Sponsors and Collaborators

    • Korea Otsuka Pharmaceutical Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Korea Otsuka Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03386851
    Other Study ID Numbers:
    • 031-402-00089
    First Posted:
    Dec 29, 2017
    Last Update Posted:
    Feb 14, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Schizophrenia

    Study Results

    No Results Posted as of Feb 14, 2022