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Completed

NCT Number: NCT03386851

Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder

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).

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Key information

Conditions

Schizophrenia Bipolar 1 Disorder Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St.John of God Hospital

Gwangju, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The incidence rate and the number of Adverse Events (AE)/ Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR

    Time frame: until 28 days after discontinuation

Secondary outcomes

  1. Mean change from baseline to last visit in Clinical Global Impression - Severity of Illness scale (CGI-S) score.

    Time frame: at least 12, 24 weeks interval from baseline

  2. Clinical Global Impression - Improvement scale (CGI-I) score at the last visit

    Time frame: at least 12, 24 weeks interval from baseline

  3. Mean change from baseline to last visit inPersonal and Social Performance Scale (PSP) score.

    Time frame: 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"

    Time frame: at least 12, 24 weeks interval from baseline

Sponsors and collaborators

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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"

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2017
Registry last updated
Feb 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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