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Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder

NCT ID: NCT03386851

Last Updated: 2022-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1030 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-13

Study Completion Date

2021-05-25

Brief Summary

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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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Detailed Description

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Conditions

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Schizophrenia Bipolar 1 Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St.John of God Hospital

Gwangju, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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031-402-00089

Identifier Type: -

Identifier Source: org_study_id

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