SchizophreniaNCT03386851
Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder
An observational study of Schizophrenia and Bipolar 1 Disorder, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Schizophrenia, Bipolar 1 Disorder
- How many people
- 1,030 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Dec 2016to 25 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Schizophrenia or bipolar 1 disorder
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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"
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).
- Conditions
- Schizophrenia, Bipolar 1 Disorder
- Medical subject headings
- Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate and the number of Adverse Events (AE)/ Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR
Measured: until 28 days after discontinuation
Secondary outcomes (4)
Mean change from baseline to last visit in Clinical Global Impression - Severity of Illness scale (CGI-S) score.
Measured: at least 12, 24 weeks interval from baseline
Clinical Global Impression - Improvement scale (CGI-I) score at the last visit
Measured: at least 12, 24 weeks interval from baseline
Mean change from baseline to last visit inPersonal and Social Performance Scale (PSP) score.
Measured: 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"
Measured: at least 12, 24 weeks interval from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start13 Dec 2016
- Primary completion25 May 2021
- Study completion25 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,030 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386851
- Sponsor's protocol ID
- 031-402-00089
- Status last verified
- Feb 2022
- First submitted
- 22 Dec 2017
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT03386851
- Acronym / sponsor ID
- 031-402-00089
- Conditions
- Schizophrenia, Bipolar 1 Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,030 participants (actual)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2016 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Schizophrenia or bipolar 1 disorder
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
Clinical Global Impression - Improvement scale (CGI-I) score at the last visit
Time frame: at least 12, 24 weeks interval from baseline
Mean change from baseline to last visit inPersonal and Social Performance Scale (PSP) score.
Time frame: 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"
Time frame: at least 12, 24 weeks interval from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Bipolar 1 Disorder, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.