CompletedNCT03386851Updated Feb 14, 2022

Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder

An observational study in Schizophrenia and Bipolar 1 Disorder, sponsored by Korea Otsuka Pharmaceutical Co., Ltd.. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-02-14.

Sponsored by Korea Otsuka Pharmaceutical Co., Ltd. (part of Otsuka Holdings Co., Ltd.) · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 1,030
Ages: 19 Years and older
Sex: All

Study 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).

Conditions studied

Schizophrenia
Bipolar 1 Disorder

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Schizophrenia 3,539

In context

Schizophrenia

3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.

This study's enrollment of 1,030 is above the median of 178 across 503 observational studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 42 studies on the registry; 3 are open to participants now.

Browse Korea Otsuka Pharmaceutical Co., Ltd. studies →All Otsuka Holdings Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Patients with Schizophrenia or bipolar 1 disorder

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Observational model: Case-only
Time perspective: Prospective
Enrollment: 1,030 participants (actual)
Patient registry: No

What researchers measure

Primary outcomes

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

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

Study locations

1 site

St.John of God Hospital
Gwangju, South Korea

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2016 to primary completion in May 2021, 53 months.

Of 138 observational studies under Schizophrenia, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 114. This study's 53 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered: Dec 22, 2017
First posted: Dec 29, 2017
StartActual: Dec 13, 2016
Primary completionActual: May 25, 2021
CompletionActual: May 25, 2021
Last update: Feb 14, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03386851
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Dec 29, 2017
Start date: Dec 13, 2016
Primary completion: May 25, 2021
Completion: May 25, 2021
Last update: Feb 14, 2022

Oversight

FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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