NCT00216723: Aripiprazole after marketing in Korean adults

Medicine Signal Editorial Desk
Updated 2026-10-10

Registry status when checked 2026-10-10Completed

Study: Korean postmarketing observation of aripiprazole in adults with schizophrenia, schizoaffective disorder, or bipolar disorder, sponsored by Korea Otsuka. 1 2

Design and measurements: This was a prospective, multicenter, open-label observational study, not a randomized comparison against another antipsychotic. The record specifies follow-up of 12 weeks for schizophrenia and eight weeks for bipolar disorder, with safety and clinical effectiveness assessments. Enrollment of 3,000 was anticipated, rather than verified as the actual number analyzed. 1 2

What is established: The historical record is marked completed, with an October 2013 update. No numerical symptom improvement, adverse-event frequency, or comparative effectiveness estimate was verified. The intended large sample should not be presented as 3,000 documented treatment successes. 1 2

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00216723. Original study registration: sponsor, design, population, endpoints and dated history.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00216723. Original study registration: sponsor, design, population, endpoints and dated history.

2. ICH GCP — ICH GCP — readable reproduction of the sponsor-submitted ClinicalTrials.gov record. Supports the registration details quoted here; not an independent clinical-results publication.Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.