Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features.
Public ClinicalTrials.gov record NCT01122927. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Long-term, Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Flexible-Dose Oral Aripiprazole (OPC-14597) as Maintenance Treatment in Adolescent Patients With Schizophrenia or Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open-label study consisting of a screening period, a conversion/titration phase (Phase 1), an open-label treatment phase (Phase 2), and a follow-up period. The study will enroll new subjects (hereafter referred as "de novo" subjects) with schizophrenia, or bipolar I disorder, manic or mixed episode with or without psychotic features, and rollover subjects with schizophrenia from 31-09-266 (hereafter referred to as "Study 266"). All de novo subjects must enter the screening period of the study. Subjects who are screened and are not required to go through Phase 1 will complete a Phase 2 baseline visit prior to their participation in Phase 2. Study Design: Treatment, Single Group Assignment, Open Label, Active Control, Safety/Efficacy Study
Study identification
- NCT ID
- NCT01122927
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 524 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 10 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2010 (Type not available)
- Primary completion
- Aug 2014 (Actual)
- Completion
- Sep 2014 (Actual)
- Last update posted
- Feb 8, 2016
2010 – 2014
United States locations
- U.S. sites
- 23
- U.S. states
- 16
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Study Site | Dothan | Alabama | 36303 | — |
| Study Site | Downey | California | 90241 | — |
| Study Site | Miami | Florida | 33155 | — |
| Study Site | Miami | Florida | 33166 | — |
| Study Site | Atlanta | Georgia | 30308 | — |
| Study Site | Smyrna | Georgia | 30080 | — |
| Study Site | Oak Brook | Illinois | 60523 | — |
| Study Site | Wichita | Kansas | 67214 | — |
| Study Site | Minneapolis | Minnesota | 55454 | — |
| Study Site | Buffalo | New York | 14215 | — |
| Study Site | Stony Brook | New York | 11794 | — |
| Study Site | Chapel Hill | North Carolina | 27517 | — |
| Study Site | Cincinnati | Ohio | 45219 | — |
| Study Site | Cleveland | Ohio | 44106 | — |
| Study Site | Oklahoma City | Oklahoma | 73116 | — |
| Study Site | Philadelphia | Pennsylvania | 19139 | — |
| Study Site | Houston | Texas | 77090 | — |
| Study Site | San Antonio | Texas | 78258 | — |
| Study Site | The Woodlands | Texas | 77381 | — |
| Study Site | Richmond | Virginia | 23230 | — |
| Study Site | Bellevue | Washington | 98004 | — |
| Study Site | Bothell | Washington | 98011 | — |
| Study Site | Milwaukee | Wisconsin | 53227 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 78 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01122927, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 8, 2016 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01122927 live on ClinicalTrials.gov.