Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia
Public ClinicalTrials.gov record NCT01149655. 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, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aripiprazole (OPC 14597) as Maintenance Treatment in Adolescent Patients With Schizophrenia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This will be a randomized, double-blind, placebo-controlled study consisting of a screening period, a conversion phase (Phase 1), a stabilization phase (Phase 2), and a double-blind maintenance treatment phase (Phase 3), and a follow up period. Subjects may be either outpatients or inpatients between screening and through the time they reach stabilization at the end of Phase 2; hospitalization is not a study requirement. However, eligible subjects must be outpatients at the beginning of Phase 3. Subjects will be assessed weekly during Phase 1, weekly for the first 4 weeks of Phase 2 and 3, and biweekly for the remaining weeks during each of Phases 2 and 3. Subjects will be encouraged to call the investigators with any exacerbation of psychotic symptoms and/or any tolerability issues. The investigator will also have the option to phone the subjects and their guardian(s) at any time to ensure clinical stability. A data monitoring committee (DMC) will provide oversight for safety monitoring and reviewing the interim analysis. One interim analysis is planned after 75% of the total expected number of impending relapse events (28 events) are achieved and will be conducted by an independent data analysis center. The DMC will make a recommendation about stopping or continuing the study based on safety and efficacy reviews. The results of the interim analysis and individual subject data will remain blinded to the sponsor during the course of the study until the DMC determines that the study will conclude based on the results of the interim analysis, or the study is completed after 37 endpoint events.
Study identification
- NCT ID
- NCT01149655
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 252 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 13 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
- Jun 30, 2011
- Primary completion
- Oct 31, 2013
- Completion
- Nov 30, 2013
- Last update posted
- Apr 1, 2015
2011 – 2013
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Study Site | Downy | California | 90241 | — |
| Study Site | Glendale | California | 91204 | — |
| Study Site | Miami | Florida | 33155 | — |
| Study Site | Miami Springs | Florida | 33166 | — |
| Study Site | Atlanta | Georgia | 30308 | — |
| Study Site | Bloomfield Hills | Michigan | 48302 | — |
| Study Site | Chapel Hill | North Carolina | 27517 | — |
| Study Site | Bothell | Washington | 98011 | — |
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 44 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01149655, 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 Apr 1, 2015 · Synced Sep 28, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01149655 live on ClinicalTrials.gov.