Trials / Terminated
TerminatedNCT01122927
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.
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 524 (actual)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 10 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
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
Conditions
- Adolescent Schizophrenia
- Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aripiprazole | Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg) pill taken orally once per day |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2014-08-01
- Completion
- 2014-09-01
- First posted
- 2010-05-13
- Last updated
- 2016-02-08
- Results posted
- 2016-02-08
Locations
101 sites across 13 countries: United States, Bulgaria, Croatia, Hungary, India, Malaysia, Philippines, Poland, Romania, Russia, Serbia, Taiwan, Ukraine
Source: ClinicalTrials.gov record NCT01122927. Inclusion in this directory is not an endorsement.