drugset / Trial / NCT01009047
An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of extended-release (ER) paliperidone compared to aripiprazole (atypical antipsychotic) in symptomatic (having symptoms) adolescent participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations \[imagining things\], and withdrawal into the self) .
Timeline
- Start
- 2009-12
- Primary completion
- 2012-06
- Completion
- 2012-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aripiprazole | Other / unclassified | 5 mg | Oral |
| Comparator | Aripiprazole | Other / unclassified | 10 mg | Oral |
| Comparator | Aripiprazole | Other / unclassified | 15 mg | Oral |
| Subject | Paliperidone | Unknown | 3 mg | Oral |
| Subject | Paliperidone | Unknown | 6 mg | Oral |
| Subject | Paliperidone | Unknown | 9 mg | Oral |