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NCT01009047 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 228
- Enrollment target
NCT01009047: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT01009047 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 228 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01009047, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 228 participants
- Enrollment target
Study 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) .
Primary Outcome
The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Interventions
- DRUG Aripiprazole
- DRUG Paliperidone extended release (ER)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2009-12 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
What the finished NCT01009047 record still lists
NCT01009047 is an interventional study that assigns participants to a tested intervention. The registered 228 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Aripiprazole is the first listed.
NCT01009047 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01009047 about?
NCT01009047 is a clinical study titled "An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia". 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, detachmen...
What is the current status of trial NCT01009047?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 228 participants. The study started on 2009-12. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01009047?
The interventions under investigation include: Aripiprazole (DRUG), Paliperidone extended release (ER) (DRUG).
Who is sponsoring clinical trial NCT01009047?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01009047's enrollment target sits among peer trials
228 1309th of 2000 higher than 691 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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