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NCT00490971 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Effectiveness and Safety of Extended-Release (ER) Paliperidone Compared With Placebo in Delaying the Recurrence of Symptoms in Bipolar I Disorder
A Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 3
- Development phase
- 768
- Enrollment target
NCT00490971: Completed Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
NCT00490971 is a Phase 3 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 768 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00490971, a Phase 3 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 768 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effectiveness and safety of oral extended-release (ER) paliperidone compared with placebo in the prevention of the recurrence of mood symptoms in patients with Bipolar I Disorder who initially respond to treatment of an acute manic or mixed episode with paliperidone ER. Olanzapine was included as an active control arm, although the study is not designed to allow for a direct comparison of olanzapine with paliperidone.
Primary Outcome
Time to first recurrence of any mood symptoms (ie, manic or depressive) associated with bipolar I disorder during the maintenance phase, after maintaining clinical stability during continued treatment with paliperidone ER over a period of 15 weeks. The time period was from occurrence of acute manic or mixed episode to Week 15. This outcome was measured using combination of various scales, hospitalization for any mood symptoms, use of any medicines for an mood episode and clinical events suggesti
Interventions
- DRUG Placebo
- DRUG Olanzapine
- DRUG Paliperidone ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 768 participants |
| Start Date | 2006-05 |
| Est. Completion | 2010-04 |
| Phase | Phase 3 |
What the finished NCT00490971 record still lists
NCT00490971 is an interventional study that assigns participants to a tested intervention. The registered 768 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00490971 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00490971 about?
NCT00490971 is a clinical study titled "A Study to Evaluate the Effectiveness and Safety of Extended-Release (ER) Paliperidone Compared With Placebo in Delaying the Recurrence of Symptoms in Bipolar I Disorder". The purpose of this study is to evaluate the effectiveness and safety of oral extended-release (ER) paliperidone compared with placebo in the prevention of the recurrence of mood symptoms in patients with Bipolar I Disorder who initially respond to treatment of an acute manic or mixed episode with p...
What is the current status of trial NCT00490971?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 768 participants. The study started on 2006-05. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00490971?
The interventions under investigation include: Placebo (DRUG), Olanzapine (DRUG), Paliperidone ER (DRUG).
Who is sponsoring clinical trial NCT00490971?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00490971's enrollment target sits among peer trials
768 445th of 2000 higher than 1,556 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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