CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 768 enrolled
Drug / intervention
Olanzapine +2 moredrug
Likely dose
Olanzapine 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00490971
NCT00490971Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Extended-Release Paliperidone as Maintenance Treatment After an Acute Manic or Mixed Episode Associated With Bipolar I Disorder

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Jun 25, 2007·Updated Apr 15, 2015

In Brief

A Phase 3 clinical trial evaluating Olanzapine, Paliperidone ER, and 1 other intervention for Bipolar Disorder. Completed, enrolled 768 participants across 78 sites in 16 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesBulgaria, China, Costa Rica, France, Germany, India, Malaysia, Panama, Poland, Romania, Russia, Serbia, South Africa, Turkey (Türkiye), Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 25, 2007
Enrollment StartMay 1, 2006
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 19.0 years ago

Interventions

Olanzapinedrug

Once daily in dose range of 5 to 20 mg/day for 15 weeks, then until recurrence

Paliperidone ERdrug

Once daily in dose range of 3 to 12 mg/day for 15 weeks, then until recurrence

Placebodrug

Once daily until recurrence (only after initial 15 weeks on paliperidone ER)