ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00490971

Public ClinicalTrials.gov record NCT00490971. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 19, 2026, 9:34 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT00490971
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Industry
Enrollment
768 participants

Conditions and interventions

Interventions

  • Olanzapine Drug
  • Paliperidone ER Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2006
Primary completion
Mar 31, 2010
Completion
Mar 31, 2010
Last update posted
Apr 14, 2015

2006 – 2010

United States locations

U.S. sites
16
U.S. states
12
U.S. cities
16
Facility City State ZIP Site status
Not listed Scottsdale Arizona
Not listed Riverside California
Not listed San Diego California
Not listed Jacksonville Florida
Not listed Honolulu Hawaii
Not listed Chicago Illinois
Not listed Hoffman Estates Illinois
Not listed Wichita Kansas
Not listed New Orleans Louisiana
Not listed Willingboro New Jersey
Not listed Cincinnati Ohio
Not listed Lyndhurst Ohio
Not listed Philadelphia Pennsylvania
Not listed Arlington Texas
Not listed Austin Texas
Not listed Bellevue Washington

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 62 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00490971, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 14, 2015 · Synced May 19, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00490971 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →