A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder
Public ClinicalTrials.gov record NCT00309699. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone Compared With Flexibly-Dosed Quetiapine and Placebo in the Treatment of Acute Manic and Mixed Episodes in Bipolar Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the effectiveness and safety of flexible-doses paliperidone ER (3 to 12 mg as needed) compared with placebo over 3 weeks in patients with Bipolar I Disorder who are experiencing an acute manic or mixed episode. This study will also evaluate the effects of paliperidone ER on global functioning, and will compare the effectiveness of flexible doses of paliperidone ER to that of quetiapine over 12 weeks.
Study identification
- NCT ID
- NCT00309699
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 493 participants
Conditions and interventions
Conditions
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 2006 (Type not available)
- Primary completion
- Sep 2007 (Actual)
- Completion
- Nov 2007 (Actual)
- Last update posted
- Jun 20, 2014
2006 – 2007
United States locations
- U.S. sites
- 22
- U.S. states
- 12
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Cerritos | California | — | — |
| Not listed | Garden Grove | California | — | — |
| Not listed | Oceanside | California | — | — |
| Not listed | San Diego | California | — | — |
| Not listed | Bradenton | Florida | — | — |
| Not listed | Fort Lauderdale | Florida | — | — |
| Not listed | Kissimmee | Florida | — | — |
| Not listed | Maitland | Florida | — | — |
| Not listed | South Miami | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | Prairie Village | Kansas | — | — |
| Not listed | Lake Charles | Louisiana | — | — |
| Not listed | Shreveport | Louisiana | — | — |
| Not listed | Flowood | Mississippi | — | — |
| Not listed | Clementon | New Jersey | — | — |
| Not listed | Moore | Oklahoma | — | — |
| Not listed | Oklahoma City | Oklahoma | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Memphis | Tennessee | — | — |
| Not listed | Dallas | Texas | — | — |
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 25 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00309699, 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 Jun 20, 2014 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00309699 live on ClinicalTrials.gov.