Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
Public ClinicalTrials.gov record NCT00081380. 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
Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo as Adjunct to Mood Stabilizers (Lithium or Divalproex) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients (Abbreviated)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Study identification
- NCT ID
- NCT00081380
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 710 participants
Conditions and interventions
Conditions
Interventions
- Seroquel®, quetiapine fumarate (atypical antipsychotic) Drug
- lithium (mood stabilizer) Drug
- divalproex (mood stabilizer) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Mar 2004 (Type not available)
- Primary completion
- Not listed
- Completion
- Sep 2006 (Actual)
- Last update posted
- Dec 22, 2008
2004 – 2006
United States locations
- U.S. sites
- 81
- U.S. states
- 31
- U.S. cities
- 81
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Birmingham | Alabama | — | — |
| Research Site | Scottsdale | Arizona | — | — |
| Research Site | Little Rock | Arkansas | — | — |
| Research Site | Anaheim | California | — | — |
| Research Site | Cerritos | California | — | — |
| Research Site | Chula Vista | California | — | — |
| Research Site | Culver City | California | — | — |
| Research Site | Garden Grove | California | — | — |
| Research Site | La Mesa | California | — | — |
| Research Site | Oceanside | California | — | — |
| Research Site | Orange | California | — | — |
| Research Site | Pico Rivera | California | — | — |
| Research Site | Riverside | California | — | — |
| Research Site | Rosemead | California | — | — |
| Research Site | San Diego | California | — | — |
| Research Site | San Francisco | California | — | — |
| Research Site | Santa Ana | California | — | — |
| Research Site | Farmington | Connecticut | — | — |
| Research Site | New Britain | Connecticut | — | — |
| Research Site | Jacksonville | Florida | — | — |
| Research Site | Miami | Florida | — | — |
| Research Site | Orlando | Florida | — | — |
| Research Site | West Palm Beach | Florida | — | — |
| Research Site | Winter Park | Florida | — | — |
| Research Site | Atlanta | Georgia | — | — |
| Research Site | Decatur | Georgia | — | — |
| Research Site | Marietta | Georgia | — | — |
| Research Site | Smyrna | Georgia | — | — |
| Research Site | Honolulu | Hawaii | — | — |
| Research Site | Chicago | Illinois | — | — |
| Research Site | Hoffman Estates | Illinois | — | — |
| Research Site | Joliet | Illinois | — | — |
| Research Site | Evansville | Indiana | — | — |
| Research Site | Greenwood | Indiana | — | — |
| Research Site | Indianapolis | Indiana | — | — |
| Research Site | Wichita | Kansas | — | — |
| Research Site | Florence | Kentucky | — | — |
| Research Site | Lake Charles | Louisiana | — | — |
| Research Site | New Orleans | Louisiana | — | — |
| Research Site | Shreveport | Louisiana | — | — |
| Research Site | Baltimore | Maryland | — | — |
| Research Site | Rockville | Maryland | — | — |
| Research Site | Pittsfield | Massachusetts | — | — |
| Research Site | New Baltimore | Michigan | — | — |
| Research Site | St Louis | Missouri | — | — |
| Research Site | Clementon | New Jersey | — | — |
| Research Site | Moorestown | New Jersey | — | — |
| Research Site | West Caldwell | New Jersey | — | — |
| Research Site | Albuquerque | New Mexico | — | — |
| Research Site | Brooklyn | New York | — | — |
| Research Site | New York | New York | — | — |
| Research Site | The Bronx | New York | — | — |
| Research Site | Butner | North Carolina | — | — |
| Research Site | Raleigh | North Carolina | — | — |
| Research Site | Beachwood | Ohio | — | — |
| Research Site | Cincinnati | Ohio | — | — |
| Research Site | Dayton | Ohio | — | — |
| Research Site | Medina | Ohio | — | — |
| Research Site | Oklahoma City | Oklahoma | — | — |
| Research Site | Tulsa | Oklahoma | — | — |
| Research Site | Eugene | Oregon | — | — |
| Research Site | Portland | Oregon | — | — |
| Research Site | Emmaus | Pennsylvania | — | — |
| Research Site | Moon Township | Pennsylvania | — | — |
| Research Site | Philadelphia | Pennsylvania | — | — |
| Research Site | Charleston | South Carolina | — | — |
| Research Site | Memphis | Tennessee | — | — |
| Research Site | Austin | Texas | — | — |
| Research Site | Dallas | Texas | — | — |
| Research Site | DeSoto | Texas | — | — |
| Research Site | Houston | Texas | — | — |
| Research Site | Irving | Texas | — | — |
| Research Site | San Antonio | Texas | — | — |
| Research Site | Wichita Falls | Texas | — | — |
| Research Site | Charlottesville | Virginia | — | — |
| Research Site | Falls Church | Virginia | — | — |
| Research Site | Richmond | Virginia | — | — |
| Research Site | Virginia Beach | Virginia | — | — |
| Research Site | Bellevue | Washington | — | — |
| Research Site | Kirkland | Washington | — | — |
| Research Site | Morgantown | West Virginia | — | — |
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 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00081380, 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 Dec 22, 2008 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00081380 live on ClinicalTrials.gov.