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Completed Phase 3 Interventional

Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder

ClinicalTrials.gov ID: NCT00081380

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.

ClinicalTrials.gov public records Last synced May 12, 2026, 8:30 AM EDT

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)

Study identification

NCT ID
NCT00081380
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
AstraZeneca
Industry
Enrollment
710 participants

Conditions and interventions

Interventions

  • Seroquel®, quetiapine fumarate (atypical antipsychotic) Drug
  • divalproex (mood stabilizer) Drug
  • lithium (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
Feb 29, 2004
Primary completion
Not listed
Completion
Aug 31, 2006
Last update posted
Dec 21, 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 21, 2008 · Synced May 12, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00081380 live on ClinicalTrials.gov.

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