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Completed Phase 3 Interventional

Quetiapine Fumarate Bipolar Maintenance Monotherapy

ClinicalTrials.gov ID: NCT00314184

Public ClinicalTrials.gov record NCT00314184. 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 Sep 2, 2026, 6:59 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, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Quetiapine Fumarate and Lithium as Monotherapy for up to 104 Weeks Maintenance Treatment of Bipolar I Disorder in Adult Patients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up to 104 weeks of maintenance treatment in adult patients with Bipolar I Disorder. 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
NCT00314184
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
AstraZeneca
Industry
Enrollment
1,255 participants

Conditions and interventions

Interventions

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 28, 2005
Primary completion
Not listed
Completion
Jun 30, 2007
Last update posted
Dec 21, 2008

2005 – 2007

United States locations

U.S. sites
30
U.S. states
21
U.S. cities
30
Facility City State ZIP Site status
Research Site Cerritos California
Research Site San Diego California
Research Site Santa Ana California
Research Site Washington D.C. District of Columbia
Research Site Gainesville Florida
Research Site Jacksonville Florida
Research Site North Miami Florida
Research Site Orlando Florida
Research Site Atlanta Georgia
Research Site Eagle Idaho
Research Site Hoffman Estates Illinois
Research Site Terre Haute Indiana
Research Site Shreveport Louisiana
Research Site Flowood Mississippi
Research Site Saint Charles Missouri
Research Site Las Vegas Nevada
Research Site Clementon New Jersey
Research Site Rochester New York
Research Site Raleigh North Carolina
Research Site Fargo North Dakota
Research Site Portland Oregon
Research Site Salem Oregon
Research Site Philadelphia Pennsylvania
Research Site Memphis Tennessee
Research Site Austin Texas
Research Site Lake Jackson Texas
Research Site Richmond Virginia
Research Site Bellevue Washington
Research Site Kirkland Washington
Research Site Seattle 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 65 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00314184, 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 Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00314184 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →