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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 Oct 20, 2026, 7:06 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

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
Mar 2005 (Type not available)
Primary completion
Not listed
Completion
Jul 2007 (Actual)
Last update posted
Dec 22, 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 22, 2008 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00314184 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →