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Completed Phase 3 Interventional

Phase 3 /Seroquel SR Acute Mania Monotherapy - US

ClinicalTrials.gov ID: NCT00422123

Public ClinicalTrials.gov record NCT00422123. 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 29, 2026, 9:45 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

A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Mania

Brief summary

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

The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Mania for 3 weeks. 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
NCT00422123
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
AstraZeneca
Industry
Enrollment
447 participants

Conditions and interventions

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
Jan 2007 (Type not available)
Primary completion
Not listed
Completion
Jul 2007 (Actual)
Last update posted
Mar 25, 2009

2007

United States locations

U.S. sites
51
U.S. states
25
U.S. cities
51
Facility City State ZIP Site status
Research Site Phoenix Arizona — —
Research Site Little Rock Arkansas — —
Research Site Cerritos California — —
Research Site Garden Grove California — —
Research Site Oceanside California — —
Research Site Pico Rivera California — —
Research Site San Diego California — —
Research Site Santa Ana California — —
Research Site Torrance California — —
Research Site Denver Colorado — —
Research Site Washington D.C. District of Columbia — —
Research Site Aventura Florida — —
Research Site EAST Bradenton Florida — —
Research Sitew Fort Lauderdale Florida — —
Research Site Hollywood Florida — —
Research Site Leesburg Florida — —
Research Site Tampa Florida — —
Research Site Atlanta Georgia — —
Research Site Honolulu Hawaii — —
Research Site Hoffman Estates Illinois — —
Research Site Naperville Illinois — —
Research Site OAK Brook Terrace Illinois — —
Research Site Greenwood Indiana — —
Research Site Indianapolis Indiana — —
Research Site Newton Kansas — —
Research Site Wichita Kansas — —
Research Site Lake Charles Louisiana — —
Research Site New Orleans Louisiana — —
Research Site Shreveport Louisiana — —
Research Site Rockville Maryland — —
Research Site St Louis Missouri — —
Research Site Kenilworth New Jersey — —
Research Site Willingboro New Jersey — —
Research Site Elmsford New York — —
Research Site Holliswood New York — —
Research Site Durham North Carolina — —
Research Site Beachwood Ohio — —
Research Site Oklahoma City Oklahoma — —
Research Site Moon Township Pennsylvania — —
Research Site Philadelphia Pennsylvania — —
Research Site Charleston South Carolina — —
Research Site Memphis Tennessee — —
Research Site Nashville Tennessee — —
Research Site Austin Texas — —
Research Site DeSoto Texas — —
Research Site Houston Texas — —
Research Site Irving Texas — —
Research Site San Antonio Texas — —
Research Site Arlington Virginia — —
Research Site Richmond Virginia — —
Research Site Bellevue Washington — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00422123, 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 Mar 25, 2009 · Synced Oct 29, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00422123 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →