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Phase 3 /Seroquel SR Acute Mania Monotherapy - US | Clinical Trials | Clareo Health

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COMPLETEDPhase 3NCT00422123

Phase 3 /Seroquel SR Acute Mania Monotherapy - US

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: ...

Lead sponsor: AstraZeneca•51 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

AstraZeneca

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Provision of written informed consent
•Documented diagnosis of Bipolar Disorder, with most recent episode being manic or mixed
•Inpatient hospital admission for the first 4 days of study treatment

Exclusion Criteria

•\>8 mood episodes within the last 12 months
•Use of prohibited medication
•Substance or alcohol abuse or dependence
•Current suicide risk or suicide attempt within last 6 months.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 25, 2009Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment447

Start dateJan 2007

Last updatedMar 25, 2009

Condition

Affective Psychosis, Bipolar Manic Disorder Manic-Depressive Psychosis Mania Manic State+1 more

Locations shown

Research Site

Phoenix, Arizona

Research Site

Little Rock, Arkansas

Research Site

Cerritos, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 25, 2009Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions