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: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

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Key information

Conditions

Affective Psychosis, Bipolar Bipolar Disorder Bipolar and Related Disorders Mania Manic Disorder Manic State Manic-Depressive Psychosis Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychoses, Manic-Depressive Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quetiapine fumarate (Seroquel) SR

Drug

Primary outcomes

Change from baseline to final visit in the YMRS total score

Secondary outcomes

Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start: 2007
Study completion: 2007
First posted: Jan 15, 2007
Registry last updated: Mar 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed