Quetiapine Fumarate Bipolar Maintenance Monotherapy

NCT ID: NCT00314184

Last Updated: 2008-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar Disorder

Keywords

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Bipolar I disorder.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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quetiapine fumarate

Intervention Type DRUG

Other Intervention Names

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Seroquel

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* 18 years or older
* A diagnosis of Bipolar I Disorder
* Have a current manic, depressed or mixed episode
* Have had a manic, depressed or mixed episode during the last 26 weeks that was treated with quetiapine
* Female patients of childbearing potential must be using a reliable method of contraception

Exclusion Criteria

* Pregnancy
* Substance or alcohol dependence at enrollment
* Unstable thyroid function
* Unstable Diabetes
* Unstable or inadequately treated medical illness e.g., angina pectoris and hypertension
* Use of an experimental drug within 30 days of enrollment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca CNS Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Cerritos, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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Washington D.C., District of Columbia, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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North Miami, Florida, United States

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Orlando, Florida, United States

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Atlanta, Georgia, United States

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Eagle, Idaho, United States

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Hoffman Estates, Illinois, United States

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Terre Haute, Indiana, United States

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Shreveport, Louisiana, United States

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Flowood, Mississippi, United States

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Saint Charles, Missouri, United States

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Las Vegas, Nevada, United States

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Clementon, New Jersey, United States

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Rochester, New York, United States

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Raleigh, North Carolina, United States

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Fargo, North Dakota, United States

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Portland, Oregon, United States

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Salem, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Lake Jackson, Texas, United States

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Richmond, Virginia, United States

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Bellevue, Washington, United States

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Kirkland, Washington, United States

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Seattle, Washington, United States

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Capital Federal, , Argentina

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Córdoba, , Argentina

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La Plata, , Argentina

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Lanús, , Argentina

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Mendoza, , Argentina

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Rosario, , Argentina

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Burgas, , Bulgaria

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Antioquia, , Colombia

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Barranquilla, , Colombia

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Bogotá, , Colombia

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Pereira, , Colombia

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Ahmedabad, , India

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Chennai, , India

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Jaipur, , India

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Kanpur, , India

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Lucknow, , India

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Mangalore, , India

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Manipal, , India

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Mumbai, , India

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New Delhi, , India

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Visakhapatnam, , India

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Kaunas, , Lithuania

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Klaipėda, , Lithuania

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Vilnius, , Lithuania

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Kuala Lumpur, , Malaysia

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Sarawak, , Malaysia

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León, , Mexico

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México, , Mexico

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San Luis Potosí City, , Mexico

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Lima, , Peru

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Cebu City, , Philippines

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Davao City, , Philippines

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Mandaluyong, , Philippines

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Manila, , Philippines

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Quezon City, , Philippines

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Arad, , Romania

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Brasov, , Romania

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Com Jebel, , Romania

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Craiova, , Romania

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Iași, , Romania

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Oradea, , Romania

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Piteşti, , Romania

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Sibiu, , Romania

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Târgovişte, , Romania

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Târgu Mureş, , Romania

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Kazan', , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Kaohsiung Hsien, , Taiwan

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Taipei, , Taiwan

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Taoyuan, , Taiwan

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Taoyuan Hsien, , Taiwan

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Bangkok, , Thailand

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Dnipro, , Ukraine

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Kharkiv, , Ukraine

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Kiev, , Ukraine

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Kyiv, , Ukraine

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Lviv, , Ukraine

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Odesa, , Ukraine

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Simferopol, , Ukraine

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Vinnitsa, , Ukraine

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Countries

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Chile United States Argentina Bulgaria Colombia India Lithuania Malaysia Mexico Peru Philippines Romania Russia Taiwan Thailand Ukraine

References

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Weisler RH, Nolen WA, Neijber A, Hellqvist A, Paulsson B; Trial 144 Study Investigators. Continuation of quetiapine versus switching to placebo or lithium for maintenance treatment of bipolar I disorder (Trial 144: a randomized controlled study). J Clin Psychiatry. 2011 Nov;72(11):1452-64. doi: 10.4088/JCP.11m06878.

Reference Type DERIVED
PMID: 22054050 (View on PubMed)

Other Identifiers

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EUDRACT 2004-000915-25

Identifier Type: -

Identifier Source: secondary_id

D1447C00144

Identifier Type: -

Identifier Source: org_study_id