Quetiapine Fumarate Bipolar Maintenance Monotherapy (SPaRCLe)

December 19, 2008 updated by: AstraZeneca

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

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 Overview

Status

Completed

Conditions

Bipolar Disorder

Intervention / Treatment

Drug: quetiapine fumarate

Study Type

Interventional

Enrollment (Actual)

1255

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Capital Federal, Argentina
    - Research Site
  - Cordoba, Argentina
    - Research Site
  - La Plata, Argentina
    - Research Site
  - Lanus, Argentina
    - Research Site
  - Mendoza, Argentina
    - Research Site
  - Rosario, Argentina
    - Research Site
Bulgaria
- - Bourgas, Bulgaria
    - Research Site
  - Plovdiv, Bulgaria
    - Research Site
  - Sofia, Bulgaria
    - Research Site
Colombia
- - Antioquia, Colombia
    - Research Site
  - Barranquilla, Colombia
    - Research Site
  - Bogota, Colombia
    - Research Site
  - Pereira, Colombia
    - Research Site
India
- - Ahmedabad, India
    - Research Site
  - Chennai, India
    - Research Site
  - Jaipur, India
    - Research Site
  - Kanpur, India
    - Research Site
  - Lucknow, India
    - Research Site
  - Mangalore, India
    - Research Site
  - Manipal, India
    - Research Site
  - Mumbai, India
    - Research Site
  - New Delhi, India
    - Research Site
  - Visakhapatnam, India
    - Research Site
Lithuania
- - Kaunas, Lithuania
    - Research Site
  - Klaipeda, Lithuania
    - Research Site
  - Vilnius, Lithuania
    - Research Site
Malaysia
- - Kuala Lumpur, Malaysia
    - Research Site
  - Sarawak, Malaysia
    - Research Site
Mexico
- - Leon, Mexico
    - Research Site
  - Mexico, Mexico
    - Research Site
  - San Luis Potosi, Mexico
    - Research Site
Peru
- - Lima, Peru
    - Research Site
Philippines
- - Cebu City, Philippines
    - Research Site
  - Davao City, Philippines
    - Research Site
  - Mandaluyong City, Philippines
    - Research Site
  - Manila, Philippines
    - Research Site
  - Quezon City, Philippines
    - Research Site
Romania
- - Arad, Romania
    - Research Site
  - Brasov, Romania
    - Research Site
  - Bucuresti, Romania
    - Research Site
  - Cluj-Napoca, Romania
    - Research Site
  - Com Jebel, Romania
    - Research Site
  - Craiova, Romania
    - Research Site
  - Iasi, Romania
    - Research Site
  - Oradea, Romania
    - Research Site
  - Pitesti, Romania
    - Research Site
  - Sibiu, Romania
    - Research Site
  - Targoviste, Romania
    - Research Site
  - Targu Mures, Romania
    - Research Site
Russian Federation
- - Kazan, Russian Federation
    - Research Site
  - Moscow, Russian Federation
    - Research Site
  - St. Petersburg, Russian Federation
    - Research Site
Taiwan
- - Kaohsiung Hsien, Taiwan
    - Research Site
  - Taipei, Taiwan
    - Research Site
  - Taoyuan City, Taiwan
    - Research Site
  - Taoyuan Hsien, Taiwan
    - Research Site
Thailand
- - Bangkok, Thailand
    - Research Site
Ukraine
- - Dnepropetrovsk, Ukraine
    - Research Site
  - Kharkiv, Ukraine
    - Research Site
  - Kiev, Ukraine
    - Research Site
  - Kyiv, Ukraine
    - Research Site
  - Lviv, Ukraine
    - Research Site
  - Odessa, Ukraine
    - Research Site
  - Simferopol, Ukraine
    - Research Site
  - Vinnitsa, Ukraine
    - Research Site
United States
- California
  - Cerritos, California, United States
    - Research Site
  - San Diego, California, United States
    - Research Site
  - Santa Ana, California, United States
    - Research Site
- District of Columbia
  - Washington, District of Columbia, United States
    - Research Site
- Florida
  - Gainesville, Florida, United States
    - Research Site
  - Jacksonville, Florida, United States
    - Research Site
  - North Miami, Florida, United States
    - Research Site
  - Orlando, Florida, United States
    - Research Site
- Georgia
  - Atlanta, Georgia, United States
    - Research Site
- Idaho
  - Eagle, Idaho, United States
    - Research Site
- Illinois
  - Hoffman Estates, Illinois, United States
    - Research Site
- Indiana
  - Terre Haute, Indiana, United States
    - Research Site
- Louisiana
  - Shreveport, Louisiana, United States
    - Research Site
- Mississippi
  - Flowood, Mississippi, United States
    - Research Site
- Missouri
  - St. Charles, Missouri, United States
    - Research Site
- Nevada
  - Las Vegas, Nevada, United States
    - Research Site
- New Jersey
  - Clementon, New Jersey, United States
    - Research Site
- New York
  - Rochester, New York, United States
    - Research Site
- North Carolina
  - Raleigh, North Carolina, United States
    - Research Site
- North Dakota
  - Fargo, North Dakota, United States
    - Research Site
- Oregon
  - Portland, Oregon, United States
    - Research Site
  - Salem, Oregon, United States
    - Research Site
- Pennsylvania
  - Philadelphia, Pennsylvania, United States
    - Research Site
- Tennessee
  - Memphis, Tennessee, United States
    - Research Site
- Texas
  - Austin, Texas, United States
    - Research Site
  - Lake Jackson, Texas, United States
    - Research Site
- Virginia
  - Richmond, Virginia, United States
    - Research Site
- Washington
  - Bellevue, Washington, United States
    - Research Site
  - Kirkland, Washington, United States
    - Research Site
  - Seattle, Washington, United States
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time from randomization to recurrence of a mood event

Secondary Outcome Measures

Outcome Measure
Time from randomization to recurrence of a manic event
Time from randomization to recurrence of a depressed event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Study Director: AstraZeneca CNS Medical Science Director, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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. Erratum In: J Clin Psychiatry. 2014 Mar;75(3):290.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

April 11, 2006

First Submitted That Met QC Criteria

April 11, 2006

First Posted (Estimate)

April 13, 2006

Study Record Updates

Last Update Posted (Estimate)

December 22, 2008

Last Update Submitted That Met QC Criteria

December 19, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Bipolar I disorder.

Additional Relevant MeSH Terms

Other Study ID Numbers

D1447C00144
EUDRACT 2004-000915-25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.