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Seroquel plus Mood Stabilizer Compared to Placebo plus Mood Stabilizer in the Maintenance of Bipolar I Disorder Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Seroquel plus Mood Stabilizer Compared to Placebo plus Mood Stabilizer in the Maintenance of Bipolar I Disorder conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Seroquel plus Mood Stabilizer Compared to Placebo plus Mood Stabilizer in the Maintenance of Bipolar I Disorder Clinical research trials and Seroquel plus Mood Stabilizer Compared to Placebo plus Mood Stabilizer in the Maintenance of Bipolar I Disorder medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Seroquel plus Mood Stabilizer Compared to Placebo plus Mood Stabilizer in the Maintenance of Bipolar I Disorder. Seroquel plus Mood Stabilizer Compared to Placebo plus Mood Stabilizer in the Maintenance of Bipolar I Disorder Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Seroquel plus Mood Stabilizer Compared to Placebo plus Mood Stabilizer in the Maintenance of Bipolar I Disorder clinical trial. Participants oftentimes recieve the finest healthcare available for their Seroquel plus Mood Stabilizer Compared to Placebo plus Mood Stabilizer in the Maintenance of Bipolar I Disorder condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Seroquel plus Mood Stabilizer Compared to Placebo plus Mood Stabilizer in the Maintenance of Bipolar I Disorder  Seroquel plus Mood Stabilizer Compared to Placebo plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
Seroquel plus Mood Stabilizer Compared to Placebo plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
For Condition: Bipolar Disorder
Status: Recruiting
Sponsor(s): AstraZeneca ,
Synopsis: The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase.
Details:
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Open label Phase: - A diagnosis of Bipolar I Disorder, Most Recent Episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Depressed (296.5x), or Bipolar I Disorder, Most recent Episode Mixed (296.6x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV) - At least 1 manic, depressed or mixed episode in the 2 years prior to the index episode - One of the following: a. A current manic, depressed or mixed episode by DSM-IV criteria. b. A past manic, depressed or mixed episode within 26 weeks as documented by medical records, that was treated with quetiapine and mood stabilizer (lithium or divalproex). Since this episode, treatment with this combination must not have been interrupted for more than 2 weeks continuously. Inclusion Criteria - Randomized Treatment Phase: - Has been prescribed a dose of quetiapine within the range 400 to 800 mg/day and mood stabilizer (lithium or divalproex) for at least 12 weeks. - YMRS 12 and MADRS 12 assessed at a minimum of 4 consecutive visits spanning at least 12 weeks, with the allowance of a single excursion. An excursion is defined as a visit in which the YMRS or MADRS (or both) score equals 13 or 14. The excursion may not occur at the last of the consecutive visits. Exclusion Criteria - Open-label Phase: - Diagnosis of an anxiety disorder as defined by DSM-IV, which was treated with medication within the past year - Known intolerance or lack of response to quetiapine fumarate or to the assigned mood stabilizer, as judged by the investigator - Pregnancy or lactation. Female patients of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test at enrollment - Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria Exclusion Criteria - Randomized Treatment Phase: - Hospitalization due to a mood event (manic, depressed or mixed) during the Open-label treatment Phase - Electroconvulsive therapy (ECT) during the Open-label treatment Phase - Attempt to commit suicide or homicide during the Open-label treatment Phase - Substance or alcohol dependence (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
Total Enrollment:
Location and Contact Information:
Research Site *Recruiting*
San Diego, California,
United States
Recruiting
Research Site *Recruiting*
Bronx, New York,
United States
Recruiting
Research Site *Recruiting*
Tulsa, Oklahoma,
United States
Recruiting
Research Site *Recruiting*
Edmonton, Alberta,
Canada
Recruiting
Research Site *Recruiting*
St. Louis, Missouri,
United States
Recruiting
Research Site *Recruiting*
Irving, Texas,
United States
Recruiting
Research Site *Recruiting*
San Antonio, Texas,
United States
Recruiting
Research Site *Recruiting*
Victoria, British Columbia,
Canada
Recruiting
Research Site *Recruiting*
Hamilton, Ontario,
Canada
Recruiting
Research Site *Recruiting*
Markham, Ontario,
Canada
Recruiting
Research Site *Recruiting*
Chula Vista, California,
United States
Recruiting
Research Site *Recruiting*
Pico Rivera, California,
United States
Recruiting
Research Site *Recruiting*
Marietta, Georgia,
United States
Recruiting
Research Site *Recruiting*
Honolulu, Hawaii,
United States
Recruiting
Research Site *Recruiting*
Richmond, Virginia,
United States
Recruiting
Research Site *Recruiting*
Anaheim, California,
United States
Recruiting
Research Site *Recruiting*
Santa Ana, California,
United States
Recruiting
Research Site *Recruiting*
Farmington, Connecticut,
United States
Recruiting
Research Site *Recruiting*
Indianapolis, Indiana,
United States
Recruiting
Research Site *Recruiting*
New Orleans, Louisiana,
United States
Recruiting
Research Site *Recruiting*
Butner, North Carolina,
United States
Recruiting
Research Site *Recruiting*
Florence, Kentucky,
United States
Recruiting
Research Site *Recruiting*
Raleigh, North Carolina,
United States
Recruiting
Research Site *Recruiting*
Austin, Texas,
United States
Recruiting
Research Site *Recruiting*
Bellevue, Washington,
United States
Recruiting
Research Site *Recruiting*
Kirkland, Washington,
United States
Recruiting
Research Site *Recruiting*
Halifax, Nova Scotia,
Canada
Recruiting
Research Site *Recruiting*
Toronto, Ontario,
Canada
Recruiting
Research Site *Recruiting*
Shreveport, Louisiana,
United States
Recruiting
Research Site *Recruiting*
Clementon, New Jersey,
United States
Recruiting
Research Site *Recruiting*
Albuquerque, New Mexico,
United States
Recruiting
Research Site *Recruiting*
Emmaus, Pennsylvania,
United States
Recruiting
Research Site *Recruiting*
Riverside, California,
United States
Recruiting
Research Site *Recruiting*
Chicago, Illinois,
United States
Recruiting
Research Site *Recruiting*
Beachwood, Ohio,
United States
Recruiting
Research Site *Recruiting*
Morgantown, West Virginia,
United States
Recruiting
Research Site *Recruiting*
Orlando, Florida,
United States
Recruiting
Research Site *Recruiting*
Winter Park, Florida,
United States
Recruiting
Research Site *Recruiting*
Quebec, ,
Canada
Recruiting
Research Site *Recruiting*
Kingston, Ontario,
Canada
Recruiting
Research Site *Recruiting*
Little Rock, Arkansas,
United States
Recruiting
Research Site *Recruiting*
Oceanside, California,
United States
Recruiting
Research Site *Recruiting*
Wichita, Kansas,
United States
Recruiting
Research Site *Recruiting*
Portland, Oregon,
United States
Recruiting
Research Site *Recruiting*
Desoto, Texas,
United States
Recruiting
Research Site *Recruiting*
Garden Grove, California,
United States
Recruiting
Research Site *Recruiting*
Orange, California,
United States
Recruiting
Research Site *Recruiting*
San Francisco, California,
United States
Recruiting
Research Site *Recruiting*
Greenwood, Indiana,
United States
Recruiting
Research Site *Recruiting*
Oklahoma City, Oklahoma,
United States
Recruiting
Research Site *Recruiting*
Dallas, Texas,
United States
Recruiting
Research Site *Recruiting*
Mississauga, Ontario,
Canada
Recruiting
Research Site *Recruiting*
Oshawa, Ontario,
Canada
Recruiting
Research Site *Recruiting*
Rosemead, California,
United States
Recruiting
Research Site *Recruiting*
New Britain, Connecticut,
United States
Recruiting
Research Site *Recruiting*
Smyrna, Georgia,
United States
Recruiting
Research Site *Recruiting*
New Baltimore, Michigan,
United States
Recruiting
Research Site *Recruiting*
Moorestown, New Jersey,
United States
Recruiting
Research Site *Recruiting*
Charleston, South Carolina,
United States
Recruiting
Research Site *Recruiting*
Winnipeg, Manitoba,
Canada
Recruiting
Research Site *Recruiting*
Cerritos, California,
United States
Recruiting
Research Site *Recruiting*
West Palm Beach, Florida,
United States
Recruiting
Research Site *Recruiting*
Evansville, Indiana,
United States
Recruiting
Research Site *Recruiting*
Baltimore, Maryland,
United States
Recruiting
Research Site *Recruiting*
Cincinnati, Ohio,
United States
Recruiting
Research Site *Recruiting*
Moon Township, Pennsylvania,
United States
Recruiting
Research Site *Recruiting*
Vancouver, British Columbia,
Canada
Recruiting
Research Site *Recruiting*
Scottsdale, Arizona,
United States
Recruiting
Research Site *Recruiting*
Decatur, Georgia,
United States
Recruiting
Research Site *Recruiting*
Hoffman Estates, Illinois,
United States
Recruiting
Research Site *Recruiting*
Rockville, Maryland,
United States
Recruiting
Research Site *Recruiting*
Pittsfield, Massachusetts,
United States
Recruiting
Research Site *Recruiting*
Brooklyn, New York,
United States
Recruiting
Research Site *Recruiting*
Dayton, Ohio,
United States
Recruiting
Research Site *Recruiting*
Medina, Ohio,
United States
Recruiting
Research Site *Recruiting*
Philadelphia, Pennsylvania,
United States
Recruiting
Research Site *Recruiting*
Wichita Falls, Texas,
United States
Recruiting
Research Site *Recruiting*
Virginia Beach, Virginia,
United States
Recruiting
Research Site *Recruiting*
Verdun, Quebec,
Canada
Recruiting
Research Site *Recruiting*
Birmingham, Alabama,
United States
Recruiting
Research Site *Recruiting*
Miami, Florida,
United States
Recruiting
Research Site *Recruiting*
Atlanta, Georgia,
United States
Recruiting
Research Site *Recruiting*
Lake Charles, Louisiana,
United States
Recruiting
Research Site *Recruiting*
New York City, New York,
United States
Recruiting
Research Site *Recruiting*
Houston, Texas,
United States
Recruiting
Research Site *Recruiting*
La Mesa, California,
United States
Recruiting
Research Site *Recruiting*
Culver City, California,
United States
Recruiting
Research Site *Recruiting*
Joliet, Illinois,
United States
Recruiting
Research Site *Recruiting*
Eugene, Oregon,
United States
Recruiting
Research Site *Recruiting*
Falls Church, Virginia,
United States
Recruiting
Research Site *Recruiting*
Jacksonville, Florida,
United States
Recruiting
Research Site *Recruiting*
West Caldwell, New Jersey,
United States
Recruiting
Research Site *Recruiting*
Memphis, Tennessee,
United States
Recruiting
Research Site *Recruiting*
Charlottesville, Virginia,
United States
Recruiting
Research Site *Recruiting*
Montreal, Quebec,
Canada
Recruiting
Additional Information:
Study ID Numbers: D1447C00127;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081380
Other Bipolar Disorder Studies:
1. The Assessment of a weight-gain agent for the Treatment of Olanzapine-Associated Anti-obesity Agent in Patients with Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, and Bipolar I Disorder
2. Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients with Bipolar Depression
3. Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder
4. A study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder.
5. Maintenance Therapies in Bipolar Disorders
Related Studies:
Other Bipolar Disorder Clinical Trials
Other Massachusetts Clinical Trials
Other Pittsfield Clinical Trials
Seroquel plus Mood Stabilizer Compared to Placebo plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
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