|
Seroquel plus Mood Stabilizer Compared to Placebo plus Mood Stabilizer in the Maintenance of Bipolar I Disorder Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about 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 devoted 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 take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as 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 access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes 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. Subjects often receive the most expert healthcare possible for their Seroquel plus Mood Stabilizer Compared to Placebo plus Mood Stabilizer in the Maintenance of Bipolar I Disorder condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
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. Treatment of Early Age Mania
2. An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
3. Evaluation of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Mood Disorders
4. Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)
5. Acupuncture as a Supplemental Treatment for Bipolar Depression
Related Studies:
Other Bipolar Disorder Clinical Trials
Other Ontario Clinical Trials
Other Kingston Clinical Trials
Seroquel plus Mood Stabilizer Compared to Placebo plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
|
|
|
|
|
|
|
|
