Bipolar Study in Adults at Least 18 Years of Age
Lamictal for Use in Treatment of Bipolar Disorder In Adults. A Practical Clinical Assessment of Tolerability and Clinical Effectiveness.
1 other identifier
interventional
1,200
1 country
308
Brief Summary
Bipolar study of tolerability, clinical response and patient satisfaction
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2003
Shorter than P25 for phase_4
308 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 3, 2003
CompletedFirst Posted
Study publicly available on registry
September 5, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedSeptember 1, 2016
August 1, 2016
1 year
September 3, 2003
August 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint will be the rate of rash during 12 weeks.
12 Weeks
Secondary Outcomes (1)
Change from baseline in Week 5 and Week 12 Clinical Global Impression-Bipolar version (CGI-BP) Severityand Improvement scores.
12 Weeks
Study Arms (1)
Arm 1
OTHEROpen label single arm study
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of bipolar I disorder.
- Must be on a stable regimen of psychiatric medication for at least 2 months prior to study.
- If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception.
You may not qualify if:
- Patients with a clinically significant psychiatric or physiologic comorbidity including significant substance abuse, depression or mania which is of an unstable of progressive nature that could interfere in participation of this study.
- Presence of untreated thyroid disease.
- Patient is actively suicidal or homicidal.
- Patient has history of severe hepatic or renal insufficiency.
- Patient is currently participating in another clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (308)
GSK Investigational Site
Albertville, Alabama, 35950, United States
GSK Investigational Site
Anniston, Alabama, 36207, United States
GSK Investigational Site
Birmingham, Alabama, 35209, United States
GSK Investigational Site
Birmingham, Alabama, 35223, United States
GSK Investigational Site
Birmingham, Alabama, 35234, United States
GSK Investigational Site
Fairhope, Alabama, 36532, United States
GSK Investigational Site
Huntsville, Alabama, 35802, United States
GSK Investigational Site
Tuscaloosa, Alabama, 35404, United States
GSK Investigational Site
Chandler, Arizona, 85225, United States
GSK Investigational Site
Phoenix, Arizona, 85004, United States
GSK Investigational Site
Phoenix, Arizona, 85018, United States
GSK Investigational Site
Phoenix, Arizona, 85032, United States
GSK Investigational Site
Phoenix, Arizona, 85044, United States
GSK Investigational Site
Rogers, Arizona, 72756, United States
GSK Investigational Site
Tucson, Arizona, 85719, United States
GSK Investigational Site
Fort Smith, Arkansas, 72903, United States
GSK Investigational Site
Little Rock, Arkansas, 72201, United States
GSK Investigational Site
North Little Rock, Arkansas, 72113, United States
GSK Investigational Site
Bakersfield, California, 93309, United States
GSK Investigational Site
Beverly Hills, California, 90210, United States
GSK Investigational Site
Burbank, California, 91501, United States
GSK Investigational Site
Campbell, California, 95008, United States
GSK Investigational Site
Cerritos, California, 90703, United States
GSK Investigational Site
El Centro, California, 92243, United States
GSK Investigational Site
Fairfield, California, 94533, United States
GSK Investigational Site
La Mesa, California, 91941, United States
GSK Investigational Site
Laguna Hills, California, 92653, United States
GSK Investigational Site
Los Angeles, California, 90011, United States
GSK Investigational Site
Los Angeles, California, 90089, United States
GSK Investigational Site
Oceanside, California, 92056, United States
GSK Investigational Site
Petaluma, California, 94952, United States
GSK Investigational Site
Poway, California, 92064, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
Sacramento, California, 95825, United States
GSK Investigational Site
San Diego, California, 92103, United States
GSK Investigational Site
San Diego, California, 92114, United States
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
San Jose, California, 95123, United States
GSK Investigational Site
Santa Ana, California, 92705, United States
GSK Investigational Site
Santa Barbara, California, 93102, United States
GSK Investigational Site
Sherman Oaks, California, 91403, United States
GSK Investigational Site
Torrance, California, 90505, United States
GSK Investigational Site
West Hollywood, California, 90048, United States
GSK Investigational Site
Boulder, Colorado, 80303, United States
GSK Investigational Site
Fort Collins, Colorado, 80525, United States
GSK Investigational Site
Hamden, Connecticut, 06514, United States
GSK Investigational Site
Mansfield Center, Connecticut, 06250, United States
GSK Investigational Site
Norwich, Connecticut, 06360, United States
GSK Investigational Site
Wethersfield, Connecticut, 06109, United States
GSK Investigational Site
Newark, Delaware, 19713, United States
GSK Investigational Site
Wilmington, Delaware, 19808, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20011, United States
GSK Investigational Site
Altamonte Springs, Florida, 32714, United States
GSK Investigational Site
Boca Raton, Florida, 33432, United States
GSK Investigational Site
Boca Raton, Florida, 33433, United States
GSK Investigational Site
Boynton Beach, Florida, 33426, United States
GSK Investigational Site
Bradenton, Florida, 34209, United States
GSK Investigational Site
Brandon, Florida, 33511, United States
GSK Investigational Site
Casselberry, Florida, 32730, United States
GSK Investigational Site
Clearwater, Florida, 33764, United States
GSK Investigational Site
Coral Springs, Florida, 33065, United States
GSK Investigational Site
Davie, Florida, 33024, United States
GSK Investigational Site
Daytona Beach, Florida, 32114, United States
GSK Investigational Site
Destin, Florida, 32541, United States
GSK Investigational Site
Fort Walton Beach, Florida, 32548, United States
GSK Investigational Site
Gainesville, Florida, 32607, United States
GSK Investigational Site
Jacksonville, Florida, 32216, United States
GSK Investigational Site
Jacksonville, Florida, 32257, United States
GSK Investigational Site
Jacksonville Beach, Florida, 32250, United States
GSK Investigational Site
Lakeland, Florida, 33803, United States
GSK Investigational Site
Miami, Florida, 32216, United States
GSK Investigational Site
Miami, Florida, 33125, United States
GSK Investigational Site
Miami, Florida, 33157, United States
GSK Investigational Site
Miami, Florida, 33176, United States
GSK Investigational Site
North Miami, Florida, 33161, United States
GSK Investigational Site
Ocala, Florida, 34471, United States
GSK Investigational Site
Ocala, Florida, 34474, United States
GSK Investigational Site
Orange City, Florida, 32763, United States
GSK Investigational Site
Orlando, Florida, 32803, United States
GSK Investigational Site
Palm Beach Gardens, Florida, 33410, United States
GSK Investigational Site
Pensacola, Florida, 32503, United States
GSK Investigational Site
Plantation, Florida, 33324, United States
GSK Investigational Site
Sarasota, Florida, 34238, United States
GSK Investigational Site
St. Petersburg, Florida, 33701, United States
GSK Investigational Site
St. Petersburg, Florida, 33702, United States
GSK Investigational Site
Syracuse, Florida, 13202, United States
GSK Investigational Site
Tampa, Florida, 33603, United States
GSK Investigational Site
West Palm Beach, Florida, 33407, United States
GSK Investigational Site
Wilton Manors, Florida, 33311, United States
GSK Investigational Site
Winter Park, Florida, 32789, United States
GSK Investigational Site
Winter Park, Florida, 32792, United States
GSK Investigational Site
Zephyrhills, Florida, 33540, United States
GSK Investigational Site
Atlanta, Georgia, 30030, United States
GSK Investigational Site
Atlanta, Georgia, 30309-7520, United States
GSK Investigational Site
Atlanta, Georgia, 30338, United States
GSK Investigational Site
Decatur, Georgia, 30030, United States
GSK Investigational Site
Lawrenceville, Georgia, 30045, United States
GSK Investigational Site
Macon, Georgia, 31201, United States
GSK Investigational Site
Roswell, Georgia, 30075, United States
GSK Investigational Site
Stockbridge, Georgia, 30281, United States
GSK Investigational Site
Warner Robins, Georgia, 31093, United States
GSK Investigational Site
Boise, Idaho, 83702, United States
GSK Investigational Site
Boise, Idaho, 83704, United States
GSK Investigational Site
Boise, Idaho, 83706, United States
GSK Investigational Site
Alton, Illinois, 62002, United States
GSK Investigational Site
Bourbonnais, Illinois, 60914, United States
GSK Investigational Site
Chicago, Illinois, 60657, United States
GSK Investigational Site
East Moline, Illinois, 61244, United States
GSK Investigational Site
Evergreen Park, Illinois, 60805, United States
GSK Investigational Site
Fairview Heights, Illinois, 62208, United States
GSK Investigational Site
Granite City, Illinois, 62040, United States
GSK Investigational Site
Joliet, Illinois, 60435, United States
GSK Investigational Site
Libertyville, Illinois, 60048, United States
GSK Investigational Site
Lisle, Illinois, 60532, United States
GSK Investigational Site
Oakbrook Terrace, Illinois, 60181, United States
GSK Investigational Site
Orland Park, Illinois, 60462, United States
GSK Investigational Site
Park Ridge, Illinois, 60068, United States
GSK Investigational Site
Rockford, Illinois, 61108, United States
GSK Investigational Site
Schaumburg, Illinois, 60194, United States
GSK Investigational Site
Vernon Hills, Illinois, 60061, United States
GSK Investigational Site
Wheaton, Illinois, 60187, United States
GSK Investigational Site
Danville, Indiana, 46122, United States
GSK Investigational Site
Evansville, Indiana, 47715, United States
GSK Investigational Site
Fort Wayne, Indiana, 46805, United States
GSK Investigational Site
Lafayette, Indiana, 47904, United States
GSK Investigational Site
Mishawaka, Indiana, 46545, United States
GSK Investigational Site
Plymouth, Indiana, 46563, United States
GSK Investigational Site
Valparaiso, Indiana, 46383, United States
GSK Investigational Site
Cedar Rapids, Iowa, 52402, United States
GSK Investigational Site
Dubuque, Iowa, 52001, United States
GSK Investigational Site
Leavenworth, Kansas, 66048, United States
GSK Investigational Site
Overland Park, Kansas, 66211, United States
GSK Investigational Site
Shawnee Mission, Kansas, 66214, United States
GSK Investigational Site
Topeka, Kansas, 66606, United States
GSK Investigational Site
Wichita, Kansas, 67205, United States
GSK Investigational Site
Wichita, Kansas, 67206, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
GSK Investigational Site
Wichita, Kansas, 67211, United States
GSK Investigational Site
Hopkinsville, Kentucky, 42240, United States
GSK Investigational Site
Lexington, Kentucky, 40509, United States
GSK Investigational Site
Baton Rouge, Louisiana, 70806, United States
GSK Investigational Site
Houma, Louisiana, 70360, United States
GSK Investigational Site
Lake Charles, Louisiana, 70601, United States
GSK Investigational Site
Shreveport, Louisiana, 71101, United States
GSK Investigational Site
Annapolis, Maryland, 21403, United States
GSK Investigational Site
Baltimore, Maryland, 21239, United States
GSK Investigational Site
Batlimore, Maryland, 21208, United States
GSK Investigational Site
Burtonsville, Maryland, 20866, United States
GSK Investigational Site
Ellicott City, Maryland, 21043, United States
GSK Investigational Site
Gaithersburg, Maryland, 20877, United States
GSK Investigational Site
Glen Burnie, Maryland, 21061, United States
GSK Investigational Site
Laurel, Maryland, 20707, United States
GSK Investigational Site
Rockville, Maryland, 20852, United States
GSK Investigational Site
Towson, Maryland, 21204, United States
GSK Investigational Site
Towson, Maryland, 21286, United States
GSK Investigational Site
Adrian, Michigan, 49221, United States
GSK Investigational Site
Bay City, Michigan, 48706, United States
GSK Investigational Site
Benton Harbor, Michigan, 49022, United States
GSK Investigational Site
Bloomfield Hills, Michigan, 48302, United States
GSK Investigational Site
Brownstown Township, Michigan, 48183, United States
GSK Investigational Site
Clinton Township, Michigan, 48036, United States
GSK Investigational Site
East Lansing, Michigan, 48823, United States
GSK Investigational Site
Farmington Hills, Michigan, 48334, United States
GSK Investigational Site
Flint, Michigan, 48507, United States
GSK Investigational Site
Flint, Michigan, 48532, United States
GSK Investigational Site
Mount Clemens, Michigan, 48043, United States
GSK Investigational Site
Rochester Hills, Michigan, 48307, United States
GSK Investigational Site
Royal Oak, Michigan, 48067, United States
GSK Investigational Site
Duluth, Minnesota, 55802, United States
GSK Investigational Site
Minneapolis, Minnesota, 55454, United States
GSK Investigational Site
Oakdale, Minnesota, 55128, United States
GSK Investigational Site
Flowood, Mississippi, 39232, United States
GSK Investigational Site
Gulfport, Mississippi, 39503, United States
GSK Investigational Site
Joplin, Missouri, 64804, United States
GSK Investigational Site
Kansas City, Missouri, 64108, United States
GSK Investigational Site
Saint Charles, Missouri, 63301, United States
GSK Investigational Site
Springfield, Missouri, 65804, United States
GSK Investigational Site
St Louis, Missouri, 63117, United States
GSK Investigational Site
St Louis, Missouri, 63128, United States
GSK Investigational Site
St Louis, Missouri, 63136-3675, United States
GSK Investigational Site
Billings, Montana, 59101, United States
GSK Investigational Site
Lincoln, Nebraska, 68502, United States
GSK Investigational Site
Omaha, Nebraska, 68124, United States
GSK Investigational Site
Omaha, Nebraska, 68131, United States
GSK Investigational Site
Henderson, Nevada, 89074, United States
GSK Investigational Site
Las Vegas, Nevada, 89030, United States
GSK Investigational Site
Las Vegas, Nevada, 89102, United States
GSK Investigational Site
Manchester, New Hampshire, 03104, United States
GSK Investigational Site
Long Branch, New Jersey, 07740, United States
GSK Investigational Site
Princeton, New Jersey, 08540, United States
GSK Investigational Site
Albuquerque, New Mexico, 87108, United States
GSK Investigational Site
Las Cruces, New Mexico, 88011, United States
GSK Investigational Site
Albany, New York, 31701, United States
GSK Investigational Site
Amityville, New York, 11701, United States
GSK Investigational Site
Farmingdale, New York, 11735, United States
GSK Investigational Site
Latham, New York, 12110, United States
GSK Investigational Site
New Rochelle, New York, 10801, United States
GSK Investigational Site
New York, New York, 10023, United States
GSK Investigational Site
Olean, New York, 14760, United States
GSK Investigational Site
Port Jefferson, New York, 11777, United States
GSK Investigational Site
Smithtown, New York, 11787, United States
GSK Investigational Site
The Bronx, New York, 10461, United States
GSK Investigational Site
Cary, North Carolina, 27511, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27514, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27517, United States
GSK Investigational Site
Charlotte, North Carolina, 28211, United States
GSK Investigational Site
Cornelius, North Carolina, 28031, United States
GSK Investigational Site
Durham, North Carolina, 27705, United States
GSK Investigational Site
Fayetteville, North Carolina, 28305, United States
GSK Investigational Site
Forest City, North Carolina, 28043, United States
GSK Investigational Site
Goldsboro, North Carolina, 27530, United States
GSK Investigational Site
Greensboro, North Carolina, 27408, United States
GSK Investigational Site
Greenville, North Carolina, 27834, United States
GSK Investigational Site
Greenville, North Carolina, 27858, United States
GSK Investigational Site
High Point, North Carolina, 27262, United States
GSK Investigational Site
Raleigh, North Carolina, 27605, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Raleigh, North Carolina, 27612, United States
GSK Investigational Site
Wilmington, North Carolina, 28401, United States
GSK Investigational Site
Avon Lake, Ohio, 44012, United States
GSK Investigational Site
Cincinnati, Ohio, 45206, United States
GSK Investigational Site
Cincinnati, Ohio, 45243, United States
GSK Investigational Site
Cuyahoga Falls, Ohio, 44221, United States
GSK Investigational Site
Dayton, Ohio, 45459, United States
GSK Investigational Site
Warren, Ohio, 44483, United States
GSK Investigational Site
Youngstown, Ohio, 44512, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73109, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73118, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73120, United States
GSK Investigational Site
Tulsa, Oklahoma, 74120, United States
GSK Investigational Site
Tulsa, Oklahoma, 74136, United States
GSK Investigational Site
Milwaukie, Oregon, 97222, United States
GSK Investigational Site
Portland, Oregon, 97210, United States
GSK Investigational Site
Colmar, Pennsylvania, 18915, United States
GSK Investigational Site
Doyletown, Pennsylvania, 18901, United States
GSK Investigational Site
Kingston, Pennsylvania, 18704, United States
GSK Investigational Site
McKeesport, Pennsylvania, 15132, United States
GSK Investigational Site
Media, Pennsylvania, 19063, United States
GSK Investigational Site
Natrona Heights, Pennsylvania, 15065, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19139, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15243, United States
GSK Investigational Site
Reading, Pennsylvania, 19610, United States
GSK Investigational Site
Charleston, South Carolina, 29407, United States
GSK Investigational Site
Moncks Corner, South Carolina, 29461, United States
GSK Investigational Site
North Charleston, South Carolina, 29406, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Cordova, Tennessee, 38016, United States
GSK Investigational Site
Johnson City, Tennessee, 37601, United States
GSK Investigational Site
Kingsport, Tennessee, 37664, United States
GSK Investigational Site
Knoxville, Tennessee, 37919, United States
GSK Investigational Site
Knoxville, Tennessee, 37922, United States
GSK Investigational Site
Madison, Tennessee, 37115, United States
GSK Investigational Site
Murfreesboro, Tennessee, 37129, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
GSK Investigational Site
Nashville, Tennessee, 37204, United States
GSK Investigational Site
Arlington, Texas, 76012, United States
GSK Investigational Site
Austin, Texas, 78759, United States
GSK Investigational Site
Bedford, Texas, 76022, United States
GSK Investigational Site
Conroe, Texas, 77304, United States
GSK Investigational Site
Dallas, Texas, 75219, United States
GSK Investigational Site
Houston, Texas, 77007, United States
GSK Investigational Site
Houston, Texas, 77014, United States
GSK Investigational Site
Houston, Texas, 77027, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Houston, Texas, 77042, United States
GSK Investigational Site
Houston, Texas, 77057, United States
GSK Investigational Site
Houston, Texas, 77074, United States
GSK Investigational Site
Humble, Texas, 77338, United States
GSK Investigational Site
Humble, Texas, 77339, United States
GSK Investigational Site
Irving, Texas, 75062, United States
GSK Investigational Site
Kingwood, Texas, 77339, United States
GSK Investigational Site
Nacogdoches, Texas, 75965, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
San Antonio, Texas, 78232, United States
GSK Investigational Site
Sugar Land, Texas, 77478, United States
GSK Investigational Site
Tyler, Texas, 75702, United States
GSK Investigational Site
Salt Lake City, Utah, 84102, United States
GSK Investigational Site
Williston, Vermont, 04495, United States
GSK Investigational Site
Arlington, Virginia, 22205, United States
GSK Investigational Site
Ashburn, Virginia, 20147, United States
GSK Investigational Site
Charlottesville, Virginia, 22903, United States
GSK Investigational Site
Charlottesville, Virginia, 22911, United States
GSK Investigational Site
Christiansburg, Virginia, 24073, United States
GSK Investigational Site
Danville, Virginia, 24541, United States
GSK Investigational Site
Falls Church, Virginia, 22041, United States
GSK Investigational Site
Midlothian, Virginia, 23112, United States
GSK Investigational Site
Newport News, Virginia, 23606, United States
GSK Investigational Site
Norfolk, Virginia, 23505, United States
GSK Investigational Site
Portsmouth, Virginia, 23703, United States
GSK Investigational Site
Richmond, Virginia, 23230, United States
GSK Investigational Site
Suffolk, Virginia, 23434, United States
GSK Investigational Site
Virginia Beach, Virginia, 23452, United States
GSK Investigational Site
Bellingham, Washington, 98225, United States
GSK Investigational Site
Everett, Washington, 98201, United States
GSK Investigational Site
Renton, Washington, 98055, United States
GSK Investigational Site
Spokane, Washington, 99204, United States
GSK Investigational Site
Tacoma, Washington, 98499, United States
GSK Investigational Site
Charleston, West Virginia, 25301, United States
GSK Investigational Site
Charleston, West Virginia, 25309, United States
GSK Investigational Site
Weirton, West Virginia, 26062, United States
GSK Investigational Site
Mequion, Wisconsin, 53092, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53226, United States
GSK Investigational Site
Racine, Wisconsin, 53403, United States
GSK Investigational Site
Waukesha, Wisconsin, 53188, United States
GSK Investigational Site
Wauwatosa, Wisconsin, 53213, United States
GSK Investigational Site
West Allis, Wisconsin, 53227, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2003
First Posted
September 5, 2003
Study Start
August 1, 2003
Primary Completion
August 1, 2004
Study Completion
August 1, 2004
Last Updated
September 1, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.