Bipolar Study in Adults at Least 18 Years of Age

August 31, 2016 updated by: GlaxoSmithKline

Lamictal for Use in Treatment of Bipolar Disorder In Adults. A Practical Clinical Assessment of Tolerability and Clinical Effectiveness.

Bipolar study of tolerability, clinical response and patient satisfaction

Study Overview

Status

Completed

Conditions

Bipolar Disorder

Intervention / Treatment

Drug: lamotrigine

Study Type

Interventional

Enrollment (Actual)

1200

Phase

Phase 4

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

United States
- Alabama
  - Albertville, Alabama, United States, 35950
    - GSK Investigational Site
  - Anniston, Alabama, United States, 36207
    - GSK Investigational Site
  - Birmingham, Alabama, United States, 35209
    - GSK Investigational Site
  - Birmingham, Alabama, United States, 35234
    - GSK Investigational Site
  - Birmingham, Alabama, United States, 35223
    - GSK Investigational Site
  - Fairhope, Alabama, United States, 36532
    - GSK Investigational Site
  - Huntsville, Alabama, United States, 35802
    - GSK Investigational Site
  - Tuscaloosa, Alabama, United States, 35404
    - GSK Investigational Site
- Arizona
  - Chandler, Arizona, United States, 85225
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85018
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85004
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85032
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85044
    - GSK Investigational Site
  - Rogers, Arizona, United States, 72756
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85719
    - GSK Investigational Site
- Arkansas
  - Fort Smith, Arkansas, United States, 72903
    - GSK Investigational Site
  - Little Rock, Arkansas, United States, 72201
    - GSK Investigational Site
  - North Little Rock, Arkansas, United States, 72113
    - GSK Investigational Site
- California
  - Bakersfield, California, United States, 93309
    - GSK Investigational Site
  - Beverly Hills, California, United States, 90210
    - GSK Investigational Site
  - Burbank, California, United States, 91501
    - GSK Investigational Site
  - Campbell, California, United States, 95008
    - GSK Investigational Site
  - Cerritos, California, United States, 90703
    - GSK Investigational Site
  - El Centro, California, United States, 92243
    - GSK Investigational Site
  - Fairfield, California, United States, 94533
    - GSK Investigational Site
  - La Mesa, California, United States, 91941
    - GSK Investigational Site
  - Laguna Hills, California, United States, 92653
    - GSK Investigational Site
  - Los Angeles, California, United States, 90089
    - GSK Investigational Site
  - Los Angeles, California, United States, 90011
    - GSK Investigational Site
  - Oceanside, California, United States, 92056
    - GSK Investigational Site
  - Petaluma, California, United States, 94952
    - GSK Investigational Site
  - Poway, California, United States, 92064
    - GSK Investigational Site
  - Riverside, California, United States, 92506
    - GSK Investigational Site
  - Sacramento, California, United States, 95825
    - GSK Investigational Site
  - San Diego, California, United States, 92103
    - GSK Investigational Site
  - San Diego, California, United States, 92123
    - GSK Investigational Site
  - San Diego, California, United States, 92114
    - GSK Investigational Site
  - San Jose, California, United States, 95123
    - GSK Investigational Site
  - Santa Ana, California, United States, 92705
    - GSK Investigational Site
  - Santa Barbara, California, United States, 93102
    - GSK Investigational Site
  - Sherman Oaks, California, United States, 91403
    - GSK Investigational Site
  - Torrance, California, United States, 90505
    - GSK Investigational Site
  - West Hollywood, California, United States, 90048
    - GSK Investigational Site
- Colorado
  - Boulder, Colorado, United States, 80303
    - GSK Investigational Site
  - Fort Collins, Colorado, United States, 80525
    - GSK Investigational Site
- Connecticut
  - Hamden, Connecticut, United States, 06514
    - GSK Investigational Site
  - Mansfield Center, Connecticut, United States, 06250
    - GSK Investigational Site
  - Norwich, Connecticut, United States, 06360
    - GSK Investigational Site
  - Wethersfield, Connecticut, United States, 06109
    - GSK Investigational Site
- Delaware
  - Newark, Delaware, United States, 19713
    - GSK Investigational Site
  - Wilmington, Delaware, United States, 19808
    - GSK Investigational Site
- District of Columbia
  - Washington, District of Columbia, United States, 20011
    - GSK Investigational Site
- Florida
  - Altamonte Springs, Florida, United States, 32714
    - GSK Investigational Site
  - Boca Raton, Florida, United States, 33432
    - GSK Investigational Site
  - Boca Raton, Florida, United States, 33433
    - GSK Investigational Site
  - Boynton Beach, Florida, United States, 33426
    - GSK Investigational Site
  - Bradenton, Florida, United States, 34209
    - GSK Investigational Site
  - Brandon, Florida, United States, 33511
    - GSK Investigational Site
  - Casselberry, Florida, United States, 32730
    - GSK Investigational Site
  - Clearwater, Florida, United States, 33764
    - GSK Investigational Site
  - Coral Springs, Florida, United States, 33065
    - GSK Investigational Site
  - Davie, Florida, United States, 33024
    - GSK Investigational Site
  - Daytona Beach, Florida, United States, 32114
    - GSK Investigational Site
  - Destin, Florida, United States, 32541
    - GSK Investigational Site
  - Fort Walton Beach, Florida, United States, 32548
    - GSK Investigational Site
  - Gainesville, Florida, United States, 32607
    - GSK Investigational Site
  - Jacksonville, Florida, United States, 32216
    - GSK Investigational Site
  - Jacksonville, Florida, United States, 32257
    - GSK Investigational Site
  - Jacksonville Beach, Florida, United States, 32250
    - GSK Investigational Site
  - Lakeland, Florida, United States, 33803
    - GSK Investigational Site
  - Miami, Florida, United States, 33125
    - GSK Investigational Site
  - Miami, Florida, United States, 33176
    - GSK Investigational Site
  - Miami, Florida, United States, 33157
    - GSK Investigational Site
  - Miami, Florida, United States, 32216
    - GSK Investigational Site
  - North Miami, Florida, United States, 33161
    - GSK Investigational Site
  - Ocala, Florida, United States, 34471
    - GSK Investigational Site
  - Ocala, Florida, United States, 34474
    - GSK Investigational Site
  - Orange City, Florida, United States, 32763
    - GSK Investigational Site
  - Orlando, Florida, United States, 32803
    - GSK Investigational Site
  - Palm Beach Gardens, Florida, United States, 33410
    - GSK Investigational Site
  - Pensacola, Florida, United States, 32503
    - GSK Investigational Site
  - Plantation, Florida, United States, 33324
    - GSK Investigational Site
  - Sarasota, Florida, United States, 34238
    - GSK Investigational Site
  - St. Petersburg, Florida, United States, 33701
    - GSK Investigational Site
  - St. Petersburg, Florida, United States, 33702
    - GSK Investigational Site
  - Syracuse, Florida, United States, 13202
    - GSK Investigational Site
  - Tampa, Florida, United States, 33603
    - GSK Investigational Site
  - West Palm Beach, Florida, United States, 33407
    - GSK Investigational Site
  - Wilton Manors, Florida, United States, 33311
    - GSK Investigational Site
  - Winter Park, Florida, United States, 32789
    - GSK Investigational Site
  - Winter Park, Florida, United States, 32792
    - GSK Investigational Site
  - Zephyrhills, Florida, United States, 33540
    - GSK Investigational Site
- Georgia
  - Atlanta, Georgia, United States, 30338
    - GSK Investigational Site
  - Atlanta, Georgia, United States, 30309-7520
    - GSK Investigational Site
  - Atlanta, Georgia, United States, 30030
    - GSK Investigational Site
  - Decatur, Georgia, United States, 30030
    - GSK Investigational Site
  - Lawrenceville, Georgia, United States, 30045
    - GSK Investigational Site
  - Macon, Georgia, United States, 31201
    - GSK Investigational Site
  - Roswell, Georgia, United States, 30075
    - GSK Investigational Site
  - Stockbridge, Georgia, United States, 30281
    - GSK Investigational Site
  - Warner Robins, Georgia, United States, 31093
    - GSK Investigational Site
- Idaho
  - Boise, Idaho, United States, 83702
    - GSK Investigational Site
  - Boise, Idaho, United States, 83706
    - GSK Investigational Site
  - Boise, Idaho, United States, 83704
    - GSK Investigational Site
- Illinois
  - Alton, Illinois, United States, 62002
    - GSK Investigational Site
  - Bourbonnais, Illinois, United States, 60914
    - GSK Investigational Site
  - Chicago, Illinois, United States, 60657
    - GSK Investigational Site
  - East Moline, Illinois, United States, 61244
    - GSK Investigational Site
  - Evergreen Park, Illinois, United States, 60805
    - GSK Investigational Site
  - Fairview Heights, Illinois, United States, 62208
    - GSK Investigational Site
  - Granite City, Illinois, United States, 62040
    - GSK Investigational Site
  - Joliet, Illinois, United States, 60435
    - GSK Investigational Site
  - Libertyville, Illinois, United States, 60048
    - GSK Investigational Site
  - Lisle, Illinois, United States, 60532
    - GSK Investigational Site
  - Oakbrook Terrace, Illinois, United States, 60181
    - GSK Investigational Site
  - Orland Park, Illinois, United States, 60462
    - GSK Investigational Site
  - Park Ridge, Illinois, United States, 60068
    - GSK Investigational Site
  - Rockford, Illinois, United States, 61108
    - GSK Investigational Site
  - Schaumburg, Illinois, United States, 60194
    - GSK Investigational Site
  - Vernon Hills, Illinois, United States, 60061
    - GSK Investigational Site
  - Wheaton, Illinois, United States, 60187
    - GSK Investigational Site
- Indiana
  - Danville, Indiana, United States, 46122
    - GSK Investigational Site
  - Evansville, Indiana, United States, 47715
    - GSK Investigational Site
  - Fort Wayne, Indiana, United States, 46805
    - GSK Investigational Site
  - Lafayette, Indiana, United States, 47904
    - GSK Investigational Site
  - Mishawaka, Indiana, United States, 46545
    - GSK Investigational Site
  - Plymouth, Indiana, United States, 46563
    - GSK Investigational Site
  - Valparaiso, Indiana, United States, 46383
    - GSK Investigational Site
- Iowa
  - Cedar Rapids, Iowa, United States, 52402
    - GSK Investigational Site
  - Dubuque, Iowa, United States, 52001
    - GSK Investigational Site
- Kansas
  - Leavenworth, Kansas, United States, 66048
    - GSK Investigational Site
  - Overland Park, Kansas, United States, 66211
    - GSK Investigational Site
  - Shawnee Mission, Kansas, United States, 66214
    - GSK Investigational Site
  - Topeka, Kansas, United States, 66606
    - GSK Investigational Site
  - Wichita, Kansas, United States, 67207
    - GSK Investigational Site
  - Wichita, Kansas, United States, 67205
    - GSK Investigational Site
  - Wichita, Kansas, United States, 67211
    - GSK Investigational Site
  - Wichita, Kansas, United States, 67206
    - GSK Investigational Site
- Kentucky
  - Hopkinsville, Kentucky, United States, 42240
    - GSK Investigational Site
  - Lexington, Kentucky, United States, 40509
    - GSK Investigational Site
- Louisiana
  - Baton Rouge, Louisiana, United States, 70806
    - GSK Investigational Site
  - Houma, Louisiana, United States, 70360
    - GSK Investigational Site
  - Lake Charles, Louisiana, United States, 70601
    - GSK Investigational Site
  - Shreveport, Louisiana, United States, 71101
    - GSK Investigational Site
- Maryland
  - Annapolis, Maryland, United States, 21403
    - GSK Investigational Site
  - Baltimore, Maryland, United States, 21239
    - GSK Investigational Site
  - Batlimore, Maryland, United States, 21208
    - GSK Investigational Site
  - Burtonsville, Maryland, United States, 20866
    - GSK Investigational Site
  - Ellicott City, Maryland, United States, 21043
    - GSK Investigational Site
  - Gaithersburg, Maryland, United States, 20877
    - GSK Investigational Site
  - Glen Burnie, Maryland, United States, 21061
    - GSK Investigational Site
  - Laurel, Maryland, United States, 20707
    - GSK Investigational Site
  - Rockville, Maryland, United States, 20852
    - GSK Investigational Site
  - Towson, Maryland, United States, 21204
    - GSK Investigational Site
  - Towson, Maryland, United States, 21286
    - GSK Investigational Site
- Michigan
  - Adrian, Michigan, United States, 49221
    - GSK Investigational Site
  - Bay City, Michigan, United States, 48706
    - GSK Investigational Site
  - Benton Harbor, Michigan, United States, 49022
    - GSK Investigational Site
  - Bloomfield Hills, Michigan, United States, 48302
    - GSK Investigational Site
  - Brownstown Township, Michigan, United States, 48183
    - GSK Investigational Site
  - Clinton Township, Michigan, United States, 48036
    - GSK Investigational Site
  - East Lansing, Michigan, United States, 48823
    - GSK Investigational Site
  - Farmington Hills, Michigan, United States, 48334
    - GSK Investigational Site
  - Flint, Michigan, United States, 48532
    - GSK Investigational Site
  - Flint, Michigan, United States, 48507
    - GSK Investigational Site
  - Mount Clemens, Michigan, United States, 48043
    - GSK Investigational Site
  - Rochester Hills, Michigan, United States, 48307
    - GSK Investigational Site
  - Royal Oak, Michigan, United States, 48067
    - GSK Investigational Site
- Minnesota
  - Duluth, Minnesota, United States, 55802
    - GSK Investigational Site
  - Minneapolis, Minnesota, United States, 55454
    - GSK Investigational Site
  - Oakdale, Minnesota, United States, 55128
    - GSK Investigational Site
- Mississippi
  - Flowood, Mississippi, United States, 39232
    - GSK Investigational Site
  - Gulfport, Mississippi, United States, 39503
    - GSK Investigational Site
- Missouri
  - Joplin, Missouri, United States, 64804
    - GSK Investigational Site
  - Kansas City, Missouri, United States, 64108
    - GSK Investigational Site
  - Springfield, Missouri, United States, 65804
    - GSK Investigational Site
  - St. Charles, Missouri, United States, 63301
    - GSK Investigational Site
  - St. Louis, Missouri, United States, 63117
    - GSK Investigational Site
  - St. Louis, Missouri, United States, 63128
    - GSK Investigational Site
  - St. Louis, Missouri, United States, 63136-3675
    - GSK Investigational Site
- Montana
  - Billings, Montana, United States, 59101
    - GSK Investigational Site
- Nebraska
  - Lincoln, Nebraska, United States, 68502
    - GSK Investigational Site
  - Omaha, Nebraska, United States, 68131
    - GSK Investigational Site
  - Omaha, Nebraska, United States, 68124
    - GSK Investigational Site
- Nevada
  - Henderson, Nevada, United States, 89074
    - GSK Investigational Site
  - Las Vegas, Nevada, United States, 89102
    - GSK Investigational Site
  - Las Vegas, Nevada, United States, 89030
    - GSK Investigational Site
- New Hampshire
  - Manchester, New Hampshire, United States, 03104
    - GSK Investigational Site
- New Jersey
  - Long Branch, New Jersey, United States, 07740
    - GSK Investigational Site
  - Princeton, New Jersey, United States, 08540
    - GSK Investigational Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87108
    - GSK Investigational Site
  - Las Cruces, New Mexico, United States, 88011
    - GSK Investigational Site
- New York
  - Albany, New York, United States, 31701
    - GSK Investigational Site
  - Amityville, New York, United States, 11701
    - GSK Investigational Site
  - Bronx, New York, United States, 10461
    - GSK Investigational Site
  - Farmingdale, New York, United States, 11735
    - GSK Investigational Site
  - Latham, New York, United States, 12110
    - GSK Investigational Site
  - New Rochelle, New York, United States, 10801
    - GSK Investigational Site
  - New York, New York, United States, 10023
    - GSK Investigational Site
  - Olean, New York, United States, 14760
    - GSK Investigational Site
  - Port Jefferson, New York, United States, 11777
    - GSK Investigational Site
  - Smithtown, New York, United States, 11787
    - GSK Investigational Site
- North Carolina
  - Cary, North Carolina, United States, 27511
    - GSK Investigational Site
  - Chapel Hill, North Carolina, United States, 27514
    - GSK Investigational Site
  - Chapel Hill, North Carolina, United States, 27517
    - GSK Investigational Site
  - Charlotte, North Carolina, United States, 28211
    - GSK Investigational Site
  - Cornelius, North Carolina, United States, 28031
    - GSK Investigational Site
  - Durham, North Carolina, United States, 27705
    - GSK Investigational Site
  - Fayetteville, North Carolina, United States, 28305
    - GSK Investigational Site
  - Forest City, North Carolina, United States, 28043
    - GSK Investigational Site
  - Goldsboro, North Carolina, United States, 27530
    - GSK Investigational Site
  - Greensboro, North Carolina, United States, 27408
    - GSK Investigational Site
  - Greenville, North Carolina, United States, 27834
    - GSK Investigational Site
  - Greenville, North Carolina, United States, 27858
    - GSK Investigational Site
  - High Point, North Carolina, United States, 27262
    - GSK Investigational Site
  - Raleigh, North Carolina, United States, 27607
    - GSK Investigational Site
  - Raleigh, North Carolina, United States, 27612
    - GSK Investigational Site
  - Raleigh, North Carolina, United States, 27609
    - GSK Investigational Site
  - Raleigh, North Carolina, United States, 27605
    - GSK Investigational Site
  - Wilmington, North Carolina, United States, 28401
    - GSK Investigational Site
- Ohio
  - Avon Lake, Ohio, United States, 44012
    - GSK Investigational Site
  - Cincinnati, Ohio, United States, 45206
    - GSK Investigational Site
  - Cincinnati, Ohio, United States, 45243
    - GSK Investigational Site
  - Cuyahoga Falls, Ohio, United States, 44221
    - GSK Investigational Site
  - Dayton, Ohio, United States, 45459
    - GSK Investigational Site
  - Warren, Ohio, United States, 44483
    - GSK Investigational Site
  - Youngstown, Ohio, United States, 44512
    - GSK Investigational Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73120
    - GSK Investigational Site
  - Oklahoma City, Oklahoma, United States, 73103
    - GSK Investigational Site
  - Oklahoma City, Oklahoma, United States, 73118
    - GSK Investigational Site
  - Oklahoma City, Oklahoma, United States, 73109
    - GSK Investigational Site
  - Tulsa, Oklahoma, United States, 74136
    - GSK Investigational Site
  - Tulsa, Oklahoma, United States, 74120
    - GSK Investigational Site
- Oregon
  - Milwaukie, Oregon, United States, 97222
    - GSK Investigational Site
  - Portland, Oregon, United States, 97210
    - GSK Investigational Site
- Pennsylvania
  - Colmar, Pennsylvania, United States, 18915
    - GSK Investigational Site
  - Doyletown, Pennsylvania, United States, 18901
    - GSK Investigational Site
  - Kingston, Pennsylvania, United States, 18704
    - GSK Investigational Site
  - McKeesport, Pennsylvania, United States, 15132
    - GSK Investigational Site
  - Media, Pennsylvania, United States, 19063
    - GSK Investigational Site
  - Natrona Heights, Pennsylvania, United States, 15065
    - GSK Investigational Site
  - Philadelphia, Pennsylvania, United States, 19139
    - GSK Investigational Site
  - Pittsburgh, Pennsylvania, United States, 15243
    - GSK Investigational Site
  - Reading, Pennsylvania, United States, 19610
    - GSK Investigational Site
- South Carolina
  - Charleston, South Carolina, United States, 29407
    - GSK Investigational Site
  - Moncks Corner, South Carolina, United States, 29461
    - GSK Investigational Site
  - North Charleston, South Carolina, United States, 29406
    - GSK Investigational Site
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - GSK Investigational Site
  - Cordova, Tennessee, United States, 38016
    - GSK Investigational Site
  - Johnson City, Tennessee, United States, 37601
    - GSK Investigational Site
  - Kingsport, Tennessee, United States, 37664
    - GSK Investigational Site
  - Knoxville, Tennessee, United States, 37922
    - GSK Investigational Site
  - Knoxville, Tennessee, United States, 37919
    - GSK Investigational Site
  - Madison, Tennessee, United States, 37115
    - GSK Investigational Site
  - Murfreesboro, Tennessee, United States, 37129
    - GSK Investigational Site
  - Nashville, Tennessee, United States, 37203
    - GSK Investigational Site
  - Nashville, Tennessee, United States, 37204
    - GSK Investigational Site
- Texas
  - Arlington, Texas, United States, 76012
    - GSK Investigational Site
  - Austin, Texas, United States, 78759
    - GSK Investigational Site
  - Bedford, Texas, United States, 76022
    - GSK Investigational Site
  - Conroe, Texas, United States, 77304
    - GSK Investigational Site
  - Dallas, Texas, United States, 75219
    - GSK Investigational Site
  - Houston, Texas, United States, 77030
    - GSK Investigational Site
  - Houston, Texas, United States, 77027
    - GSK Investigational Site
  - Houston, Texas, United States, 77074
    - GSK Investigational Site
  - Houston, Texas, United States, 77014
    - GSK Investigational Site
  - Houston, Texas, United States, 77042
    - GSK Investigational Site
  - Houston, Texas, United States, 77057
    - GSK Investigational Site
  - Houston, Texas, United States, 77007
    - GSK Investigational Site
  - Humble, Texas, United States, 77338
    - GSK Investigational Site
  - Humble, Texas, United States, 77339
    - GSK Investigational Site
  - Irving, Texas, United States, 75062
    - GSK Investigational Site
  - Kingwood, Texas, United States, 77339
    - GSK Investigational Site
  - Nacogdoches, Texas, United States, 75965
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78229
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78232
    - GSK Investigational Site
  - Sugar Land, Texas, United States, 77478
    - GSK Investigational Site
  - Tyler, Texas, United States, 75702
    - GSK Investigational Site
- Utah
  - Salt Lake City, Utah, United States, 84102
    - GSK Investigational Site
- Vermont
  - Williston, Vermont, United States, 04495
    - GSK Investigational Site
- Virginia
  - Arlington, Virginia, United States, 22205
    - GSK Investigational Site
  - Ashburn, Virginia, United States, 20147
    - GSK Investigational Site
  - Charlottesville, Virginia, United States, 22903
    - GSK Investigational Site
  - Charlottesville, Virginia, United States, 22911
    - GSK Investigational Site
  - Christiansburg, Virginia, United States, 24073
    - GSK Investigational Site
  - Danville, Virginia, United States, 24541
    - GSK Investigational Site
  - Falls Church, Virginia, United States, 22041
    - GSK Investigational Site
  - Midlothian, Virginia, United States, 23112
    - GSK Investigational Site
  - Newport News, Virginia, United States, 23606
    - GSK Investigational Site
  - Norfolk, Virginia, United States, 23505
    - GSK Investigational Site
  - Portsmouth, Virginia, United States, 23703
    - GSK Investigational Site
  - Richmond, Virginia, United States, 23230
    - GSK Investigational Site
  - Suffolk, Virginia, United States, 23434
    - GSK Investigational Site
  - Virginia Beach, Virginia, United States, 23452
    - GSK Investigational Site
- Washington
  - Bellingham, Washington, United States, 98225
    - GSK Investigational Site
  - Everett, Washington, United States, 98201
    - GSK Investigational Site
  - Renton, Washington, United States, 98055
    - GSK Investigational Site
  - Spokane, Washington, United States, 99204
    - GSK Investigational Site
  - Tacoma, Washington, United States, 98499
    - GSK Investigational Site
- West Virginia
  - Charleston, West Virginia, United States, 25301
    - GSK Investigational Site
  - Charleston, West Virginia, United States, 25309
    - GSK Investigational Site
  - Weirton, West Virginia, United States, 26062
    - GSK Investigational Site
- Wisconsin
  - Mequion, Wisconsin, United States, 53092
    - GSK Investigational Site
  - Milwaukee, Wisconsin, United States, 53226
    - GSK Investigational Site
  - Racine, Wisconsin, United States, 53403
    - GSK Investigational Site
  - Waukesha, Wisconsin, United States, 53188
    - GSK Investigational Site
  - Wauwatosa, Wisconsin, United States, 53213
    - GSK Investigational Site
  - West Allis, Wisconsin, United States, 53227
    - GSK Investigational 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:

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.

Exclusion Criteria:

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.

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: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm 1 Open label single arm study	Drug: lamotrigine Lamotrigine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary endpoint will be the rate of rash during 12 weeks. Time Frame: 12 Weeks	12 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Week 5 and Week 12 Clinical Global Impression-Bipolar version (CGI-BP) Severityand Improvement scores. Time Frame: 12 Weeks	12 Weeks

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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.

Helpful Links

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

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

August 1, 2003

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

September 3, 2003

First Submitted That Met QC Criteria

September 4, 2003

First Posted (Estimate)

September 5, 2003

Study Record Updates

Last Update Posted (Estimate)

September 1, 2016

Last Update Submitted That Met QC Criteria

August 31, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

SCA40917

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

Clinical Study Report
Information identifier: SCA40917

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Information identifier: SCA40917

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set
Information identifier: SCA40917

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Information identifier: SCA40917

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Information identifier: SCA40917

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Information identifier: SCA40917

Information comments: For additional information about this study please refer to the GSK Clinical Study Register

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.

Clinical Trials on Bipolar Disorder

ProgenaBiome

Recruiting

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Bipolar Disorder | Bipolar I Disorder | Bipolar II Disorder | Bipolar Type I Disorder | Bipolar Disorder Mild | Bipolar Disorder Moderate | Bipolar Disorder Severe

United States
Rush University Medical Center
The Ryan Licht Sang Bipolar Foundation

Completed

Using Neuroplasticity-Based Computerized Training to Improve Emotion Regulation in Bipolar Disorder (BRAINS) (BRAINS)

Bipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar Disorder I | Bipolar Affective Disorder

United States
University of Pittsburgh
National Alliance for Research on Schizophrenia and Depression

Completed

Sensoril(Ashwaganhda)for Bipolar Disorder

Bipolar I Disorder | Bipolar II Disorder | Bipolar Disorder NOS

United States
Region Stockholm
Karolinska Institutet

Recruiting

Braining- Aerobic Physical Activity as Add on Treatment in Bipolar Depression

Bipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II Disorder | Bipolar Affective Disorder; Remission in | Bipolar Affective Disorder, Currently Depressed, Moderate

Sweden
Hospital de Clinicas de Porto Alegre
Federal University of Rio Grande do Sul; Hospital Moinhos de Vento

Active, not recruiting

Naturalistic Study of Ketamine in the Treatment of Depression

Bipolar Disorder | Bipolar Depression | Major Depressive Disorder | Bipolar I Disorder | Affective Disorder | Bipolar II Disorder

Brazil
Medical University of South Carolina
Milken Institute

Completed

Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder

Bipolar Disorder | Bipolar I Disorder | Bipolar II Disorder

United States
Mayo Clinic

Completed

Microbiome of Depression & Treatment Response to Citalopram

Major Depressive Disorder, Bipolar I and Bipolar II

United States
Joshua Rosenblat

Recruiting

Maintenance Ketamine Infusions for Treatment-Resistant Bipolar Depression (KET-BD-Sustain)

Bipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II Disorder

Canada
Myriad Genetic Laboratories, Inc.
University of Minnesota

Completed

Bipolar Proteomic Assay Validation Study

Major Depressive Disorder, Bipolar I and Bipolar II

United States
Centre for Addiction and Mental Health
University Health Network, Toronto

Not yet recruiting

Theta-Burst Stimulation for Bipolar Depression (TRIBE)

Bipolar Disorder | Bipolar Depression | Treatment- Resistant Bipolar Disorder | Type 2 Bipolar Disorder

Canada

Clinical Trials on lamotrigine

University of Cincinnati
American Epilepsy Society; Epilepsy Foundation

Completed

Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy: Single-Dose 6-Period Replicate Design (EQUIGEN Single-Dose Study)

Epilepsy

United States
University of Maryland, Baltimore

Completed

BEEP Follow Up: Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients

Epilepsy

United States
GlaxoSmithKline

Completed

Conversion To Monotherapy With Lamictal Extended Release Tablets For Treatment Of Partial Epilepsy

Epilepsy, Partial

United States, Korea, Republic of, Ukraine, Chile, Costa Rica, Russian Federation, Puerto Rico, Argentina
University of Chicago

Completed

Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation

Dermatillomania | Pathologic Skin Picking | Neurotic Excoriation | Psychogenic Excoriation

United States
University of Maryland, Baltimore
Food and Drug Administration (FDA)

Completed

Lamotrigine Bioequivalence

Epilepsy

United States
GlaxoSmithKline

Completed

Lamotrigine Pregnancy Registry (LAM05)

Epilepsy | Bipolar Disorder
University of Cincinnati
American Epilepsy Society; Epilepsy Foundation

Completed

Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy: Chronic-Dose 4-Period Replicate Design (Chronic Dose)

Epilepsy

United States
GlaxoSmithKline

Completed

Bioequivalence and Food Effect of 250mg of Lamotrigine XR

Epilepsy

United States
GlaxoSmithKline

Completed

Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers

Mental Disorders

United States
University Hospitals Cleveland Medical Center
GlaxoSmithKline

Completed

Lamotrigine for Symptoms of Geriatric Bipolar Depression (Geri-BD SAD)

Bipolar Disorder | Depression, Bipolar

United States

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.

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

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Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

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Secondary Outcome Measures

Outcome Measure

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Collaborators and Investigators

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First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

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Clinical Trials on Bipolar Disorder

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