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Bipolar Study in Adults at Least 18 Years of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00067938
First received: September 3, 2003
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

Bipolar study of tolerability, clinical response and patient satisfaction


Condition Intervention Phase
Bipolar Disorder
Drug: lamotrigine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study of Tolerability, Clinical Response, and Satisfaction in Adult Bipolar I Subjects Optimizing Initiation of Therapy Using Administration of Dermatological Precautions and LAMICTAL Titration Packs

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The primary endpoint will be the rate of rash during 12 weeks. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Week 5 and Week 12 Clinical Global Impression-Bipolar version (CGI-BP) Severityand Improvement scores. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment: 1200
Study Start Date: August 2003
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Open label single arm study
Drug: lamotrigine
Lamotrigine
Other Name: lamotrigine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067938

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00067938     History of Changes
Other Study ID Numbers: SCA40917
Study First Received: September 3, 2003
Last Updated: October 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
bipolar disorder
lamotrigine

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Anticonvulsants
Lamotrigine
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 20, 2014