Bipolar Study in Adults at Least 18 Years of Age

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00067938
Collaborator
(none)
1,200
308
1
12
3.9
0.3

Study Details

Study Description

Brief Summary

Bipolar study of tolerability, clinical response and patient satisfaction

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
1200 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Lamictal for Use in Treatment of Bipolar Disorder In Adults. A Practical Clinical Assessment of Tolerability and Clinical Effectiveness.
Study Start Date :
Aug 1, 2003
Actual Primary Completion Date :
Aug 1, 2004
Actual Study Completion Date :
Aug 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Other: Arm 1

Open label single arm study

Drug: lamotrigine
Lamotrigine

Outcome Measures

Primary Outcome Measures

  1. The primary endpoint will be the rate of rash during 12 weeks. [12 Weeks]

Secondary Outcome Measures

  1. Change from baseline in Week 5 and Week 12 Clinical Global Impression-Bipolar version (CGI-BP) Severityand Improvement scores. [12 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 GSK Investigational Site Albertville Alabama United States 35950
2 GSK Investigational Site Anniston Alabama United States 36207
3 GSK Investigational Site Birmingham Alabama United States 35209
4 GSK Investigational Site Birmingham Alabama United States 35223
5 GSK Investigational Site Birmingham Alabama United States 35234
6 GSK Investigational Site Fairhope Alabama United States 36532
7 GSK Investigational Site Huntsville Alabama United States 35802
8 GSK Investigational Site Tuscaloosa Alabama United States 35404
9 GSK Investigational Site Chandler Arizona United States 85225
10 GSK Investigational Site Phoenix Arizona United States 85004
11 GSK Investigational Site Phoenix Arizona United States 85018
12 GSK Investigational Site Phoenix Arizona United States 85032
13 GSK Investigational Site Phoenix Arizona United States 85044
14 GSK Investigational Site Rogers Arizona United States 72756
15 GSK Investigational Site Tucson Arizona United States 85719
16 GSK Investigational Site Fort Smith Arkansas United States 72903
17 GSK Investigational Site Little Rock Arkansas United States 72201
18 GSK Investigational Site North Little Rock Arkansas United States 72113
19 GSK Investigational Site Bakersfield California United States 93309
20 GSK Investigational Site Beverly Hills California United States 90210
21 GSK Investigational Site Burbank California United States 91501
22 GSK Investigational Site Campbell California United States 95008
23 GSK Investigational Site Cerritos California United States 90703
24 GSK Investigational Site El Centro California United States 92243
25 GSK Investigational Site Fairfield California United States 94533
26 GSK Investigational Site La Mesa California United States 91941
27 GSK Investigational Site Laguna Hills California United States 92653
28 GSK Investigational Site Los Angeles California United States 90011
29 GSK Investigational Site Los Angeles California United States 90089
30 GSK Investigational Site Oceanside California United States 92056
31 GSK Investigational Site Petaluma California United States 94952
32 GSK Investigational Site Poway California United States 92064
33 GSK Investigational Site Riverside California United States 92506
34 GSK Investigational Site Sacramento California United States 95825
35 GSK Investigational Site San Diego California United States 92103
36 GSK Investigational Site San Diego California United States 92114
37 GSK Investigational Site San Diego California United States 92123
38 GSK Investigational Site San Jose California United States 95123
39 GSK Investigational Site Santa Ana California United States 92705
40 GSK Investigational Site Santa Barbara California United States 93102
41 GSK Investigational Site Sherman Oaks California United States 91403
42 GSK Investigational Site Torrance California United States 90505
43 GSK Investigational Site West Hollywood California United States 90048
44 GSK Investigational Site Boulder Colorado United States 80303
45 GSK Investigational Site Fort Collins Colorado United States 80525
46 GSK Investigational Site Hamden Connecticut United States 06514
47 GSK Investigational Site Mansfield Center Connecticut United States 06250
48 GSK Investigational Site Norwich Connecticut United States 06360
49 GSK Investigational Site Wethersfield Connecticut United States 06109
50 GSK Investigational Site Newark Delaware United States 19713
51 GSK Investigational Site Wilmington Delaware United States 19808
52 GSK Investigational Site Washington District of Columbia United States 20011
53 GSK Investigational Site Altamonte Springs Florida United States 32714
54 GSK Investigational Site Boca Raton Florida United States 33432
55 GSK Investigational Site Boca Raton Florida United States 33433
56 GSK Investigational Site Boynton Beach Florida United States 33426
57 GSK Investigational Site Bradenton Florida United States 34209
58 GSK Investigational Site Brandon Florida United States 33511
59 GSK Investigational Site Casselberry Florida United States 32730
60 GSK Investigational Site Clearwater Florida United States 33764
61 GSK Investigational Site Coral Springs Florida United States 33065
62 GSK Investigational Site Davie Florida United States 33024
63 GSK Investigational Site Daytona Beach Florida United States 32114
64 GSK Investigational Site Destin Florida United States 32541
65 GSK Investigational Site Fort Walton Beach Florida United States 32548
66 GSK Investigational Site Gainesville Florida United States 32607
67 GSK Investigational Site Jacksonville Beach Florida United States 32250
68 GSK Investigational Site Jacksonville Florida United States 32216
69 GSK Investigational Site Jacksonville Florida United States 32257
70 GSK Investigational Site Lakeland Florida United States 33803
71 GSK Investigational Site Miami Florida United States 32216
72 GSK Investigational Site Miami Florida United States 33125
73 GSK Investigational Site Miami Florida United States 33157
74 GSK Investigational Site Miami Florida United States 33176
75 GSK Investigational Site North Miami Florida United States 33161
76 GSK Investigational Site Ocala Florida United States 34471
77 GSK Investigational Site Ocala Florida United States 34474
78 GSK Investigational Site Orange City Florida United States 32763
79 GSK Investigational Site Orlando Florida United States 32803
80 GSK Investigational Site Palm Beach Gardens Florida United States 33410
81 GSK Investigational Site Pensacola Florida United States 32503
82 GSK Investigational Site Plantation Florida United States 33324
83 GSK Investigational Site Sarasota Florida United States 34238
84 GSK Investigational Site St. Petersburg Florida United States 33701
85 GSK Investigational Site St. Petersburg Florida United States 33702
86 GSK Investigational Site Syracuse Florida United States 13202
87 GSK Investigational Site Tampa Florida United States 33603
88 GSK Investigational Site West Palm Beach Florida United States 33407
89 GSK Investigational Site Wilton Manors Florida United States 33311
90 GSK Investigational Site Winter Park Florida United States 32789
91 GSK Investigational Site Winter Park Florida United States 32792
92 GSK Investigational Site Zephyrhills Florida United States 33540
93 GSK Investigational Site Atlanta Georgia United States 30030
94 GSK Investigational Site Atlanta Georgia United States 30309-7520
95 GSK Investigational Site Atlanta Georgia United States 30338
96 GSK Investigational Site Decatur Georgia United States 30030
97 GSK Investigational Site Lawrenceville Georgia United States 30045
98 GSK Investigational Site Macon Georgia United States 31201
99 GSK Investigational Site Roswell Georgia United States 30075
100 GSK Investigational Site Stockbridge Georgia United States 30281
101 GSK Investigational Site Warner Robins Georgia United States 31093
102 GSK Investigational Site Boise Idaho United States 83702
103 GSK Investigational Site Boise Idaho United States 83704
104 GSK Investigational Site Boise Idaho United States 83706
105 GSK Investigational Site Alton Illinois United States 62002
106 GSK Investigational Site Bourbonnais Illinois United States 60914
107 GSK Investigational Site Chicago Illinois United States 60657
108 GSK Investigational Site East Moline Illinois United States 61244
109 GSK Investigational Site Evergreen Park Illinois United States 60805
110 GSK Investigational Site Fairview Heights Illinois United States 62208
111 GSK Investigational Site Granite City Illinois United States 62040
112 GSK Investigational Site Joliet Illinois United States 60435
113 GSK Investigational Site Libertyville Illinois United States 60048
114 GSK Investigational Site Lisle Illinois United States 60532
115 GSK Investigational Site Oakbrook Terrace Illinois United States 60181
116 GSK Investigational Site Orland Park Illinois United States 60462
117 GSK Investigational Site Park Ridge Illinois United States 60068
118 GSK Investigational Site Rockford Illinois United States 61108
119 GSK Investigational Site Schaumburg Illinois United States 60194
120 GSK Investigational Site Vernon Hills Illinois United States 60061
121 GSK Investigational Site Wheaton Illinois United States 60187
122 GSK Investigational Site Danville Indiana United States 46122
123 GSK Investigational Site Evansville Indiana United States 47715
124 GSK Investigational Site Fort Wayne Indiana United States 46805
125 GSK Investigational Site Lafayette Indiana United States 47904
126 GSK Investigational Site Mishawaka Indiana United States 46545
127 GSK Investigational Site Plymouth Indiana United States 46563
128 GSK Investigational Site Valparaiso Indiana United States 46383
129 GSK Investigational Site Cedar Rapids Iowa United States 52402
130 GSK Investigational Site Dubuque Iowa United States 52001
131 GSK Investigational Site Leavenworth Kansas United States 66048
132 GSK Investigational Site Overland Park Kansas United States 66211
133 GSK Investigational Site Shawnee Mission Kansas United States 66214
134 GSK Investigational Site Topeka Kansas United States 66606
135 GSK Investigational Site Wichita Kansas United States 67205
136 GSK Investigational Site Wichita Kansas United States 67206
137 GSK Investigational Site Wichita Kansas United States 67207
138 GSK Investigational Site Wichita Kansas United States 67211
139 GSK Investigational Site Hopkinsville Kentucky United States 42240
140 GSK Investigational Site Lexington Kentucky United States 40509
141 GSK Investigational Site Baton Rouge Louisiana United States 70806
142 GSK Investigational Site Houma Louisiana United States 70360
143 GSK Investigational Site Lake Charles Louisiana United States 70601
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145 GSK Investigational Site Annapolis Maryland United States 21403
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149 GSK Investigational Site Ellicott City Maryland United States 21043
150 GSK Investigational Site Gaithersburg Maryland United States 20877
151 GSK Investigational Site Glen Burnie Maryland United States 21061
152 GSK Investigational Site Laurel Maryland United States 20707
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154 GSK Investigational Site Towson Maryland United States 21204
155 GSK Investigational Site Towson Maryland United States 21286
156 GSK Investigational Site Adrian Michigan United States 49221
157 GSK Investigational Site Bay City Michigan United States 48706
158 GSK Investigational Site Benton Harbor Michigan United States 49022
159 GSK Investigational Site Bloomfield Hills Michigan United States 48302
160 GSK Investigational Site Brownstown Township Michigan United States 48183
161 GSK Investigational Site Clinton Township Michigan United States 48036
162 GSK Investigational Site East Lansing Michigan United States 48823
163 GSK Investigational Site Farmington Hills Michigan United States 48334
164 GSK Investigational Site Flint Michigan United States 48507
165 GSK Investigational Site Flint Michigan United States 48532
166 GSK Investigational Site Mount Clemens Michigan United States 48043
167 GSK Investigational Site Rochester Hills Michigan United States 48307
168 GSK Investigational Site Royal Oak Michigan United States 48067
169 GSK Investigational Site Duluth Minnesota United States 55802
170 GSK Investigational Site Minneapolis Minnesota United States 55454
171 GSK Investigational Site Oakdale Minnesota United States 55128
172 GSK Investigational Site Flowood Mississippi United States 39232
173 GSK Investigational Site Gulfport Mississippi United States 39503
174 GSK Investigational Site Joplin Missouri United States 64804
175 GSK Investigational Site Kansas City Missouri United States 64108
176 GSK Investigational Site Springfield Missouri United States 65804
177 GSK Investigational Site St. Charles Missouri United States 63301
178 GSK Investigational Site St. Louis Missouri United States 63117
179 GSK Investigational Site St. Louis Missouri United States 63128
180 GSK Investigational Site St. Louis Missouri United States 63136-3675
181 GSK Investigational Site Billings Montana United States 59101
182 GSK Investigational Site Lincoln Nebraska United States 68502
183 GSK Investigational Site Omaha Nebraska United States 68124
184 GSK Investigational Site Omaha Nebraska United States 68131
185 GSK Investigational Site Henderson Nevada United States 89074
186 GSK Investigational Site Las Vegas Nevada United States 89030
187 GSK Investigational Site Las Vegas Nevada United States 89102
188 GSK Investigational Site Manchester New Hampshire United States 03104
189 GSK Investigational Site Long Branch New Jersey United States 07740
190 GSK Investigational Site Princeton New Jersey United States 08540
191 GSK Investigational Site Albuquerque New Mexico United States 87108
192 GSK Investigational Site Las Cruces New Mexico United States 88011
193 GSK Investigational Site Albany New York United States 31701
194 GSK Investigational Site Amityville New York United States 11701
195 GSK Investigational Site Bronx New York United States 10461
196 GSK Investigational Site Farmingdale New York United States 11735
197 GSK Investigational Site Latham New York United States 12110
198 GSK Investigational Site New Rochelle New York United States 10801
199 GSK Investigational Site New York New York United States 10023
200 GSK Investigational Site Olean New York United States 14760
201 GSK Investigational Site Port Jefferson New York United States 11777
202 GSK Investigational Site Smithtown New York United States 11787
203 GSK Investigational Site Cary North Carolina United States 27511
204 GSK Investigational Site Chapel Hill North Carolina United States 27514
205 GSK Investigational Site Chapel Hill North Carolina United States 27517
206 GSK Investigational Site Charlotte North Carolina United States 28211
207 GSK Investigational Site Cornelius North Carolina United States 28031
208 GSK Investigational Site Durham North Carolina United States 27705
209 GSK Investigational Site Fayetteville North Carolina United States 28305
210 GSK Investigational Site Forest City North Carolina United States 28043
211 GSK Investigational Site Goldsboro North Carolina United States 27530
212 GSK Investigational Site Greensboro North Carolina United States 27408
213 GSK Investigational Site Greenville North Carolina United States 27834
214 GSK Investigational Site Greenville North Carolina United States 27858
215 GSK Investigational Site High Point North Carolina United States 27262
216 GSK Investigational Site Raleigh North Carolina United States 27605
217 GSK Investigational Site Raleigh North Carolina United States 27607
218 GSK Investigational Site Raleigh North Carolina United States 27609
219 GSK Investigational Site Raleigh North Carolina United States 27612
220 GSK Investigational Site Wilmington North Carolina United States 28401
221 GSK Investigational Site Avon Lake Ohio United States 44012
222 GSK Investigational Site Cincinnati Ohio United States 45206
223 GSK Investigational Site Cincinnati Ohio United States 45243
224 GSK Investigational Site Cuyahoga Falls Ohio United States 44221
225 GSK Investigational Site Dayton Ohio United States 45459
226 GSK Investigational Site Warren Ohio United States 44483
227 GSK Investigational Site Youngstown Ohio United States 44512
228 GSK Investigational Site Oklahoma City Oklahoma United States 73103
229 GSK Investigational Site Oklahoma City Oklahoma United States 73109
230 GSK Investigational Site Oklahoma City Oklahoma United States 73118
231 GSK Investigational Site Oklahoma City Oklahoma United States 73120
232 GSK Investigational Site Tulsa Oklahoma United States 74120
233 GSK Investigational Site Tulsa Oklahoma United States 74136
234 GSK Investigational Site Milwaukie Oregon United States 97222
235 GSK Investigational Site Portland Oregon United States 97210
236 GSK Investigational Site Colmar Pennsylvania United States 18915
237 GSK Investigational Site Doyletown Pennsylvania United States 18901
238 GSK Investigational Site Kingston Pennsylvania United States 18704
239 GSK Investigational Site McKeesport Pennsylvania United States 15132
240 GSK Investigational Site Media Pennsylvania United States 19063
241 GSK Investigational Site Natrona Heights Pennsylvania United States 15065
242 GSK Investigational Site Philadelphia Pennsylvania United States 19139
243 GSK Investigational Site Pittsburgh Pennsylvania United States 15243
244 GSK Investigational Site Reading Pennsylvania United States 19610
245 GSK Investigational Site Charleston South Carolina United States 29407
246 GSK Investigational Site Moncks Corner South Carolina United States 29461
247 GSK Investigational Site North Charleston South Carolina United States 29406
248 GSK Investigational Site Bristol Tennessee United States 37620
249 GSK Investigational Site Cordova Tennessee United States 38016
250 GSK Investigational Site Johnson City Tennessee United States 37601
251 GSK Investigational Site Kingsport Tennessee United States 37664
252 GSK Investigational Site Knoxville Tennessee United States 37919
253 GSK Investigational Site Knoxville Tennessee United States 37922
254 GSK Investigational Site Madison Tennessee United States 37115
255 GSK Investigational Site Murfreesboro Tennessee United States 37129
256 GSK Investigational Site Nashville Tennessee United States 37203
257 GSK Investigational Site Nashville Tennessee United States 37204
258 GSK Investigational Site Arlington Texas United States 76012
259 GSK Investigational Site Austin Texas United States 78759
260 GSK Investigational Site Bedford Texas United States 76022
261 GSK Investigational Site Conroe Texas United States 77304
262 GSK Investigational Site Dallas Texas United States 75219
263 GSK Investigational Site Houston Texas United States 77007
264 GSK Investigational Site Houston Texas United States 77014
265 GSK Investigational Site Houston Texas United States 77027
266 GSK Investigational Site Houston Texas United States 77030
267 GSK Investigational Site Houston Texas United States 77042
268 GSK Investigational Site Houston Texas United States 77057
269 GSK Investigational Site Houston Texas United States 77074
270 GSK Investigational Site Humble Texas United States 77338
271 GSK Investigational Site Humble Texas United States 77339
272 GSK Investigational Site Irving Texas United States 75062
273 GSK Investigational Site Kingwood Texas United States 77339
274 GSK Investigational Site Nacogdoches Texas United States 75965
275 GSK Investigational Site San Antonio Texas United States 78229
276 GSK Investigational Site San Antonio Texas United States 78232
277 GSK Investigational Site Sugar Land Texas United States 77478
278 GSK Investigational Site Tyler Texas United States 75702
279 GSK Investigational Site Salt Lake City Utah United States 84102
280 GSK Investigational Site Williston Vermont United States 04495
281 GSK Investigational Site Arlington Virginia United States 22205
282 GSK Investigational Site Ashburn Virginia United States 20147
283 GSK Investigational Site Charlottesville Virginia United States 22903
284 GSK Investigational Site Charlottesville Virginia United States 22911
285 GSK Investigational Site Christiansburg Virginia United States 24073
286 GSK Investigational Site Danville Virginia United States 24541
287 GSK Investigational Site Falls Church Virginia United States 22041
288 GSK Investigational Site Midlothian Virginia United States 23112
289 GSK Investigational Site Newport News Virginia United States 23606
290 GSK Investigational Site Norfolk Virginia United States 23505
291 GSK Investigational Site Portsmouth Virginia United States 23703
292 GSK Investigational Site Richmond Virginia United States 23230
293 GSK Investigational Site Suffolk Virginia United States 23434
294 GSK Investigational Site Virginia Beach Virginia United States 23452
295 GSK Investigational Site Bellingham Washington United States 98225
296 GSK Investigational Site Everett Washington United States 98201
297 GSK Investigational Site Renton Washington United States 98055
298 GSK Investigational Site Spokane Washington United States 99204
299 GSK Investigational Site Tacoma Washington United States 98499
300 GSK Investigational Site Charleston West Virginia United States 25301
301 GSK Investigational Site Charleston West Virginia United States 25309
302 GSK Investigational Site Weirton West Virginia United States 26062
303 GSK Investigational Site Mequion Wisconsin United States 53092
304 GSK Investigational Site Milwaukee Wisconsin United States 53226
305 GSK Investigational Site Racine Wisconsin United States 53403
306 GSK Investigational Site Waukesha Wisconsin United States 53188
307 GSK Investigational Site Wauwatosa Wisconsin United States 53213
308 GSK Investigational Site West Allis Wisconsin United States 53227

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00067938
Other Study ID Numbers:
  • SCA40917
First Posted:
Sep 5, 2003
Last Update Posted:
Sep 1, 2016
Last Verified:
Aug 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 1, 2016