Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with Bipolar Disorder
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lamotrigine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS) | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline scores at Week 8 for the Hamilton Depression Rating Scale (HAMD-17, HAMD-31, Bech Melancholia Scale (BMS), and HAMD - Item 1), Clinical Global Impressions of Severity (CGI-S) and Improvement (CGI-I). | 8 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Beverly Hills | California | 90210 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34523118 | Derived | Hashimoto Y, Kotake K, Watanabe N, Fujiwara T, Sakamoto S. Lamotrigine in the maintenance treatment of bipolar disorder. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD013575. doi: 10.1002/14651858.CD013575.pub2. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| SCA30924 | Annotated Case Report Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| La Jolla |
| California |
| 92093 |
| United States |
| GSK Investigational Site | San Diego | California | 92108 | United States |
| GSK Investigational Site | Santa Ana | California | 92705 | United States |
| GSK Investigational Site | Marietta | Georgia | 30060 | United States |
| GSK Investigational Site | Terre Haute | Indiana | 47802 | United States |
| GSK Investigational Site | Shreveport | Louisiana | 71101 | United States |
| GSK Investigational Site | Saint Charles | Missouri | 63301 | United States |
| GSK Investigational Site | Princeton | New Jersey | 08540 | United States |
| GSK Investigational Site | New York | New York | 10021 | United States |
| GSK Investigational Site | Pleasantville | New York | 10570 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27609 | United States |
| GSK Investigational Site | Brecksville | Ohio | 44141 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45242 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44106 | United States |
| GSK Investigational Site | Eugene | Oregon | 97401 | United States |
| GSK Investigational Site | Portland | Oregon | 97210 | United States |
| GSK Investigational Site | Columbia | South Carolina | 29201 | United States |
| GSK Investigational Site | San Antonio | Texas | 77090 | United States |
| GSK Investigational Site | Brown Deer | Wisconsin | 53223 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| SCA30924 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCA30924 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCA30924 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCA30924 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCA30924 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCA30924 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077213 | Lamotrigine |
| ID | Term |
|---|---|
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided