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This study is an 8-week evaluation of an investigational drug for treating depression in bipolar patients. Depressed patients will be given either an investigational drug or placebo and receive psychiatric assessments of their depression at weekly visits. Study drug and all study-related visits are provided at no cost to the patient. The patient agrees to meet with study research staff for roughly 11 clinic visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| lamotrigine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Experimental treatment arm |
| |
| lamotrigine |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS) | Eight 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) | Eight weeks |
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Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Burbank | California | 91506 | 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 |
|---|---|---|---|
| SCA100223 | Study Protocol | 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.
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| Drug |
Experimental treatment |
|
|
| Loma Linda |
| California |
| 92354 |
| United States |
| GSK Investigational Site | San Diego | California | 92108 | 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 | Clementon | New Jersey | 08021 | 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 | Charlotte | North Carolina | 28209 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27609 | United States |
| GSK Investigational Site | Beachwood | Ohio | 44122 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73118 | United States |
| GSK Investigational Site | Eugene | Oregon | 97401 | United States |
| GSK Investigational Site | Columbia | South Carolina | 29201 | United States |
| GSK Investigational Site | Galveston | Texas | 77555-0188 | United States |
| GSK Investigational Site | Houston | Texas | 77090 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| SCA100223 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCA100223 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCA100223 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCA100223 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCA100223 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCA100223 | Dataset Specification | 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 |
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| ID | Term |
|---|---|
| D000077213 | Lamotrigine |
| ID | Term |
|---|---|
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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