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This is a 12-week study for the treatment of chronic persistent symptoms in participants with schizophrenia. Participants on a stable, optimal dose of up to two atypical antipsychotics who fulfill the screening criteria will be randomized to receive either an FDA-approved drug or placebo in addition to the current treatment. Safety will be closely monitored through vital signs, various tests, and blood and urine samples.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lamotrigine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the total score of the Positive and Negative Symptom Scale (PANSS) at Week 12. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| - Efficacy - Change from baseline in PANSS positive symptoms at Week 12 - Change from baseline in the Scale for the Assessment of Negative Symptoms (SANS) at Week 12 - Change from baseline in PANSS general psychopathology symptoms at Week 12. | 12 Weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Little Rock | Arkansas | 72201 | United States | ||
| GSK Investigational Site |
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| 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 |
|---|---|---|---|
| 101464 | 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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| Garden Grove |
| California |
| 92845 |
| United States |
| GSK Investigational Site | Glendale | California | 91206 | United States |
| GSK Investigational Site | Los Angeles | California | 90033 | United States |
| GSK Investigational Site | Pico Rivera | California | 90660 | United States |
| GSK Investigational Site | San Diego | California | 92126 | United States |
| GSK Investigational Site | Sherman Oaks | California | 91403 | United States |
| GSK Investigational Site | Coral Springs | Florida | 33065 | United States |
| GSK Investigational Site | Maitland | Florida | 32751 | United States |
| GSK Investigational Site | Miami | Florida | 33125 | United States |
| GSK Investigational Site | North Miami | Florida | 33161 | United States |
| GSK Investigational Site | Winter Park | Florida | 32789 | United States |
| GSK Investigational Site | Niles | Illinois | 60714 | United States |
| GSK Investigational Site | Oak Brook | Illinois | 60523 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46202-5200 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46202 | United States |
| GSK Investigational Site | Staten Island | New York | 10305 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States |
| GSK Investigational Site | Bellaire | Texas | 77401 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Madison | Wisconsin | 53711-2027 | United States |
| GSK Investigational Site | Edmonton | Alberta | T5K 2J5 | Canada |
| GSK Investigational Site | Edmonton | Alberta | T6G 2C8 | Canada |
| GSK Investigational Site | Kelowna | British Columbia | V1W 4V5 | Canada |
| GSK Investigational Site | Winnipeg | Manitoba | R3E 3N4 | Canada |
| GSK Investigational Site | Miramichi | New Brunswick | E1V 3G5 | Canada |
| GSK Investigational Site | Dartmouth | Nova Scotia | B2Y 3S3 | Canada |
| GSK Investigational Site | Sydney | Nova Scotia | B1S 2E8 | Canada |
| GSK Investigational Site | Burlington | Ontario | L7N 3V2 | Canada |
| GSK Investigational Site | Greater Sudbury | Ontario | P3E 1X3 | Canada |
| GSK Investigational Site | London | Ontario | N6A 4G5 | Canada |
| GSK Investigational Site | Mississauga | Ontario | L5M 4N4 | Canada |
| GSK Investigational Site | Toronto | Ontario | M6M 3Z5 | Canada |
| GSK Investigational Site | Windsor | Ontario | N9C 3Z4 | Canada |
| GSK Investigational Site | Bedford | Bedfordshire | MK42 9DJ | United Kingdom |
| GSK Investigational Site | Cambridge | Cambridgeshire | CB1 5EF | United Kingdom |
| GSK Investigational Site | Glasgow | Lanarkshire | G66 3UG | United Kingdom |
| GSK Investigational Site | Coventry | Warwickshire | CV2 2DX | United Kingdom |
| GSK Investigational Site | Hull | HU6 7RX | United Kingdom |
For additional information about this study please refer to the GSK Clinical Study Register |
| 101464 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101464 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101464 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101464 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101464 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic 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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