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The objective of this study is to evaluate the effectiveness of a marketed drug in the treatment of schizophrenia, as an add-on therapy to antipsychotics over a 12-week period. Subjects with schizophrenia who have been maintained on a stable dose of antipsychotics and who fulfill the screening entrance criteria will have an assessment 1-7 days after the first visit to confirm eligibility.
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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 7 items of the Positive and Negative Symptom Scale (PANSS) positive symptom subscale for lamotrigine vs. placebo at Week 12. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the PANSS total score at Week 12; Change from baseline in the Scale for the Assessment of Negative Symptoms (SANS) at Week 12; Change from baseline in the Clinical Global Impression-Severity of Illness (CGI-S) score 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18004124 | Background | Goff DC, Keefe R, Citrome L, Davy K, Krystal JH, Large C, Thompson TR, Volavka J, Webster EL. Lamotrigine as add-on therapy in schizophrenia: results of 2 placebo-controlled trials. J Clin Psychopharmacol. 2007 Dec;27(6):582-9. doi: 10.1097/jcp.0b013e31815abf34. |
| 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 |
|---|---|---|---|
| SCA30926 | Informed Consent 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.
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| Garden Grove |
| California |
| 92845 |
| United States |
| GSK Investigational Site | La Mesa | California | 91942 | United States |
| GSK Investigational Site | National City | California | 91950 | United States |
| GSK Investigational Site | Oceanside | California | 92056 | United States |
| GSK Investigational Site | Rosemead | California | 91770 | United States |
| GSK Investigational Site | San Diego | California | 92126 | United States |
| GSK Investigational Site | Hartford | Connecticut | 06106 | United States |
| GSK Investigational Site | Maitland | Florida | 32751 | United States |
| GSK Investigational Site | North Miami | Florida | 33161 | United States |
| GSK Investigational Site | Granite City | Illinois | 62040 | United States |
| GSK Investigational Site | Glen Burnie | Maryland | 21061 | United States |
| GSK Investigational Site | Rockville | Maryland | 20852 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02114 | United States |
| GSK Investigational Site | Reno | Nevada | 89512 | United States |
| GSK Investigational Site | Clementon | New Jersey | 08021 | United States |
| GSK Investigational Site | Kenilworth | New Jersey | 07033 | United States |
| GSK Investigational Site | Orangeburg | New York | 10962 | United States |
| GSK Investigational Site | Rochester | New York | 14620 | United States |
| GSK Investigational Site | Butner | North Carolina | 27509 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28211 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27603 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27609 | United States |
| GSK Investigational Site | Beachwood | Ohio | 44122 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44106 | United States |
| GSK Investigational Site | Lyndhurst | Ohio | 44124 | United States |
| GSK Investigational Site | Norristown | Pennsylvania | 19401 | United States |
| GSK Investigational Site | Austin | Texas | 78756 | United States |
| GSK Investigational Site | Bellaire | Texas | 77401 | United States |
| GSK Investigational Site | DeSoto | Texas | 75115 | United States |
| GSK Investigational Site | Midvale | Utah | 84047 | United States |
| GSK Investigational Site | Milwaukee | Wisconsin | 53226 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| SCA30926 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCA30926 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCA30926 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCA30926 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCA30926 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| 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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