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This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paroxetine hydrochloride hydrate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the LSAS total score at week 12 (Score at week 12 - Score at week 0) | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients responding with a CGI Global Improvement Item score. Change from baseline in the CGI Severity of Illness score. Change from baseline in the HAM-D total score. Proportion of patients continuing treatment. | 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 | Fukuoka | 802-0006 | Japan | |||
| GSK Investigational Site |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 8, 2017 | |
| Reset | Oct 31, 2017 | |
| Release | Nov 8, 2017 | |
| Unrelease | Aug 15, 2018 | |
| Release | Aug 27, 2018 | |
| Unrelease | Aug 30, 2018 | |
| Release | Aug 30, 2018 | |
| Reset | Jan 31, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 8, 2017 | Oct 31, 2017 | |||
| Nov 8, 2017 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| D001008 | Anxiety Disorders |
| D004194 | Disease |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Fukuoka |
| 810-0001 |
| Japan |
| GSK Investigational Site | Fukuoka | 815-0041 | Japan |
| GSK Investigational Site | Saitama | 332-0012 | Japan |
| GSK Investigational Site | Tokyo | 107-0062 | Japan |
| GSK Investigational Site | Tokyo | 120-0033 | Japan |
| GSK Investigational Site | Tokyo | 143-8541 | Japan |
| GSK Investigational Site | Tokyo | 144-0052 | Japan |
| GSK Investigational Site | Tokyo | 152-0012 | Japan |
| GSK Investigational Site | Tokyo | 154-0004 | Japan |
| GSK Investigational Site | Tokyo | 160-0023 | Japan |
| GSK Investigational Site | Tokyo | 170-0002 | Japan |
| GSK Investigational Site | Tokyo | 170-0005 | Japan |
| GSK Investigational Site | Tokyo | 178-0063 | Japan |
| GSK Investigational Site | Tokyo | 194-0022 | Japan |
| GSK Investigational Site |
| Aug 27, 2018 | Aug 30, 2018 |
| Aug 30, 2018 | Jan 31, 2019 |