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To compare by neuroimaging techniques the way Social Anxiety patients respond to public speaking before and after a drug administration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm 1 | Active Comparator | Paroxetine treatment during 8 weeks |
|
| arm 2 | Placebo Comparator | Placebo treatment during 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo treatment during 8 weeks | Drug | comparator |
| |
| Paroxetine treatment during 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| fMRI BOLD response in the amygdala and insula elicited by the Matching Emotional Face paradigm at baseline and after 8 weeks of treatment. State-anxiety inventory (STAI-S) after the Public Speaking challenge (only patients). | baseline and after 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| fMRI BOLD response in selected neuroanatomical ROI elicited by the by Resting State and by other exploratory paradigms at baseline (all subjects) and after 8 weeks of treatment with paroxetine compared to placebo (only patients). | baseline and after 8 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 | Barcelona | E-08003 | Spain |
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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 |
| Results for study TMT106386 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| TMT106386 | 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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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| Drug |
treatment drug |
|
|
For additional information about this study please refer to the GSK Clinical Study Register |
| TMT106386 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TMT106386 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TMT106386 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TMT106386 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TMT106386 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |