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This six-arm study is being conducted to measure the effect of a combination of paroxetine and vestipitant on the arousal induced by public speaking in Seasonal Effective Disorder (SAD) patients, using functional brain imaging readouts (i.e., WAT(Wave Analysis Technology) PET(Positron Emission Tomography)), after one or eight weeks of treatment. The effect of paroxetine alone after one or eight weeks of treatment will also be measured.
A double-blind, double dummy, placebo-controlled, randomised, parallel group positron emission tomography study to investigate the effects of a 8 week administration of vestipitant and paroxetine in combination or paroxetine alone on regional cerebral blood flow during a public speaking test in subjects affected by social anxiety disorder.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vestipitant | Drug | |||
| paroxetine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess, by mean of Positron Emission Tomography, the degree of regional Cerebral Blood Flow in different brain regions involved in the emotional brain circuit during public speaking task before treatment and after eight weeks of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess symptomatic and physiological measures of anxiety induced by the public speaking task and social anxiety symptoms during eight weeks of treatment. To evaluate safety, tolerability and the effect on sexual function of treatment. |
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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 | Uppsala | SE-753 23 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24666527 | Derived | Faria V, Ahs F, Appel L, Linnman C, Bani M, Bettica P, Pich EM, Wahlstedt K, Fredrikson M, Furmark T. Amygdala-frontal couplings characterizing SSRI and placebo response in social anxiety disorder. Int J Neuropsychopharmacol. 2014 Aug;17(8):1149-57. doi: 10.1017/S1461145714000352. Epub 2014 Mar 26. |
| 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 |
|---|---|---|---|
| NKP102280 | Statistical Analysis Plan | 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 |
|---|---|
| D003866 | Depressive Disorder |
| D001008 | Anxiety Disorders |
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
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| ID | Term |
|---|---|
| C534550 | vestipitant |
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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For additional information about this study please refer to the GSK Clinical Study Register |
| NKP102280 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKP102280 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKP102280 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKP102280 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKP102280 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |