A Study To Compare Emotional Changes In Subjects With Social Anxiety Disorder

Phase 1

Completed

• Conditions: Social Phobia
• Interventions: Drug: Placebo treatment during 8 weeks; Drug: Paroxetine treatment during 8 weeks

• Registration Number: NCT00470483
• Lead Sponsor: GlaxoSmithKline

Brief Summary

To compare by neuroimaging techniques the way Social Anxiety patients respond to public speaking before and after a drug administration

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-22
• Study First Submitted: 2007-05-03
• Study First Submitted QC: 2007-05-03
• Study First Posted: 2007-05-07
• Primary Completion: 2009-01-07
• Study Completion: 2009-01-07
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-13
• Last Update Posted: 2017-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arm 2	Placebo treatment during 8 weeks	Placebo treatment during 8 weeks
arm 1	Paroxetine treatment during 8 weeks	Paroxetine treatment during 8 weeks

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇪🇸 Barcelona, Spain