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

GlaxoSmithKline56 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Social Phobia

Interventions

Placebo treatment during 8 weeksDRUG

comparator

Paroxetine treatment during 8 weeksDRUG

treatment drug

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: * Outpatient with Social Anxiety Disorder * The subject is healthy * Willing to restrict alcohol intake * Capable of giving informed consent Exclusion criteria: * Subjects with depression or any other psychiatric condition * Subjects positive for HIV or hepatitis * Subjects taking drugs or other medication * Pregnant or becoming pregnant during the study * Subjects who have donated blood * Subjects who are left-handed * Subjects with claustrophobia * Subjects with an electronic device or ferromagnetic metal foreign body

Locations (1)

GSK Investigational Site

Barcelona, Spain

Outcomes

Primary Outcomes

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).

Time frame: baseline and after 8 weeks

Secondary Outcomes

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).

Time frame: baseline and after 8 weeks

Data from ClinicalTrials.gov

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