Social Phobia
Conditions
Keywords
PET, Social Anxiety Disorder, fRMI
Brief summary
To compare by neuroimaging techniques the way Social Anxiety patients respond to public speaking before and after a drug administration
Interventions
DRUGPlacebo treatment during 8 weeks
comparator
DRUGParoxetine treatment during 8 weeks
treatment drug
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
Countries
Spain
Outcome results
None listed