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NCT00470483 Clinical Trial

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

Social Phobia Clinical Trial

Official title:
A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, fMRI and PET Study Comparing Emotional Challenge-induced Regional Cerebral Blood Flow Changes Before and After 8 Weeks of Treatment With Placebo and Paroxetine in Subjects With Social Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00470483
Other study ID # TMT106386
Secondary ID
Status Completed
Phase Phase 1
First received May 3, 2007
Last updated July 13, 2017
Start date January 22, 2007
Est. completion date January 7, 2009

Study information
Verified date July 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date January 7, 2009
Est. primary completion date January 7, 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo treatment during 8 weeks
comparator
• Paroxetine treatment during 8 weeks
treatment drug

Locations
Country Name City State
Spain GSK Investigational Site Barcelona

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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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