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OpenTrials
Completed

NCT Number: NCT00470483

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

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

Completed

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Key information

Conditions

Social Phobia Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Barcelona, E-08003, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo treatment during 8 weeks

Drug

comparator

Paroxetine treatment during 8 weeks

Drug

treatment drug

Other names: Placebo treatment during 8 weeks

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 7, 2007
Registry last updated
Jul 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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