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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00470483
First received: May 3, 2007
Last updated: March 15, 2012
Last verified: February 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Anxiety Disorders
Social Anxiety Disorder
 Drug: Placebo treatment during 8 weeks
Drug: Paroxetine treatment during 8 weeks
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 56
Study Start Date: January 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: arm 1 Drug: Paroxetine treatment during 8 weeks
treatment drug
Other Names:
  • Paroxetine treatment during 8 weeks
  • Placebo treatment during 8 weeks
Placebo Comparator: arm 2 Drug: Placebo treatment during 8 weeks
comparator

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470483

Locations
Spain
GSK Investigational Site
Barcelona, Spain, E-08003
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00470483     History of Changes
Other Study ID Numbers: TMT106386
Study First Received: May 3, 2007
Last Updated: March 15, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by GlaxoSmithKline:
PET
fRMI
Social Anxiety Disorder

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013