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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00470483
First Posted: May 7, 2007
Last Update Posted: July 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
To compare by neuroimaging techniques the way Social Anxiety patients respond to public speaking before and after a drug administration

Condition Intervention Phase
Social Phobia Drug: Placebo treatment during 8 weeks Drug: Paroxetine treatment during 8 weeks Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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
Actual Study Start Date: January 22, 2007
Study Completion Date: January 7, 2009
Primary Completion Date: January 7, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: arm 1
Paroxetine treatment during 8 weeks
Drug: Paroxetine treatment during 8 weeks
treatment drug
Other Name: Placebo treatment during 8 weeks
Placebo Comparator: arm 2
Placebo treatment during 8 weeks
Drug: Placebo treatment during 8 weeks
comparator

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470483


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

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: TMT106386
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: TMT106386
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: TMT106386
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: TMT106386
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: TMT106386
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: TMT106386
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00470483     History of Changes
Other Study ID Numbers: TMT106386
First Submitted: May 3, 2007
First Posted: May 7, 2007
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://

Keywords provided by GlaxoSmithKline:
PET
Social Anxiety Disorder
fRMI

Additional relevant MeSH terms:
Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors