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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00470483
Collaborator
(none)
56
Enrollment
1
Location
2
Arms
23.5
Actual Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebo treatment during 8 weeks
  • Drug: Paroxetine treatment during 8 weeks
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
56 participants
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
Actual Study Start Date :
Jan 22, 2007
Actual Primary Completion Date :
Jan 7, 2009
Actual Study Completion Date :
Jan 7, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: arm 1

Paroxetine treatment during 8 weeks

Drug: Paroxetine treatment during 8 weeks
treatment drug
Other Names:
  • Placebo treatment during 8 weeks

    		•
    Placebo Comparator: arm 2

    Placebo treatment during 8 weeks

    Drug: Placebo treatment during 8 weeks
    comparator

    Outcome Measures

    Primary Outcome Measures

    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). [baseline and after 8 weeks]

    Secondary Outcome Measures

    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). [baseline and after 8 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GSK Investigational Site Barcelona Spain E-08003

    Sponsors and Collaborators

    • GlaxoSmithKline

    Investigators

    • Study Director: GSK Clinical Trials, GlaxoSmithKline

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT00470483
    Other Study ID Numbers:
    • TMT106386
    First Posted:
    May 7, 2007
    Last Update Posted:
    Jul 18, 2017
    Last Verified:
    Jul 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by GlaxoSmithKline
    PET
    Social Anxiety Disorder
    fRMI
    Additional relevant MeSH terms:
    Anxiety Disorders
    Phobia, Social
    Paroxetine

    Study Results

    No Results Posted as of Jul 18, 2017