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

Primary Purpose

Social Phobia

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Placebo treatment during 8 weeks
Paroxetine treatment during 8 weeks
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Phobia focused on measuring PET, Social Anxiety Disorder, fRMI

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

arm 1

arm 2

Arm Description

Paroxetine treatment during 8 weeks

Placebo treatment during 8 weeks

Outcomes

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).

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).

Full Information

First Posted
May 3, 2007
Last Updated
July 13, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00470483
Brief Title
A Study To Compare Emotional Changes In Subjects With Social Anxiety Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 22, 2007 (Actual)
Primary Completion Date
January 7, 2009 (Actual)
Study Completion Date
January 7, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia
Keywords
PET, Social Anxiety Disorder, fRMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
arm 1
Arm Type
Active Comparator
Arm Description
Paroxetine treatment during 8 weeks
Arm Title
arm 2
Arm Type
Placebo Comparator
Arm Description
Placebo treatment during 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo treatment during 8 weeks
Intervention Description
comparator
Intervention Type
Drug
Intervention Name(s)
Paroxetine treatment during 8 weeks
Other Intervention Name(s)
Placebo treatment during 8 weeks
Intervention Description
treatment drug
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
E-08003
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TMT106386
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TMT106386
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TMT106386
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TMT106386
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TMT106386
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TMT106386
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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