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
About this trial
This is an interventional treatment trial for Social Phobia focused on measuring PET, Social Anxiety Disorder, fRMI
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
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
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
We'll reach out to this number within 24 hrs