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

July 13, 2017 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, E-08003
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
baseline and after 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
baseline and after 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2007

Primary Completion (Actual)

January 7, 2009

Study Completion (Actual)

January 7, 2009

Study Registration Dates

First Submitted

May 3, 2007

First Submitted That Met QC Criteria

May 3, 2007

First Posted (Estimate)

May 7, 2007

Study Record Updates

Last Update Posted (Actual)

July 18, 2017

Last Update Submitted That Met QC Criteria

July 13, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMT106386

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Informed Consent Form
    Information identifier: TMT106386
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Study Protocol
    Information identifier: TMT106386
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Dataset Specification
    Information identifier: TMT106386
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individual Participant Data Set
    Information identifier: TMT106386
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: TMT106386
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistical Analysis Plan
    Information identifier: TMT106386
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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