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

NCT ID: NCT00470483

Last Updated: 2017-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-22

Study Completion Date

2009-01-07

Brief Summary

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

Detailed Description

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Conditions

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Social Phobia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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arm 1

Paroxetine treatment during 8 weeks

Group Type ACTIVE_COMPARATOR

Paroxetine treatment during 8 weeks

Intervention Type DRUG

treatment drug

arm 2

Placebo treatment during 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo treatment during 8 weeks

Intervention Type DRUG

comparator

Interventions

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Placebo treatment during 8 weeks

comparator

Intervention Type DRUG

Paroxetine treatment during 8 weeks

treatment drug

Intervention Type DRUG

Other Intervention Names

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Placebo treatment during 8 weeks

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Barcelona, , Spain

Site Status

Countries

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Spain

Study Documents

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Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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TMT106386

Identifier Type: -

Identifier Source: org_study_id

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