A Study To Compare Emotional Changes In Subjects With Social Anxiety Disorder - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00470483

Purpose

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

Condition	Intervention	Phase
Social Anxiety Disorder	Drug: Paroxetine treatment during 8 weeks Drug: Placebo treatment during 8 weeks	Phase I

MedlinePlus related topics: Anxiety

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by GlaxoSmithKline:

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). [ Time Frame: baseline and after 8 weeks ]

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). [ Time Frame: baseline and after 8 weeks ]

Enrollment:	56
Study Start Date:	January 2007
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
arm 2: Placebo Comparator	Drug: Placebo treatment during 8 weeks comparator
arm 1: Active Comparator	Drug: Paroxetine treatment during 8 weeks treatment drug

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470483

Locations

Spain
GSK Investigational Site
Barcelona, Spain, E-08003

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	TMT106386
Study First Received:	May 3, 2007
Last Updated:	March 20, 2009
ClinicalTrials.gov Identifier:	NCT00470483 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by GlaxoSmithKline:

Social Anxiety Disorder
PET
fRMI

Study placed in the following topic categories:

Neurotransmitter Agents
Anxiety Disorders
Mental Disorders
Psychotropic Drugs
Antidepressive Agents, Second-Generation

Phobic Disorders
Serotonin Uptake Inhibitors
Paroxetine
Antidepressive Agents
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Phobic Disorders
Paroxetine
Serotonin Uptake Inhibitors

Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on May 07, 2009