Treatment Of Patients With Social Anxiety Disorder

This study has been completed.

First Received: November 8, 2006 Last Updated: May 15, 2009 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00397722

Purpose

GW876008 is a drug which may change mans reaction to stress, by decreasing the fear, physical and behavior symptoms that people with SocAD experience in social situations.

Condition	Intervention	Phase
Social Anxiety Disorder	Drug: GW876008 Drug: paroxetine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study CRH103390: A 12 Week Flexible Dose Study of GW876008, Placebo and Active Control (Paroxetine) in the Treatment of Social Anxiety Disorder (SocAD)

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change in clinical rating scales after dosing: questionnaires

Secondary Outcome Measures:

ECG and vital signs: duration of study Adverse events: duration of study Clinical labs: duration of study Blood levels of GW876008: duration of study

Estimated Enrollment:	280
Study Start Date:	November 2006

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

are diagnosed with generalized social anxiety disorder/social phobia.

Exclusion criteria:

have a diagnosis of major depressive disorder
have a history of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397722

Show 35 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	CRH103390
Study First Received:	November 8, 2006
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00397722 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by GlaxoSmithKline:

effectiveness
safety
outpatients with a diagnosis of Social Anxiety disorder (SocAD).

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 September 01, 2009