A Study Of A New Medicine (GW679769) For The Treatment Of Social Anxiety Disorder

This study has been completed.

First Received: January 5, 2006 Last Updated: May 15, 2009 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00273039

Purpose

The purpose of this study is to test the safety and efficacy of GW679769 and paroxetine in subjects with Social Anxiety Disorder

Condition	Intervention	Phase
Social Anxiety Disorder	Drug: paroxetine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Forced Dose Titration Study Evaluating the Efficacy and Safety of GW679769 and Paroxetine in Subjects With Social Anxiety Disorder

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate GW679769

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

The primary outcome measure will be the change from baseline in the Liebowitz Social Anxiety Scale (LSAS)

Secondary Outcome Measures:

Secondary outcome measures include the change from baseline in the following scales: the Clinical Global Impression-Global Improvement, the Clinical Global Impression -Severity of Illness, and the Sheehan Disability Scale.

Estimated Enrollment:	227
Study Start Date:	August 2005

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with Generalized Social Anxiety Disorder as the primary diagnosis.
If female, must commit to consistent and correct use of an acceptable method of birth control.

Exclusion Criteria:

Patients with any other psychiatric disorder as a primary diagnosis or within 6 months prior to screening.
Patients with Body Dysmophic Disorder, Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder.
Patients who pose a current suicidal or homicidal risk or have made a suicide attempt within the past 6 months or have ever been homicidal.
Patients who have a positive urine test at screen for illegal drug use and/or a history of substance abuse or dependence (alcohol or drugs) within the past 12 months.
Patients with an unstable medical disorder.
Female patients who are pregnant, lactating, or planning to become pregnant during a specified time during the study.
Patients who are taking other psychoactive medications.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273039

Show 26 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	NKF100110
Study First Received:	January 5, 2006
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00273039 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by GlaxoSmithKline:

Social Anxiety Disorder
Anxiety
Psychiatry

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