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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anxiety Disorders; Social Anxiety Disorder

Intervention: paroxetine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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

Secondary outcome: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

GSK Investigational Site, Buenos Aires C1122AAN, Argentina

GSK Investigational Site, Ciudad Autonoma de Buenos Aires C1062ABF, Argentina

GSK Investigational Site, San José, Costa Rica

GSK Investigational Site, Mexico, D.F. 03740, Mexico

GSK Investigational Site, Edmonton, Alberta T6L 5X8, Canada

GSK Investigational Site, Kelowna, British Columbia V1Y 2H4, Canada

GSK Investigational Site, La Plata/Buenos Aires, Buenos Aires B1896AEH, Argentina

GSK Investigational Site, Beverly Hills, California 90210, United States

GSK Investigational Site, Burbank, California 91506, United States

GSK Investigational Site, Cordoba, Córdova 5000, Argentina

GSK Investigational Site, Jacksonville, Florida 32216, United States

GSK Investigational Site, Miami, Florida 33125, United States

GSK Investigational Site, North Miami, Florida 33161, United States

GSK Investigational Site, Orlando, Florida 32806, United States

GSK Investigational Site, Smyrna, Georgia 30080, United States

GSK Investigational Site, Oakbrook Terrace, Illinois 60181, United States

GSK Investigational Site, Rockville, Maryland 20852, United States

GSK Investigational Site, Miramichi, New Brunswick E1V 3G5, Canada

GSK Investigational Site, New York, New York 10021, United States

GSK Investigational Site, New York, New York 10024, United States

GSK Investigational Site, Monterrey, Nuevo León 64170, Mexico

GSK Investigational Site, Oklahoma City, Oklahoma 73104, United States

GSK Investigational Site, Philadelphia, Pennsylvania 19149, United States

GSK Investigational Site, Providencia / Santiago, Región Metro De Santiago 7500710, Chile

GSK Investigational Site, Santiago, Región Metro De Santiago 7580208, Chile

GSK Investigational Site, Lake Jackson, Texas 77566, United States

Additional Information

Starting date: August 2005
Last updated: April 14, 2015

Page last updated: August 23, 2015

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