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

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

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

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders; Social Anxiety Disorder
• Intervention / Treatment: Drug: paroxetine

• Study Type: Interventional
• Enrollment (Actual): 242
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1122AAN
    • GSK Investigational Site
  • Ciudad Autonoma de Buenos Aires, Argentina, C1062ABF
    • GSK Investigational Site
  • Buenos Aires
    • La Plata/Buenos Aires, Buenos Aires, Argentina, B1896AEH
      • GSK Investigational Site
  • Córdova
    • Cordoba, Córdova, Argentina, 5000
      • GSK Investigational Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6L 5X8
      • GSK Investigational Site
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 2H4
      • GSK Investigational Site
  • New Brunswick
    • Miramichi, New Brunswick, Canada, E1V 3G5
      • GSK Investigational Site
• Chile
  • Región Metro De Santiago
    • Providencia / Santiago, Región Metro De Santiago, Chile, 7500710
      • GSK Investigational Site
    • Santiago, Región Metro De Santiago, Chile, 7580208
      • GSK Investigational Site
• Costa Rica
  • San José, Costa Rica
    • GSK Investigational Site
• Mexico
  • Mexico, D.F., Mexico, 03740
    • GSK Investigational Site
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64170
      • GSK Investigational Site
• United States
  • California
    • Beverly Hills, California, United States, 90210
      • GSK Investigational Site
    • Burbank, California, United States, 91506
      • GSK Investigational Site
  • Florida
    • Jacksonville, Florida, United States, 32216
      • GSK Investigational Site
    • Miami, Florida, United States, 33125
      • GSK Investigational Site
    • North Miami, Florida, United States, 33161
      • GSK Investigational Site
    • Orlando, Florida, United States, 32806
      • GSK Investigational Site
  • Georgia
    • Smyrna, Georgia, United States, 30080
      • GSK Investigational Site
  • Illinois
    • Oakbrook Terrace, Illinois, United States, 60181
      • GSK Investigational Site
  • Maryland
    • Rockville, Maryland, United States, 20852
      • GSK Investigational Site
  • New York
    • New York, New York, United States, 10021
      • GSK Investigational Site
    • New York, New York, United States, 10024
      • GSK Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • GSK Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19149
      • GSK Investigational Site
  • Texas
    • Lake Jackson, Texas, United States, 77566
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): September 1, 2006
• Study Completion (Actual): September 1, 2006

Study Registration Dates

• First Submitted: January 5, 2006
• First Submitted That Met QC Criteria: January 6, 2006
• First Posted (Estimate): January 9, 2006

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Anxiety; Psychiatry; Social Anxiety Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Phobic Disorders; Disease; Anxiety Disorders; Phobia, Social; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Paroxetine
• Other Study ID Numbers: NKF100110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Informed Consent Form
   Information identifier: NKF100110
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Dataset Specification
   Information identifier: NKF100110
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Annotated Case Report Form
   Information identifier: NKF100110
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Study Protocol
   Information identifier: NKF100110
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Individual Participant Data Set
   Information identifier: NKF100110
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Statistical Analysis Plan
   Information identifier: NKF100110
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Clinical Study Report
   Information identifier: NKF100110
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No