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Treatment Of Patients With Social Anxiety Disorder

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00397722
First received: November 8, 2006
Last updated: October 1, 2010
Last verified: October 2010
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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
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
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW876008 Drug: paroxetine
    Other Names:
    • GW876008
    • paroxetine
  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: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00397722     History of Changes
Other Study ID Numbers: CRH103390
Study First Received: November 8, 2006
Last Updated: October 1, 2010
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).

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013