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Treatment Of Patients With Social Anxiety Disorder

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: November 8, 2006
Last updated: October 1, 2010
Last verified: October 2010
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
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:

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 Name: GW876008

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00397722

  Show 35 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: Study Director, GSK Identifier: NCT00397722     History of Changes
Other Study ID Numbers: CRH103390
Study First Received: November 8, 2006
Last Updated: October 1, 2010

Keywords provided by GlaxoSmithKline:
outpatients with a diagnosis of Social Anxiety disorder (SocAD).

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Pathologic Processes
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors processed this record on June 23, 2017