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Long-Term Study Of Paroxetine in Women and Men (SAD)

This study has been completed.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00264654
  Purpose

This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD)


Condition Intervention Phase
Phobic Disorders
Drug: BRL29060A
Drug: paroxetine hydrochloride hydrate
Phase III

MedlinePlus related topics:   Anxiety    Phobias   

ChemIDplus related topics:   Paroxetine    Paroxetine hydrochloride    Paroxetine Mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Social Phobia/Social Anxiety Disorder (SAD) -A Open-Label, Uncontrolled, Long-Term Study- <Phase III Study>

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in the LSAS total score at week 52 (Score at week 52- Score at week 0) [ Time Frame: 52 Weeks ]

Secondary Outcome Measures:
  • Proportion of patients responding with a CGI Global Improvement Item. Change from baseline in the CGI Severity of Illness score. Change from baseline in the HAM-D total score. Proportion of patients continuing treatment. [ Time Frame: 52 Weeks ]

Enrollment:   50
Study Start Date:   July 2005

  Eligibility
Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion criteria:

  • Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia/Social Anxiety Disorder) according to DSM-IV-TR criteria.
  • Must give a written informed consent.
  • If the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.
  • Patients have a minimum score of 60 on the LSAS total score.

Exclusion criteria:

  • Patients primarily diagnosed with a disorder that is categorized into Axis I excluding SAD by DSM-IV-TR (e.g. major depression, dysthymic disorder, specific phobia (simple phobia) , obsessive compulsive disorder, panic disorder) within 24 weeks before week -2.
  • Patients with a history or complication of schizophrenia and bipolar disorder
  • Patients with a complication of body dysmorphic disorder.
  • Patients with evidence of substance abuse (alcohol or drugs).
  • substance dependence by DSM-IV-TR criteria within 24 weeks before week -2.
  • Patients who started psychotherapy and cognitive-behavioural therapy within 24 weeks before week-2, except for supportive psychotherapy.
  • Patients receiving electro-convulsive therapy (ECT) within 12 weeks before week -2.
  • Patients being pregnant, lactating or are of childbearing potential and are likely to become pregnant.
  • Patients with 3 or more points of HAM-D Item No. 3, or who are likely to attempt suicide.
  • Patients with a history or complication of cancer or malignant tumor.
  • Patients receiving MAO inhibitors (FP®) within 14 days before expected week 0 visit date.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264654

Locations
Japan
GSK Clinical Trials Call Center    
      Tokyo, Japan, 144
GSK Clinical Trials Call Center    
      Tokyo, Japan, 184
GSK Clinical Trials Call Center    
      Tokyo, Japan, 107
GSK Clinical Trials Call Center    
      Tokyo, Japan, 194
GSK Clinical Trials Call Center    
      Tokyo, Japan, 164
GSK Clinical Trials Call Center    
      Tokyo, Japan, 108
GSK Clinical Trials Call Center    
      Yokohama-city, Japan, 220
GSK Clinical Trials Call Center    
      Saitama-city, Japan, 330
GSK Clinical Trials Call Center    
      Kawaguchi-city, Japan, 332
GSK Clinical Trials Call Center    
      Tokyo, Japan, 154

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     GSK Clinical Trials, MD     GlaxoSmithKline    
  More Information


Study ID Numbers:   PIR104777
First Received:   December 9, 2005
Last Updated:   June 28, 2007
ClinicalTrials.gov Identifier:   NCT00264654
Health Authority:   Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Social  
Anxiety  
Disorder  
(SAD)  

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Phobic Disorders
Paroxetine
Serotonin

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on October 10, 2008




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