Social Anxiety Disorder Study Of Paroxetine

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: April 25, 2006
Last updated: April 11, 2013
Last verified: July 2012

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

Condition Intervention Phase
Social Phobia
Drug: Paroxetine hydrochloride hydrate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Social Phobia/Social Anxiety Disorder (SAD) -A Double-blind, Placebo-controlled Study- <Phase III Study>

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in the LSAS total score at week 12 (Score at week 12 - Score at week 0) [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:
  • Proportion of patients responding with a CGI Global Improvement Item score. 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: 12 Weeks ]

Enrollment: 390
Study Start Date: December 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Paroxetine hydrochloride hydrate
    Other Name: Paroxetine hydrochloride hydrate

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

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. But 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 24weeks 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 identifier: NCT00318669

GSK Investigational Site
Fukuoka, Japan, 815-0041
GSK Investigational Site
Fukuoka, Japan, 802-0006
GSK Investigational Site
Fukuoka, Japan, 810-0001
GSK Investigational Site
Saitama, Japan, 332-0012
GSK Investigational Site
Tokyo, Japan, 160-0023
GSK Investigational Site
Tokyo, Japan, 152-0012
GSK Investigational Site
Tokyo, Japan, 143-8541
GSK Investigational Site
Tokyo, Japan, 170-0002
GSK Investigational Site
Tokyo, Japan, 194-0022
GSK Investigational Site
Tokyo, Japan, 107-0062
GSK Investigational Site
Tokyo, Japan, 144-0052
GSK Investigational Site
Tokyo, Japan, 178-0063
GSK Investigational Site
Tokyo, Japan, 120-0033
GSK Investigational Site
Tokyo, Japan, 154-0004
GSK Investigational Site
Tokyo, Japan, 170-0005
GSK Investigational Site
Unknown, Spain
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline Identifier: NCT00318669     History of Changes
Other Study ID Numbers: PIR104776
Study First Received: April 25, 2006
Last Updated: April 11, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders
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 processed this record on April 17, 2014