Social Anxiety Disorder Study Of Paroxetine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00318669
First received: April 25, 2006
Last updated: April 11, 2013
Last verified: July 2012
  Purpose

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
  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. 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
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 ClinicalTrials.gov identifier: NCT00318669

Locations
Japan
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
Spain
GSK Investigational Site
Unknown, Spain
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov 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:
Anxiety
SAD
Social
Disorder

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 July 23, 2014