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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00264654
First received: December 9, 2005
Last updated: April 11, 2013
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Social Phobia
 Drug: BRL29060A
Drug: paroxetine hydrochloride hydrate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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>

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Phobias
U.S. FDA Resources

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: October 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: BRL29060A Drug: paroxetine hydrochloride hydrate
    Other Names:
    • BRL29060A
    • 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.
  • 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 Investigational Site
Saitama, Japan, 332-0012
GSK Investigational Site
Tokyo, Japan, 194-0022
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: NCT00264654     History of Changes
Other Study ID Numbers: PIR104777
Study First Received: December 9, 2005
Last Updated: April 11, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Social
(SAD)
Anxiety
Disorder

Additional relevant MeSH terms:
Phobic Disorders
Anxiety 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 June 18, 2013