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>”

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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: BRL29060A
• Drug: paroxetine hydrochloride hydrate

Primary 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 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
    

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00264654

Study ID Number: PIR104777

ClinicalTrials.gov Identifier: NCT00264654

Health Authority: Japan: Ministry of Health, Labor and Welfare