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

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 Overview

• Status: Completed
• Conditions: Social Phobia
• Intervention / Treatment: Drug: BRL29060A; Drug: paroxetine hydrochloride hydrate

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• • • GSK Investigational Site
• Japan
  • Saitama, Japan, 332-0012
    • GSK Investigational Site
  • Tokyo, Japan, 194-0022
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the LSAS total score at week 52 (Score at week 52- Score at week 0)	52 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	52 Weeks

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): November 1, 2005
• Study Completion (Actual): November 1, 2005

Study Registration Dates

• First Submitted: December 9, 2005
• First Submitted That Met QC Criteria: December 12, 2005
• First Posted (Estimate): December 13, 2005

Study Record Updates

• Last Update Posted (Estimate): April 15, 2013
• Last Update Submitted That Met QC Criteria: April 11, 2013
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Anxiety; Social; Disorder; (SAD)
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobia, Social; Phobic Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Paroxetine
• Other Study ID Numbers: PIR104777