Social Anxiety Disorder Study Of Paroxetine

Social Phobia Clinical Trial

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>

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318669
• Other study ID #: PIR104776
• Status: Completed
• Phase: Phase 3
• First received: April 25, 2006
• Last updated: April 11, 2013
• Start date: December 2005
• Est. completion date: November 2006

Study information

• Verified date: July 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Phobic Disorders
• Social Phobia

Intervention

Drug:
• Paroxetine hydrochloride hydrate

Locations

Country	Name	City	State
	GSK Investigational Site
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Saitama
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the LSAS total score at week 12 (Score at week 12 - Score at week 0)		12 Weeks
Secondary	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.		12 Weeks