Long-term Study Of Paroxetine in Women and Men

Social Phobia Clinical Trial

— SAD  

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>

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264654
• Other study ID #: PIR104777
• Status: Completed
• Phase: Phase 3
• First received: December 9, 2005
• Last updated: April 11, 2013
• Start date: October 2005
• Est. completion date: November 2005

Study information

• Verified date: May 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• 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: 50
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• 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.

• 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 Design

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

Related Conditions & MeSH terms

• Social Phobia

Intervention

Drug:
• BRL29060A

• paroxetine hydrochloride hydrate

Locations

Country	Name	City	State
Japan	GSK Investigational Site	Saitama
Japan	GSK Investigational Site	Tokyo
Spain	GSK Investigational Site	Unknown

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Japan,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the LSAS total score at week 52 (Score at week 52- Score at week 0)		52 Weeks
Secondary	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