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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00264654
Other study ID # PIR104777
Secondary ID
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


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
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