NCT00318669

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

April 15, 2013

Status Verified

July 1, 2012

Enrollment Period

11 months

First QC Date

April 25, 2006

Last Update Submit

April 11, 2013

Conditions

Social Phobia

Keywords

AnxietySADSocialDisorder

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the LSAS total score at week 12 (Score at week 12 - Score at week 0)

    12 Weeks

Secondary Outcomes (1)

  • 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

Interventions

Paroxetine hydrochloride hydrateDRUG

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

GSK Investigational Site

Fukuoka, 802-0006, Japan

Location

GSK Investigational Site

Fukuoka, 810-0001, Japan

Location

GSK Investigational Site

Fukuoka, 815-0041, Japan

Location

GSK Investigational Site

Saitama, 332-0012, Japan

Location

GSK Investigational Site

Tokyo, 107-0062, Japan

Location

GSK Investigational Site

Tokyo, 120-0033, Japan

Location

GSK Investigational Site

Tokyo, 143-8541, Japan

Location

GSK Investigational Site

Tokyo, 144-0052, Japan

Location

GSK Investigational Site

Tokyo, 152-0012, Japan

Location

GSK Investigational Site

Tokyo, 154-0004, Japan

Location

GSK Investigational Site

Tokyo, 160-0023, Japan

Location

GSK Investigational Site

Tokyo, 170-0002, Japan

Location

GSK Investigational Site

Tokyo, 170-0005, Japan

Location

GSK Investigational Site

Tokyo, 178-0063, Japan

Location

GSK Investigational Site

Tokyo, 194-0022, Japan

Location

GSK Investigational Site

Location

MeSH Terms

Conditions

Phobia, SocialAnxiety DisordersDisease

Condition Hierarchy (Ancestors)

Phobic DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2006

First Posted

April 27, 2006

Study Start

December 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

April 15, 2013

Record last verified: 2012-07

Locations

JP(15)