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Status:

COMPLETED

Social Anxiety Disorder Study Of Paroxetine

Lead Sponsor:

GlaxoSmithKline

Conditions:

Social Phobia

Eligibility:

All Genders

18-64 years

Phase:

PHASE3

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    December 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2006

    Estimated Enrollment :

    390 Patients enrolled

    Trial Details

    Trial ID

    NCT00318669

    Start Date

    December 1 2005

    End Date

    November 1 2006

    Last Update

    April 15 2013

    Active Locations (16)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (16 locations)

    1

    GSK Investigational Site

    Fukuoka, Japan, 802-0006

    2

    GSK Investigational Site

    Fukuoka, Japan, 810-0001

    3

    GSK Investigational Site

    Fukuoka, Japan, 815-0041

    4

    GSK Investigational Site

    Saitama, Japan, 332-0012