Overview

Social Anxiety Disorder Study Of Paroxetine

Status:
Completed
Trial end date:
2006-11-01
Target enrollment:
0
Participant gender:
All
Summary
This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Paroxetine
Criteria
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.