Social Anxiety Disorder Study Of Paroxetine

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Social Phobia

Treatments

Drug: Paroxetine hydrochloride hydrate

Study type

Interventional

Funder types

Industry

Identifiers

PIR104776

Details and patient eligibility

About

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

Enrollment

390 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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.