Long-term Study Of Paroxetine in Women and Men

• Status: Completed
• Trial end date: 2005-11-01
• 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.

• 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.