Long-term Study Of Paroxetine in Women and Men (SAD)
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Change from baseline in the LSAS total score at week 52 (Score at week 52- Score at week 0) [ Time Frame: 52 Weeks ]
Secondary Outcome Measures :
Proportion of patients responding with a CGI Global Improvement Item. Change from baseline in the CGI Severity of Illness score. Change from baseline in the HAM-D total score. Proportion of patients continuing treatment. [ Time Frame: 52 Weeks ]
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Ages Eligible for Study:
18 Years to 64 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.