Long-term Study Of Paroxetine in Women and Men (SAD)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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.