Social Phobia
Conditions
Keywords
Anxiety, SAD, Social, Disorder
Brief summary
This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD).
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the LSAS total score at week 12 (Score at week 12 - Score at week 0) | 12 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients responding with a CGI Global Improvement Item score. Change from baseline in the CGI Severity of Illness score. Change from baseline in the HAM-D total score. Proportion of patients continuing treatment. | 12 Weeks |
Countries
Japan
Outcome results
None listed