Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT00318669
Eligibility 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. 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT00318669
Study Brief:
Protocol Section:
NCT00318669