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:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT01316302
Eligibility Criteria:
Inclusion Criteria:
* Subjects must give written informed consent prior to any study procedures.
* Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia/Social Anxiety Disorder, Generalized Subtype) according to DSM-IV-TR criteria, as determined by psychiatric evaluation with the Principal Investigator.
* A minimum score of 60 on the LSAS total score at both Screening and Baseline visits.
* A total HAM-D score of less than 15 at the Screening visit.
* CGI Severity score of 4 or greater at both Screening and Baseline visits.
* Female subjects of childbearing potential must commit to an effective form of contraception for the duration of the trial. Effective forms of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), and implantable contraceptive devices.
Exclusion Criteria:
* An Axis I disorder other than SAD (e.g., post-traumatic stress disorder, obsessive compulsive disorder, panic disorder) within 24 weeks of the Baseline visit. Subjects with co-morbid MDD, GAD, dysthymia, or specific phobias will be allowed if GSAD is the primary disorder in terms of clinical severity, as determined by the investigator.
* Any history or complication of schizophrenia or bipolar disorder.
* Any complication of body dysmorphic disorder.
* Substance dependence, as defined by DSM-IV-TR criteria, within 24 weeks of the Baseline visit.
* Subjects who are currently pregnant, lactating, or of childbearing potential and not practicing an effective method of contraception.
* Subjects scoring \>2 on item #3 of the HAM-D, or who, in the opinion of the PI, are at a clinically significant risk for suicide.
* Systolic blood pressure ≥165 and/or diastolic blood pressure ≥95.
* Positive Urine Drug Screen at the Screening visit.
* Any current unstable and/or clinically significant medical condition, based on history or as evidenced in Screening laboratory and ECG assessments.
* Any history or complication of cancer or malignant tumor.
* Fluoxetine within 28 days of Baseline
* MAO inhibitors within 14 days of Baseline - Any other psychotropics (including SSRIs, SNRIs, and benzodiazepines) within 14 days of Baseline. Zolpidem (Ambien®) PRN is allowed for insomnia if not taken more than 3 times per week.
* Subjects who started psychotherapy or cognitive-behavioral therapy within 24 weeks of the Baseline visit, except for supportive psychotherapy.
* Electro-convulsive therapy (ECT) within 12 weeks of the Baseline visit.
* Treatment refractory GSAD
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01316302
Study Brief:
Protocol Section:
NCT01316302