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 @ 5:13 PM
Ignite Modification Date:
2025-12-24 @ 5:13 PM
NCT ID:
NCT00215150
Eligibility Criteria:
Inclusion Criteria:
* adults 18-65 years of age
* primary diagnosis of SAD, using Diagnostic Standard Manual(DSM-IV) criteria
* minimum Clinical Global Impression of Severity (CGI-S) score of 4 at baseline
* minimum Brief Social Phobia Scale(BSPS) score of 20 at baseline
* written informed consent
* negative serum pregnancy test for women of childbearing potential
* normal EKG
Exclusion Criteria:
* current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition
* any current primary anxiety disorder other than SAD
* current primary depression
* history of substance abuse or dependence within the last 3 months
* suicide risk or serious suicide attempt within the last year
* clinically significant medical condition or laboratory or EKG abnormality
* women of childbearing potential who are unwilling to practice an acceptable method of contraception
* patients needing concurrent use of psychotropic medications
* history of hypersensitivity to sertraline or ziprasidone
* recent (less than 2 months) initiation of psychotherapy for SAD
* history of failure to respond to augmentation with an adequate trial of an atypical antipsychotic
* patients who are currently taking any of the following medications: Erythromycin, Biaxin, Avelox, Zithromax, Amantadine, Levaquin, Tamoxifen, Tegretol, Nizoral, and Levitra
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00215150
Study Brief:
Protocol Section:
NCT00215150