Trial Information

Summary: Improving Outcomes in Pharmacotherapy of Treatment Refractory Social Phobia

We are currently enrolling individuals in our research study to determine the effectiveness of several existing treatments for Generalized Social Anxiety Disorder (a form of fear or discomfort in a wide variety of situations involving performing in front of or interacting with other people). The study will compare the usefulness of three different medication strategies for treating individuals with social anxiety disorder who have not responded well to an established treatment (i.e., the medication sertraline, also known as ZoloftÒ). Each of these 3 medication strategies involve taking a medication that is currently marketed for anxiety and approved by the U.S. Food and Drug Administration (FDA) for sale for the treatment of anxiety. Participants will complete the study in 11-23 weeks, for a total of either 8 study visits or 15 study visits. Participation includes a 1-hour interview, completing multiple questionnaires, measurements of your blood pressure, heart rate, height, and weight, a blood draw, an electrocardiogram (ECG), collection of a urine sample, and a pregnancy test if you are female. The study begins with a 10-week period of taking sertraline (ZoloftÒ), followed by 12 weeks of taking either setraline alone, sertraline and clonazsepam, or venlafaxine extended-release, if your symptoms do not significantly improve after the first 10 weeks of treatment. At the end of the study, you will enter follow-up care with the study doctor. The study also includes a genetic component, in that your blood with be analyzed to see if DNA “markers” can predict who did best with which treatment once the study has ended. There will be no cost to you for your participation in this study.

Eligibility Criteria:
1.Male or female outpatients 18 years or older with a primary diagnosis of generalized social anxiety disorder (as determined by the psychiatrists who conduct our initial screening process).
2.Physical examination, electrocardiogram, and laboratory findings without clinically significant abnormalities.
3.Willingness and ability to comply with the requirements of the study protocol.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.