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Therapeutic Areas: Psychiatry/Psychology
Disease Category: Social Anxiety Disorder (SAD)

Trial Information

D-Cycloserine Enhancement of Exposure in Social Phobia

We are currently enrolling individuals in our research study to determine the effectiveness of a combination of therapy and an experimental medication 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). 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. Once the patient has been determined eligible for the study, they will undergo 12 weekly sessions of Cognitive Behavioral Therapy lasting approximately two and a half hours each. During these sessions, patients will receive information on the nature of social phobia and a model of treatment and will receive weekly training in how to become more comfortable with social situations, with the goal of achieving confidence in social interactions. As part of this training, the therapist will practice social interactions with the patient, who will also be asked to practice what they have learned outside of the therapists’ office. For the third, fourth, fifth, sixth, and seventh sessions of the twelve-session program of Cognitive Behavioral Therapy, the patient will be asked to arrive one hour early to take one of the study pill, a 50mg pill of either d-cycloserine or placebo, which participants will be randomly assigned to. A physician will be available in the unlikely event that a patient begins to experience side effects. Before the treatment starts, before the eighth session, and one week after the final session patients will have their levels of symptoms assessed with measures of mood, anxiety, and avoidance. Upon completion of the study, participants will be asked to return for a one-month, three-month, and nine month-followup. 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.
4.Patients currently on psychotropic medications will be excluded.

Ryan J Jacoby
Massachusetts General Hospital
55 Fruit Street
Boston, MA 02114
Phone: 617-726-6944
EMail: rjjacoby@partners.org

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