Treatment for Social Anxiety Disorder
Social Anxiety Disorder (SAD) is among the most common psychiatric conditions and is associated with significant distress and dysfunction in affected individuals. Although treatment with cognitive behavioral therapy (CBT) results in some of the best outcomes, many patients do not respond to this intervention. This study investigates the relative benefits of the addition of D-cycloserine (DCS) to a standard program of CBT for the treatment of SAD. DCS has been used for many years as an antibiotic medication. When used as an antibiotic medication, DCS is given in much higher dosage and for a much longer period of time than in the present study.
This 4-year study will systematically assess the efficacy of DCS augmentation of CBT for the treatment of SAD. The study comprises a randomized, controlled trial to compare the relative short-term and long-term benefits of 12 CBT sessions that include five DCS-augmented (50 mg) sessions with the same CBT protocol that includes five placebo-augmented sessions.
This study is being conducted by the Psychotherapy and Emotion Research Laboratory (PERL), directed by Stefan G. Hofmann, Ph.D. For more information about PERL, please see their website at www.bu.edu/CARD/coglab.
Inclusion Criteria
- Male or female outpatients > 18 years of age with a primary psychiatric diagnosis (designated by the patient as the most important source of current distress) of generalized social anxiety disorder (GSAD) as defined by DSM-IV criteria.
- A total score of greater or equal than 60 on the LSAS.
- Physical examination, electrocardiogram, and laboratory findings without clinically significant abnormalities.
- Willingness and ability to comply with the requirements of the study protocol.
Exclusion Criteria
- A lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders or obsessive-compulsive disorder; an eating disorder in the past 6 months; organic brain syndrome, mental retardation or other cognitive dysfunction that could interfere with capacity to engage in therapy; a history of substance or alcohol abuse or dependence (other than nicotine) in the last 6 months or otherwise unable to commit to refraining from alcohol use during the acute period of study participation.
- Patients with posttraumatic stress disorder within the past 6 months are excluded. Entry of patients with other mood or anxiety disorders will be permitted if the social anxiety disorder is judged to be the predominant disorder, in order to increase accrual of a clinically relevant sample. Patients with significant suicidal ideation (MADRS item 10 score > 3) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
- Patients must be off concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers) for at least 2 weeks prior to initiation of randomized treatment.
- Significant personality dysfunction likely to interfere with study participation.
- Serious medical illness or instability for which hospitalization may be likely within the next year.
If you believe that you may qualify for this study, feel free to call our main desk at (617) 353-9610, or email Bonnie Brown, our nurse administrator, at to receive more information.
For more information, see Clinicaltrials.gov
