Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder

Social anxiety disorder is a prevalent and disabling condition for which effective long-term
treatments need to be identified. Paroxetine is effective in treating the acute symptoms of
social anxiety, but longer-term management remains a challenge. Cognitive behavioral therapy
(CBT) has been effective in treating depression and panic disorder symptoms; it may also be
effective in augmenting paroxetine response and reducing relapse after medication
discontinuation. This study will examine the effects of paroxetine treatment alone and in
combination with CBT.

Participants in this study will receive paroxetine for 12 weeks. After 12 weeks,
participants will be randomly assigned to either add weekly sessions of CBT to their
treatment or to continue taking paroxetine alone for another 16 weeks. After the 16-week
treatment period, participants will have their treatments tapered and will be followed for
an additional 24 weeks. Social anxiety symptoms, rates of remission, and quality of life
will be assessed.

Inclusion Criteria:

- DSM-IV criteria for generalized social phobia

- Willing and able to give written informed consent

- English-speaking

Exclusion Criteria:

- Prior or current diagnosis of schizophrenia, schizoaffective disorder, organic mental
disorder, bipolar disorder, or antisocial, schizotypal, and schizoid personality
disorders

- Suicidal thoughts

- History of failed paroxetine treatment of at least 6 weeks' duration at adequate
doses or a history of failed outcome of a previous adequate trial of CBT

- Clinically significant and/or unstable medical disease

- Pregnancy or breast-feeding. Women of childbearing potential will be required to sign
a statement indicating their intention to avoid pregnancy during the study through
the use of an effective method of contraception.

- Alcohol or substance abuse or dependence within the past 3 months. Patients with a
positive drug screen but no substance abuse disorder will be eligible for the study,
provided they have not met criteria for abuse/dependence within the last 6 months and
provide two clean urine samples 2 weeks apart.

- Current or past history of seizure disorder (except febrile seizure in childhood)

- Conditions that contraindicate the use of paroxetine

- Inability to tolerate or unwillingness to accept a drug-free period of 4 weeks for
monoamine oxidase inhibitors (MAOIs) or fluoxetine and 2 weeks for other selective
serotonin reuptake inhibitors (SSRIs), neuroleptics, antidepressants,
benzodiazepines, mood stabilizers, buspirone, beta-adrenergic blockers, or other
psychotropic drugs prior to beginning the study

- Currently receiving psychotherapy