Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Intervention: Paroxetine; Cognitive behavioral therapy (CBT)
Intervention description: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.; CBT will consist of 16 weekly treatment sessions.
Intervention MeSH terms: Paroxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open trial of paroxetine (Phase 1) followed by randomization to either continued paroxetine or continued paroxetine plus cognitive behavioral therapy (Phase 2) for patients showing partial response to paroxetine in Phase 1.
Masking: Single (Outcomes Assessor)
Masking description: Independent evaluators were unaware of randomized condition in the augmentation phase (Phase 2).
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Social Phobia

Summary:

      This study will examine whether the addition of cognitive behavioral therapy can improve the
      efficacy of the medication paroxetine (Paxil®) in treating individuals with social anxiety
      disorder. Patients with social anxiety disorder will undergo a 12-week open trial with
      paroxetine. Those who complete the open trial having achieved only partial response will be
      randomized to receive cognitive behavioral therapy (CBT) in addition to paroxetine or to
      continue on paroxetine alone for an additional 16 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (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