Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder

Last updated: May 16, 2017
Sponsor: Temple University
Overall Status: Completed

Phase

3

Condition

Anxiety Disorders

Panic Disorders

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT00074802
R01MH064481
DSIR 83-ATAS
GSK ID: 101618
R01MH064726
R01MH064481
  • Ages 18-65
  • All Genders

Study 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

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

Exclusion Criteria:

  • Prior or current diagnosis of schizophrenia, schizoaffective disorder, organic mentaldisorder, bipolar disorder, or antisocial, schizotypal, and schizoid personalitydisorders

  • Suicidal thoughts

  • History of failed paroxetine treatment of at least 6 weeks' duration at adequate dosesor 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 signa statement indicating their intention to avoid pregnancy during the study through theuse of an effective method of contraception.

  • Alcohol or substance abuse or dependence within the past 3 months. Patients with apositive 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 andprovide 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 formonoamine oxidase inhibitors (MAOIs) or fluoxetine and 2 weeks for other selectiveserotonin reuptake inhibitors (SSRIs), neuroleptics, antidepressants, benzodiazepines,mood stabilizers, buspirone, beta-adrenergic blockers, or other psychotropic drugsprior to beginning the study

  • Currently receiving psychotherapy

Study Design

Total Participants: 150
Study Start date:
December 01, 2003
Estimated Completion Date:
May 31, 2008

Study Description

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 many patients achieve less than optimal response. CBT has also been effective in treating social anxiety disorder; thus,it may also be effective in augmenting paroxetine response. This study will examine the effects of paroxetine treatment alone and in combination with CBT among patients who achieve less than optimal response after an open trial with paroxetine.

Participants in this study will receive paroxetine for 12 weeks (Phase 1). After 12 weeks, participants who have completed this open trial but have achieved some but less than optimal response will move forward to Phase 2. To be eligible to move forward to Phase 2, patients must have achieved at least a 10% improvement in their open-trial Liebowitz Social Anxiety Scale Scores (LSAS) but still have an LSAS score of 30 or greater. Patients meeting these criteria will be randomly assigned to either add weekly sessions of CBT to their treatment or to continue taking paroxetine alone for another 16 weeks. Social anxiety symptoms, rates of response and remission, fear of negative evaluation, disability and quality of life will be assessed.

Connect with a study center

  • New York State Psychiatric Institute Anxiety Disorders Clinic

    New York, New York 10032
    United States

    Site Not Available

  • Adult Anxiety Clinic of Temple University

    Philadelphia, Pennsylvania 19122-6085
    United States

    Site Not Available

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