Social anxiety disorder is a prevalent, chronic and disabling condition. Paroxetine has received FDA approval on the basis of its acute efficacy for this disorder, but much about longer-term management remains uncertain. There are virtually no data regarding next steps in treatment despite evidence that most patients who receive acute paroxetine therapy still exhibit significant residual symptoms. Furthermore, there are also no data regarding methods for minimizing relapse when medication is discontinued despite evidence that relapse rates in such circumstances are high. Cognitive-behavioral therapy (CBT) is a good candidate for augmenting paroxetine response and reducing relapse after medication discontinuation as it has been shown to be an effective treatment in its own right and often associated with lesser relapse than medication alone. Although CBT has been found to be useful in these circumstances for depression and panic disorder, there have been no similar studies in social anxiety disorder. This application will examine the ability of CBT to augment acute paroxetine response and reduce relapse following paroxetine discontinuation in social anxiety disorder. It will also examine the degree of residual symptoms and disability as well as rates of remission and improvements in quality of life in response to paroxetine alone or with the addition of CBT. Predictors of acute response and relapse after treatment is discontinued will also be explored. To achieve these ends, two hundred fifty patients will receive 12 weeks of open treatment with paroxetine. Patients showing at least some benefit will be randomized to continued paroxetine with or without CBT for 16 additional weeks. All treatment will then be tapered and patients will be followed for 24 additional weeks. Overall, this study should provide important information about the augmentation of paroxetine treatment for patients with social anxiety disorder, effective methods for reducing relapse, and who may benefit from paroxetine treatment or relapse when medication is withdrawn. It will also increase understanding of the interplay of psychosocial and pharmacological treatment methods and psychological and biological factors in patients' total response to treatment.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH064481-02
Application #
6791261
Study Section
Interventions Research Review Committee (ITV)
Program Officer
Street, Linda L
Project Start
2003-08-15
Project End
2007-05-31
Budget Start
2004-06-01
Budget End
2005-05-31
Support Year
2
Fiscal Year
2004
Total Cost
$304,763
Indirect Cost
Name
Temple University
Department
Psychology
Type
Schools of Arts and Sciences
DUNS #
057123192
City
Philadelphia
State
PA
Country
United States
Zip Code
19122
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