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Sponsored by: |
National Institute of Mental Health (NIMH) |
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00074802 |
This study will determine whether the addition of cognitive behavioral therapy can improve the effectiveness of the medication paroxetine (Paxil®) in treating individuals with social anxiety disorder.
Condition | Intervention | Phase |
Social Anxiety Disorder |
Drug: Paroxetine Behavioral: Cognitive behavioral therapy (CBT) |
Phase III |
MedlinePlus related topics: | Anxiety |
ChemIDplus related topics: | Paroxetine Paroxetine hydrochloride Paroxetine Mesylate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | CBT Augmentation of Paroxetine for Social Anxiety |
Enrollment: | 153 |
Study Start Date: | December 2003 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Participants will receive treatment with paroxetine
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Drug: Paroxetine
Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
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2: Experimental
Participants will receive treatment with paroxetine plus cognitive behavioral therapy
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Drug: Paroxetine
Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
Behavioral: Cognitive behavioral therapy (CBT)
CBT will consist of 16 weekly treatment sessions.
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |||||
New York State Psychiatric Institute Anxiety Disorders Clinic | |||||
New York, New York, United States, 10032 | |||||
United States, Pennsylvania | |||||
Adult Anxiety Clinic of Temple University | |||||
Philadelphia, Pennsylvania, United States, 19122-6085 |
Principal Investigator: | Richard Heimberg, PhD | Adult Anxiety Clinic of Temple University |
Principal Investigator: | Michael Liebowitz, MD | New York State Psychiatric Institute Anxiety Disorders Clinic |
Adult Anxiety Clinic of Temple University 
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Responsible Party: | Temple University ( Richard Heimberg, Principal Investigator ) |
Study ID Numbers: | R01 MH64481, DSIR 83-ATAS, R01 MH64726, GSK ID: 101618 |
First Received: | December 19, 2003 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00074802 |
Health Authority: | United States: Federal Government |
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