Status:
COMPLETED
Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder
Lead Sponsor:
Temple University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Social Anxiety Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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. Patien...
Detailed 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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00074802
Start Date
December 1 2003
End Date
May 1 2008
Last Update
June 14 2017
Active Locations (2)
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1
New York State Psychiatric Institute Anxiety Disorders Clinic
New York, New York, United States, 10032
2
Adult Anxiety Clinic of Temple University
Philadelphia, Pennsylvania, United States, 19122-6085