Clinical trial NCT00074802: Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder
Official title: CBT Augmentation of Paroxetine for Social Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Social Anxiety Disorder
Keywords: Social Phobia
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-12-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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. 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.

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, 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.

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

Primary outcomes:
measure: Liebowitz Social Anxiety Scale (LSAS)
timeFrame: Change measured from Week 12 to Week 28
Secondary outcomes:
measure: Clinical Global Impression Improvement Scale (CGI-I)
timeFrame: Responder and remitter status measured at Week 28
measure: Social Interaction Anxiety Scale (SIAS)
timeFrame: Change measured from Week 12 to Week 28
measure: Social Phobia Scale (SPS)
timeFrame: Change measured from Week 12 to Week 28
measure: Brief Fear of Negative Evaluation Scale (BFNE)
timeFrame: Change measured from Week 12 to Week 28
measure: Liebowitz Self-Report Disability Scale (LSRDS)
timeFrame: Change measured from Week 12 to Week 28
measure: Quality of Life Inventory (QOLI)
timeFrame: Change measured from Week 12 to Week 28
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute Anxiety Disorders Clinic
state: New York
city: Philadelphia
country: United States
facility: Adult Anxiety Clinic of Temple University
state: Pennsylvania
Study officials:
affiliation: Adult Anxiety Clinic of Temple University
name: Richard Heimberg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York State Psychiatric Institute Anxiety Disorders Clinic
name: Michael Liebowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: