NCT00074802

Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder

CBT Augmentation of Paroxetine for Social Anxiety

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Temple University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Social Anxiety Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2003-12-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2003-12-22
• Last updated: 2017-06-14
• Results posted: 2017-06-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study