drugset / Trial / NCT00074802
Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder
Phase 3
Completed
150 enrolled
Temple University
National Institute of Mental Health (NIMH) · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2003-12
- Primary completion
- 2008-05
- Completion
- 2008-05
Outcome
Missed primary endpoint
registry analysis (superiority test); Paroxetine Continuation vs Paroxetine With CBT Augmentation; p = .267; Mean Difference (Net) -5.43 (95% CI -15.05 to 4.19); Mixed Models Analysis NCT00074802 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paroxetine | Small molecule | 20 mg | — |
| Subject | Paroxetine | Small molecule | 50 mg | — |