CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 150 enrolled
Drug / intervention
Paroxetine +1 moredrug
Likely dose
Paroxetine 20–50 mg orally once daily (flexible dosing)AI-extracted
Key inclusion· 3
  • Diagnosis of generalized social phobia per DSM-IV criteria
  • Able to provide written informed consent
  • English-speaking
Key exclusion· 8
  • Prior or current schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, or antisocial/schizotypal/schizoid personality disorders
  • Suicidal thoughts
  • History of failed paroxetine treatment (≥6 weeks at adequate doses) or failed prior adequate CBT trial
  • Clinically significant or unstable medical disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00074802
NCT00074802Phase 3Completed

CBT Augmentation of Paroxetine for Social Anxiety

Temple University·interventional·Posted Dec 22, 2003·Updated Jun 14, 2017

In Brief

A Phase 3 clinical trial evaluating Paroxetine and Cognitive behavioral therapy (CBT) for Social Anxiety Disorder. Completed, enrolled 150 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 22, 2003
Enrollment StartDec 1, 2003
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 22.5 years ago

Interventions

Paroxetinedrug

Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.

Cognitive behavioral therapy (CBT)behavioral

CBT will consist of 16 weekly treatment sessions.