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Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder

NCT00074802 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-06-14

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Temple University

    lead OTHER

Principal Investigators

  • Richard Heimberg, PhD · Adult Anxiety Clinic of Temple University

  • Michael Liebowitz, MD · New York State Psychiatric Institute Anxiety Disorders Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2008-05-31
Completion
2008-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00074802 on ClinicalTrials.gov