Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 19, 2003

Last Updated Date

September 18, 2008

Start Date ^†

December 2003

Current Primary Outcome Measures ^†

Liebowitz Social Anxiety Scale [ Time Frame: Measured at baseline and Weeks 12, 28, and 52 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00074802 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Social Interaction Anxiety Scale [ Time Frame: Measured at baseline and Weeks 12, 28, and 52 ] [ Designated as safety issue: No ]
Sheehan Disability Scale [ Time Frame: Measured at baseline and Weeks 12, 28, and 52 ] [ Designated as safety issue: No ]
Quality of Life Inventory [ Time Frame: Measured at baseline and Weeks 12, 28, and 52 ] [ Designated as safety issue: No ]
Clinical Global Impression Improvement Scale [ Time Frame: Measured at baseline and Weeks 12, 28, and 52 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Clinical Global Impression Improvement Scale; measured at baseline and Weeks 12, 28, and 52
Social Interaction Anxiety Scale; measured at baseline and Weeks 12, 28, and 52
Sheehan Disability Scale; measured at baseline and Weeks 12, 28, and 52
Quality of Life Inventory; measured at baseline and Weeks 12, 28, and 52

Descriptive Information

Brief Title ^†

Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder

Official Title ^†

CBT Augmentation of Paroxetine for Social Anxiety

Brief Summary

This study will determine whether the addition of cognitive behavioral therapy can improve the effectiveness of the medication paroxetine (Paxil®) in treating individuals with social anxiety disorder.

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 longer-term management remains a challenge. Cognitive behavioral therapy (CBT) has been effective in treating depression and panic disorder symptoms; it may also be effective in augmenting paroxetine response and reducing relapse after medication discontinuation. This study will examine the effects of paroxetine treatment alone and in combination with CBT.

Participants in this study will receive paroxetine for 12 weeks. After 12 weeks, participants will be randomly assigned to either add weekly sessions of CBT to their treatment or to continue taking paroxetine alone for another 16 weeks. After the 16-week treatment period, participants will have their treatments tapered and will be followed for an additional 24 weeks. Social anxiety symptoms, rates of remission, and quality of life will be assessed.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Social Anxiety Disorder

Intervention ^†

Drug: Paroxetine
Behavioral: Cognitive behavioral therapy (CBT)

Study Arms / Comparison Groups

Experimental: Participants will receive treatment with paroxetine
Experimental: Participants will receive treatment with paroxetine plus cognitive behavioral therapy

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

153

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00074802

Responsible Party

Richard Heimberg, Principal Investigator, Temple University

Secondary IDs ^††

DSIR 83-ATAS, R01 MH64726, GSK ID: 101618

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

Investigators ^†

Principal Investigator:	Richard Heimberg, PhD	Adult Anxiety Clinic of Temple University
Principal Investigator:	Michael Liebowitz, MD	New York State Psychiatric Institute Anxiety Disorders Clinic

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

September 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.