Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder

NCT00074802 | Completed Phase 3 Results DMC FDA Drug

• 4 other identifiers: R01MH064481DSIR 83-ATASR01MH064726GSK ID: 101618
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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

Social Anxiety Disorder

Keywords

Social Phobia

Outcome Measures

Primary Outcomes (1)

• Liebowitz Social Anxiety Scale (LSAS)

  The LSAS is a 24-item clinician-administered measure, which provides 0-3 ratings for anxiety and avoidance of social and performance situations. Anxiety and avoidance ratings are summed across items, yielding a range of scores from 0-144, with higher scores representing greater severity of social anxiety symptoms. We examined amount of change from week 12 to week 28 as the primary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.

  Change measured from Week 12 to Week 28

Secondary Outcomes (6)

• Clinical Global Impression Improvement Scale (CGI-I)

  Responder and remitter status measured at Week 28

• Social Interaction Anxiety Scale (SIAS)

  Change measured from Week 12 to Week 28

• Social Phobia Scale (SPS)

  Change measured from Week 12 to Week 28

• Brief Fear of Negative Evaluation Scale (BFNE)

  Change measured from Week 12 to Week 28

• Liebowitz Self-Report Disability Scale (LSRDS)

  Change measured from Week 12 to Week 28

Study Arms (2)

Paroxetine Continuation

EXPERIMENTAL

Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.

Drug: Paroxetine

Paroxetine with CBT Augmentation

EXPERIMENTAL

Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.

Drug: Paroxetine; Behavioral: Cognitive behavioral therapy (CBT)

Interventions

Paroxetine DRUG

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

Also known as: Paxil

Paroxetine Continuation; Paroxetine with CBT Augmentation

Cognitive behavioral therapy (CBT) BEHAVIORAL

CBT will consist of 16 weekly treatment sessions.

Paroxetine with CBT Augmentation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM-IV) criteria for generalized social phobia
• Willing and able to give written informed consent
• English-speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• Temple University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

New York State Psychiatric Institute Anxiety Disorders Clinic

New York, New York, 10032, United States

Location

Adult Anxiety Clinic of Temple University

Philadelphia, Pennsylvania, 19122-6085, United States

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

Paroxetine; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Limitations include the small size of the randomized sample and the lack of a placebo arm in the randomization phase of the study.

Results Point of Contact

• Title: Richard G. Heimberg, Ph.D.
• Organization: Temple University

heimberg@temple.edu

215.204.7489

Study Officials

• Richard Heimberg, PhD

  Adult Anxiety Clinic of Temple University

  PRINCIPAL INVESTIGATOR

• Michael Liebowitz, MD

  New York State Psychiatric Institute Anxiety Disorders Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent evaluators were unaware of randomized condition in the augmentation phase (Phase 2).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open trial of paroxetine (Phase 1) followed by randomization to either continued paroxetine or continued paroxetine plus cognitive behavioral therapy (Phase 2) for patients showing partial response to paroxetine in Phase 1.

Study Record Dates

• First Submitted: December 19, 2003
• First Posted: December 22, 2003
• Study Start: December 1, 2003
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)