Home | Clinical Trials | D-Cycloserine Enhancement of Exposure in Social Phobia |

D-Cycloserine Enhancement of Exposure in Social Phobia

Purpose: 

This study will assess the effectiveness of D-cycloserine combined with cognitive-behavior therapy in treating people with social anxiety disorder

Condition: 
Social Anxiety Disorder
Intervention: 
Cognitive behavior therapy plus d-cycloserine or placebo
Study Type: 
Interventional
Study Design: 

Allocation: Randomized
Control: Placebo Control
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resources: 

MedlinePlus related topics: Anxiety Phobias

Primary Outcome Measures: 

Social Phobic Disorders Severity and Change Form

Liebowitz Social Anxiety Scale (LSAS)

 

Secondary Outcome Measures: 

Social Phobia and Anxiety Inventory

Quality of Life Enjoyment and Satisfaction Questionnaire

Liebowitz Self-Rated Disability Scale

Range of Impaired Functioning Tool

Enrollment: 
192
Study Start Date: 
December 2007
Primary Completion Date: 
December 2011
Groups: 

1: Experimental: Participants will receive D-cycloserine augmented cognitive behavioral therapy

2. Placebo Comparator: Participants will receive placebo augmented cognitive behavioral therapy

 

 
Assigned Interventions: 

1. Drug: D-cycloserine 50 mg

    Behavioral: Cognitive behavioral therapy (CBT).  CBT sessions aim to help participants become more comfortable with social situations.

2. Drug: Placebo (same dosage as active pill).

     Behavioral: Cognitive behavioral therapy (CBT).  CBT sessions aim to help participants become more comfortable with social situations.

 
Ages of Eligibility: 
18 years or older
Gender: 
Both
Inclusion Criteria: 
  • Meets DSM-IV criteria for generalized social anxiety disorder (GSAD)
  • Total score of greater than or equal to 60 on the LSAS
  • Physical examination, electrocardiogram, and laboratory findings without clinically significant abnormalities
Exclusion Criteria: 
  • Lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders, or obsessive-compulsive disorder
  • Eating disorder within the 6 months prior to study entry
  • History of organic brain syndrome, mental retardation, or other cognitive dysfunction
  • Substance or alcohol abuse or dependence (other than nicotine) within the 6 months prior to study entry or inability to refrain from alcohol use during the acute period of study participation
  • Post-traumatic stress disorder within 6 months prior to study entry; entry of patients with other mood or anxiety disorders will be permitted if the social anxiety disorder is judged to be the predominant disorder
  • Suicidal thoughts
  • Taking concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers) within 2 weeks of study entry
  • Significant personality dysfunction
  • Serious medical illness or instability for which hospitalization may be likely within the next year
Contacts: 

Stefan G. Hofmann, PhD (617) 353-9233, anxiety@bu.edu

Mark H. Pollack, MD (617) 643-3080, mpollack@partners.org

Jasper A. Smits, PhD, (214) 768-4310, anxiety@smu.edu

Locations: 

Boston University, Boston, Massachusetts, United States, 02215

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Southern Methodist University, Dallas, TX, United States, 75205

Sponsors & Collaborators: 

National Institute of Mental Health (NIMH)

Investigators: 

Principal Investigator: Stefan G. Hofmann, PhD Boston University
Principal Investigator: Mark H. Pollack, MD Massachusetts General Hospital
Study Director: Jasper A. Smits, PhD Southern Methodist University

 

Responsible Party: 
Boston University ( Stefan G. Hofmann, PhD )
Study ID Numbers: 
Clinical Trials.gov Identifier: NCT00515879. Other Study ID Numbers: R01 MH078308, DATR A2-AIR
Health Authority: 
United States: Federal Government