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Effect of D-Cycloserine Plus Cognitive Behavioral Therapy on People With Social Phobia

This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), August 2008

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00515879
  Purpose

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


Condition Intervention Phase
Social Anxiety Disorder
Drug: D-cycloserine
Behavioral: Cognitive behavioral therapy (CBT)
Drug: Placebo
Phase III

MedlinePlus related topics:   Anxiety    Phobias   

ChemIDplus related topics:   Cycloserine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   D-Cycloserine Enhancement of Exposure in Social Phobia

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Social Phobic Disorders Severity and Change Form [ Time Frame: Measured at Months 3, 6, and 9 post-treatment ] [ Designated as safety issue: No ]
  • Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: Measured at Months 3, 6, and 9 post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Social Phobia and Anxiety Inventory [ Time Frame: Measured at Months 3, 6, and 9 post-treatment ] [ Designated as safety issue: No ]
  • Quality of Life Enjoyment and Satisfaction Questionnaire [ Time Frame: Measured at Months 3, 6, and 9 post-treatment ] [ Designated as safety issue: No ]
  • Liebowitz Self-Rated Disability Scale [ Time Frame: Measured at Months 3, 6, and 9 post-treatment ] [ Designated as safety issue: No ]
  • Range of Impaired Functioning Tool [ Time Frame: Measured at Months 3, 6, and 9 post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:   192
Study Start Date:   December 2007
Estimated Study Completion Date:   December 2011
Estimated Primary Completion Date:   December 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Participants will receive D-cycloserine augmented cognitive behavioral therapy
Drug: D-cycloserine
50 mg
Behavioral: Cognitive behavioral therapy (CBT)
CBT sessions aim to help participants become more comfortable with social situations.
2: Placebo Comparator
Participants will receive placebo augmented cognitive behavioral therapy
Behavioral: Cognitive behavioral therapy (CBT)
CBT sessions aim to help participants become more comfortable with social situations.
Drug: Placebo
Same dosage as active pill

Detailed Description:

Social anxiety disorder (SAD) is among the most common psychiatric conditions and is associated with significant distress and dysfunction in social situations. Although treatment with cognitive-behavior therapy (CBT) is known to help remedy SAD, many patients do not respond to this treatment and most do not reach full recovery. In CBT, patients undergo repeated and prolonged exposure practices to feared social situations to learn better ways to deal with anxiety in these settings. Exposure therapy is based on animal models of extinction of conditioned fears, and recent animal research has identified some of the core pathways and neurotransmitters involved in fear extinction. D-cycloserine (DCS) is a drug that appears to facilitate learning and the process of extinction of conditioned fear in both animals and humans. This study will assess the effectiveness of DCS combined with CBT in treating people with SAD.

Participants in this double-blind study will be randomly assigned to an active or control group. All participants will attend 18 study visits at the Center for Anxiety and Related Disorders over a 12-month period. There will be 12 CBT sessions of 90 minutes each and 6 assessment visits. The CBT sessions will help participants to become more comfortable with social situations. During 5 of the CBT sessions, participants will receive a pill containing either DCS or sugar (placebo). Assessment visits will include interviews, self-report questionnaires, and laboratory tests. These visits will occur at Weeks 1, 7, and 12 during treatment and at Months 3, 6, and 9 post-treatment.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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 and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515879

Contacts
Contact: Stefan G. Hofmann, PhD     617-353-9233     shofmann@bu.edu    
Contact: Mark H. Pollack, MD     617-643-3080     mpollack@partners.org    

Locations
United States, Massachusetts
Boston University     Recruiting
      Boston, Massachusetts, United States, 02215
      Contact: Stefan G. Hofmann, PhD     617-353-9233     shofmann@bu.edu    
      Contact: Bonnie Brown, RN     617-353-9610     bonnieb@bu.edu    

Sponsors and Collaborators

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    
  More Information

Publications:

Responsible Party:   Boston University ( Stefan G. Hofmann, PhD )
Study ID Numbers:   R01 MH78308, DATR A2-AIR
First Received:   August 10, 2007
Last Updated:   August 25, 2008
ClinicalTrials.gov Identifier:   NCT00515879
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Generalized subtype  

Study placed in the following topic categories:
Cycloserine
Anxiety Disorders
Mental Disorders
Phobic Disorders

Additional relevant MeSH terms:
Antimetabolites
Anti-Bacterial Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Infective Agents, Urinary
Antitubercular Agents
Renal Agents
Pharmacologic Actions
Antibiotics, Antitubercular

ClinicalTrials.gov processed this record on September 05, 2008




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