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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00515879 |
This study will assess the effectiveness of D-cycloserine combined with cognitive-behavior therapy in treating people with social anxiety disorder.
Condition | Intervention | Phase |
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Social Anxiety Disorder |
Drug: D-cycloserine Behavioral: Cognitive behavioral therapy (CBT) Drug: Placebo |
Phase III |
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 |
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 |
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1: Experimental
Participants will receive D-cycloserine augmented cognitive behavioral therapy
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Drug: D-cycloserine
50 mg
Behavioral: Cognitive behavioral therapy (CBT)
CBT sessions aim to help participants become more comfortable with social situations.
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2: Placebo Comparator
Participants will receive placebo augmented cognitive behavioral therapy
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Behavioral: Cognitive behavioral therapy (CBT)
CBT sessions aim to help participants become more comfortable with social situations.
Drug: Placebo
Same dosage as active pill
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stefan G. Hofmann, PhD | 617-353-9233 | shofmann@bu.edu |
Contact: Mark H. Pollack, MD | 617-643-3080 | mpollack@partners.org |
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 |
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: | R01 MH78308, DATR A2-AIR |
Study First Received: | August 10, 2007 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00515879 |
Health Authority: | United States: Federal Government |
Generalized subtype |
Cycloserine Anxiety Disorders Mental Disorders Phobic Disorders |
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