Effect of D-cycloserine Plus Cognitive Behavioral Therapy on People With Social Phobia
|Social Anxiety Disorder||Drug: D-cycloserine Behavioral: Cognitive behavioral therapy (CBT) Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||D-cycloserine Enhancement of Exposure in Social Phobia|
- Social Phobic Disorders Severity and Change Form [ Time Frame: Measured at Months 3 (immediately after treatment) ]Social Phobic Disorders Severity and Change Form (SPD-SC Form; Liebowitz et al., 1992) is an expansion and adaptation of the Clinical Global Impression Scale (CGI) by Guy (1976) to SAD. Similar to the original CGI scale, the SPD-SC Form is rated by an independent evaluator on a 7-point scale to indicate severity (1=normal/not ill; 2 = minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most severely ill) and improvement (1=very much improved; 2=much improved; . 3=minimally improved' 4 = no change; 5=nimimal deterioration; 6=severe deterioration; 7=very severe deterioration). The primary outcome measure is units of a scale ranging from 1 (very much improved) to 7 (very severe deterioration).
- Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: Measured at Months 3 ]The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations; it is widely used in treatment studies of SAD. Total scores range from 0 (no anxiety) to 144 (maximum).
- Social Phobia and Anxiety Inventory [ Time Frame: Measured at Months 3, 6, and 9 post-treatment ]
- Quality of Life Enjoyment and Satisfaction Questionnaire [ Time Frame: Measured at Months 3, 6, and 9 post-treatment ]
- Liebowitz Self-Rated Disability Scale [ Time Frame: Measured at Months 3, 6, and 9 post-treatment ]
- Range of Impaired Functioning Tool [ Time Frame: Measured at Months 3, 6, and 9 post-treatment ]
|Study Start Date:||December 2007|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: CBT plus d-cycloserine
Participants will receive cognitive behavioral therapy plus D-cycloserine
Other Name: SeromycinBehavioral: Cognitive behavioral therapy (CBT)
CBT sessions aim to help participants become more comfortable with social situations.
Placebo Comparator: CBT plus placebo
Participants will receive cognitive behavioral therapy plus pill placebo
Behavioral: Cognitive behavioral therapy (CBT)
CBT sessions aim to help participants become more comfortable with social situations.Drug: Placebo
Same dosage as active pill
Other Name: Sugar pill
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 9-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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515879
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02215|
|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|