NCT00515879

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

D-cycloserine Enhancement of Exposure in Social Phobia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Boston University Charles River Campus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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 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.

Conditions

• Social Anxiety Disorder

Interventions

Type	Name	Description
DRUG	D-cycloserine	50 mg
BEHAVIORAL	Cognitive behavioral therapy (CBT)	CBT sessions aim to help participants become more comfortable with social situations.
DRUG	Placebo	Same dosage as active pill

Timeline

• Start date: 2007-12-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2007-08-14
• Last updated: 2019-02-26
• Results posted: 2015-07-23

Locations

1 site across 1 country: United States