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

Boston University Charles River Campus

Status and phase: Completed; Phase 3

Conditions: Social Anxiety Disorder

Treatments: Drug: D-cycloserine; Behavioral: Cognitive behavioral therapy (CBT); Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00515879

R01MH075889 (U.S. NIH Grant/Contract)

R01MH078308 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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169 participants in 2 patient groups, including a placebo group

CBT plus d-cycloserine

Experimental group

Description:

Participants will receive cognitive behavioral therapy plus D-cycloserine

Treatment:

Behavioral: Cognitive behavioral therapy (CBT)

Drug: D-cycloserine

CBT plus placebo

Placebo Comparator group

Description:

Participants will receive cognitive behavioral therapy plus pill placebo

Treatment:

Drug: Placebo

Behavioral: Cognitive behavioral therapy (CBT)