Dose Timing of D-Cycloserine to Augment CBT for Social Anxiety Disorder

Summary

The purpose of this study is to examine the efficacy of 50 mg of d-cycloserine in comparison to placebo (a pill containing no medication) for improving the effectiveness of cognitive-behavioral therapy (CBT) in reducing symptoms associated with social anxiety disorder. In addition, the study will examine whether the effectiveness of d-cycloserine depends on the timing of the pill administration (i.e., 1- hour before the session or immediately after the session) as well as the success of the CBT therapy sessions. The investigators hypothesize that the tailored post-session DCS administration condition will outperform the other conditions (pre-session DCS, placebo, and non-tailored post-session DCS). This will be evidenced by short- and long-term improvements in social anxiety severity.

Conditions

• Social Anxiety Disorder

Interventions

DRUG

D-Cycloserine

D-cycloserine is a medication thought to be associated with fear extinction.

DRUG

Placebo

Sugar pill

BEHAVIORAL

Cognitive Behavioral Therapy

This will be a 5-session version of a group CBT protocol with 4-6 patients and 2 therapists per group emphasizing repeated exposure practices. Session 1 involves an introduction and orientation to the CBT model. Sessions 2-5 emphasize repeated exposure tasks, which consist of role-play activities to confront fearful situations in a group setting while disputing cognitive distortions (coupled with the fading of safety behaviors). At the conclusion of each exposure session, patients will be encouraged to continue to apply home-practice strategies (such as giving speeches in front of a mirror). Continued practice of the interventions will be considered part of treatment, and patients will be asked to refrain from alternative treatment for four weeks following completion of the last treatment session.

Sponsors & Collaborators

• Rush University Medical Center

  collaborator OTHER

• Boston University

  collaborator OTHER

• Southern Methodist University

  collaborator OTHER

• University of Texas at Austin

  lead OTHER

Principal Investigators

• Mark Pollack, M.D. · Rush University Medical Center

• Stefan Hofmann, Ph.D. · Boston University

• Jasper A Smits, Ph.D. · University of Texas at Austin

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-04-30

Primary Completion

2018-07-01

Completion

2018-07-01

Countries

• United States

Study Locations