The Use of Quetiapine (Seroquel) in the Treatment of Social Phobia: Public Speaking Environment
Condition: Social Phobia
MeSH terms: Phobic Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pilot study that will focus on the collection of preliminary data to determine the
      efficacy of quetiapine for individuals with social phobia. We hypothesize that individuals
      will react with less self-reported anxiety and physiological reactivity in the drug condition
      than in the placebo condition. If true, this would constitute a strong signal for a
      significant treatment effect for quetiapine in social phobia. A positive treatment effect in
      this study would provide rationale for further investigation of the efficacy of quetiapine
      for cue reactivity for individuals with social phobia. Further study would include increased
      sample size in order to obtain statistical power and replication of findings. We will utilize
      the IR formulation of quetiapine.
    

Detailed description: 
      Primary Objective:

      The purpose of this study is to evaluate the use of quetiapine to diminish cue reactivity to
      a Virtual Reality environment for individuals with Social Phobia. The following primary and
      secondary outcome measures will be administered to subjects during each Virtual Reality
      exposure in treatment and non-treatment conditions. The outcome measures have demonstrated
      adequate reliability and validity in the detection of clinical change for individuals with
      social phobia in open label studies using quetiapine (Schutters, van Megen, and Westenberg,
      2005). The Personal Report of Confidence as a Speaker (PRCS; Paul, 1966) will be utilized as
      the primary measure to establish individual diagnosis and severity level. Pertaub and Slater
      (2002) demonstrated the sensitivity of the PRCS in measuring anxiety responses to virtual
      audiences. A total score of 21 or greater on the PRCS will be required for study inclusion
      (Carrigan and Levis, 1999). Carrigan and Lewis (1999) reported a mean score of 23.73 on the
      30-item PRCS for individuals reporting fear of public speaking. Subjective units of distress
      ratings and measures of blood pressure and heart rate will be obtained within session in
      order to measure immediate changes in subject's cue reactivity to VRE stimuli. The outcome
      measures include:

      Primary Measure: Personal Report of Confidence as a Speaker (PRCS)

      Secondary Measures:

      Liebowitz Social Anxiety Scale (LSAS) Clinical Global Impressions-Improvement Scale (CGI)
      Brief Social Phobia Scale Social Phobia Inventory Fear of Negative Evaluation Scale Hamilton
      Rating Scale for Anxiety In session-Subjective Units of Distress Blood Pressure and heart
      rate monitored within session

      Design:

      A crossover, double-blind within subjects design will be used. The two conditions are placebo
      and drug prior to exposure to social anxiety cues in the virtual environment. Each subject
      will be in both conditions over the course of two visits. Each subject will be in only one
      condition on the first visit and will then cross-over to the other condition on the second
      visit. Order will be counter-balanced across subjects. The treatment phase of the study will
      include the two afore mentioned visits, totaling 60 minutes each. This will include the
      treatment and pre-post assessment
    

Intervention name(s): quetiapine
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: social phobia, anxiety, quetiapine