The Use of Quetiapine (Seroquel) in the Treatment of Social Phobia: Public Speaking Environment
Information source: University of Minnesota
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Social Phobia
Intervention: quetiapine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Minnesota Official(s) and/or principal investigator(s):
David E Adson, M.D., Principal Investigator, Affiliation: University of Minnesota
Christopher B Donahue, Ph.D., Principal Investigator, Affiliation: Univeristy of Minnesota
Matt Kushner, Ph.D. LP, Principal Investigator, Affiliation: University of Minnesota
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.
Clinical Details
Official title: The Use of Quetiapine (Seroquel) in the Treatment of Social Phobia: Effects on Cue Reactivity in Response to Virtual Reality Public Speaking Environment
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Personal Report of Confidence as a Speaker (PRCS)
Secondary outcome: Liebowitz Social Anxiety Scale (LSAS)Brief Social Phobia Scale Social Phobia Inventory Fear of Negative Evaluation Scale In session-Subjective Units of Distress Blood Pressure and heart rate monitored within session
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
Eligibility
Minimum age: 18 Years.
Maximum age: 25 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 18-25
- Primary DSM-IV Axis I diagnosis of social phobia, specific fear of public speaking
- PRCS total score: 21 or greater (1 SD above population norm of 14. 2)
Exclusion Criteria:
- Current contraindications/sensitivity to quetiapine
- Current prescription of benzodiazepine, tranquilizer, or antipsychotic medication
- Current Psychotic episode
- Current Manic episode
- Current Depressive episode
- Current drug or alcohol dependence
- A patient with diabetes mellitus (DM) fulfilling one of the following criteria:
- Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) 8. 5%.
- Admitted to hospital for treatment of DM or DM related illness within the past 12
weeks
- Not under physician care for DM.
- Physician responsible for patient's DM care has not indicated that the patient's
DM is controlled.
Locations and Contacts
University of Minnesota, Minneapolis, Minnesota 55454, United States
Additional Information
Starting date: December 2006
Ending date: September 2007
Last updated: October 17, 2007
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