The Use of Quetiapine (Seroquel) in the Treatment of Social Phobia: Public Speaking Environment

October 26, 2011 updated by: University of Minnesota

The Use of Quetiapine (Seroquel) in the Treatment of Social Phobia: Effects on Cue Reactivity in Response to Virtual Reality Public Speaking Environment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 23 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Personal Report of Confidence as a Speaker (PRCS)

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: David E Adson, M.D., University of Minnesota
  • Principal Investigator: Christopher B Donahue, Ph.D., Univeristy of Minnesota
  • Principal Investigator: Matt Kushner, Ph.D. LP, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

November 30, 2006

First Submitted That Met QC Criteria

November 30, 2006

First Posted (Estimate)

December 4, 2006

Study Record Updates

Last Update Posted (Estimate)

October 27, 2011

Last Update Submitted That Met QC Criteria

October 26, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0608M91257
  • M91527

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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