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| Sponsor: | University of Minnesota - Clinical and Translational Science Institute |
|---|---|
| Collaborator: |
AstraZeneca |
| Information provided by: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT00407199 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Social Phobia |
Drug: quetiapine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
| 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 |
| Enrollment: | 20 |
| Study Start Date: | December 2006 |
| Study Completion Date: | September 2007 |
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| Ages Eligible for Study: | 18 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
A patient with diabetes mellitus (DM) fulfilling one of the following criteria:
Contacts and Locations| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55454 | |
| Principal Investigator: | David E Adson, M.D. | University of Minnesota - Clinical and Translational Science Institute |
| Principal Investigator: | Christopher B Donahue, Ph.D. | Univeristy of Minnesota |
| Principal Investigator: | Matt Kushner, Ph.D. LP | University of Minnesota - Clinical and Translational Science Institute |
More Information
| Study ID Numbers: | 0608M91257, M91527 |
| Study First Received: | November 30, 2006 |
| Last Updated: | October 17, 2007 |
| ClinicalTrials.gov Identifier: | NCT00407199 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
social phobia, anxiety, quetiapine |
|
Quetiapine Tranquilizing Agents Anxiety Disorders Mental Disorders Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Phobic Disorders Central Nervous System Agents Pharmacologic Actions |
