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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborator: AstraZeneca
• Treatments: Quetiapine Fumarate

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.