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

NCT00407199 | Completed Phase 4

• 2 other identifiers: 0608M91257M91527
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Social Phobia

Keywords

social phobia, anxiety, quetiapine

Outcome Measures

Primary Outcomes (1)

• Personal Report of Confidence as a Speaker (PRCS)

Secondary Outcomes (6)

• Liebowitz Social Anxiety Scale (LSAS)

• Brief Social Phobia Scale

• Social Phobia Inventory

• Fear of Negative Evaluation Scale

• In session-Subjective Units of Distress

Interventions

quetiapine DRUG

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead
• AstraZeneca: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (1)

• Donahue CB, Kushner MG, Thuras PD, Murphy TG, Van Demark JB, Adson DE. Effect of quetiapine vs. placebo on response to two virtual public speaking exposures in individuals with social phobia. J Anxiety Disord. 2009 Apr;23(3):362-8. doi: 10.1016/j.janxdis.2008.12.004. Epub 2008 Dec 24.

  PMID: 19157776 RESULT

MeSH Terms

Conditions

Phobia, Social; Anxiety Disorders

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Phobic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2006
• First Posted: December 4, 2006
• Study Start: December 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: October 27, 2011

Record last verified: 2011-10

Locations

US (1)