Social PhobiaPhase 4NCT00407199
The Use of Quetiapine (Seroquel) in the Treatment of Social Phobia: Public Speaking Environment
A Phase 4 study testing quetiapine in people with Social Phobia, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Social Phobia
- What is being tested?
- quetiapine
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Sep 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55454
About this 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
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.
Read the 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
- Conditions
- Social Phobia
- Being tested
- quetiapine
- Keywords
- social phobia, anxiety, quetiapine
- Medical subject headings
- Phobia, Social, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quetiapineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Blood Pressure and heart rate monitored within session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social PhobiaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- David E Adson, M.D., Principal investigator, University of MinnesotaChristopher B Donahue, Ph.D., Principal investigator, Univeristy of MinnesotaMatt Kushner, Ph.D. LP, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407199
- Sponsor's protocol ID
- 0608M91257
- Other IDs
- M91527
- Status last verified
- Oct 2011
- First submitted
- 30 Nov 2006
- Last updated
- 27 Oct 2011
- Results posted
- No
Publications
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.
PubMed 19157776
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00407199
- Acronym / sponsor ID
- 0608M91257
- Conditions
- Social Phobia
- Keywords
- social phobia, anxiety, quetiapine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Dec 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 4 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (11 listed)
- Current contraindications/sensitivity to quetiapine
- Current prescription of benzodiazepine, tranquilizer, or antipsychotic medication
- Current Psychotic episode
- Current Manic episode
- Current Depressive episode
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quetiapine | Drug | – |
Primary outcome
Personal Report of Confidence as a Speaker (PRCS)
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2011.
- Results publication: PubMed 19157776Donahue 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David E Adson, M.D. principal investigator
University of Minnesota
Christopher B Donahue, Ph.D. principal investigator
Univeristy of Minnesota
Matt Kushner, Ph.D. LP principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing quetiapine in people with Social Phobia, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Report of Confidence as a Speaker (PRCS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00407199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2011.