Social Anxiety DisorderPhase 2/3NCT00215254
Quetiapine in Social Anxiety Disorder
A Phase 2/3 study testing quetiapine in people with Social Anxiety Disorder, run by Duke University at 1 site in United States.
Trial summary
The purpose of the study is to examine the effectiveness and tolerability of quetiapine for the treatment of social anxiety disorder (SAD). The hypothesis is that quetiapine will be effective and well-tolerated for patients with social anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- quetiapine
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Feb 2006
- Phase
- Phase 2/3
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult outpatients 18-65 years of age
- primary diagnosis of social anxiety disorder, using DSM-IV criteria
- minimum CGI severity score of 4 at baseline
- minimum BSPS score of 20 at baseline
- written informed consent
- negative serum pregnancy test for women of childbearing potential
Who cannot join
- current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition
- any current primary anxiety disorder other than SAD or current primary depression
- history of substance abuse or dependence with the last 6 months
- suicide risk or serious suicide attempt within the last year
- clinically significant medical condition or laboratory abnormality
- women of childbearing potential who are unwilling to practice an acceptable method of contraception
- concomitant medication use for psychotropic purposes
- history of hypersensitivity to quetiapine
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Quetiapine in Social Anxiety Disorder
The purpose of the study is to examine the effectiveness and tolerability of quetiapine for the treatment of social anxiety disorder (SAD). The hypothesis is that quetiapine will be effective and well-tolerated for patients with social anxiety disorder.
Read the detailed description
This is an eight week, randomized, double-blind, placebo-controlled trial of quetiapine (100-400 mg/day)in social anxiety disorder.
- Conditions
- Social Anxiety Disorder
- Being tested
- quetiapine
- Keywords
- quetiapine, social anxiety disorder, antipsychotic, pilot study
- Medical subject headings
- Phobia, Social
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.
Brief Social Phobia Scale (BSPS)
Secondary outcomes (8)
Clinical Global Impressions of Severity (CGI-S)
Clinical Global Impressions of Improvement (CGI-I)
Social Phobia Inventory (SPIN)
Hospital Anxiety and Depression Scale (HADS)
Connor Davidson Resilience Scale (CD-RISC)
Sheehan Disability Inventory (SDI)
Barnes Akathisis Scale (BAS)
Simpson-Angus Scale (SAS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Jonathan Davidson, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215254
- Sponsor's protocol ID
- 5639-04-3R0
- Status last verified
- Mar 2006
- First submitted
- 20 Sep 2005
- Last updated
- 19 Dec 2006
- Results posted
- No