Social Anxiety DisorderEarly Phase 1NCT00606541
An Open Label, Double-blind Discontinuation Study of Quetiapine Extended Release(XR)
A Early Phase 1 study testing Quetiapine XR in people with Social Anxiety Disorder, run by Duke University at 1 site in United States.
Trial summary
Purpose of Study: To examine 1) the short and long-term effectiveness and tolerability of quetiapine (extended release) XR for the treatment of social anxiety disorder (SAD); and 2) continuation effects of quetiapine XR in preventing SAD relapse. 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 XR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Nov 2012
- Phase
- Early Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18-65 years of age
- A primary diagnosis of SAD,using Diagnostic Standard Manual IV(DSM-IV) criteria
- Minimum CGI severity score of 4 and minimum Brief Social Phobia Scale (BSPS) score of 20 at baseline
- Written informed consent
- A negative serum pregnancy test for women of childbearing potential.
Who cannot join
- Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental 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 within 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
Show all 9Show fewer
- Subjects needing concurrent use of psychotropic medications
- History of hypersensitivity to quetiapine
- History of cataracts.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: An Open Label, Double-blind Discontinuation Study of Quetiapine (Extended Release) XR in Social Anxiety Disorder
Purpose of Study: To examine 1) the short and long-term effectiveness and tolerability of quetiapine (extended release) XR for the treatment of social anxiety disorder (SAD); and 2) continuation effects of quetiapine XR in preventing SAD relapse.
- Conditions
- Social Anxiety Disorder
- Being tested
- Quetiapine XR, Placebo
- Keywords
- Social Anxiety Disorder, Quetiapine XR, Prevention, tolerability
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine XRDrug
Also called Seroquel XR
This is an investigator-initiated, single site study, consisting of two phases: 1) 8-week, open label treatment with quetiapine XR (50-400 mg/day) in subjects (n=55 in order to randomize 20 into each of the quetiapine XR and PBO arms in the 2nd phase of the study) with SAD; and 2) in those who demonstrate at least minimal improvement (i.e. CGI≤3), 12-weeks randomized, double-blind treatment with either quetiapine XR or placebo (PBO).
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Quetiapine XR 50mg-400mg per day Receives: Drug: Quetiapine XR |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kaplan Meier survival of Clinical Global Impression of Improvement (CGI-I)
Measured: 20 weeks
Secondary outcomes (1)
Percentage of CGI-I, BSPS, SPIN
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2011
- Study completionNov 2012
Why it stopped: The study was terminated by the sponsor due to budgetary issues
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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Zhang, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606541
- Sponsor's protocol ID
- Pro00002146
- Other IDs
- eIRB2146, IRUSQUET0452
- Status last verified
- Dec 2012
- First submitted
- 22 Jan 2008
- Last updated
- 1 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Double-blind Discontinuation Study of Quetiapine (Extended Release) XR in Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00606541
- Acronym / sponsor ID
- Pro00002146
- Conditions
- Social Anxiety Disorder
- Keywords
- Social Anxiety Disorder, Quetiapine XR, Prevention, tolerability
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated by the sponsor due to budgetary issues
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 4 Feb 2008 (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.
Purpose of Study: To examine 1) the short and long-term effectiveness and tolerability of quetiapine (extended release) XR for the treatment of social anxiety disorder (SAD); and 2) continuation effects of quetiapine XR in preventing SAD relapse.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Quetiapine XRQuetiapine XR 50mg-400mg per day |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults 18-65 years of age
- A primary diagnosis of SAD,using Diagnostic Standard Manual IV(DSM-IV) criteria
- Minimum CGI severity score of 4 and minimum Brief Social Phobia Scale (BSPS) score of 20 at baseline
- Written informed consent
- A negative serum pregnancy test for women of childbearing potential.
Key exclusion criteria (9 listed)
- Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental 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 within the last 6 months
- Suicide risk or serious suicide attempt within the last year
- Clinically significant medical condition or laboratory abnormality
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 XRAlso: Seroquel XRThis is an investigator-initiated, single site study, consisting of two phases: 1) 8-week, open label treatment with quetiapine XR (50-400 mg/day) in subjects (n=55 in order to randomize 20 into each of the quetiapine XR and PBO arms in the 2nd phase of the study) with SAD; and 2) in those who demonstrate at least minimal improvement (i.e. CGI≤3), 12-weeks randomized, double-blind treatment with either quetiapine XR or placebo (PBO). | Drug | 1 |
| PlaceboPlacebo | Drug | 2 |
Primary outcome
Kaplan Meier survival of Clinical Global Impression of Improvement (CGI-I)
Time frame: 20 weeks
1 secondary outcome
Percentage of CGI-I, BSPS, SPIN
Time frame: 20 weeks
Results and safety
The study was stopped early (reason given: The study was terminated by the sponsor due to budgetary issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
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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.
Wei Zhang, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Quetiapine XR in people with Social Anxiety Disorder, run by Duke University 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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 1 Aug 2014. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: The study was terminated by the sponsor due to budgetary issues). Results are not available in the source record.
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?
Kaplan Meier survival of Clinical Global Impression of Improvement (CGI-I) (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2014.