Social Anxiety DisorderPhase 3NCT00302770
Efficacy of Quetiapine in Generalised Social Anxiety Disorder
A Phase 3 study testing quetiapine in people with Social Anxiety Disorder, run by AstraZeneca at 1 site in Netherlands.
Trial summary
This trial will explore the efficacy of quetiapine in Social Anxiety Disorder, generalized type. The following elements of response will be tested: number of responders to treatment, time to response, effect size as measured with the LSAS 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
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2006to Dec 2006
- Phase
- Phase 3
- 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
- Written Confirmed Consent,
- All patients meet the DSM IV criteria for generalized social anxiety disorder,
- A score ≥ 60 on the LSAS,
- male and female aged between 18 and 65 years
Who cannot join
- Presence of any primary axis I diagnosis other than social anxiety disorder according to DSM-IV,
- alcohol and/or substance abuse according to DSM-IV criteria within the last 12 months,
- any personality disorder as the primary diagnosis, with the exception of avoidant personality disorder,
- patients at risk of suicide
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Quetiapine in Generalised Social Anxiety Disorder, a Double-blind, Placebo-controlled Study
This trial will explore the efficacy of quetiapine in Social Anxiety Disorder, generalized type. The following elements of response will be tested: number of responders to treatment, time to response, effect size as measured with the LSAS
- Conditions
- Social Anxiety Disorder
- Being tested
- quetiapine
- Keywords
- Patients with SAD
- 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.
Change on Lebowitz Social Anxiety Scale (LSAS) from baseline to endpoint
Secondary outcomes (1)
Number of responders, time to onset of response of sustained response to treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2006
- Study completionDec 2006
Why it stopped: This study was terminated due to poor enrollment
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 AstraZenecaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Netherlands Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302770
- Sponsor's protocol ID
- D1449C00008
- Status last verified
- Jan 2011
- First submitted
- 13 Mar 2006
- Last updated
- 27 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Quetiapine in Generalised Social Anxiety Disorder, a Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT00302770
- Acronym / sponsor ID
- D1449C00008
- Conditions
- Social Anxiety Disorder
- Keywords
- Patients with SAD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated due to poor enrollment
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 15 Mar 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 trial will explore the efficacy of quetiapine in Social Anxiety Disorder, generalized type. The following elements of response will be tested: number of responders to treatment, time to response, effect size as measured with the LSAS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written Confirmed Consent,
- All patients meet the DSM IV criteria for generalized social anxiety disorder,
- A score ≥ 60 on the LSAS,
- male and female aged between 18 and 65 years
Key exclusion criteria (4 listed)
- Presence of any primary axis I diagnosis other than social anxiety disorder according to DSM-IV,
- alcohol and/or substance abuse according to DSM-IV criteria within the last 12 months,
- any personality disorder as the primary diagnosis, with the exception of avoidant personality disorder,
- patients at risk of suicide
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
Change on Lebowitz Social Anxiety Scale (LSAS) from baseline to endpoint
1 secondary outcome
Number of responders, time to onset of response of sustained response to treatment
Results and safety
The study was stopped early (reason given: This study was terminated due to poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2011.
Related trials for Social Anxiety Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Recruiting
Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale
Caregiver Anxiety, Acquired Brain Injury
Not yet recruiting
Online Study on the Impact of a Self-Help Tool for Social Anxiety
Social Anxiety
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
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.
AstraZeneca Netherlands Medical Director, MD study director
AstraZeneca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing quetiapine in people with Social Anxiety Disorder, run by AstraZeneca at 1 site in Netherlands.
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 4 inclusion and 4 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 27 Jan 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 Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: This study was terminated due to poor enrollment). 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?
Change on Lebowitz Social Anxiety Scale (LSAS) from baseline to endpoint. 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 27 Jan 2011.