Social Anxiety DisorderPhase 3NCT00773162
Flushing in Social Anxiety Disorder on Seroquel
A Phase 3 study testing Seroquel and Sugar Pill in people with Social Anxiety Disorder, run by START Clinic for Mood and Anxiety Disorders at 1 site in Canada.
Trial summary
To add to our understanding of the relationship between blushing, symptom severity and potential mechanisms that underlie blushing in patients with Social Phobia (SP), the investigators propose comparing SP patients' vascular responses to topical m-N pre and post treatment with Seroquel or placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Seroquel and Sugar Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2008to Aug 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient has provided signed informed consent prior to any study-related procedures
- Outpatient male or female aged 18-65 (inclusive).
- Patients with a primary diagnosis of Social Phobia to DSM IV (300.23) criteria (diagnosis to be made using the MINI International Neuropsychiatric Interview (MINI).
- Score of > 60 on the LSAS.
- On the basis of a physical examination, medical history and basic laboratory screening, the patient is, in the investigator's opinion, in suitable condition.
Who cannot join
- Pregnancy or lactation
- Any DSM-IV Axis I disorder not defined in the inclusion criteria
- Patients who, in the opinion of the investigator, pose an immediate risk of suicide or a danger to self or others
- Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
- Use of any of the following P450 3A4 inhibitors in the 14 days preceding enrollment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine, and saquinavir.
- Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids.
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- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization
- Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by the DSM-IV criteria
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
- Positive drug screen result at screening visit and if clinically relevant judged by the investigator
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- Unstable or inadequately treated medical illnesses (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
- Involvement in the planning or conduct of the study
- Previous enrollment or randomization of treatment in the present study
- Participation in another drug trail within 4 weeks prior enrollment into this study or longer in accordance with local requirements
- Continuation or commencement of formal psychotherapy
- Current use of or commencement of antidepressant and anxiolytic medications
- Patients, who have been on an antidepressant or other anxiolytic prior to the study, will have discontinues these more than two weeks prior to entry into the study. Those who have been on fluoxetine, will have been off for at least five weeks.
- Patients, who have been on a herbal or alternative treatment judged to be potentially anxiolytic or with psychobiological activity, will have terminated usage of the agent more than two weeks prior to entering the study
- Previous reactions to Niacin administration
- Use of a non-steroidal anti-inflammatory
- Any psychotic disorder
- Eating disorder as defined in the DSM IV
- Mental retardation or other cognitive disorder
- Laboratory values at screening or in medical history that may be considered through clinical interpretation to be significant
- Serious illness: Liver or renal insufficiency, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic or metabolic disturbance
- An absolute neutrophil count (ANC) of <1.5 x 109 per liter.
- Unstable Diabetes Mellitus/HbA1c
Trial locations and contacts
1 site in 1 country.
Canada1 site
START Clinic for the Mood and Anxiety Disorders
Toronto, Ontario, M4W 2N4
About this study
Official title: A Single-center, Randomized, Double-blind, Phase III Comparison of the Efficacy and Safety of Quetiapine Fumarate (Oral Extended Release Tablets) to Placebo in Social Phobia Patients and Changes in Their Vasodilatory Response to Methyl-Nicotinate
To add to our understanding of the relationship between blushing, symptom severity and potential mechanisms that underlie blushing in patients with Social Phobia (SP), the investigators propose comparing SP patients' vascular responses to topical m-N pre and post treatment with Seroquel or placebo.
Atypical antipsychotics such as seroquel have been used successfully as adjunctive treatments in other anxiety disorders, including PTSD (Labatte, 2001; Krashin \& Oates, 1999; McDougle et al., 2000; Pfanner et al., 2000; Bogetto et al., 2000) and Generalized Anxiety Disorder (Katzman et al., 2005). Responses to the blushing exposure will be assessed prior to and following treatment with seroquel or placebo and at one month following intervention. Levels of prostaglandin will be compared between groups and will also be correlated with symptom severity in the clinical groups.
The objective of this randomized, double blind flexible -dose study will be to evaluate the efficacy , safety and tolerability of seroquel SR 50mg to 800mg and placebo in outpatient subjects diagnosed with SP. The study will begin with a single week of Seroquel 50mg or placebo. Subsequently, tablets will be administered by the investigator in a flexible dose fashion during the visits. Patients will be followed up weekly (biweekly after week 6) and at the clinician's discretion. After the fist week the patients' dosage will be increased up to a maximum of 800 mg daily with expected average dose of 300mg dail. This dose will remain fixed after 8 weeks of treatment until week 16.
- Conditions
- Social Anxiety Disorder
- Being tested
- Seroquel, Sugar Pill
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeroquelDrug
Also called Quetiapine
seroquel XR- oral extended release tablets, 50mg - 300mg, 16 weeks
Sugar PillDrug
Sugar pill to match seroquel
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Sugar Pill |
| 2 | Active comparator | Not described Receives: Drug: Seroquel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in intensity of the vasodilatory response to 10 mM topical m-N over 16 weeks.
Measured: 20 weeks
Secondary outcomes (1)
Mean change from baseline on the HAM-A, CGI, SF-36, LSAS, SPIN, SIAS, SPS, ASI, BAI, BDI, SHEEHAN, EUROQUEL, BIS/BAS, PSWQ, IUS
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 posted16 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionAug 2013
- Study completionAug 2013
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.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- START Clinic for Mood and Anxiety Disorders
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Dr. Martin A. Katzman, START Clinic for Mood and Anxiety Disorders
- Investigators
- Martin A Katzman, MD, Principal investigator, START Clinic for Mood and Anxiety Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773162
- Sponsor's protocol ID
- AzSeroSP
- Status last verified
- Feb 2014
- First submitted
- 15 Oct 2008
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Phase III Comparison of the Efficacy and Safety of Quetiapine Fumarate (Oral Extended Release Tablets) to Placebo in Social Phobia Patients and Changes in Their Vasodilatory Response to Methyl-Nicotinate
- ClinicalTrials.gov ID
- NCT00773162
- Acronym / sponsor ID
- AzSeroSP
- Conditions
- Social Anxiety Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- START Clinic for Mood and Anxiety DisordersUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Oct 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 16 Oct 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.
To add to our understanding of the relationship between blushing, symptom severity and potential mechanisms that underlie blushing in patients with Social Phobia (SP), the investigators propose comparing SP patients' vascular responses to topical m-N pre and post treatment with Seroquel or placebo.
Atypical antipsychotics such as seroquel have been used successfully as adjunctive treatments in other anxiety disorders, including PTSD (Labatte, 2001; Krashin \& Oates, 1999; McDougle et al., 2000; Pfanner et al., 2000; Bogetto et al., 2000) and Generalized Anxiety Disorder (Katzman et al., 2005). Responses to the blushing exposure will be assessed prior to and following treatment with seroquel or placebo and at one month following intervention. Levels of prostaglandin will be compared between groups and will also be correlated with symptom severity in the clinical groups.
The objective of this randomized, double blind flexible -dose study will be to evaluate the efficacy , safety and tolerability of seroquel SR 50mg to 800mg and placebo in outpatient subjects diagnosed with SP. The study will begin with a single week of Seroquel 50mg or placebo. Subsequently, tablets will be administered by the investigator in a flexible dose fashion during the visits. Patients will be followed up weekly (biweekly after week 6) and at the clinician's discretion. After the fist week the patients' dosage will be increased up to a maximum of 800 mg daily with expected average dose of 300mg dail. This dose will remain fixed after 8 weeks of treatment until week 16.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Sugar Pill |
| 2 | Active comparator | Drug: Seroquel |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient has provided signed informed consent prior to any study-related procedures
- Outpatient male or female aged 18-65 (inclusive).
- Patients with a primary diagnosis of Social Phobia to DSM IV (300.23) criteria (diagnosis to be made using the MINI International Neuropsychiatric Interview (MINI).
- Score of > 60 on the LSAS.
- On the basis of a physical examination, medical history and basic laboratory screening, the patient is, in the investigator's opinion, in suitable condition.
Key exclusion criteria (28 listed)
- Pregnancy or lactation
- Any DSM-IV Axis I disorder not defined in the inclusion criteria
- Patients who, in the opinion of the investigator, pose an immediate risk of suicide or a danger to self or others
- Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
- Use of any of the following P450 3A4 inhibitors in the 14 days preceding enrollment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine, and saquinavir.
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 |
|---|---|---|
| SeroquelAlso: Quetiapineseroquel XR- oral extended release tablets, 50mg - 300mg, 16 weeks | Drug | 2 |
| Sugar PillSugar pill to match seroquel | Drug | 1 |
Primary outcome
Changes in intensity of the vasodilatory response to 10 mM topical m-N over 16 weeks.
Time frame: 20 weeks
1 secondary outcome
Mean change from baseline on the HAM-A, CGI, SF-36, LSAS, SPIN, SIAS, SPS, ASI, BAI, BDI, SHEEHAN, EUROQUEL, BIS/BAS, PSWQ, IUS
Time frame: 20 weeks
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 25 Feb 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.
Martin A Katzman, MD principal investigator
START Clinic for Mood and Anxiety Disorders
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 Seroquel and Sugar Pill in people with Social Anxiety Disorder, run by START Clinic for Mood and Anxiety Disorders at 1 site in Canada.
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 28 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 25 Feb 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 Canada. 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?
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 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?
Changes in intensity of the vasodilatory response to 10 mM topical m-N over 16 weeks. (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 25 Feb 2014.