Specific PhobiaPhase 2QUISSNCT00872716
Quetiapine in Specific Phobia
A Phase 2 study testing Quetiapine XR in people with Specific Phobia, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The study hypothesis is that quetiapine XR has anxiolytic properties. The study aims to investigate the putative anxiolytic properties of quetiapine XR in patients with anxiety disorders. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Specific Phobia
- What is being tested?
- Quetiapine XR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Mar 2011
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written informed consent
- A diagnosis of simple phobia by Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)
- Females or males aged 18 to 70 years
- Females of childbearing potential must have a negative serum pregnancy test within 7 days prior or at enrolment and be willing to use an effective method of birth control for the duration of the study. Effective methods of birth control are defined as those which result in a low failure rate (i.e. pearl-index < 1%) when used consistently and correctly such as: a hormonal oral, transdermal, or injectable contraceptive agent with a double-barrier method; an implantable contraceptive device with a failure rate less than 1% for at least 3 months prior to enrolment; vasectomized partner
- Able to understand and comply with the requirements of the study
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 imminent 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 cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment 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 3A4 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 DSM-IV criteria
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
- Involvement in the planning and conduct of the study
- Previous enrolment or randomization of treatment in the present study.
- Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
- A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria: Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%; Admitted to hospital for treatment of DM or DM related illness in past 12 weeks; Not under physician care for DM; Physician responsible for patient's DM care has not indicated that patient's DM is controlled; Physician responsible for patient's DM care has not approved patient's participation in the study; Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomization. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks; Taking insulin, if the daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks. Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
- An absolute neutrophil count (ANC) of <= 1.5 x 109 per liter
- Exclusion criteria for magnetic resonance imaging procedures: cardiac pacemaker or defibrillator; injured by a metallic object that was NOT removed; cochlear (ear) implants; surgery involving a metallic implant (e.g. knee replacement); weight more than 300 lbs/136 kg (weight limit for scanner bed); Intra-Uterine Device (IUD); claustrophobia.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Muenster, Department of Psychiatry
Münster, 48149
About this study
Official title: Anxiolytic Effects of Single-dose Quetiapine XR Administration on Clinical Symptoms and Amygdala Activation During Exposure in Patients With Simple Phobia
The study hypothesis is that quetiapine XR has anxiolytic properties. The study aims to investigate the putative anxiolytic properties of quetiapine XR in patients with anxiety disorders. Therefore, in a proof-of-concept design patients with simple phobia will be selected to investigate specific anxiolytic and antipanic activity during acute anxiety. Moreover, in a combined fMRI/visual stimulus presentation paradigm activity of fear-network associated brain structures such as the amygdala will be investigated under treatment with quetiapine XR or placebo. Additionally, genetic factors potentially mediating anxiolytic properties of quetiapine will be studied.
- Conditions
- Specific Phobia
- Being tested
- Quetiapine XR, Placebo
- Keywords
- specific phobia, simple phobia, anxiety disorder
- Medical subject headings
- Phobia, Specific, Anxiety Disorders
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, - Seroquel Prolong, - ATC-Code: N05A H04
100 mg single-dose Quetiapine XR
PlaceboOther
Also called no other name
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine XR | Experimental | 100 mg single-dose Quetiapine XR Receives: Drug: Quetiapine XR |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS-Anxiety
Measured: on study day
Secondary outcomes (9)
State-Trait-Anxiety-Inventory (STAI)
Measured: on study day
Beck Anxiety Inventory (BAI)
Measured: on study day
Phobia specific questionnaire
Measured: on study day
Acute Panic Inventory (API)
Measured: on study day
Profile of Mood States (POMS)
Measured: on study day
VAS-Avoidance
Measured: on study day
VAS-Tension
Measured: on study day
VAS-Sedation
Measured: on study day
amygdala reactivity
Measured: on study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specific PhobiaStudies 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Peter M Zwanzger, Prof Dr med, Principal investigator, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872716
- Sponsor's protocol ID
- D1443L00051
- Other IDs
- EudraCT-Nr: 2008-001371-30
- Acronym
- QUISS
- Status last verified
- Mar 2011
- First submitted
- 30 Mar 2009
- Last updated
- 31 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiolytic Effects of Single-dose Quetiapine XR Administration on Clinical Symptoms and Amygdala Activation During Exposure in Patients With Simple Phobia
- ClinicalTrials.gov ID
- NCT00872716
- Acronym / sponsor ID
- QUISS / D1443L00051
- Conditions
- Specific Phobia
- Keywords
- specific phobia, simple phobia, anxiety disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Apr 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 31 Mar 2009 (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.
The study hypothesis is that quetiapine XR has anxiolytic properties. The study aims to investigate the putative anxiolytic properties of quetiapine XR in patients with anxiety disorders. Therefore, in a proof-of-concept design patients with simple phobia will be selected to investigate specific anxiolytic and antipanic activity during acute anxiety. Moreover, in a combined fMRI/visual stimulus presentation paradigm activity of fear-network associated brain structures such as the amygdala will be investigated under treatment with quetiapine XR or placebo. Additionally, genetic factors potentially mediating anxiolytic properties of quetiapine will be studied.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quetiapine XR | Experimental | Drug: Quetiapine XR100 mg single-dose Quetiapine XR |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of written informed consent
- A diagnosis of simple phobia by Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)
- Females or males aged 18 to 70 years
- Females of childbearing potential must have a negative serum pregnancy test within 7 days prior or at enrolment and be willing to use an effective method of birth control for the duration of the study. Effective methods of birth control are defined as those which result in a low failure rate (i.e. pearl-index < 1%) when used consistently and correctly such as: a hormonal oral, transdermal, or injectable contraceptive agent with a double-barrier method; an implantable contraceptive device with a failure rate less than 1% for at least 3 months prior to enrolment; vasectomized partner
- Able to understand and comply with the requirements of the study
Key exclusion criteria (17 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 imminent 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 cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment 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 |
|---|---|---|
| Quetiapine XRAlso: - Seroquel XR, - Seroquel Prolong, - ATC-Code: N05A H04100 mg single-dose Quetiapine XR | Drug | Quetiapine XR |
| PlaceboAlso: no other namePlacebo | Other | Placebo |
Primary outcome
VAS-Anxiety
Time frame: on study day
9 secondary outcomes
State-Trait-Anxiety-Inventory (STAI)
Time frame: on study day
Beck Anxiety Inventory (BAI)
Time frame: on study day
Phobia specific questionnaire
Time frame: on study day
Acute Panic Inventory (API)
Time frame: on study day
Profile of Mood States (POMS)
Time frame: on study day
VAS-Avoidance
Time frame: on study day
VAS-Tension
Time frame: on study day
VAS-Sedation
Time frame: on study day
amygdala reactivity
Time frame: on study day
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 31 Mar 2011.
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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.
Peter M Zwanzger, Prof Dr med principal investigator
University Hospital Muenster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Quetiapine XR in people with Specific Phobia, run by University Hospital Muenster at 1 site in Germany.
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 17 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 31 Mar 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
VAS-Anxiety (time frame: on study day). 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 31 Mar 2011.