DepressionPhase 1PETNCT00832221
Positron Emission Tomography (PET) Study With [11C]Raclopride to Determine Central D2 Dopamine Occupancy of SEROQUEL
A Phase 1 study testing SEROQUEL XR (quetiapine), SEROQUEL IR (quetiapine) and radioligand [11C]raclopride in people with Depression, run by AstraZeneca at 1 site in Sweden.
Trial summary
The aim of this study is to relate pharmacokinetics of two different formulations of quetiapine to PET measured receptor occupancy in the brains of healthy subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- SEROQUEL XR (quetiapine), SEROQUEL IR (quetiapine) and radioligand [11C]raclopride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2009to Sep 2009
- Phase
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal MRI scan
- Body mass index 19-30 kg/m2 and weight of 50-100 kg
- Clinically normal physical findings, medical history and laboratory values
Who cannot join
- Trauma or sickness last 2 weeks before the first PET examination.
- A history or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic, pulmonary, renal disease or other condition as judged by the Investigator
- Any previous participation in a PET study
- Subjects suffer from claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, 1-sequence Cross-over, Positron Emission Tomography (PET) Study With [11C]Raclopride to Determine Central D2 Dopamine Receptor Occupancy of Quetiapine Fumarate Immediate Release (SEROQUEL®) With Quetiapine Fumarate Extended Release (SEROQUEL XR®) in Healthy Male Volunteers
The aim of this study is to relate pharmacokinetics of two different formulations of quetiapine to PET measured receptor occupancy in the brains of healthy subjects.
- Conditions
- Depression
- Being tested
- SEROQUEL XR (quetiapine), SEROQUEL IR (quetiapine), radioligand [11C]raclopride
- Keywords
- PET, Phase 1, Depression, SEROQUEL, Positron Emission Tomography, Drug profile comparison
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEROQUEL XR (quetiapine)Drug
repeated dose of oral tablets, 8 times per subject
SEROQUEL IR (quetiapine)Drug
repeated dose of oral tablets, 4 times per subject
radioligand [11C]racloprideDrug
single dose of iv admin, 5 times per subject
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: SEROQUEL XR (quetiapine); Drug: radioligand [11C]raclopride |
| 2 | Active comparator | Not described Receives: Drug: SEROQUEL IR (quetiapine); Drug: radioligand [11C]raclopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positron emission tomography using the radioligand [11C]raclopride
Measured: 5 visits
Secondary outcomes (2)
Adverse Events (AEs), vital signs and changes in laboratory parameters, physical examinations, Alertness Visual Analogue Scale.
Measured: 5 visits. Some tests will be done several times per visit. All tests will not be performed at every visit.
Pharmacokinetics of quetiapine and its main active metabolite
Measured: 22 samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startJan 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ingemar Bylesjö, MD, PhD, Principal investigator, AstraZeneca Clinical Pharmacology Unit, Stockholm, SwedenSophia Bengtsson, Study director, AstraZeneca R&D, Södertälje, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832221
- Sponsor's protocol ID
- D1443C00038
- Other IDs
- EudractCT 2008-006553-40
- Acronym
- PET
- Status last verified
- Sep 2009
- First submitted
- 29 Jan 2009
- Last updated
- 14 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Nord M, Nyberg S, Brogren J, Jucaite A, Halldin C, Farde L. Comparison of D(2) dopamine receptor occupancy after oral administration of quetiapine fumarate immediate-release and extended-release formulations in healthy subjects. Int J Neuropsychopharmacol. 2011 Nov;14(10):1357-66. doi: 10.1017/S1461145711000514. Epub 2011 Apr 11.
PubMed 21477416
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, 1-sequence Cross-over, Positron Emission Tomography (PET) Study With [11C]Raclopride to Determine Central D2 Dopamine Receptor Occupancy of Quetiapine Fumarate Immediate Release (SEROQUEL®) With Quetiapine Fumarate Extended Release (SEROQUEL XR®) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00832221
- Acronym / sponsor ID
- PET / D1443C00038
- Conditions
- Depression
- Keywords
- PET, Phase 1, Depression, SEROQUEL, Positron Emission Tomography, Drug profile comparison
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Study completion
- Sep 2009 (actual)
- First posted
- 30 Jan 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 aim of this study is to relate pharmacokinetics of two different formulations of quetiapine to PET measured receptor occupancy in the brains of healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: SEROQUEL XR (quetiapine), Drug: radioligand [11C]raclopride |
| 2 | Active comparator | Drug: SEROQUEL IR (quetiapine), Drug: radioligand [11C]raclopride |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal MRI scan
- Body mass index 19-30 kg/m2 and weight of 50-100 kg
- Clinically normal physical findings, medical history and laboratory values
Key exclusion criteria (4 listed)
- Trauma or sickness last 2 weeks before the first PET examination.
- A history or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic, pulmonary, renal disease or other condition as judged by the Investigator
- Any previous participation in a PET study
- Subjects suffer from claustrophobia
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 |
|---|---|---|
| SEROQUEL XR (quetiapine)repeated dose of oral tablets, 8 times per subject | Drug | 1 |
| SEROQUEL IR (quetiapine)repeated dose of oral tablets, 4 times per subject | Drug | 2 |
| radioligand [11C]raclopridesingle dose of iv admin, 5 times per subject | Drug | 1, 2 |
Primary outcome
Positron emission tomography using the radioligand [11C]raclopride
Time frame: 5 visits
2 secondary outcomes
Adverse Events (AEs), vital signs and changes in laboratory parameters, physical examinations, Alertness Visual Analogue Scale.
Time frame: 5 visits. Some tests will be done several times per visit. All tests will not be performed at every visit.
Pharmacokinetics of quetiapine and its main active metabolite
Time frame: 22 samples
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 14 Sep 2009.
- Derived from this study: PubMed 21477416Nord M, Nyberg S, Brogren J, Jucaite A, Halldin C, Farde L. Comparison of D(2) dopamine receptor occupancy after oral administration of quetiapine fumarate immediate-release and extended-release formulations in healthy subjects. Int J Neuropsychopharmacol. 2011 Nov;14(10):1357-66. doi: 10.1017/S1461145711000514. Epub 2011 Apr 11.
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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.
Ingemar Bylesjö, MD, PhD principal investigator
AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden
Sophia Bengtsson study director
AstraZeneca R&D, Södertälje, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SEROQUEL XR (quetiapine), SEROQUEL IR (quetiapine) and radioligand [11C]raclopride in people with Depression, run by AstraZeneca at 1 site in Sweden.
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 3 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: finished, as of the sponsor's last update on 14 Sep 2009. 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 Sweden. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Positron emission tomography using the radioligand [11C]raclopride (time frame: 5 visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00832221, which also lists 1 linked publication.
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 14 Sep 2009.