SchizophreniaNCT00392743
A Study to Compare Two Different Brain Imaging Techniques in Healthy Volunteers and in Schizophrenic Patients
An observational study of Schizophrenia, run by GlaxoSmithKline at 7 sites in Spain.
Trial summary
A direct comparison of Positron Emission Tomography (PET) (11C-Raclopride) and Single Photon Emission Computed Tomography (SPECT) (123I-IBZM) D2 RO measurements would allow GSK to gain understanding on the SPECT results obtained with SB773812, and to accurately interpret future D2 RO results from either PET or SPECT… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- pet/spect scan
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 7 sitesSpain
- Study dates
- Dec 2006to May 2007
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a methodology study.
Who may be able to join
- Not pregnant or becoming pregnant during the study.
- No abnormality in clinical examination, clinical laboratory test or ECG.
- Not taking drugs
- Patients with schizophrenia, schizophreniform disorder or schizoaffective disorders.
- Patients with at least 1 month antipsychotic monotherapy with either risperidone, olanzapine or clozapine.
- Healthy volunteers with no neurological or psychiatric illness.
Who cannot join
- Have received other antipsychotic during the last month or neuroleptics during the last year.
- If you have taken part in investigations you should not receive a radiation dose of more than 10 mSv over any 3 year period.
- History of bleeding disorder or are taking medication that affects blood clotting
- History of substance dependence (except nicotine)
- Claustrophobia
- Gross head deformity.
- Unable to lie still in the PET or SPECT camera for 1 hour and a half.
- The presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
GSK Investigational Site
Barcelona, 08003
GSK Investigational Site
Barcelona, 08025
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Barcelona
GSK Investigational Site
Espluges de Llobregat, 08950
GSK Investigational Site
Sant Boi de Llobregat, 08830
About this study
Official title: An Open-label, Cross-over Study, to Compare the PET and SPECT Measurement of Antipsychotic-induced D2 Receptor Occupancy, in a Group of Healthy Volunteers and in Another Group of Patients With Schizophrenia and Other Psychotic Disorders
A direct comparison of Positron Emission Tomography (PET) (11C-Raclopride) and Single Photon Emission Computed Tomography (SPECT) (123I-IBZM) D2 RO measurements would allow GSK to gain understanding on the SPECT results obtained with SB773812, and to accurately interpret future D2 RO results from either PET or SPECT studies with new compounds.
- Conditions
- Schizophrenia
- Being tested
- pet/spect scan
- Keywords
- Bolus, 11C-Raclopride, Schizophrenia, 123I-IBZM, SPECT, Receptor Occupancy, PET, MRI, Antipsychotics, Bolus/Infusion
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pet/spect scanProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| pet/spect scan | Not described Receives: Procedure: pet/spect scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET and SPECT striatal binding potential
Measured: at day 1
Secondary outcomes (1)
plasma concentrations at the time of scanning,
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2006 (estimated)
- Study startDec 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Observational
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392743
- Sponsor's protocol ID
- TMT108154
- Status last verified
- Oct 2012
- First submitted
- 24 Oct 2006
- Last updated
- 5 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Cross-over Study, to Compare the PET and SPECT Measurement of Antipsychotic-induced D2 Receptor Occupancy, in a Group of Healthy Volunteers and in Another Group of Patients With Schizophrenia and Other Psychotic Disorders
- ClinicalTrials.gov ID
- NCT00392743
- Acronym / sponsor ID
- TMT108154
- Conditions
- Schizophrenia
- Keywords
- Bolus, 11C-Raclopride, Schizophrenia, 123I-IBZM, SPECT, Receptor Occupancy, PET, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 26 Oct 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.
A direct comparison of Positron Emission Tomography (PET) (11C-Raclopride) and Single Photon Emission Computed Tomography (SPECT) (123I-IBZM) D2 RO measurements would allow GSK to gain understanding on the SPECT results obtained with SB773812, and to accurately interpret future D2 RO results from either PET or SPECT studies with new compounds.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pet/spect scan | – | Procedure: pet/spect scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a methodology study.
Key inclusion criteria (6 listed)
- Not pregnant or becoming pregnant during the study.
- No abnormality in clinical examination, clinical laboratory test or ECG.
- Not taking drugs
- Patients with schizophrenia, schizophreniform disorder or schizoaffective disorders.
- Patients with at least 1 month antipsychotic monotherapy with either risperidone, olanzapine or clozapine.
Key exclusion criteria (8 listed)
- Have received other antipsychotic during the last month or neuroleptics during the last year.
- If you have taken part in investigations you should not receive a radiation dose of more than 10 mSv over any 3 year period.
- History of bleeding disorder or are taking medication that affects blood clotting
- History of substance dependence (except nicotine)
- 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 |
|---|---|---|
| pet/spect scan | Procedure or surgery | pet/spect scan |
Primary outcome
PET and SPECT striatal binding potential
Time frame: at day 1
1 secondary outcome
plasma concentrations at the time of scanning,
Time frame: at day 1
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 5 Nov 2012.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by GlaxoSmithKline at 7 sites in Spain.
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 6 inclusion and 8 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 5 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. 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.
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?
PET and SPECT striatal binding potential (time frame: at day 1). 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 5 Nov 2012.